21 U.S.C. § 343 — Misbranded food

Page 83 TITLE 21—FOOD AND DRUGS § 343 EFFECTIVE DATE OF 1950 AMENDMENT Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as an Effective Date note under section 347 of this title. EFFECTIVE DATE; POSTPONEMENT Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postpone- ment in Certain Cases note under section 301 of this title. SHORT TITLE Pub. L. 88–625, § 1, Oct. 3, 1964, 78 Stat. 1002, provided: ‘‘That this Act [amending provisions set out as a note under this section and section 135 of Title 7, Agri- culture] may be cited as the ‘Food Additives Transi- tional Provisions Amendment of 1964’.’’ UPDATING GUIDANCE RELATING TO FISH AND FISHERIES PRODUCTS HAZARDS AND CONTROLS Pub. L. 111–353, title I, § 103(h), Jan. 4, 2011, 124 Stat. 3898, provided that: ‘‘The Secretary shall, not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], update the Fish and Fisheries Products Hazards and Control Guidance to take into account ad- vances in technology that have occurred since the pre- vious publication of such Guidance by the Secretary.’’ GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS Pub. L. 111–353, title I, § 114, Jan. 4, 2011, 124 Stat. 3921, provided that: ‘‘(a) IN GENERAL.—Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program’s Model Or- dinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Pro- gram of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations)[)], where such guidance, regula- tion or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representa- tives a report which shall include— ‘‘(1) an assessment of how post harvest processing or other equivalent controls feasibly may be imple- mented in the fastest, safest, and most economical manner; ‘‘(2) the projected public health benefits of any pro- posed post harvest processing; ‘‘(3) the projected costs of compliance with such post harvest processing measures; ‘‘(4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oys- ters; ‘‘(5) criteria for ensuring post harvest processing standards will be applied equally to shellfish im- ported from all nations of origin; ‘‘(6) an evaluation of alternative measures to pre- vent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and ‘‘(7) the extent to which the Food and Drug Admin- istration has consulted with the States and other reg- ulatory agencies, as appropriate, with regard to post harvest processing measures. ‘‘(b) LIMITATION.—Subsection (a) shall not apply to the guidance described in section 103(h) [section 103(h) of Pub. L. 111–353, set out as a note above]. ‘‘(c) REVIEW AND EVALUATION.—Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall— ‘‘(1) review and evaluate the report described in (a) and report to Congress on the findings of the esti- mates and analysis in the report; ‘‘(2) compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated foods, including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such other regulated foods; and ‘‘(3) evaluate the impact of post harvest processing on the competitiveness of the domestic oyster indus- try in the United States and in international mar- kets. ‘‘(d) WAIVER.—The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agree- ment between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference. ‘‘(e) PUBLIC ACCESS.—Any report prepared under this section shall be made available to the public.’’ DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COM- MODITY PURCHASE PROGRAMS Pub. L. 104–180, title VII, § 733, Aug. 6, 1996, 110 Stat. 1601, provided that: ‘‘Hereafter, notwithstanding any other provision of law, any domestic fish or fish prod- uct produced in compliance with food safety standards or procedures accepted by the Food and Drug Adminis- tration as satisfying the requirements of the ‘Proce- dures for the Safe and Sanitary Processing and Import- ing of Fish and Fish Products’ (published by the Food and Drug Administration as a final regulation in the Federal Register of December 18, 1995), shall be deemed to have met any inspection requirements of the Depart- ment of Agriculture or other Federal agency for any Federal commodity purchase program, including the program authorized under section 32 of the Act of Au- gust 24, 1935 (7 U.S.C. 612c) except that the Department of Agriculture or other Federal agency may utilize lot inspection to establish a reasonable degree of certainty that fish or fish products purchased under a Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product specifications.’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 343. Misbranded food A food shall be deemed to be misbranded— (a) False or misleading label If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which section 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title. (b) Offer for sale under another name If it is offered for sale under the name of an- other food. (c) Imitation of another food If it is an imitation of another food, unless its label bears, in type of uniform size and promi- nence, the word ‘‘imitation’’ and, immediately thereafter, the name of the food imitated. (d) Misleading container If its container is so made, formed, or filled as to be misleading. Page 84 TITLE 21—FOOD AND DRUGS § 343 1 So in original. Probably should be followed by a comma. (e) Package form If in package form unless it bears a label con- taining (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the con- tents in terms of weight, measure, or numerical count, except that under clause (2) of this para- graph reasonable variations shall be permitted, and exemptions as to small packages shall be es- tablished, by regulations prescribed by the Sec- retary. (f) Prominence of information on label If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not promi- nently placed thereon with such conspicuous- ness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and un- derstood by the ordinary individual under cus- tomary conditions of purchase and use. (g) Representation as to definition and standard of identity If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 341 of this title, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the defi- nition and standard, and, insofar as may be re- quired by such regulations, the common names of optional ingredients (other than spices, fla- voring, and coloring) present in such food. (h) Representation as to standards of quality and fill of container If it purports to be or is represented as— (1) a food for which a standard of quality has been prescribed by regulations as provided by section 341 of this title, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; (2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 341 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regu- lations specify, a statement that it falls below such standard; or (3) a food that is pasteurized unless— (A) such food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation promulgated under this chapter; or (B)(i) such food has been subjected to a safe process or treatment that— (I) is reasonably certain to achieve de- struction or elimination in the food of the most resistant microorganisms of public health significance that are likely to occur in the food; (II) is at least as protective of the public health as a process or treatment described in subparagraph (A); (III) is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and (IV) is the subject of a notification to the Secretary, including effectiveness data regarding the process or treatment; and (ii) at least 120 days have passed after the date of receipt of such notification by the Secretary without the Secretary making a determination that the process or treatment involved has not been shown to meet the re- quirements of subclauses (I) through (III) of clause (i). For purposes of paragraph (3), a determination by the Secretary that a process or treatment has not been shown to meet the requirements of subclauses (I) through (III) of subparagraph (B)(i) shall constitute final agency action under such subclauses. (i) Label where no representation as to defini- tion and standard of identity Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingre- dient and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food; except that spices, flavorings, and colors not required to be certified under section 379e(c) of this title 1 unless sold as spices, flavorings, or such colors, may be designated as spices, flavorings, and colorings without naming each. To the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary. (j) Representation for special dietary use If it purports to be or is represented for special dietary uses, unless its label bears such informa- tion concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, nec- essary in order fully to inform purchasers as to its value for such uses. (k) Artificial flavoring, artificial coloring, or chemical preservatives If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, un- less it bears labeling stating that fact, except that to the extent that compliance with the re- quirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream. The pro- visions of this paragraph with respect to chem- ical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil. (l) Pesticide chemicals on raw agricultural com- modities If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a Page 85 TITLE 21—FOOD AND DRUGS § 343 pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the com- mon or usual name and the function of such chemical, except that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade. (m) Color additives If it is a color additive, unless its packaging and labeling are in conformity with such pack- aging and labeling requirements, applicable to such color additive, as may be contained in reg- ulations issued under section 379e of this title. (n) Packaging or labeling of drugs in violation of regulations If its packaging or labeling is in violation of an applicable regulation issued pursuant to sec- tion 1472 or 1473 of title 15. (o) Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73 (p) Repealed. Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882 (q) Nutrition information (1) Except as provided in subparagraphs (3), (4), and (5), if it is a food intended for human con- sumption and is offered for sale, unless its label or labeling bears nutrition information that pro- vides— (A)(i) the serving size which is an amount customarily consumed and which is expressed in a common household measure that is appro- priate to the food, or (ii) if the use of the food is not typically ex- pressed in a serving size, the common house- hold unit of measure that expresses the serv- ing size of the food, (B) the number of servings or other units of measure per container, (C) the total number of calories— (i) derived from any source, and (ii) derived from the total fat, in each serving size or other unit of measure of the food, (D) the amount of the following nutrients: Total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein con- tained in each serving size or other unit of measure, (E) any vitamin, mineral, or other nutrient required to be placed on the label and labeling of food under this chapter before October 1, 1990, if the Secretary determines that such in- formation will assist consumers in maintain- ing healthy dietary practices. The Secretary may by regulation require any in- formation required to be placed on the label or labeling by this subparagraph or subparagraph (2)(A) to be highlighted on the label or labeling by larger type, bold type, or contrasting color if the Secretary determines that such highlighting will assist consumers in maintaining healthy di- etary practices. (2)(A) If the Secretary determines that a nu- trient other than a nutrient required by sub- paragraph (1)(C), (1)(D), or (1)(E) should be in- cluded in the label or labeling of food subject to subparagraph (1) for purposes of providing infor- mation regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices, the Secretary may by regulation require that information relating to such additional nutrient be included in the label or labeling of such food. (B) If the Secretary determines that the