21 U.S.C. § 387i — Records and reports on tobacco products

Page 683 TITLE 21—FOOD AND DRUGS § 387i (2) Amendment of order to require recall (A) In general If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the to- bacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. (B) Notice An amended order under subparagraph (A)— (i) shall not include recall of a tobacco product from individuals; and (ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product. In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant num- ber of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title. (3) Remedy not exclusive The remedy provided by this subsection shall be in addition to remedies provided by subsection (a). (June 25, 1938, ch. 675, § 908, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1804.) Editorial Notes PRIOR PROVISIONS A prior section 908 of act June 25, 1938, was renum- bered section 1008 and is classified to section 398 of this title. § 387i. Records and reports on tobacco products (a) In general Every person who is a tobacco product manu- facturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adul- terated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence— (1) may require a tobacco product manufac- turer or importer to report to the Secretary whenever the manufacturer or importer re- ceives or otherwise becomes aware of informa- tion that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the prod- uct or any significant increase in the fre- quency of a serious, expected adverse product experience; (2) shall require reporting of other signifi- cant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported; (3) shall not impose requirements unduly burdensome to a tobacco product manufac- turer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this sub- chapter; (4) when prescribing the procedure for mak- ing requests for reports or information, shall require that each request made under such regulations for submission of a report or infor- mation to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or infor- mation; (5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the full- est extent practicable such report or informa- tion; and (6) may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, re- port, or information submitted under this sub- chapter. In prescribing regulations under this subsection, the Secretary shall have due regard for the pro- fessional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, re- ports, and information concerning any indi- vidual who has been a patient, irrespective of whether or when he ceases to be a patient. (b) Reports of removals and corrections (1) In general Except as provided in paragraph (2), the Sec- retary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the re- moval or correction was undertaken— (A) to reduce a risk to health posed by the tobacco product; or (B) to remedy a violation of this sub- chapter caused by the tobacco product which may present a risk to health. A tobacco product manufacturer or importer of a tobacco product who undertakes a correc- tive action or removal from the market of a tobacco product which is not required to be re- ported under this subsection shall keep a record of such correction or removal. (2) Exception No report of the corrective action or re- moval of a tobacco product may be required under paragraph (1) if a report of the correc- tive action or removal is required and has been submitted under subsection (a). (June 25, 1938, ch. 675, § 909, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1805.) Page 684 TITLE 21—FOOD AND DRUGS § 387j Editorial Notes PRIOR PROVISIONS A prior section 909 of act June 25, 1938, was renum- bered section 1009 and is classified to section 399 of this title. § 387j. Application for review of certain tobacco products (a) In general (1) New tobacco product defined For purposes of this section the term ‘‘new tobacco product’’ means— (A) any tobacco product (including those products in test markets) that was not com- mercially marketed in the United States as of February 15, 2007; or (B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nico- tine, or any other additive or ingredient) of a tobacco product where the modified prod- uct was commercially marketed in the United States after February 15, 2007. (2) Premarket review required (A) New products An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless— (i) the manufacturer has submitted a re- port under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product— (I) is substantially equivalent to a to- bacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and (II) is in compliance with the require- ments of this chapter; or (ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title. (B) Application to certain post-February 15, 2007, products Subparagraph (A) shall not apply to a to- bacco product— (i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and (ii) for which a report was submitted under section 387e(j) of this title within such 21-month period, except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not sub- stantially equivalent. (3) Substantially equivalent defined (A) In general In this section and section 387e(j) of this title, the term ‘‘substantially equivalent’’ or ‘‘substantial equivalence’’ means, with re- spect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the to- bacco product— (i) has the same characteristics as the predicate tobacco product; or (ii) has different characteristics and the information submitted contains informa- tion, including clinical data if deemed nec- essary by the Secretary, that dem- onstrates that it is not appropriate to reg- ulate the product under this section be- cause the product does not raise different questions of public health. (B) Characteristics In subparagraph (A), the term ‘‘character- istics’’ means the materials, ingredients, de- sign, composition, heating source, or other features of a tobacco product. (C) Limitation A tobacco product may not be found to be substantially equivalent to a predicate to- bacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated. (4) Health information (A) Summary As part of a submission under section 387e(j) of this title respecting a tobacco product, the person required to file a pre- market notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person. (B) Required information Any summary under subparagraph (A) re- specting a tobacco product shall contain de- tailed information regarding data con- cerning adverse health effects and shall be made available to the public by the Sec- retary within 30 days of the issuance of a de- termination that such tobacco product is substantially equivalent to another tobacco product. (b) Application (1) Contents An application under this section shall con- tain— (A) full reports of all information, pub- lished or known to, or which should reason- ably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco prod- uct and whether such tobacco product pre- sents less risk than other tobacco products; (B) a full statement of the components, in- gredients, additives, and properties, and of the principle or principles of operation, of such tobacco product; (C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when rel- evant, packing and installation of, such to- bacco product; (D) an identifying reference to any tobacco product standard under section 387g of this