21 U.S.C. § 387o — Regulation requirement
submitted 88 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 1,217 words · no verdicts yet
Within three years, the FDA must make rules for testing and reporting what's in tobacco products. Companies may need to disclose test results to protect public health. Small manufacturers get extra time and possible delays to comply.
(a) Testing, reporting, and disclosure: Within 36 months after June 22, 2009, the Secretary* must make rules that follow subsection (b).
(b) Contents of rules: These rules must do two things. (1) They must require companies to test and report on what's in tobacco products — ingredients, additives, and smoke — by brand* and subbrand, wherever the Secretary decides testing protects public health. If a company sells identical products under different labels, packaging, or trademarks, all those versions count as one brand for testing. (2) The rules may require manufacturers, packagers, or importers to disclose tar and nicotine* test results through labels, ads, or other means. They may also require disclosure of test results for other ingredients or smoke constituents, if the Secretary decides the public needs to know to protect public health, and the disclosure won't mislead people about tobacco's health risks.
(c) Authority: The Secretary can conduct or require testing, reporting, or disclosure of what's in tobacco products, including smoke.
(d) Small tobacco product* manufacturers. (1) First compliance date: The first rules under (a) can't apply to small manufacturers until the later of two dates — two years after the rules are finalized, or the date bigger manufacturers must start complying. (2) Testing and reporting initial compliance period: (A) The first rules must give small manufacturers four years to test and report on all their products. The first year of that window lines up with whichever date applies under (1). Each year, a small manufacturer must test 25% of its products, starting with its largest-selling products first (or another order the Secretary sets). (B) The Secretary can delay an individual small manufacturer's deadline case by case, if the manufacturer shows undue hardship — but no small manufacturer can get more than 5 years total past the date bigger manufacturers must comply. (3) For later or additional testing, small manufacturers get the same 4-year-style timeframe as in (2)(A) — except for a new product, or a product modified as described in section 387j(a)(1)(B), where the small manufacturer must follow the same timeframe as bigger manufacturers. (4) Two or more small manufacturers can join together to buy lab testing services as a group, to get fair access and pricing.
(e) Extensions for limited laboratory capacity. (1) The rules must say a small manufacturer isn't violating this section before its deadline if: (A) its products meet every other requirement of this subchapter; and (B) the conditions in (2) are met. (2) Those conditions: at least 90 days before its reporting deadline, the manufacturer must show the Secretary that (A) it sent its products for testing early enough to reasonably expect the lab to finish by the deadline; (B) the products are still waiting on the lab; and (C) no lab — that one or any other — can finish testing by the deadline at normal, non-rushed prices. (3) If the Secretary verifies those conditions are met, the Secretary must tell the manufacturer it won't be in violation until the testing is reported, or until one year past the deadline — whichever comes first. If the Secretary hasn't decided by the deadline, the manufacturer isn't in violation until the Secretary finds the conditions weren't met, or until one year passes — whichever comes first. (4) The Secretary can grant further extensions, in chunks of up to one year each, if evidence shows a lack of lab capacity beyond what (3) already allows.
(f) Rule of construction: Nothing in (d) or (e) extends any other deadline, or changes any other timeframe, anywhere else in this chapter or in the Family Smoking Prevention and Tobacco Control Act.
Not later than 36 months after June 22, 2009, the Secretary* shall promulgate regulations under this chapter that meet the requirements of subsection (b).
The regulations promulgated under subsection (a)—
shall require testing and reporting of tobacco product* constituents, ingredients, and additives, including smoke constituents, by brand* and subbrand that the Secretary determines should be tested to protect the public health, provided that, for purposes of the testing requirements of this paragraph, tobacco products manufactured and sold by a single tobacco product manufacturer* that are identical in all respects except the labels, packaging design, logo, trade dress, trademark, brand name, or any combination thereof, shall be considered as a single brand; and
may require that tobacco product manufacturers, packagers, or importers make disclosures relating to the results of the testing of tar and nicotine* through labels or advertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke constituents, ingredients, or additives, that the Secretary determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related disease.
The Secretary shall have the authority under this subchapter to conduct or to require the testing, reporting, or disclosure of tobacco product constituents, including smoke constituents.
The initial regulations promulgated under subsection (a) shall not impose requirements on small tobacco product manufacturers before the later of—
the end of the 2-year period following the final promulgation of such regulations; and
the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers.
The initial regulations promulgated under subsection (a) shall give each small tobacco product manufacturer* a 4-year period over which to conduct testing and reporting for all of its tobacco products. Subject to paragraph (1), the end of the first year of such 4-year period shall coincide with the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufacturers or the end of the 2-year period following the final promulgation of such regulations, as described in paragraph (1)(A). A small tobacco product manufacturer shall be required—
to conduct such testing and reporting for 25 percent of its tobacco products during each year of such 4-year period; and
to conduct such testing and reporting for its largest-selling tobacco products (as determined by the Secretary) before its other tobacco products, or in such other order of priority as determined by the Secretary.
Notwithstanding subparagraph (A), the Secretary may, on a case-by-case basis, delay the date by which an individual small tobacco product manufacturer must conduct testing and reporting for its tobacco products under this section based upon a showing of undue hardship to such manufacturer. Notwithstanding the preceding sentence, the Secretary shall not extend the deadline for a small tobacco product manufacturer to conduct testing and reporting for all of its tobacco products beyond a total of 5 years after the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufacturers.
The regulations promulgated under subsection (a) shall provide that, with respect to any subsequent or additional testing and reporting of tobacco products required under this section, such testing and reporting by a small tobacco product manufacturer shall be conducted in accordance with the timeframes described in paragraph (2)(A), except that, in the case of a new product, or if there has been a modification described in section 387j(a)(1)(B) of this title of any product of a small tobacco product manufacturer since the last testing and reporting required under this section, the Secretary shall require that any subsequent or additional testing and reporting be conducted in accordance with the same timeframe applicable to manufacturers that are not small tobacco product manufacturers.
The Secretary shall allow any 2 or more small tobacco product manufacturers to join together to purchase laboratory testing services required by this section on a group basis in order to ensure that such manufacturers receive access to, and fair pricing of, such testing services.
The regulations promulgated under subsection (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—
the tobacco products of such manufacturer are in compliance with all other requirements of this subchapter; and
the conditions described in paragraph (2) are met.
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 reporting 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 tobacco product manufacturer provides evidence to the Secretary demonstrating that—
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 expectation of completion by the deadline;
the products currently are awaiting testing by the laboratory; and
neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees.
The Secretary, taking into account the laboratory 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 tobacco product manufacturer that the manufacturer shall not be considered to be in violation 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 requirements 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.
In addition to the time that may be provided under paragraph (3), the Secretary may provide further extensions of time, in increments of no more than 1 year, for required testing and reporting to occur if the Secretary determines, based on evidence properly and timely submitted by a small tobacco product manufacturer in accordance with paragraph (2), that a lack of available laboratory capacity prevents the manufacturer from completing the required testing during the period described in paragraph (3).
Nothing in subsection (d) or (e) shall be construed to authorize the extension of any deadline, or to otherwise affect any timeframe, under any provision of this chapter or the Family Smoking Prevention and Tobacco Control Act other than this section.
Source credit: (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.)
- 1938Enacted · Pub. L. 111-31 · 123 Stat. 1820
A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-31 on 1938-06-25.
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