infor- mation relating to a nutrient required by sub- paragraph (1)(C), (1)(D), or (1)(E) or clause (A) of this subparagraph to be included in the label or labeling of food is not necessary to assist con- sumers in maintaining healthy dietary prac- tices, the Secretary may by regulation remove information relating to such nutrient from such requirement. (3) For food that is received in bulk containers at a retail establishment, the Secretary may, by regulation, provide that the nutrition informa- tion required by subparagraphs (1) and (2) be dis- played at the location in the retail establish- ment at which the food is offered for sale. (4)(A) The Secretary shall provide for fur- nishing the nutrition information required by subparagraphs (1) and (2) with respect to raw ag- ricultural commodities and raw fish by issuing voluntary nutrition guidelines, as provided by clause (B) or by issuing regulations that are mandatory as provided by clause (D). (B)(i) Upon the expiration of 12 months after November 8, 1990, the Secretary, after providing an opportunity for comment, shall issue guide- lines for food retailers offering raw agricultural commodities or raw fish to provide nutrition in- formation specified in subparagraphs (1) and (2). Such guidelines shall take into account the ac- tions taken by food retailers during such 12- month period to provide to consumers nutrition information on raw agricultural commodities and raw fish. Such guidelines shall only apply— (I) in the case of raw agricultural commod- ities, to the 20 varieties of vegetables most fre- quently consumed during a year and the 20 va- rieties of fruit most frequently consumed dur- ing a year, and (II) to the 20 varieties of raw fish most fre- quently consumed during a year. The vegetables, fruits, and raw fish to which such guidelines apply shall be determined by the Secretary by regulation and the Secretary may apply such guidelines regionally. (ii) Upon the expiration of 12 months after No- vember 8, 1990, the Secretary shall issue a final regulation defining the circumstances that con- stitute substantial compliance by food retailers with the guidelines issued under subclause (i). The regulation shall provide that there is not substantial compliance if a significant number of retailers have failed to comply with the guidelines. The size of the retailers and the por- tion of the market served by retailers in compli- ance with the guidelines shall be considered in determining whether the substantial-compliance standard has been met. (C)(i) Upon the expiration of 30 months after November 8, 1990, the Secretary shall issue a re- port on actions taken by food retailers to pro- Page 86 TITLE 21—FOOD AND DRUGS § 343 vide consumers with nutrition information for raw agricultural commodities and raw fish under the guidelines issued under clause (A). Such report shall include a determination of whether there is substantial compliance with the guidelines. (ii) If the Secretary finds that there is sub- stantial compliance with the guidelines, the Secretary shall issue a report and make a deter- mination of the type required in subclause (i) every two years. (D)(i) If the Secretary determines that there is not substantial compliance with the guidelines issued under clause (A), the Secretary shall at the time such determination is made issue pro- posed regulations requiring that any person who offers raw agricultural commodities or raw fish to consumers provide, in a manner prescribed by regulations, the nutrition information required by subparagraphs (1) and (2). The Secretary shall issue final regulations imposing such require- ments 6 months after issuing the proposed regu- lations. The final regulations shall become ef- fective 6 months after the date of their promul- gation. (ii) Regulations issued under subclause (i) may require that the nutrition information required by subparagraphs (1) and (2) be provided for more than 20 varieties of vegetables, 20 varieties of fruit, and 20 varieties of fish most frequently consumed during a year if the Secretary finds that a larger number of such products are fre- quently consumed. Such regulations shall per- mit such information to be provided in a single location in each area in which raw agricultural commodities and raw fish are offered for sale. Such regulations may provide that information shall be expressed as an average or range per serving of the same type of raw agricultural commodity or raw fish. The Secretary shall de- velop and make available to the persons who offer such food to consumers the information re- quired by subparagraphs (1) and (2). (iii) Regulations issued under subclause (i) shall permit the required information to be pro- vided in each area of an establishment in which raw agricultural commodities and raw fish are offered for sale. The regulations shall permit food retailers to display the required informa- tion by supplying copies of the information pro- vided by the Secretary, by making the informa- tion available in brochure, notebook or leaflet form, or by posting a sign disclosing the infor- mation. Such regulations shall also permit pres- entation of the required information to be sup- plemented by a video, live demonstration, or other media which the Secretary approves. (E) For purposes of this subparagraph, the term ‘‘fish’’ includes freshwater or marine fin fish, crustaceans, and mollusks, including shell- fish, amphibians, and other forms of aquatic ani- mal life. (F) No person who offers raw agricultural com- modities or raw fish to consumers may be pros- ecuted for minor violations of this subparagraph if there has been substantial compliance with the requirements of this paragraph. (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food— (i) except as provided in clause (H)(ii)(III), which is served in restaurants or other estab- lishments in which food is served for imme- diate human consumption or which is sold for sale or use in such establishments, (ii) except as provided in clause (H)(ii)(III), which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type de- scribed in subclause (i), and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment, (iii) which is an infant formula subject to section 350a of this title, (iv) which is a medical food as defined in sec- tion 360ee(b) of this title, or (v) which is described in section 345(2) of this title. (B) Subparagraphs (1) and (2) shall not apply to the label of a food if the Secretary determines by regulations that compliance with such sub- paragraphs is impracticable because the package of such food is too small to comply with the re- quirements of such subparagraphs and if the label of such food does not contain any nutrition information. (C) If a food contains insignificant amounts, as determined by the Secretary, of all the nutri- ents required by subparagraphs (1) and (2) to be listed in the label or labeling of food, the re- quirements of such subparagraphs shall not apply to such food if the label, labeling, or ad- vertising of such food does not make any claim with respect to the nutritional value of such food. If a food contains insignificant amounts, as determined by the Secretary, of more than one-half the nutrients required by subpara- graphs (1) and (2) to be in the label or labeling of the food, the Secretary shall require the amounts of such nutrients to be stated in a sim- plified form prescribed by the Secretary. (D) If a person offers food for sale and has an- nual gross sales made or business done in sales to consumers which is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers which is not more than $50,000, the requirements of subparagraphs (1), (2), (3), and (4) shall not apply with respect to food sold by such person to consumers unless the label or labeling of food offered by such per- son provides nutrition information or makes a nutrition claim. (E)(i) During the 12-month period for which an exemption from subparagraphs (1) and (2) is claimed pursuant to this subclause, the require- ments of such subparagraphs shall not apply to any food product if— (I) the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r), (II) the person who claims for such product an exemption from such subparagraphs em- ployed fewer than an average of 100 full-time equivalent employees, (III) such person provided the notice de- scribed in subclause (iii), and (IV) in the case of a food product which was sold in the 12-month period preceding the pe- riod for which an exemption was claimed, fewer than 100,000 units of such product were sold in the United States during such pre- Page 87 TITLE 21—FOOD AND DRUGS § 343 ceding period, or in the case of a food product which was not sold in the 12-month period pre- ceding the period for which such exemption is claimed, fewer than 100,000 units of such prod- uct are reasonably anticipated to be sold in the United States during the period for which such exemption is claimed. (ii) During the 12-month period after the appli- cable date referred to in this sentence, the re- quirements of subparagraphs (1) and (2) shall not apply to any food product which was first intro- duced into interstate commerce before May 8, 1994, if the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r), if such person provided the notice described in subclause (iii), and if— (I) during the 12-month period preceding May 8, 1994, the person who claims for such product an exemption from such subpara- graphs employed fewer than an average of 300 full-time equivalent employees and fewer than 600,000 units of such product were sold in the United States, (II) during the 12-month period preceding May 8, 1995, the person who claims for such product an exemption from such subpara- graphs employed fewer than an average of 300 full-time equivalent employees and fewer than 400,000 units of such product were sold in the United States, or (III) during the 12-month period preceding May 8, 1996, the person who claims for such product an exemption from such subpara- graphs employed fewer than an average of 200 full-time equivalent employees and fewer than 200,000 units of such product were sold in the United States. (iii) The notice referred to in subclauses (i) and (ii) shall be given to the Secretary prior to the beginning of the period during which the ex- emption under subclause (i) or (ii) is to be in ef- fect, shall state that the person claiming such exemption for a food product has complied with the applicable requirements of subclause (i) or (ii), and shall— (I) state the average number of full-time equivalent employees such person employed during the 12 months preceding the date such person claims such exemption, (II) state the approximate number of units the person claiming the exemption sold in the United States, (III) if the exemption is claimed for a food product which was sold in the 12-month period preceding the period for which the exemption was claimed, state the approximate number of units of such product which were sold in the United States during such preceding period, and, if the exemption is claimed for a food product which was not sold in such preceding period, state the number of units of such prod- uct which such person reasonably anticipates will be sold in the United States during the pe- riod for which the exemption was claimed, and (IV) contain such information as the Sec- retary may require to verify the information required by the preceding provisions of this subclause if the Secretary has questioned the validity of such information. If a person is not an importer, has fewer than 10 full-time equivalent employees, and sells fewer than 10,000 units of any food product in any year, such person is not required to file a notice for such product under this subclause for such year. (iv) In the case of a person who claimed an ex- emption under subclause (i) or (ii), if, during the period of such exemption, the number of full- time equivalent employees of such person ex- ceeds the number in such subclause or if the number of food products sold in the United States exceeds the number in such subclause, such exemption shall extend to the expiration of 18 months after the date the number of full-time equivalent