21 U.S.C. § 387 — Definitions

Page 664 TITLE 21—FOOD AND DRUGS § 387 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see sec- tion 301 of this title and Tables. Statutory Notes and Related Subsidiaries CODIFICATION Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Pro- motes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Pa- tients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. SUBCHAPTER IX—TOBACCO PRODUCTS Editorial Notes PRIOR PROVISIONS A prior subchapter IX of this chapter, consisting of sections 391 to 399a of this title, was redesignated sub- chapter X by Pub. L. 111–31, div. A, title I, § 101(b)(1), June 22, 2009, 123 Stat. 1784. § 387. Definitions In this subchapter: (1) Additive The term ‘‘additive’’ means any substance the intended use of which results or may rea- sonably be expected to result, directly or indi- rectly, in its becoming a component or other- wise affecting the characteristic of any to- bacco product (including any substances in- tended for use as a flavoring or coloring or in producing, manufacturing, packing, proc- essing, preparing, treating, packaging, trans- porting, or holding), except that such term does not include tobacco or a pesticide chem- ical residue in or on raw tobacco or a pesticide chemical. (2) Brand The term ‘‘brand’’ means a variety of to- bacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, reg- istered trademark, brand name, identifiable pattern of colors, or any combination of such attributes. (3) Cigarette The term ‘‘cigarette’’— (A) means a product that— (i) is a tobacco product; and (ii) meets the definition of the term ‘‘cigarette’’ in section 1332(1) of title 15; and (B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, con- sumers as a cigarette or as roll-your-own to- bacco. (4) Cigarette tobacco The term ‘‘cigarette tobacco’’ means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements ap- plicable to cigarettes under this subchapter shall also apply to cigarette tobacco. (5) Commerce The term ‘‘commerce’’ has the meaning given that term by section 1332(2) of title 15. (6) Counterfeit tobacco product The term ‘‘counterfeit tobacco product’’ means a tobacco product (or the container or labeling of such a product) that, without au- thorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 387e(i)(1) of this title. (7) Distributor The term ‘‘distributor’’ as regards a tobacco product means any person who furthers the distribution of a tobacco product, whether do- mestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individ- uals for personal consumption. Common car- riers are not considered distributors for pur- poses of this subchapter. (8) Illicit trade The term ‘‘illicit trade’’ means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, dis- tribution, sale, or purchase of tobacco prod- ucts including any practice or conduct in- tended to facilitate such activity. (9) Indian country The term ‘‘Indian country’’ has the meaning given such term in section 1151 of title 18. (10) Indian tribe The term ‘‘Indian tribe’’ has the meaning given such term in section 5304(e) of title 25. (11) Little cigar The term ‘‘little cigar’’ means a product that— (A) is a tobacco product; and (B) meets the definition of the term ‘‘little cigar’’ in section 1332(7) of title 15. (12) Nicotine The term ‘‘nicotine’’ means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine. (13) Package The term ‘‘package’’ means a pack, box, car- ton, or container of any kind or, if no other container, any wrapping (including cello- phane), in which a tobacco product is offered for sale, sold, or otherwise distributed to con- sumers. (14) Retailer The term ‘‘retailer’’ means any person, gov- ernment, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service dis- plays of tobacco products are permitted. (15) Roll-your-own tobacco The term ‘‘roll-your-own tobacco’’ means any tobacco product which, because of its ap- Page 665 TITLE 21—FOOD AND DRUGS § 387 pearance, type, packaging, or labeling, is suit- able for use and likely to be offered to, or pur- chased by, consumers as tobacco for making cigarettes. (16) Small tobacco product manufacturer The term ‘‘small tobacco product manufac- turer’’ means a tobacco product manufacturer that employs fewer than 350 employees. For purposes of determining the number of em- ployees of a manufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each enti- ty that controls, is controlled by, or is under common control with such manufacturer. (17) Smoke constituent The term ‘‘smoke constituent’’ means any chemical or chemical compound in main- stream or sidestream tobacco smoke that ei- ther transfers from any component of the cig- arette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product. (18) Smokeless tobacco The term ‘‘smokeless tobacco’’ means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. (19) State; Territory The terms ‘‘State’’ and ‘‘Territory’’ shall have the meanings given to such terms in sec- tion 321 of this title. (20) Tobacco product manufacturer The term ‘‘tobacco product manufacturer’’ means any person, including any repacker or relabeler, who— (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States. (21) Tobacco warehouse (A) Subject to subparagraphs (B) and (C), the term ‘‘tobacco warehouse’’ includes any per- son— (i) who— (I) removes foreign material from to- bacco leaf through nothing other than a mechanical process; (II) humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or (III) de-stems, dries, and packs tobacco leaf for storage and shipment; (ii) who performs no other actions with re- spect to tobacco leaf; and (iii) who provides to any manufacturer to whom the person sells tobacco all informa- tion related to the person’s actions described in clause (i) that is necessary for compliance with this chapter. (B) The term ‘‘tobacco warehouse’’ excludes any person who— (i) reconstitutes tobacco leaf; (ii) is a manufacturer, distributor, or re- tailer of a tobacco product; or (iii) applies any chemical, additive, or sub- stance to the tobacco leaf other than potable water in the form of steam or mist. (C) The definition of the term ‘‘tobacco warehouse’’ in subparagraph (A) shall not apply to the extent to which the Secretary de- termines, through rulemaking, that regula- tion under this subchapter of the actions de- scribed in such subparagraph is appropriate for the protection of the public health. (22) United States The term ‘‘United States’’ means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Is- lands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States. (June 25, 1938, ch. 675, § 900, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1784.) Statutory Notes and Related Subsidiaries SEVERABILITY Pub. L. 111–31, div. A, § 5, June 22, 2009, 123 Stat. 1782, provided that: ‘‘If any provision of this division [see Short Title of 2009 Amendment note set out under sec- tion 301 of this title], of the amendments made by this division, or of the regulations promulgated under this division (or under such amendments), or the applica- tion of any such provision to any person or cir- cumstance is held to be invalid, the remainder of this division, such amendments and such regulations, and the application of such provisions to any other person or circumstance shall not be affected and shall con- tinue to be enforced to the fullest extent possible.’’ CONSTRUCTION Pub. L. 111–31, div. A, § 4, June 22, 2009, 123 Stat. 1782, provided that: ‘‘(a) INTENDED EFFECT.—Nothing in this division [see Short Title of 2009 Amendment note set out under sec- tion 301 of this title] (or an amendment made by this division) shall be construed to— ‘‘(1) establish a precedent with regard to any other industry, situation, circumstance, or legal action; or ‘‘(2) affect any action pending in Federal, State, or tribal court, or any agreement, consent decree, or contract of any kind. ‘‘(b) AGRICULTURAL ACTIVITIES.—The provisions of this division (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco and tobacco products shall not be construed to affect any authority of the Secretary of Agriculture under existing law regarding the growing, cultivation, or curing of raw tobacco. ‘‘(c) REVENUE ACTIVITIES.—The provisions of this divi- sion (or an amendment made by this division) which authorize the Secretary to take certain actions with regard to tobacco products shall not be construed to af- fect any authority of the Secretary of the Treasury under chapter 52 of the Internal Revenue Code of 1986 [26 U.S.C. 5701 et seq.].’’ FINDINGS Pub. L. 111–31, div. A, § 2, June 22, 2009, 123 Stat. 1776, provided that: ‘‘The Congress finds the following: ‘‘(1) The use of tobacco products by the Nation’s children is a pediatric disease of considerable propor- tions that results in new generations of tobacco-de- pendent children and adults. ‘‘(2) A consensus exists within the scientific and medical communities that tobacco products are in- herently dangerous and cause cancer, heart disease, and other serious adverse health effects. ‘‘(3) Nicotine is an addictive drug. Page 666 TITLE 21—FOOD AND DRUGS § 387 ‘‘(4) Virtually all new users of tobacco products are under the minimum legal age to purchase such prod- ucts. ‘‘(5) Tobacco advertising and marketing contribute significantly to the use of nicotine-containing to- bacco products by adolescents. ‘‘(6) Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed. ‘‘(7) Federal and State governments have lacked the legal and regulatory authority and resources they need to address comprehensively the public health and societal problems caused by the use of tobacco products. ‘‘(8) Federal and State public health officials, the public health community, and the public at large rec- ognize that the tobacco industry should be subject to ongoing oversight. ‘‘(9) Under article I, section 8 of the Constitution, the Congress is vested with the responsibility for reg- ulating interstate commerce and commerce with In- dian tribes. ‘‘(10) The sale, distribution, marketing, advertising, and use of tobacco products are activities in and sub- stantially affecting interstate commerce because they are sold, marketed, advertised, and distributed in interstate commerce on a nationwide basis, and have a substantial effect on the Nation’s economy. ‘‘(11) The sale, distribution, marketing, advertising, and use of such products substantially affect inter- state commerce through the health care and other costs attributable to the use of tobacco products. ‘‘(12) It is in the public interest for Congress to enact legislation that provides the Food and Drug Administration with the authority to regulate to- bacco products and the advertising and promotion of such products. The benefits to the American people from enacting such legislation would be significant in human and economic terms. ‘‘(13) Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year, and