21 USC 387o - Regulation requirement

U.S Code last checked for updates: Oct 18, 2024

§ 387o.

Regulation requirement

(a)

Testing, reporting, and disclosure

(b)

Contents of rules

The regulations promulgated under subsection (a)—

(1)

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

(2)

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.

(c)

Authority

(d)

Small tobacco product manufacturers

(1)

First compliance date

The initial regulations promulgated under subsection (a) shall not impose requirements on small tobacco product manufacturers before the later of—

(A)

the end of the 2-year period following the final promulgation of such regulations; and

(B)

the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers.

(2)

Testing and reporting initial compliance period

(A)

4-year period

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—

(i)

to conduct such testing and reporting for 25 percent of its tobacco products during each year of such 4-year period; and

(ii)

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.

(B)

Case-by-case delay

(3)

Subsequent and additional testing and reporting

(4)

Joint laboratory testing services

(e)

Extensions for limited laboratory capacity

(1)

In general

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—

(A)

the tobacco products of such manufacturer are in compliance with all other requirements 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 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—

(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 expectation 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

(4)

Additional extension

(f)

Rule of construction

(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.)

cite as: 21 USC 387o