employees or food products sold ex- ceeded the applicable number. (v) For any food product first introduced into interstate commerce after May 8, 2002, the Sec- retary may by regulation lower the employee or units of food products requirement of subclause (i) if the Secretary determines that the cost of compliance with such lower requirement will not place an undue burden on persons subject to such lower requirement. (vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)— (I) the term ‘‘unit’’ means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers, (II) the term ‘‘food product’’ means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods, and (III) the term ‘‘person’’ in the case of a cor- poration includes all domestic and foreign af- filiates of the corporation. (F) A dietary supplement product (including a food to which section 350 of this title applies) shall comply with the requirements of subpara- graphs (1) and (2) in a manner which is appro- priate for the product and which is specified in regulations of the Secretary which shall provide that— (i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consump- tion has been established by the Secretary, ex- cept that a dietary ingredient shall not be re- quired to be listed if it is not present in a sig- nificant amount, and shall list any other die- tary ingredient present and identified as hav- ing no such recommendation; (ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving; (iii) the listing of dietary ingredients may include the source of a dietary ingredient; and (iv) the nutrition information shall imme- diately precede the ingredient information re- quired under subclause (i), except that no in- gredient identified pursuant to subclause (i) shall be required to be identified a second time. (G) Subparagraphs (1), (2), (3), and (4) shall not apply to food which is sold by a food distributor if the food distributor principally sells food to restaurants or other establishments in which Page 88 TITLE 21—FOOD AND DRUGS § 343 food is served for immediate human consump- tion and does not manufacture, process, or re- package the food it sells. (H) RESTAURANTS, RETAIL FOOD ESTABLISH- MENTS, AND VENDING MACHINES.— (i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.— Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or simi- lar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establish- ment shall disclose the information described in subclauses (ii) and (iii). (ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISH- MENTS.—Except as provided in subclause (vii), the restaurant or similar retail food establish- ment shall disclose in a clear and conspicuous manner— (I)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly asso- ciated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and (bb) a succinct statement concerning sug- gested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the con- text of a total daily diet, the significance of the caloric information that is provided on the menu; (II)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly asso- ciated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and (bb) a succinct statement concerning sug- gested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the con- text of a total daily diet, the significance of the nutrition information that is provided on the menu board; (III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon re- quest, the nutrition information required under clauses (C) and (D) of subparagraph (1); and (IV) on the menu or menu board, a promi- nent, clear, and conspicuous statement re- garding the availability of the information described in item (III). (iii) SELF-SERVICE FOOD AND FOOD ON DIS- PLAY.—Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service fa- cility, and for self-service beverages or food that is on display and that is visible to cus- tomers, a restaurant or similar retail food es- tablishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving. (iv) REASONABLE BASIS.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as de- scribed in section 101.10 of title 21, Code of Federal Regulations (or any successor regula- tion) or in a related guidance of the Food and Drug Administration. (v) MENU VARIABILITY AND COMBINATION MEALS.—The Secretary shall establish by regu- lation standards for determining and dis- closing the nutrient content for standard menu items that come in different flavors, va- rieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children’s com- bination meals, through means determined by the Secretary, including ranges, averages, or other methods. (vi) ADDITIONAL INFORMATION.—If the Sec- retary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of pro- viding information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclo- sure of such nutrient in the written form re- quired under subclause (ii)(III). (vii) NONAPPLICABILITY TO CERTAIN FOOD.— (I) IN GENERAL.—Subclauses (i) through (vi) do not apply to— (aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use); (bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom or- ders; or (cc) such other food that is part of a cus- tomary market test appearing on the menu for less than 90 days, under terms and conditions established by the Sec- retary. (II) WRITTEN FORMS.—Subparagraph (5)(C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi). (viii) VENDING MACHINES.— (I) IN GENERAL.—In the case of an article of food sold from a vending machine that— (aa) does not permit a prospective pur- chaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition in- formation at the point of purchase; and (bb) is operated by a person who is en- gaged in the business of owning or oper- ating 20 or more vending machines, the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the arti- cle. Page 89 TITLE 21—FOOD AND DRUGS § 343 (ix) VOLUNTARY PROVISION OF NUTRITION IN- FORMATION.— (I) IN GENERAL.—An authorized official of any restaurant or similar retail food estab- lishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or simi- lar retail food establishment or vending ma- chine operator with the Secretary, as speci- fied by the Secretary by regulation. (II) REGISTRATION.—Within 120 days of March 23, 2010, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regula- tions. (III) RULE OF CONSTRUCTION.—Nothing in this subclause shall be construed to author- ize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item. (x) REGULATIONS.— (I) PROPOSED REGULATION.—Not later than 1 year after March 23, 2010, the Secretary shall promulgate proposed regulations to carry out this clause. (II) CONTENTS.—In promulgating regula- tions, the Secretary shall— (aa) consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in in- gredients, and other factors, as the Sec- retary determines; and (bb) specify the format and manner of the nutrient content disclosure require- ments under this subclause. (III) REPORTING.—The Secretary shall sub- mit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary’s progress to- ward promulgating final regulations under this subparagraph. (xi) DEFINITION.—In this clause, the term ‘‘menu’’ or ‘‘menu board’’ means the primary writing of the restaurant or other similar re- tail food establishment from which a con- sumer makes an order selection. (r) Nutrition levels and health-related claims (1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or la- beling of the food which expressly or by implica- tion— (A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accord- ance with subparagraph (2), or (B) characterizes the relationship of any nu- trient which is of the type required by para- graph (q)(1) or (q)(2) to be in the label or label- ing of the food to a disease or a health-related condition unless the claim is made in accord- ance with subparagraph (3) or (5)(D). A statement of the type required by paragraph (q) that appears as part of the nutrition infor- mation required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (B). (2)(A) Except as provided in subparagraphs (4)(A)(ii) and (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a claim described in sub- paragraph (1)(A)— (i) may be made only if the characterization of the level made in the claim uses terms which are defined in regulations of the Sec- retary, (ii) may not state the absence of a nutrient unless— (I) the nutrient is usually present in the food or in a food which substitutes for the food as defined by the Secretary by regula- tion, or (II) the Secretary by regulation permits such a statement on the basis of a finding that such a statement would assist con- sumers in maintaining healthy dietary prac- tices and the statement discloses that the nutrient is not usually present in the food, (iii) may not be made with respect to the level of cholesterol in the food if the food con- tains, as determined by the Secretary by regu- lation, fat or saturated fat in an amount which increases to persons in the general pop- ulation the risk of disease or a health related condition which is diet related unless— (I) the Secretary finds by regulation that the level of cholesterol is substantially less than the level usually present in the food or in a food which substitutes for the food and which has a significant market share, or the Secretary by regulation permits a statement regarding the absence of cholesterol on the basis of a finding that cholesterol is not usu- ally present in the food and that such a statement would assist consumers in main- taining healthy dietary practices and the regulation requires that the statement dis- close that cholesterol is not usually present in the food, and (II) the label or labeling of the food dis- closes the level of such fat or saturated fat in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of cholesterol, (iv) may not be made with respect to the level of saturated fat in the food if the food contains cholesterol unless the label or label- ing of the food discloses the level of choles- terol in the food in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of satu- rated fat, (v) may not state that a food is high in die- tary fiber unless the food is low in total fat as defined by the Secretary or the label or label- ing discloses the level of total fat in the food Page 90 TITLE 21—FOOD AND DRUGS § 343 in immediate proximity to such statement and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of dietary fiber, and (vi) may not be made if the Secretary by regulation prohibits the claim because the claim is misleading in light of the level of an- other nutrient in the food. (B) If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the Secretary makes a determination that the food contains a nutrient at a level that in- creases to persons in the general population the risk of a disease or health-related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following state- ment: ‘‘See nutrition information for lll con- tent.’’ The blank shall identify the nutrient as- sociated with the increased disease or health-re- lated condition risk. In making the determina- tion described in this clause, the Secretary shall take into account the significance of the food in the total daily diet. (C) Subparagraph (2)(A) does not apply to a claim described in subparagraph (1)(A) and con- tained in the label or labeling of a food if such claim is contained in the brand name of such food and such brand name was in use on such food before October 25, 1989, unless the brand name contains a term defined by the Secretary under subparagraph (2)(A)(i). Such a claim is subject to paragraph (a). (D) Subparagraph (2) does not apply to a claim described in subparagraph (1)(A) which uses the term ‘‘diet’’ and is contained in the label or la- beling of a soft drink if (i) such claim is con- tained in the brand name of such soft drink, (ii) such brand name was in use on such soft drink before October 25, 1989, and (iii) the use of the term ‘‘diet’’ was in conformity with section 105.66 of title 21 of the Code of Federal Regula- tions. Such a claim is subject to paragraph (a). (E) Subclauses (i) through (v) of subparagraph (2)(A) do not apply to a statement in the label or labeling of food which describes the percentage of vitamins and minerals in the food in relation to the amount of such vitamins and minerals recommended for daily consumption by the Sec- retary. (F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supple- ment that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption. (G) A claim of the type described in subpara- graph (1)(A) for a nutrient, for which the Sec- retary has not promulgated a regulation under clause (A)(i), shall be authorized and may be made with respect to a food if— (i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the Na- tional Institutes of Health or the Centers for Disease Control and Prevention) or the Na- tional Academy of Sciences or any of its sub- divisions has published an authoritative state- ment, which is currently in effect, which iden- tifies the nutrient level to which the claim re- fers; (ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such per- son relied for determining that the require- ments of subclause (i) have been satisfied, (II) a copy of the statement referred to in sub- clause (i) upon which such person relied in making the claim, and (III) a balanced rep- resentation of the scientific literature relating to the nutrient level to which the claim refers; (iii) the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and (iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in sub- clause (i) and so that the claim enables the public to comprehend the information pro- vided in the claim and to understand the rel- ative significance of such information in the context of a total daily diet. For purposes of this clause, a statement shall be regarded as an authoritative statement of a sci- entific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an em- ployee of the scientific body made in the indi- vidual capacity of the employee. (H) A claim submitted under the requirements of clause (G) may be made until— (i) such time as the Secretary issues a regu- lation— (I) prohibiting or modifying the claim and the regulation has become effective, or (II) finding that the requirements of clause (G) have not been met, including finding that the petitioner had not submitted all the information required by such clause; or (ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (G) have not been met. (3)(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may only be made— (i) if the claim meets the requirements of the regulations of the Secretary promulgated under clause (B), and (ii) if the food for which the claim is made does not contain, as determined by the Sec- retary by regulation, any nutrient in an amount which increases to persons in the gen- eral population the risk of a disease or health- related condition which is diet related, taking into account the significance of the food in the total daily diet, except that the Secretary may by regulation permit such a claim based on a finding that such a claim would assist Page 91 TITLE 21—FOOD AND DRUGS § 343 consumers in maintaining healthy dietary practices and based on a requirement that the label contain a disclosure of the type required by subparagraph (2)(B). (B)(i) The Secretary shall promulgate regula- tions authorizing claims of the type described in subparagraph (1)(B) only if the Secretary deter- mines, based on the totality of publicly avail- able scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among ex- perts qualified by scientific training and experi- ence to evaluate such claims, that the claim is supported by such evidence. (ii) A regulation described in subclause (i) shall describe— (I) the relationship between a nutrient of the type required in the label or labeling of food by paragraph (q)(1) or (q)(2) and a disease or health-related condition, and (II) the significance of each such nutrient in affecting such disease or health-related condi- tion. (iii) A regulation described in subclause (i) shall require such claim to be stated in a man- ner so that the claim is an accurate representa- tion of the matters set out in subclause (ii) and so that the claim enables the public to com- prehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet. (C) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in ac- cordance with clause (B) shall be authorized and may be made with respect to a food if— (i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the Na- tional Institutes of Health or the Centers for Disease Control and Prevention) or the Na- tional Academy of Sciences or any of its sub- divisions has published an authoritative state- ment, which is currently in effect, about the relationship between a nutrient and a disease or health-related condition to which the claim refers; (ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such per- son relied for determining that the require- ments of subclause (i) have been satisfied, (II) a copy of the statement referred to in sub- clause (i) upon which such person relied in making the claim, and (III) a balanced rep- resentation of the scientific literature relating to the relationship between a nutrient and a disease or health-related condition to which the claim refers; (iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and (iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in sub- clause (i) and so that the claim enables the public to comprehend the information pro- vided in the claim and to understand the rel- ative significance of such information in the context of a total daily diet. For purposes of this clause, a statement shall be regarded as an authoritative statement of a sci- entific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an em- ployee of the scientific body made in the indi- vidual capacity of the employee. (D) A claim submitted under the requirements of clause (C) may be made until— (i) such time as the Secretary issues a regu- lation under the standard in clause (B)(i)— (I) prohibiting or modifying the claim and the regulation has become effective, or (II) finding that the requirements of clause (C) have not been met, including finding that the petitioner has not submitted all the information required by such clause; or (ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (C) have not been met. (4)(A)(i) Any person may petition the Sec- retary to issue a regulation under subparagraph (2)(A)(i) or (3)(B) relating to a claim described in subparagraph (1)(A) or (1)(B). Not later than 100 days after the petition is received by the Sec- retary, the Secretary shall issue a final decision denying the petition or file the petition for fur- ther action by the Secretary. If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary denies the peti- tion or the petition is deemed to be denied, the petition shall not be made available to the pub- lic. If the Secretary files the petition, the Sec- retary shall deny the petition or issue a pro- posed regulation to take the action requested in the petition not later than 90 days after the date of such decision. If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mu- tually agreed upon by the Secretary and the pe- titioner. If the Secretary issues a proposed regu- lation, the rulemaking shall be completed with- in 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Com- mittee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days. (ii) Any person may petition the Secretary for permission to use in a claim described in sub- Page 92 TITLE 21—FOOD AND DRUGS § 343 paragraph (1)(A) terms that are consistent with the terms defined by the Secretary under sub- paragraph (2)(A)(i). Within 90 days of the sub- mission of such a petition, the Secretary shall issue a final decision denying the petition or granting such permission. (iii) Any person may petition the Secretary for permission to use an implied claim described in subparagraph (1)(A) in a brand name. After publishing notice of an opportunity to comment on the petition in the Federal Register and mak- ing the petition available to the public, the Sec- retary shall grant the petition if the Secretary finds that such claim is not misleading and is consistent with terms defined by the Secretary under subparagraph (2)(A)(i). The Secretary shall grant or deny the petition within 100 days of the date it is submitted to the Secretary and the petition shall be considered granted if the Secretary does not act on it within such 100 days. (B) A petition under clause (A)(i) respecting a claim described in subparagraph (1)(A) or (1)(B) shall include an explanation of the reasons why the claim meets the requirements of this para- graph and a summary of the scientific data which supports such reasons. (C) If a petition for a regulation under sub- paragraph (3)(B) relies on a report from an au- thoritative scientific body of the United States, the Secretary shall consider such report and shall justify any decision rejecting the conclu- sions of such report. (5)(A) This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title. (B) Subclauses (iii) through (v) of subpara- graph (2)(A) and subparagraph (2)(B) do not apply to food which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments. (C) A subparagraph (1)(A) claim made with re- spect to a food which claim is required by a standard of identity issued under section 341 of this title shall not be subject to subparagraph (2)(A)(i) or (2)(B). (D) A subparagraph (1)(B) claim made with re- spect to a dietary supplement of vitamins, min- erals, herbs, or other similar nutritional sub- stances shall not be subject to subparagraph (3) but shall be subject to a procedure and standard, respecting the validity of such claim, estab- lished by regulation of the Secretary. (6) For purposes of paragraph (r)(1)(B), a state- ment for a dietary supplement may be made if— (A) the statement claims a benefit related to a classical nutrient deficiency disease and dis- closes the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutri- ent or dietary ingredient acts to maintain such structure or function, or describes gen- eral well-being from consumption of a nutri- ent or dietary ingredient, (B) the manufacturer of the dietary supple- ment has substantiation that such statement is truthful and not misleading, and (C) the statement contains, prominently dis- played and in boldface type, the following: ‘‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or pre- vent any disease.’’