approxi- mately 8,600,000 Americans have chronic illnesses re- lated to smoking. ‘‘(14) Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, sav- ing over 3,000,000 of them from premature death due to tobacco-induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs. ‘‘(15) Advertising, marketing, and promotion of to- bacco products have been especially directed to at- tract young persons to use tobacco products, and these efforts have resulted in increased use of such products by youth. Past efforts to oversee these ac- tivities have not been successful in adequately pre- venting such increased use. ‘‘(16) In 2005, the cigarette manufacturers spent more than $13,000,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smok- ing and tobacco use. ‘‘(17) Tobacco product advertising often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors. ‘‘(18) Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of 18 are regularly exposed to tobacco product promotional efforts. ‘‘(19) Through advertisements during and sponsor- ship of sporting events, tobacco has become strongly associated with sports and has become portrayed as an integral part of sports and the healthy lifestyle as- sociated with rigorous sporting activity. ‘‘(20) Children are exposed to substantial and un- avoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of to- bacco use, and increases the number of young people who begin to use tobacco. ‘‘(21) The use of tobacco products in motion pic- tures and other mass media glamorizes its use for young people and encourages them to use tobacco products. ‘‘(22) Tobacco advertising expands the size of the to- bacco market by increasing consumption of tobacco products including tobacco use by young people. ‘‘(23) Children are more influenced by tobacco mar- keting than adults: more than 80 percent of youth smoke three heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands. ‘‘(24) Tobacco company documents indicate that young people are an important and often crucial seg- ment of the tobacco market. Children, who tend to be more price sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices. ‘‘(25) Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people. ‘‘(26) Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from under- mining legislation prohibiting access to young people and providing for education about tobacco use. ‘‘(27) International experience shows that adver- tising regulations that are stringent and comprehen- sive have a greater impact on overall tobacco use and young people’s use than weaker or less comprehen- sive ones. ‘‘(28) Text only requirements, although not as strin- gent as a ban, will help reduce underage use of to- bacco products while preserving the informational function of advertising. ‘‘(29) It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of the tobacco industry. ‘‘(30) The final regulations promulgated by the Sec- retary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion as part 897 of title 21, Code of Federal Regulations, are consistent with the first amendment to the United States Constitution and with the standards set forth in the amendments made by this subtitle [probably means this division, see Short Title of 2009 Amendment note set out under section 301 of this title] for the regulation of tobacco products by the Food and Drug Administration, and the restriction on the sale and distribution of, includ- ing access to and the advertising and promotion of, tobacco products contained in such regulations are substantially related to accomplishing the public health goals of this division. ‘‘(31) The regulations described in paragraph (30) will directly and materially advance the Federal Gov- ernment’s substantial interest in reducing the num- ber of children and adolescents who use cigarettes and smokeless tobacco and in preventing the life- threatening health consequences associated with to- bacco use. An overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18. Tobacco advertising and promotion play a crucial role in the decision of these minors to begin using to- bacco products. Less restrictive and less comprehen- sive approaches have not [been] and will not be effec- tive in reducing the problems addressed by such regu- lations. The reasonable restrictions on the adver- tising and promotion of tobacco products contained in such regulations will lead to a significant decrease in the number of minors using and becoming addicted to those products. ‘‘(32) The regulations described in paragraph (30) impose no more extensive restrictions on commu- nication by tobacco manufacturers and sellers than Page 667 TITLE 21—FOOD AND DRUGS § 387 are necessary to reduce the number of children and adolescents who use cigarettes and smokeless to- bacco and to prevent the life-threatening health con- sequences associated with tobacco use. Such regula- tions are narrowly tailored to restrict those adver- tising and promotional practices which are most like- ly to be seen or heard by youth and most likely to en- tice them into tobacco use, while affording tobacco manufacturers and sellers ample opportunity to con- vey information about their products to adult con- sumers. ‘‘(33) Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve long-term or permanent abstinence. ‘‘(34) Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely. ‘‘(35) Tobacco products have been used to facilitate and finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups. ‘‘(36) It