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21 U.S. Code § 387j. Application for review of certain tobacco products
(a) In general
(1) New tobacco product definedFor purposes of this section the term “new tobacco product” means—
(A)
any tobacco product (including those products in test markets) that was not commercially 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 nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
(2) Premarket review required
(A) New productsAn order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—
(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product—
(I)
is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and
(II)
is in compliance with the requirements 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, productsSubparagraph (A) shall not apply to a tobacco 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 substantially equivalent.
(3) Substantially equivalent defined
(A) In generalIn this section and section 387e(j) of this title, the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—
(i)
has the same characteristics as the predicate tobacco product; or
(ii)
has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.
(B) Characteristics
In subparagraph (A), the term “characteristics” means the materials, ingredients, design, 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 tobacco 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.