. A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or pre- vent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sen- tence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall no- tify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made. (7) The Secretary may make proposed regula- tions issued under this paragraph effective upon publication pending consideration of public comment and publication of a final regulation if the Secretary determines that such action is necessary— (A) to enable the Secretary to review and act promptly on petitions the Secretary deter- mines provide for information necessary to— (i) enable consumers to develop and main- tain healthy dietary practices; (ii) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food; or (iii) ensure that scientifically sound nutri- tional and health information is provided to consumers as soon as possible; or (B) to enable the Secretary to act promptly to ban or modify a claim under this paragraph. Such proposed regulations shall be deemed final agency action for purposes of judicial review. (s) Dietary supplements If— (1) it is a dietary supplement; and (2)(A) the label or labeling of the supplement fails to list— (i) the name of each ingredient of the sup- plement that is described in section 321(ff) of this title; and (ii)(I) the quantity of each such ingredient; or (II) with respect to a proprietary blend of such ingredients, the total quantity of all in- gredients in the blend; (B) the label or labeling of the dietary sup- plement fails to identify the product by using the term ‘‘dietary supplement’’, which term may be modified with the name of such an in- gredient; (C) the supplement contains an ingredient described in section 321(ff)(1)(C) of this title, and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived; (D) the supplement— (i) is covered by the specifications of an of- ficial compendium; (ii) is represented as conforming to the specifications of an official compendium; and (iii) fails to so conform; or Page 93 TITLE 21—FOOD AND DRUGS § 343 (E) the supplement— (i) is not covered by the specifications of an official compendium; and (ii)(I) fails to have the identity and strength that the supplement is represented to have; or (II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on vali- dated assay or other appropriate methods, that the supplement is represented to meet. A dietary supplement shall not be deemed mis- branded solely because its label or labeling con- tains directions or conditions of use or warn- ings. (t) Catfish If it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae. (u) Ginseng If it purports to be or is represented as gin- seng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax. (v) Failure to label; health threat If— (1) it fails to bear a label required by the Secretary under section 381(n)(1) of this title (relating to food refused admission into the United States); (2) the Secretary finds that the food presents a threat of serious adverse health con- sequences or death to humans or animals; and (3) upon or after notifying the owner or con- signee involved that the label is required under section 381 of this title, the Secretary informs the owner or consignee that the food presents such a threat. (w) Major food allergen labeling requirements (1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless ei- ther— (A) the word ‘‘Contains’’, followed by the name of the food source from which the major food allergen is derived, is printed imme- diately after or is adjacent to the list of ingre- dients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or (B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in pa- rentheses by the name of the food source from which the major food allergen is derived, ex- cept that the name of the food source is not required when— (i) the common or usual name of the ingre- dient uses the name of the food source from which the major food allergen is derived; or (ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears else- where in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title. (2) As used in this subsection, the term ‘‘name of the food source from which the major food al- lergen is derived’’ means the name described in section 321(qq)(1) of this title; provided that in the case of a tree nut, fish, or Crustacean shell- fish, the term ‘‘name of the food source from which the major food allergen is derived’’ means the name of the specific type of nut or species of fish or Crustacean shellfish. (3) The information required under this sub- section may appear in labeling in lieu of appear- ing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an ear- lier finding under this paragraph) is effective upon publication in the Federal Register as a notice. (4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or inci- dental additive that is, or that bears or con- tains, a major food allergen shall be subject to the labeling requirements of this subsection. (5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the require- ment of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Sec- retary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health. (6)(A) Any person may petition the Secretary to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection. (B) The Secretary shall approve or deny such petition within 180 days of receipt of the peti- tion or the petition shall be deemed denied, un- less an extension of time is mutually agreed upon by the Secretary and the petitioner. (C) The burden shall be on the petitioner to provide scientific evidence (including the ana- lytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health. (D) A determination regarding a petition under this paragraph shall constitute final agen- cy action. (E) The Secretary shall promptly post to a public site all petitions received under this para- graph within 14 days of receipt and the Sec- retary shall promptly post the Secretary’s re- sponse to each. (7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient de- scribed in section 321(qq)(2) of this title from the allergen labeling requirements of this sub- section, if the person files with the Secretary a notification containing— (i) scientific evidence (including the analyt- ical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or (ii) a determination by the Secretary that the ingredient does not cause an allergic re- sponse that poses a risk to human health under a premarket approval or notification program under section 348 of this title. Page 94 TITLE 21—FOOD AND DRUGS § 343 (B) The food ingredient may be introduced or delivered for introduction into interstate com- merce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the require- ments of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health. (C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary. (x) Nonmajor food allergen labeling require- ments Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or in- cidental additive that is, or that bears or con- tains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner speci- fied by the Secretary by regulation. (y) Dietary supplements If it is a dietary supplement that is marketed in the United States, unless the label of such di- etary supplement includes a domestic address or domestic phone number through which the re- sponsible person (as described in section 379aa–1 of this title) may receive a report of a serious adverse event with such dietary supplement. (June 25, 1938, ch. 675, § 403, 52 Stat. 1047; Pub. L. 86–537, § 1, June 29, 1960, 74 Stat. 251; Pub. L. 86–618, title I, § 102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, § 6(c), formerly § 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–278, title V, § 502(a)(1), Apr. 22, 1976, 90 Stat. 411; Pub. L. 95–203, § 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat. 1452, 1453; Pub. L. 101–535, §§ 2(a), 3(a), 7, Nov. 8, 1990, 104 Stat. 2353, 2357, 2364; Pub. L. 102–108, § 2(a), (c), Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, § 107(5), (6), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§ 2(b), 3(j), Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103–417, §§ 6, 7(a)–(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105–115, title III, §§ 301–305, Nov. 21, 1997, 111 Stat. 2350–2353; Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73; Pub. L. 107–171, title X, §§ 10806(a)(2), (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L. 107–188, title III, § 308(b), June 12, 2002, 116 Stat. 672; Pub. L. 108–282, title II, § 203(a), Aug. 2, 2004, 118 Stat. 906; Pub. L. 109–462, § 3(c), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 111–148, title IV, § 4205(a), (b), Mar. 23, 2010, 124 Stat. 573.) Editorial Notes AMENDMENTS 2010—Par. (q)(5)(A)(i). Pub. L. 111–148, § 4205(a)(1), in- serted ‘‘except as provided in clause (H)(ii)(III),’’ before ‘‘which is served’’. Par. (q)(5)(A)(ii). Pub. L. 111–148, § 4205(a)(2), inserted ‘‘except as provided in clause (H)(ii)(III),’’ before ‘‘which is processed’’. Par. (q)(5)(H). Pub. L. 111–148, § 4205(b), added cl. (H). 2006—Par. (y). Pub. L. 109–462 added par. (y). 2004—Pars. (w), (x). Pub. L. 108–282 added pars. (w) and (x). 2002—Par. (h). Pub. L. 107–171, § 10808(b), added subpar. (3) and concluding provisions. Par. (t). Pub. L. 107–171, § 10806(a)(2), added par. (t). Par. (u). Pub. L. 107–171, § 10806(b)(2), added par. (u). Par. (v). Pub. L. 107–188 added par. (v). 2000—Par. (o). Pub. L. 106–554, which directed repeal of section 403(o) of the Food, Drug, and Cosmetic Act, was executed by repealing par. (o) of this section, which is section 403 of the Federal Food, Drug, and Cosmetic Act, to reflect the probable intent of Congress. Prior to repeal, par. (o) provided that a food containing sac- charin was to be deemed misbranded unless a specified warning statement was placed in a conspicuous place on its label. 1997—Par. (r)(2)(B). Pub. L. 105–115, § 305, amended cl. (B) generally. Prior to amendment, cl. (B) read as fol- lows: ‘‘If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: ‘See lllll for nutrition information.’. In the statement— ‘‘(i) the blank shall identify the panel on which the information described in the statement may be found, and ‘‘(ii) if the Secretary determines that the food con- tains a nutrient at a level which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet, the statement shall also identify such nu- trient.’’ Par. (r)(2)(G), (H). Pub. L. 105–115, § 304, added cls. (G) and (H). Par. (r)(3)(C), (D). Pub. L. 105–115, § 303, added cls. (C) and (D). Par. (r)(4)(A)(i). Pub. L. 105–115, § 302, inserted after second sentence ‘‘If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner.’’, inserted ‘‘or the peti- tion is deemed to be denied’’ after ‘‘If the Secretary de- nies the petition’’, and inserted at end ‘‘If the Sec- retary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mu- tually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rule- making shall be completed within 540 days of the date the petition is received by the Secretary. If the Sec- retary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Com- merce of the House of Representatives and the Com- mittee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.’’ Par. (r)(7). Pub. L. 105–115, § 301, added subpar. (7). 1996—Par. (p). Pub. L. 104–124 struck out par. (p), which deemed products containing saccharin and of- fered for sale, but not for immediate consumption, by retail establishment, to be misbranded, unless notice of information required by subsec. (o) was provided by manufacturer and prominently displayed near product. 1994—Par. (q)(5)(F). Pub. L. 103–417, § 7(b), amended cl. (F) generally. Prior to amendment, cl. (F) read as fol- lows: ‘‘If a food to which section 350 of this title applies (as defined in section 350(c) of this title) contains one or more of the nutrients required by subparagraph (1) or (2) to be in the label or labeling of the food, the label or labeling of such food shall comply with the require- ments of subparagraphs (1) and (2) in a manner which is appropriate for such food and which is specified in regulations of the Secretary.’’ Par. (r)(2)(F). Pub. L. 103–417, § 7(c), added cl. (F). Par. (r)(6). Pub. L. 103–417, § 6, added subpar. (6). Par. (s). Pub. L. 103–417, § 10(c), inserted at end: ‘‘A di- etary supplement shall not be deemed misbranded sole- Page 95 TITLE 21—FOOD AND DRUGS § 343 ly because its label or labeling contains directions or conditions of use or warnings.’’ Pub. L. 103–417, § 7(a), added par. (s). 1993—Par. (e). Pub. L. 103–80, § 3(j)(1), substituted ‘‘count, except that’’ for ‘‘count: Provided, That’’. Par. (i). Pub. L. 103–80, § 3(j)(2), substituted ‘‘unless sold as spices, flavorings, or such colors’’ for ‘‘, other than those sold as such’’ and ‘‘naming each. To the ex- tent’’ for ‘‘naming each: Provided, That, to the extent’’. Par. (k). Pub. L. 103–80, § 3(j)(3), substituted ‘‘, except that’’ for ‘‘: Provided, That’’. Par. (l). Pub. L. 103–80, § 3(j)(4), substituted ‘‘chemical, except that’’ for ‘‘chemical: Provided, however, That’’. Par. (q)(5)(E) to (G). Pub. L. 103–80, § 2(b), added cl. (E) and redesignated former cls. (E) and (F) as (F) and (G), respectively. Par. (r)(1)(B). Pub. L. 103–80, § 3(j)(5), substituted ‘‘(5)(D)’’ for ‘‘5(D)’’. Par. (r)(4)(B). Pub. L. 103–80, § 3(j)(6), substituted ‘‘paragraph’’ for ‘‘subsection’’. 1992—Par. (i). Pub. L. 102–571, § 107(5), substituted ‘‘379e(c)’’ for ‘‘376(c)’’. Par. (m). Pub. L. 102–571, § 107(6), substituted ‘‘379e’’ for ‘‘376’’. 1991—Par. (i). Pub. L. 102–108, § 2(c), amended direc- tory language of Pub. L. 101–535, § 7(1), (3). See 1990 Amendment note below. Par. (q)(4)(A). Pub. L. 102–108, § 2(a), substituted ‘‘(D)’’ for ‘‘(C)’’. 