is essential that the Food and Drug Admin- istration review products sold or distributed for use to reduce risks or exposures associated with tobacco products and that it be empowered to review any ad- vertising and labeling for such products. It is also es- sential that manufacturers, prior to marketing such products, be required to demonstrate that such prod- ucts will meet a series of rigorous criteria, and will benefit the health of the population as a whole, tak- ing into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘(37) Unless tobacco products that purport to re- duce the risks to the public of tobacco use actually reduce such risks, those products can cause substan- tial harm to the public health to the extent that the individuals, who would otherwise not consume to- bacco products or would consume such products less, use tobacco products purporting to reduce risk. Those who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than quitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and premature death. The costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnec- essary deaths and injuries and huge costs to our health care system. ‘‘(38) As the National Cancer Institute has found, many smokers mistakenly believe that ‘low tar’ and ‘light’ cigarettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken beliefs about the health consequences of smoking ‘low tar’ and ‘light’ ciga- rettes can reduce the motivation to quit smoking en- tirely and thereby lead to disease and death. ‘‘(39) Recent studies have demonstrated that there has been no reduction in risk on a population-wide basis from ‘low tar’ and ‘light’ cigarettes, and such products may actually increase the risk of tobacco use. ‘‘(40) The dangers of products sold or distributed as modified risk tobacco products that do not in fact re- duce risk are so high that there is a compelling gov- ernmental interest in ensuring that statements about modified risk tobacco products are complete, accu- rate, and relate to the overall disease risk of the product. ‘‘(41) As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclo- sures and advisories intended to provide clarification. ‘‘(42) Permitting manufacturers to make unsub- stantiated statements concerning modified risk to- bacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health. ‘‘(43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk re- duction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified. ‘‘(44) The Food and Drug Administration is a regu- latory agency with the scientific expertise to identify harmful substances in products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific studies sup- porting claims about the safety of products, and to evaluate the impact of labels, labeling, and adver- tising on consumer behavior in order to reduce the risk of harm and promote understanding of the im- pact of the product on health. In connection with its mandate to promote health and reduce the risk of harm, the Food and Drug Administration routinely makes decisions about whether and how products may be marketed in the United States. ‘‘(45) The Federal Trade Commission was created to protect consumers from unfair or deceptive acts or practices, and to regulate unfair methods of competi- tion. Its focus is on those marketplace practices that deceive or mislead consumers, and those that give some competitors an unfair advantage. Its mission is to regulate activities in the marketplace. Neither the Federal Trade Commission nor any other Federal agency except the Food and Drug Administration possesses the scientific expertise needed to imple- ment effectively all provisions of the Family Smok- ing Prevention and Tobacco Control Act [div. A of Pub. L. 111–31, see Short Title of 2009 Amendment note set out under section 301 of this title]. ‘‘(46) If manufacturers state or imply in commu- nications directed to consumers through the media or through a label, labeling, or advertising, that a to- bacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending upon the par- ticular language used and its context, such a state- ment could result in consumers being misled into be- lieving that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compli- ance. ‘‘(47) In August 2006 a United States district court judge found that the major United States cigarette companies continue to target and market to youth. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006). ‘‘(48) In August 2006 a United States district court judge found that the major United States cigarette companies dramatically increased their advertising and promotional spending in ways that encourage youth to start smoking subsequent to the signing of the Master Settlement Agreement in 1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006). ‘‘(49) In August 2006 a United States district court judge found that the major United States cigarette companies have designed their cigarettes to precisely control nicotine delivery levels and provide doses of nicotine sufficient to create and sustain addiction while also concealing much of their nicotine-related research. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 2006).’’ PURPOSE Pub. L. 111–31, div. A, § 3, June 22, 2009, 123 Stat. 1781, provided that: ‘‘The purposes of this division [see Short Title of 2009 Amendment note set out under section 301 of this title] are— ‘‘(1) to provide authority to the Food and Drug Ad- ministration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal reg- ulatory authority with respect to the manufacture, Page 668 TITLE 21—FOOD AND DRUGS § 387a marketing, and distribution of tobacco products as provided for in this division; ‘‘(2) to ensure that the Food and Drug Administra- tion has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on to- bacco; ‘‘(3) to authorize the Food and Drug Administration to set national standards controlling the manufac- ture of tobacco products and the identity, public dis- closure, and amount of ingredients used in such prod- ucts; ‘‘(4) to provide new and flexible enforcement au- thority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products; ‘‘(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products; ‘‘(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products; ‘‘(7) to continue to permit the sale of tobacco prod- ucts to adults in conjunction with measures to ensure that they are not sold or accessible to underage pur- chasers; ‘‘(8) to impose appropriate regulatory controls on the tobacco industry; ‘‘(9) to promote cessation to reduce disease risk and the social costs associated with tobacco-related dis- eases; and ‘‘(10) to strengthen legislation against illicit trade in tobacco products.’’ MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION Pub. L. 111–31, div. A, § 6, June 22, 2009, 123 Stat. 1783, provided that: ‘‘(a) DELAYED COMMENCEMENT OF DATES FOR SECRE- TARIAL ACTION.— ‘‘(1) IN GENERAL.—Except as provided in subsection (c), with respect to any time periods specified in this division [see Short Title of 2009 Amendment note set out under section 301 of this title] (or in an amend- ment made by this division) that begin on the date of enactment of this Act [June 22, 2009], within which the Secretary of Health and Human Services is re- quired to carry out and complete specified activities, the calculation of such time periods shall commence on the date described in subsection (b). ‘‘(2) LIMITATION.—Subsection (a) shall only apply with respect to obligations of the Secretary of Health and Human Services that must be completed within a specified time period and shall not apply to the ob- ligations of any other person or to any other provi- sion of this division (including the amendments made by this division) that do not create such obligations of the Secretary and are not contingent on actions by the Secretary. ‘‘(b) DATE DESCRIBED.—The date described in this sub- section is the first day of the first fiscal quarter fol- lowing the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary of Health and Human Services has collected fees under section 919 of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 387s] (as added by section 101). ‘‘(c) EXCEPTION.—Subsection (a) shall not apply to any time period (or date) contained— ‘‘(1) in section 102 [21 U.S.C. 387a–1], except that the reference to ‘180 days’ in subsection (a)(1) of such sec- tion shall be deemed to be ‘270 days’; and ‘‘(2) in sections 201 through 204 [amending sections 1333, 1334, and 4402 of Title 15, Commerce and Trade, and enacting provisions set out as notes under sec- tions 1333 and 4402 of Title 15] (or the amendments made by any such sections). ‘‘(d) ADJUSTMENT.—The Secretary of Health and Human Services may extend or reduce the duration of one or more time periods to which subsection (a) ap- plies if the Secretary determines appropriate [sic], ex- cept that no such period shall be extended for more than 90 days.’’ § 387a. FDA authority over tobacco products (a) In general Tobacco products, including modified risk to- bacco products for which an order has been issued in accordance with section 387k of this title, shall be regulated by the Secretary under this subchapter and shall not be subject to the provisions of subchapter V. (b) Applicability This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter. This subchapter shall also apply to any tobacco product con- taining nicotine that is not made or derived from tobacco. (c) Scope (1) In general Nothing in this subchapter, or any policy issued or regulation promulgated thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Preven- tion and Tobacco Control Act, shall be con- strued to affect, expand, or limit the Sec- retary’s authority over (including the author- ity to determine whether products may be reg- ulated), or the regulation of, products under this chapter that are not tobacco products under subchapter V or any other subchapter. (2) Limitation of authority (A) In general The provisions of this subchapter shall not apply to tobacco leaf that is not in the pos- session of a manufacturer of tobacco prod- ucts, or to the producers of tobacco leaf, in- cluding tobacco growers, tobacco ware- houses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Ad- ministration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such pro- ducer. (B) Exception Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a to- bacco product manufacturer, the producer shall be subject to this subchapter in the producer’s capacity as a manufacturer. The exception in this subparagraph shall not apply to a producer of tobacco leaf who grows tobacco under a contract with a to- bacco product manufacturer and who is not otherwise engaged in the manufacturing process. (C) Rule of construction Nothing in this subchapter shall be con- strued to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.