21 U.S.C. § 387h — Notification and other remedies

Page 682 TITLE 21—FOOD AND DRUGS § 387h regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. (E) Public availability The Secretary shall make a copy of each report and recommendation under subpara- graph (D) publicly available. (e) Menthol cigarettes (1) Referral; considerations Immediately upon the establishment of the Tobacco Products Scientific Advisory Com- mittee under section 387q(a) of this title, the Secretary shall refer to the Committee for re- port and recommendation, under section 387q(c)(4) of this title, the issue of the impact of the use of menthol in cigarettes on the pub- lic health, including such use among children, African-Americans, Hispanics, and other ra- cial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Com- mittee shall address the considerations listed in subsections (a)(3)(B)(i) and (b). (2) Report and recommendation Not later than 1 year after its establish- ment, the Tobacco Product Scientific Advi- sory Committee shall submit to the Secretary the report and recommendations required pur- suant to paragraph (1). (3) Rule of construction Nothing in this subsection shall be con- strued to limit the Secretary’s authority to take action under this section or other sec- tions of this chapter applicable to menthol. (f) Dissolvable tobacco products (1) Referral; considerations The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsection (a)(3)(B)(i). (2) Report and recommendation Not later than 2 years after its establish- ment, the Tobacco Product Scientific Advi- sory Committee shall submit to the Secretary the report and recommendations required pur- suant to paragraph (1). (3) Rule of construction Nothing in this subsection shall be con- strued to limit the Secretary’s authority to take action under this section or other sec- tions of this chapter at any time applicable to any dissolvable tobacco product. (June 25, 1938, ch. 675, § 907, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1799; amended Pub. L. 117–103, div. P, title I, § 111(f), Mar. 15, 2022, 136 Stat. 790.) Editorial Notes PRIOR PROVISIONS A prior section 907 of act June 25, 1938, was renum- bered section 1007 and is classified to section 397 of this title. AMENDMENTS 2022—Subsec. (b)(1). Pub. L. 117–103 inserted before pe- riod at end ‘‘, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class con- taining nicotine not made or derived from tobacco and products containing nicotine made or derived from to- bacco’’. § 387h. Notification and other remedies (a) Notification If the Secretary determines that— (1) a tobacco product which is introduced or delivered for introduction into interstate com- merce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and (2) notification under this subsection is nec- essary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this sub- chapter (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly re- ceive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public serv- ice announcements. Before issuing an order under this subsection, the Secretary shall con- sult with the persons who are to give notice under the order. (b) No exemption from other liability Compliance with an order issued under this section shall not relieve any person from liabil- ity under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any rem- edy provided under such order shall be taken into account. (c) Recall authority (1) In general If the Secretary finds that there is a reason- able probability that a tobacco product con- tains a manufacturing or other defect not or- dinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, import- ers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an oppor- tunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the ac- tions required by the order, the Secretary shall vacate the order. 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.)