1990—Par. (i). Pub. L. 101–535, § 7, as amended by Pub. L. 102–108, § 2(c), substituted ‘‘Unless’’ for ‘‘If it is not subject to the provisions of paragraph (g) unless’’, in- serted ‘‘and if the food purports to be a beverage con- taining vegetable or fruit juice, a statement with ap- propriate prominence on the information panel of the total percentage of such fruit or vegetable juice con- tained in the food’’, and substituted ‘‘colors not re- quired to be certified under section 376(c) of this title’’ for ‘‘colorings’’ the first time appearing. Par. (q). Pub. L. 101–535, § 2(a), added par. (q). Par. (r). Pub. L. 101–535, § 3(a), added par. (r). 1977—Par. (o). Pub. L. 95–203, § 4(a)(1), added par. (o). Par. (p). Pub. L. 95–203, § 4(b)(1), added par. (p). 1976—Par. (a). Pub. L. 94–278 inserted ‘‘(1)’’ after ‘‘If’’ and inserted ‘‘, or (2) in the case of a food to which sec- tion 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title’’ after ‘‘any particular’’. 1970—Par. (n). Pub. L. 91–601 added par. (n). 1960—Par. (k). Pub. L. 86–537, § 1(1), exempted pes- ticide chemicals when used in or on a raw agricultural commodity which is the produce of the soil. Par. (l). Pub. L. 86–537, § 1(2), added par. (l). Par. (m). Pub. L. 86–618 added par. (m). Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance gen- erally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. EFFECTIVE DATE OF 2006 AMENDMENT Pub. L. 109–462, § 3(d)(1), (2), Dec. 22, 2006, 120 Stat. 3475, provided that: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa–1 of this title and amending this section and sec- tion 331 of this title] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006]. ‘‘(2) MISBRANDING.—Section 403(y) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall apply to any dietary sup- plement labeled on or after the date that is 1 year after the date of enactment of this Act [Dec. 22, 2006].’’ EFFECTIVE DATE OF 2004 AMENDMENT Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108–282, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1994 AMENDMENT Pub. L. 103–417, § 7(e), Oct. 25, 1994, 108 Stat. 4331, pro- vided that: ‘‘Dietary supplements— ‘‘(1) may be labeled after the date of the enactment of this Act [Oct. 25, 1994] in accordance with the amendments made by this section [amending this section and section 350 of this title], and ‘‘(2) shall be labeled after December 31, 1996, in ac- cordance with such amendments.’’ EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–535, § 10(a), Nov. 8, 1990, 104 Stat. 2365, as amended by Pub. L. 102–571, title II, § 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided that: ‘‘(1) Except as provided in paragraph (2)— ‘‘(A) the amendments made by section 2 [amending this section] shall take effect 6 months after— ‘‘(i) the date of the promulgation of all final regu- lations required to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)], or ‘‘(ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347], except that section 403(q)(4) of such Act shall take ef- fect as prescribed by such section, ‘‘(B) the amendments made by section 3 [amending this section] shall take effect 6 months after— ‘‘(i) the date of the promulgation of final regula- tions to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, or ‘‘(ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any person marketing a food the brand name of which contains a term defined by the Secretary under section 403(r)(2)(A)(i) of the Fed- eral Food, Drug, and Cosmetic Act shall be given an additional 6 months to comply with section 3, ‘‘(C) the amendments made by section 4 [amending section 337 of this title] shall take effect 24 months after the date of the enactment of this Act [Nov. 8, 1990], except that such amendments shall take effect with respect to such dietary supplements [probably means dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 202(a)(1) of Pub. L. 102–571, set out below] on December 31, 1993, and ‘‘(D) the amendments made by section 5 [amending sections 321 and 345 of this title] shall take effect on the date the amendments made by section 3 take ef- fect. ‘‘(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act (as added by section 2) shall not apply with respect to food which was labeled before the effec- tive date of the amendments made by section 2 and sec- tion 403(r) of the Federal Food, Drug, and Cosmetic Act (as added by section 3) shall not apply with respect to food which was labeled before the effective date of the amendments made by section 3. Page 96 TITLE 21—FOOD AND DRUGS § 343 ‘‘(3)(A) If the Secretary finds that a person who is subject to section 403(q)(4) of such Act is unable to comply with the requirements of such section upon the effective date of final regulations to implement section 403(q) of such Act or of proposed regulations to be con- sidered as such final regulations because the Secretary has not made available to such person the information required by such section, the Secretary shall delay the application of such section to such person for such time as the Secretary may require to provide such informa- tion. ‘‘(B) If the Secretary finds that compliance with sec- tion 403(q) or 403(r)(2) of such Act would cause an undue economic hardship, the Secretary may delay the appli- cation of such sections for no more than one year.’’ Pub. L. 101–535, § 10(c), Nov. 8, 1990, 104 Stat. 2367, as amended by Pub. L. 102–108, § 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, § 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that: ‘‘(1) Except as provided in paragraphs (2) and (3), the amendments made by section 7 [amending this section] shall take effect one year after the date of the enact- ment of this Act [Nov. 8, 1990]. ‘‘(2)(A) If a food subject to section 403(g) of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or more colors required to be certified under section 721(c) [of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a label which was printed before July 1, 1991, and which is attached to the food before May 8, 1993, such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section]. ‘‘(B) If a food described in subparagraph (A)— ‘‘(i) bears a label which was printed after July 1, 1991, but before the date the proposed regulation de- scribed in clause (ii) takes effect as a final regulation and which was attached to the food before May 8, 1993, and ‘‘(ii) meets the requirements of the proposed regu- lation of the Secretary of Health and Human Services published in 56 Fed. Reg. 28592–28636 (June 21, 1991) as it pertains to the amendments made by this Act [see Short Title of 1990 Amendment note set out under section 301 of this title], such food shall not be subject to the amendments made by section 7(1) and section 7(3) [amending this section]. ‘‘(3) A food purported to be a beverage containing a vegetable or fruit juice which bears a label attached to the food before May 8, 1993, shall not be subject to the amendments made by section 7(2) [amending this sec- tion].’’ EFFECTIVE DATE OF 1977 AMENDMENT Pub. L. 95–203, § 4(a)(2), Nov. 23, 1977, 91 Stat. 1453, pro- vided that: ‘‘The amendment made by paragraph (1) [amending this section] shall apply only with respect to food introduced or delivered for introduction in inter- state commerce on and after the 90th day after the date of the enactment of this Act [Nov. 23, 1977].’’ Pub. L. 95–203, § 4(b)(2), Nov. 23, 1977, 91 Stat. 1453, pro- vided that: ‘‘The amendment made by paragraph (1) [amending this section] shall apply with respect to food which is sold in retail establishments on or after the 90th day after the effective date of the regulations of the Secretary of Health, Education, and Welfare [now Secretary of Health and Human Services] under para- graph (p)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)].’’ EFFECTIVE DATE OF 1976 AMENDMENT Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title. EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging stand- ards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade. EFFECTIVE DATE OF 1960 AMENDMENT Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title. EFFECTIVE DATE; POSTPONEMENT Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such subsections effective July 1, 1940, as provided by regulations for certain lithographed labeling and con- tainers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Post- ponement in Certain Cases note under section 301 of this title. CONSTRUCTION OF AMENDMENT BY PUB. L. 111–148 Pub. L. 111–148, title IV, § 4205(d), Mar. 23, 2010, 124 Stat. 576, provided that: ‘‘Nothing in the amendments made by this section [amending this section and sec- tion 343–1 of this title] shall be construed— ‘‘(1) to preempt any provision of State or local law, unless such provision establishes or continues into ef- fect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as added by subsection (b)) and is expressly preempted under sub- section (a)(4) of such section; ‘‘(2) to apply to any State or local requirement re- specting a statement in the labeling of food that pro- vides for a warning concerning the safety of the food or component of the food; or ‘‘(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by subsection (b)), to apply to any restaurant or similar retail food establish- ment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act [21 U.S.C. 343(q)(5)(H)(i)].’’ CONSTRUCTION OF AMENDMENT BY PUB. L. 108–282 Pub. L. 108–282, title II, § 203(b), Aug. 2, 2004, 118 Stat. 908, provided that: ‘‘The amendments made by this sec- tion [amending this section and sections 321 and 343–1 of this title] that require a label or labeling for major food allergens do not alter the authority of the Sec- retary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens.’’ CONSTRUCTION OF AMENDMENT BY PUB. L. 107–188 Nothing in amendment by Pub. L. 107–188 to be con- strued to limit authority of Secretary of Health and Human Services or Secretary of the Treasury to re- quire marking of articles of food imported or offered for import into the United States which are refused ad- mission, see section 308(c) of Pub. L. 107–188, set out as a note under section 381 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 Pub. L. 101–535, § 9, Nov. 8, 1990, 104 Stat. 2365, pro- vided that: ‘‘The amendments made by this Act [enact- ing section 343–1 of this title and amending this section and sections 321, 337, 345, and 371 of this title] shall not be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agri- culture under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry Products Inspec- tion Act [21 U.S.C. 451 et seq.], and the Egg Products In- spection Act [21 U.S.C. 1031 et seq.].’’ REGULATIONS Pub. L. 101–535, § 2(b), Nov. 8, 1990, 104 Stat. 2356, as amended by Pub. L. 102–571, title II, § 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that: Page 97 TITLE 21—FOOD AND DRUGS § 343 ‘‘(1) The Secretary of Health and Human Services shall issue proposed regulations to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months after the date of the en- actment of this Act [Nov. 8, 1990], except that the Sec- retary shall issue, not later than June 15, 1993, proposed regulations that are applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutri- tional substances to implement such section. Not later than 24 months after the date of the enactment of this Act, the Secretary shall issue final regulations to im- plement the requirements of such section, except that the Secretary shall issue, not later than December 31, 1993, such a final regulation applicable to dietary sup- plements of vitamins, minerals, herbs, or other similar nutritional substances..