21 U.S.C. § 387p — Preservation of State and local authority

Page 693 TITLE 21—FOOD AND DRUGS § 387p (4) Joint laboratory testing services The Secretary shall allow any 2 or more small tobacco product manufacturers to join together to purchase laboratory testing serv- ices required by this section on a group basis in order to ensure that such manufacturers re- ceive access to, and fair pricing of, such test- ing services. (e) Extensions for limited laboratory capacity (1) In general The regulations promulgated under sub- section (a) shall provide that a small tobacco product manufacturer shall not be considered to be in violation of this section before the deadline applicable under paragraphs (3) and (4), if— (A) the tobacco products of such manufac- turer are in compliance with all other re- quirements of this subchapter; and (B) the conditions described in paragraph (2) are met. (2) Conditions Notwithstanding the requirements of this section, the Secretary may delay the date by which a small tobacco product manufacturer must be in compliance with the testing and re- porting required by this section until such time as the testing is reported if, not later than 90 days before the deadline for reporting in accordance with this section, a small to- bacco product manufacturer provides evidence to the Secretary demonstrating that— (A) the manufacturer has submitted the required products for testing to a laboratory and has done so sufficiently in advance of the deadline to create a reasonable expecta- tion of completion by the deadline; (B) the products currently are awaiting testing by the laboratory; and (C) neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees. (3) Extension The Secretary, taking into account the lab- oratory testing capacity that is available to tobacco product manufacturers, shall review and verify the evidence submitted by a small tobacco product manufacturer in accordance with paragraph (2). If the Secretary finds that the conditions described in such paragraph are met, the Secretary shall notify the small to- bacco product manufacturer that the manu- facturer shall not be considered to be in viola- tion of the testing and reporting requirements of this section until the testing is reported or until 1 year after the reporting deadline has passed, whichever occurs sooner. If, however, the Secretary has not made a finding before the reporting deadline, the manufacturer shall not be considered to be in violation of such re- quirements until the Secretary finds that the conditions described in paragraph (2) have not been met, or until 1 year after the reporting deadline, whichever occurs sooner. (4) Additional extension In addition to the time that may be provided under paragraph (3), the Secretary may pro- vide further extensions of time, in increments of no more than 1 year, for required testing and reporting to occur if the Secretary deter- mines, based on evidence properly and timely submitted by a small tobacco product manu- facturer in accordance with paragraph (2), that a lack of available laboratory capacity prevents the manufacturer from completing the required testing during the period de- scribed in paragraph (3). (f) Rule of construction Nothing in subsection (d) or (e) shall be con- strued to authorize the extension of any dead- line, or to otherwise affect any timeframe, under any provision of this chapter or the Fam- ily Smoking Prevention and Tobacco Control Act other than this section. (June 25, 1938, ch. 675, § 915, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (f), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classi- fication of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the cal- culation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or re- duce the duration of one or more such time periods, ex- cept that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387p. Preservation of State and local authority (a) In general (1) Preservation Except as provided in paragraph (2)(A), noth- ing in this subchapter, or rules promulgated under this subchapter, shall be construed to limit the authority of a Federal agency (in- cluding the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, re- quirements established under this subchapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of to- bacco products by individuals of any age, in- formation reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this subchapter shall Page 694 TITLE 21—FOOD AND DRUGS § 387q limit or otherwise affect any State, tribal, or local taxation of tobacco products. (2) Preemption of certain State and local re- quirements (A) In general No State or political subdivision of a State may establish or continue in effect with re- spect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products. (B) Exception Subparagraph (A) does not apply to re- quirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco prod- ucts by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under sub- paragraph (A) that is exempt from disclosure under section 552(b)(4) of title 5 shall be treated as a trade secret and confidential in- formation by the State. (b) Rule of construction regarding product liabil- ity No provision of this subchapter relating to a tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State. (June 25, 1938, ch. 675, § 916, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1823.) § 387q. Tobacco Products Scientific Advisory Committee (a) Establishment Not later than 6 months after June 22, 2009, the Secretary shall establish a 12-member advi- sory committee, to be known as the Tobacco Products Scientific Advisory Committee (in this section referred to as the ‘‘Advisory Com- mittee’’). (b) Membership (1) In general (A) Members The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in medi- cine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appro- priately diversified professional back- grounds. The committee shall be composed of— (i) 7 individuals who are physicians, den- tists, scientists, or health care profes- sionals practicing in the area of oncology, pulmonology, cardiology, toxicology, phar- macology, addiction, or any other relevant specialty; (ii) 1 individual who is an officer or em- ployee of a State or local government or of the Federal Government; (iii) 1 individual as a representative of the general public; (iv) 1 individual as a representative of the interests of the tobacco manufacturing industry; (v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Com- mittee; and (vi) 1 individual as a representative of the interests of the tobacco growers. (B) Nonvoting members The members of the committee appointed under clauses (iv), (v), and (vi) of subpara- graph (A) shall serve as consultants to those described in clauses (i) through (iii) of sub- paragraph (A) and shall be nonvoting rep- resentatives. (C) Conflicts of interest No members of the committee, other than members appointed pursuant to clauses (iv), (v), and (vi) of subparagraph (A) shall, dur- ing the member’s tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any busi- ness that manufactures, distributes, mar- kets, or sells cigarettes or other tobacco products. (2) Limitation The Secretary may not appoint to the Advi- sory Committee any individual who is in the regular full-time employ of the Food and Drug Administration or any agency responsible for the enforcement of this chapter. The Sec- retary may appoint Federal officials as ex offi- cio members. (3) Chairperson The Secretary shall designate 1 of the mem- bers appointed under clauses (i), (ii), and (iii) of paragraph (1)(A) to serve as chairperson. (c) Duties The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary— (1) as provided in this subchapter; (2) on the effects of the alteration of the nic- otine yields from tobacco products; (3) on whether there is a threshold level below which nicotine yields do not produce de- pendence on the tobacco product involved; and (4) on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary. (d) Compensation; support; chapter 10 of title 5 (1) Compensation and travel Members of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meet-