[sic] Such regulations shall— ‘‘(A) require the required information to be con- veyed to the public in a manner which enables the public to readily observe and comprehend such infor- mation and to understand its relative significance in the context of a total daily diet, ‘‘(B) include regulations which establish standards, in accordance with paragraph (1)(A), to define serving size or other unit of measure for food, ‘‘(C) permit the label or labeling of food to include nutrition information which is in addition to the in- formation required by such section 403(q) and which is of the type described in subparagraph (1) or (2) of such section, and ‘‘(D) permit the nutrition information on the label or labeling of a food to remain the same or permit the information to be stated as a range even though (i) there are minor variations in the nutritional value of the food which occur in the normal course of the pro- duction or processing of the food, or (ii) the food is comprised of an assortment of similar foods which have variations in nutritional value. ‘‘(2) If the Secretary of Health and Human Services does not promulgate final regulations under paragraph (1) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with paragraph (1) shall be consid- ered as the final regulations upon the expiration of such 24 months, except that the proposed regulations applicable to dietary supplements of vitamins, min- erals, herbs, or other similar nutritional substances shall not be considered to be final regulations until De- cember 31, 1993. There shall be promptly published in the Federal Register notice of new status of the pro- posed regulations [see 57 F.R. 56347]. ‘‘(3) If the Secretary of Health and Human Services does not promulgate final regulations under section 403(q)(4) of the Federal Food, Drug, and Cosmetic Act upon the expiration of 6 months after the date on which the Secretary makes a finding that there has been no substantial compliance with section 403(q)(4)(C) of such Act, the proposed regulations issued in accordance with such section shall be considered as the final regulations upon the expiration of such 6 months. There shall be promptly published in the Federal Register notice of new status of the proposed regulations.’’ [Pub. L. 102–571, title II, § 202(a)(2)(C), Oct. 29, 1992, 106 Stat. 4501, provided that: ‘‘The amendments made by subparagraph (B) [amending sections 2(b) and 3(b) of Pub. L. 101–535, set out above and below] shall not be construed to modify the effective date of final regula- tions under sections 2(b) and 3(b) of the Nutrition La- beling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note) with respect to foods that are not such dietary supplements.’’] Pub. L. 101–535, § 3(b), Nov. 8, 1990, 104 Stat. 2360, as amended by Pub. L. 102–571, title II, § 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501, provided that: ‘‘(1)(A) Within 12 months of the date of the enactment of this Act [Nov. 8, 1990], the Secretary of Health and Human Services shall issue proposed regulations to im- plement section 403(r) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except that the Sec- retary shall issue, not later than June 15, 1993, proposed regulations that are applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutri- tional substances to implement such section. Such reg- ulations— ‘‘(i) shall identify claims described in section 403(r)(1)(A) of such Act which comply with section 403(r)(2) of such Act, ‘‘(ii) shall identify claims described in section 403(r)(1)(B) of such Act which comply with section 403(r)(3) of such Act, ‘‘(iii) shall, in defining terms used to characterize the level of any nutrient in food under section 403(r)(2)(A)(i) of such Act, define— ‘‘(I) free, ‘‘(II) low, ‘‘(III) light or lite, ‘‘(IV) reduced, ‘‘(V) less, and ‘‘(VI) high, unless the Secretary finds that the use of any such term would be misleading, ‘‘(iv) shall permit statements describing the amount and percentage of nutrients in food which are not misleading and are consistent with the terms de- fined in section 403(r)(2)(A)(i) of such Act, ‘‘(v) shall provide that if multiple claims subject to section 403(r)(1)(A) of such Act are made on a single panel of the food label or page of a labeling brochure, a single statement may be made to satisfy section 403(r)(2)(B) of such Act, ‘‘(vi) shall determine whether claims respecting the following nutrients and diseases meet the require- ments of section 403(r)(3) of such Act: Calcium and osteoporosis, dietary fiber and cancer, lipids and car- diovascular disease, lipids and cancer, sodium and hy- pertension, and dietary fiber and cardiovascular dis- ease, ‘‘(vii) shall not require a person who proposes to make a claim described in section 403(r)(1)(B) of such Act which is in compliance with such regulations to secure the approval of the Secretary before making such claim, ‘‘(viii) may permit a claim described in section 403(r)(1)(A) of such Act to be made for butter, ‘‘(ix) may, in defining terms under section 403(r)(2)(A)(i), include similar terms which are com- monly understood to have the same meaning, and ‘‘(x) shall establish, as required by section 403(r)(5)(D), the procedure and standard respecting the validity of claims made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances and shall determine whether claims respecting the following nutrients and diseases meet the requirements of section 403(r)(5)(D) of such Act: folic acid and neural tube de- fects, antioxident [sic] vitamins and cancer, zinc and immune function in the elderly, and omega-3 fatty acids and heart disease. ‘‘(B) Not later than 24 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, except that the Sec- retary shall issue, not later than December 31, 1993, such a final regulation applicable to dietary supple- ments of vitamins, minerals, herbs, or other similar nu- tritional substances..[sic] ‘‘(2) If the Secretary does not promulgate final regu- lations under paragraph (1)(B) upon the expiration of 24 months after the date of the enactment of this Act, the proposed regulations issued in accordance with para- graph (1)(A) shall be considered as the final regulations upon the expiration of such 24 months, except that the proposed regulations applicable to dietary supplements of vitamins, minerals, herbs, or other similar nutri- tional substances shall not be considered to be final regulations until December 31, 1993. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations [see 57 F.R. 56347].’’ [For construction of amendment made by section 202(a)(2)(B) of Pub. L. 102–571 to section 3(b) of Pub. L. Page 98 TITLE 21—FOOD AND DRUGS § 343 101–535 set out above, see section 202(a)(2)(C) of Pub. L. 102–571 set out above following section 2(b) of Pub. L. 101–535.] LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS Pub. L. 115–334, title XII, § 12516, Dec. 20, 2018, 132 Stat. 5000, provided that: ‘‘The food labeling require- ments under section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, that is packaged and offered for sale as a single-ingre- dient food bear the declaration ‘Includes X g Added Sugars.’.’’ FINDINGS Pub. L. 108–282, title II, § 202, Aug. 2, 2004, 118 Stat. 905, provided that: ‘‘Congress finds that— ‘‘(1) it is estimated that— ‘‘(A) approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and ‘‘(B) each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food; ‘‘(2)(A) eight major foods or food groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—account for 90 percent of food allergies; ‘‘(B) at present, there is no cure for food allergies; and ‘‘(C) a food allergic consumer must avoid the food to which the consumer is allergic; ‘‘(3)(A) in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999, the Food and Drug Administration found that 25 percent of sam- pled foods failed to list peanuts or eggs as ingredients on the food labels; and ‘‘(B) nationally, the number of recalls because of unlabeled allergens rose to 121 in 2000 from about 35 a decade earlier; ‘‘(4) a recent study shows that many parents of chil- dren with a food allergy were unable to correctly identify in each of several food labels the ingredients derived from major food allergens; ‘‘(5)(A) ingredients in foods must be listed by their ‘common or usual name’; ‘‘(B) in some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is de- rived from, or contains, a major food allergen; and ‘‘(C) in other cases, the ingredients may be declared as a class, including spices, flavorings, and certain colorings, or are exempt from the ingredient labeling requirements, such as incidental additives; and ‘‘(6)(A) celiac disease is an immune-mediated dis- ease that causes damage to the gastrointestinal tract, central nervous system, and other organs; ‘‘(B) the current recommended treatment is avoid- ance of glutens in foods that are associated with ce- liac disease; and ‘‘(C) a multicenter, multiyear study estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population.’’ RULEMAKINGS ON LABELING Pub. L. 118–42, div. B, title VII, § 745, Mar. 9, 2024, 138 Stat. 112, provided that: ‘‘(a) After the effective date of any final rule the Food and Drug Administration (FDA) publishes in con- nection with its proposed rule to update these require- ments (87 Federal Register 59168, issued on September 29, 2022), manufacturers may also continue to comply with the previous requirements promulgated by the FDA for the implied nutrient content claim ‘healthy’ through the ‘compliance date’ FDA provides in the final rule. ‘‘(b) Any food product manufactured and labeled as ‘healthy’ during the compliance period FDA provides in that final rule shall not be directly or indirectly sub- ject to any state-law requirements that are not iden- tical to either (i) the Federal requirements for the im- plied nutrition content claim ‘healthy’ that were in ef- fect as of the date FDA issues the final rule, or (ii) the updated Federal requirements that FDA promulgates in the final rule, assuming the updated requirements go into effect during the regulatory compliance period.’’ Pub. L. 108–282, title II, § 206, Aug. 2, 2004, 118 Stat. 910, provided that: ‘‘Not later than 2 years after the date of enactment of this Act [Aug. 2, 2004], the Sec- retary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Sec- retary shall issue a final rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods.’’ Pub. L. 107–171, title X, § 10809, May 13, 2002, 116 Stat. 531, provided that: ‘‘The Secretary of Health and Human Services (referred to in this section as the ‘Sec- retary’) shall publish a proposed rule and, with due con- sideration to public comment, a final rule to revise, as appropriate, the current regulation governing the la- beling of foods that have been treated to reduce pest in- festation or pathogens by treatment by irradiation using radioactive isotope, electronic beam, or x-ray. Pending promulgation of the final rule required by this subsection [probably should be ‘‘this section’’], any per- son may petition the Secretary for approval of label- ing, which is not false or misleading in any material re- spect, of a food which has been treated by irradiation using radioactive isotope, electronic beam, or x-ray. The Secretary shall approve or deny such a petition within 180 days of receipt of the petition, or the peti- tion shall be deemed denied, except to the extent addi- tional agency review is mutually agreed upon by the Secretary and the petitioner. Any denial of a petition under this subsection shall constitute final agency ac- tion subject to judicial review by the United States Court of Appeals for the District of Columbia Circuit. Any labeling approved through the foregoing petition process shall be subject to the provisions of the final rule referred to in the first sentence of the subpara- graph on the effective date of such final rule.’’ COMMISSION ON DIETARY SUPPLEMENT LABELS Pub. L. 103–417, § 12, Oct. 25, 1994, 108 Stat. 4332, pro- vided that: ‘‘(a) ESTABLISHMENT.—There shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the ‘Commission’). ‘‘(b) MEMBERSHIP.— ‘‘(1) COMPOSITION.—The Commission shall be com- posed of 7 members who shall be appointed by the President. ‘‘(2) EXPERTISE REQUIREMENT.—The members of the Commission shall consist of individuals with exper- tise and experience in dietary supplements and in the manufacture, regulation, distribution, and use of such supplements. At least three of the members of the Commission shall be qualified by scientific train- ing and experience to evaluate the benefits to health of the use of dietary supplements and one of such three members shall have experience in pharmacog- nosy, medical botany, traditional herbal medicine, or other related sciences. Members and staff of the Com- mission shall be without bias on the issue of dietary supplements. ‘‘(c) FUNCTIONS OF THE COMMISSION.—The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims. In mak- ing such recommendations, the Commission shall Page 99 TITLE 21—FOOD AND DRUGS § 343 evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appro- priate health care choices for themselves and their families. ‘‘(d) ADMINISTRATIVE POWERS OF THE COMMISSION.— ‘‘(1) HEARINGS.—The Commission may hold hear- ings, sit and act at such times and places, take such testimony, and receive such evidence as the Commis- sion considers advisable to carry out the purposes of this section. ‘‘(2) INFORMATION FROM FEDERAL AGENCIES.—The Commission may secure directly from any Federal department or agency such information as the Com- mission considers necessary to carry out the provi- sions of this section. ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary to carry out this section. ‘‘(e) REPORTS AND RECOMMENDATIONS.— ‘‘(1) FINAL REPORT REQUIRED.—Not later than 24 months after the date of enactment of this Act [Oct. 25, 1994], the Commission shall prepare and submit to the President and to the Congress a final report on the study required by this section. ‘‘(2) RECOMMENDATIONS.—The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate. ‘‘(3) ACTION ON RECOMMENDATIONS.—Within 90 days of the issuance of the report under paragraph (1), the Secretary of Health and Human Services shall pub- lish in the Federal Register a notice of any rec- ommendation of Commission for changes in regula- tions of the Secretary for the regulation of dietary supplements and shall include in such notice a notice of proposed rulemaking on such changes together with an opportunity to present views on such changes. Such rulemaking shall be completed not later than 2 years after the date of the issuance of such report. If such rulemaking is not completed on or before the expiration of such 2 years, regulations of the Secretary published in 59 FR 395–426 on Janu- ary 4, 1994, shall not be in effect.’’ EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED PRIOR TO AUGUST 8, 1994 Pub. L. 103–261, May 26, 1994, 108 Stat. 705, provided: ‘‘That before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the provision of section 403(i) of such Act added by section 7(2) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], shall not apply with respect to a food product which is contained in a package for which the label was printed before May 8, 1994 (or before August 8, 1994, in the case of a juice or milk food product if the person responsible for the la- beling of such food product exercised due diligence in obtaining before such date labels which are in compli- ance with such sections 403(q) and 403(r)(2) and such provision of section 403(i)), if, before June 15, 1994, the person who introduces or delivers for introduction such food product into interstate commerce submits to the Secretary of Health and Human Services a certification that such person will comply with this section and will comply with such sections 403(q) and 403(r)(2) and such provision of section 403(i) after August 8, 1994.’’ LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION Pub. L. 103–80, § 2(a), Aug. 13, 1993, 107 Stat. 773, pro- vided that: ‘‘(1) BEFORE MAY 8, 1995.—Before May 8, 1995, the ex- emption provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in accordance with the regulations of the Secretary of Health and Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993). ‘‘(2) AFTER MAY 8, 1995.—After May 8, 1995, the exemp- tion provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act shall only be available with respect to food when it is sold to consumers.’’ PROHIBITION ON IMPLEMENTATION OF PUB. L. 101–535 WITH RESPECT TO DIETARY SUPPLEMENTS Pub. L. 102–571, title II, § 202(a)(1), Oct. 29, 1992, 106 Stat. 4500, provided that: ‘‘Notwithstanding any other provision of law and except as provided in subsection (b) [set out as a note below] and in the amendment made by paragraph (2)(A) [amending provisions set out as notes above], the Secretary of Health and Human Services may not implement the Nutrition Labeling and Education Act of 1990 (Public Law 101–535; 104 Stat. 2353) [see Short Title of 1990 Amendments note set out under section 301 of this title], or any amendment made by such Act, earlier than December 15, 1993, with re- spect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances.’’ HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS Pub. L. 102–571, title II, § 202(b), Oct. 29, 1992, 106 Stat. 4501, provided that: ‘‘Notwithstanding section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions set out as notes above and amending provi- sions set out as notes above and under section 343–1 of this title], the Secretary of Health and Human Services may, earlier than December 15, 1993, approve claims made with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances that are claims described in clauses (vi) and (x) of sec- tion 3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535] (21 U.S.C. 343 note).’’ UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS Pub. L. 102–571, title II, § 203, Oct. 29, 1992, 106 Stat. 4502, provided that: ‘‘Notwithstanding any other provi- sion of Federal law, no regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals may be promulgated before No- vember 8, 1993 (other than regulations establishing the United States recommended daily allowances specified at section 101.9(c)(7)(iv) of title 21, Code of Federal Reg- ulations, as in effect on October 6, 1992, or regulations under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such recommended daily allowances).’’ CONSUMER EDUCATION Pub. L. 101–535, § 2(c), Nov. 8, 1990, 104 Stat. 2357, pro- vided that: ‘‘The Secretary of Health and Human Serv- ices shall carry out activities which educate consumers about— ‘‘(1) the availability of nutrition information in the label or labeling of food, and ‘‘(2) the importance of that information in main- taining healthy dietary practices.’’ STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD AND IMPURITIES IN AND TOX- ICITY OF SACCHARIN Pub. L. 95–203, § 2, Nov. 23, 1977, 91 Stat. 1451, directed Secretary of Health, Education, and Welfare to conduct a study concerning carcinogenic and other toxic sub- stances in food and impurities in and toxicity of sac- charin and make a report respecting the carcinogenic and other substances to Committee on Human Re- sources of the Senate within 12 months of Nov. 23, 1977, and a report respecting saccharin to such committee within 15 months of Nov. 23, 1977. REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT TO FORMER PAR. (o)(2) Pub. L. 95–203, § 4(a)(3), Nov. 23, 1977, 91 Stat. 1453, pro- vided that the Secretary was to report to specified con- gressional committees any action taken under former par. (o)(2) of this section. Page 100 TITLE 21—FOOD AND DRUGS § 343–1 STATE OR TERRITORIAL REQUIREMENTS Pub. L. 86–537, § 2, June 29, 1960, 74 Stat. 251, provided that: ‘‘Nothing in the amendments made by the first section of this Act [amending this section] shall affect any requirement of the laws of any State or Territory.’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 343–1. National uniform nutrition labeling (a) Except as provided in subsection (b), no State or political subdivision of a State may di- rectly or indirectly establish under any author- ity or continue in effect as to any food in inter- state commerce— (1) any requirement for a food which is the subject of a standard of identity established under section 341 of this title that is not iden- tical to such standard of identity or that is not identical to the requirement of section 343(g) of this title, except that this paragraph does not apply to a standard of identity of a State or political subdivision of a State for maple syrup that is of the type required by sections 341 and 343(g) of this title, (2) any requirement for the labeling of food of the type required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x) of this title that is not identical to the requirement of such sec- tion, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type re- quired by section 343(c) of this title and that is applicable to maple syrup, (3) any requirement for the labeling of food of the type required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or polit- ical subdivision of a State that is of the type required by section 343(h)(1) of this title and that is applicable to maple syrup, (4) any requirement for nutrition labeling of food that is not identical to the requirement of section 343(q) of this title, except that this paragraph does not apply to food that is of- fered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of own- ership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food estab- lishment complies with the voluntary provi- sion of nutrition information requirements under section 343(q)(5)(H)(ix) of this title, or (5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title, except a requirement re- specting a claim made in the label or labeling of food which is exempt under section 343(r)(5)(B) of this title. Paragraph (3) shall take effect in accordance with section 6(b) of the Nutrition Labeling and Education Act of 1990. (b) Upon petition of a State or a political sub- division of a State, the Secretary may exempt from subsection (a), under such conditions as may be prescribed by regulation, any State or local requirement that— (1) would not cause any food to be in viola- tion of any applicable requirement under Fed- eral law, (2) would not unduly burden interstate com- merce, and (3) is designed to address a particular need for information which need is not met by the requirements of the sections referred to in subsection (a). (June 25, 1938, ch. 675, § 403A, as added Pub. L. 101–535, § 6(a), Nov. 8, 1990, 104 Stat. 2362; amend- ed Pub. L. 102–108, § 2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103–396, § 3(a), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108–282, title II, § 203(c)(2), Aug. 2, 2004, 118 Stat. 908; Pub. L. 111–148, title IV, § 4205(c), Mar. 23, 2010, 124 Stat. 576.) Editorial Notes REFERENCES IN TEXT Section 6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], referred to in subsec. (a), is set out below. AMENDMENTS 2010—Subsec. (a)(4). Pub. L. 111–148 substituted ‘‘ex- cept that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food es- tablishment that is not part of a chain with 20 or more locations doing business under the same name (regard- less of the type of ownership of the locations) and offer- ing for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition in- formation requirements under section 343(q)(5)(H)(ix) of this title’’ for ‘‘except a requirement for nutrition la- beling of food which is exempt under subclause (i) or (ii) of section 343(q)(5)(A) of this title’’. 2004—Subsec. (a)(2). Pub. L. 108–282 substituted ‘‘343(i)(2), 343(w), or 343(x)’’ for ‘‘or 343(i)(2)’’. 1994—Subsec. (a)(1). Pub. L. 103–396, § 3(a)(1), inserted at end ‘‘except that this paragraph does not apply to a standard of identity of a State or political subdivision of a State for maple syrup that is of the type required by sections 341 and 343(g) of this title,’’. Subsec. (a)(2). Pub. L. 103–396, § 3(a)(2), inserted at end ‘‘except that this paragraph does not apply to a re- quirement of a State or political subdivision of a State that is of the type required by section 343(c) of this title and that is applicable to maple syrup,’’. Subsec. (a)(3). Pub. L. 103–396, § 3(a)(3), inserted at end ‘‘except that this paragraph does not apply to a re- quirement of a State or political subdivision of a State that is of the type required by section 343(h)(1) of this title and that is applicable to maple syrup,’’. 1991—Subsec. (a)(5). Pub. L. 102–108 substituted ‘‘sec- tion 343(r)(5)(B) of this title’’ for ‘‘clause (B) of such section’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2004 AMENDMENT Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108–282, set out as a note under section 321 of this title. EFFECTIVE DATE Pub. L. 101–535, § 10(b), Nov. 8, 1990, 104 Stat. 2366, as amended by Pub. L. 102–571, title I, § 107(16), title II,