Nicotine Pouches: Federal Status (2026)

Instrument

Federal premarket authorization, adulteration, minimum age 21 and tobacco product definition

Source

https://uscode.house.gov/us/usc/119-136/t21/s387j/

Retrieved

2026-11-06

Fingerprint

33f08b9dae35fb21

21 U.S.C. 387j(a)(1)-(2) (FD&C Act Sec. 910(a)(1)-(2)), Application for review of certain tobacco products [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(a) 
 In general
(1) 
 New tobacco product defined
For 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 products
An 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, products
Subparagraph (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.

21 U.S.C. 387b (FD&C Act Sec. 902), Adulterated tobacco products [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

§387b. Adulterated tobacco products
A tobacco product shall be deemed to be adulterated if⁠—
(1)  it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;
(2)  it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(3)  its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(4)  the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
(5)  it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;
(6) (A)  it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or
(B)  it is in violation of an order under section 387j(c)(1)(A) of this title;
(7)  the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or
(8)  it is in violation of section 387k of this title.

21 U.S.C. 387f(d)(5) (FD&C Act Sec. 906(d)(5)), Minimum age of sale [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(5) 
 Minimum age of sale
It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.

21 U.S.C. 321(rr)(1) (FD&C Act Sec. 201(rr)(1)), Definition of tobacco product [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(rr) (1)  The term "tobacco product" means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

Instrument

Federal premarket authorization, adulteration, minimum age 21, tobacco product definition, PACT Act ENDS definitions and USPS mail ban

Source

https://uscode.house.gov/us/usc/119-136/t21/s387j/

Retrieved

2026-11-06

Fingerprint

9701d655ad2393a1

21 U.S.C. 387j(a)(1)-(2) (FD&C Act Sec. 910(a)(1)-(2)), Application for review of certain tobacco products [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(a) 
 In general
(1) 
 New tobacco product defined
For 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 products
An 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, products
Subparagraph (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.

21 U.S.C. 387b (FD&C Act Sec. 902), Adulterated tobacco products [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

§387b. Adulterated tobacco products
A tobacco product shall be deemed to be adulterated if⁠—
(1)  it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;
(2)  it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(3)  its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(4)  the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
(5)  it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;
(6) (A)  it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or
(B)  it is in violation of an order under section 387j(c)(1)(A) of this title;
(7)  the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or
(8)  it is in violation of section 387k of this title.

21 U.S.C. 387f(d)(5) (FD&C Act Sec. 906(d)(5)), Minimum age of sale [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(5) 
 Minimum age of sale
It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.

21 U.S.C. 321(rr)(1) (FD&C Act Sec. 201(rr)(1)), Definition of tobacco product [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(rr) (1)  The term "tobacco product" means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

15 U.S.C. 375(2) (PACT Act / Jenkins Act Sec. 1(2)), Definition of cigarette [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(2) 
 Cigarette
(A) 
 In general
The term “cigarette”⁠—
(i)  has the meaning given that term in section 2341 of title 18; and
(ii)  includes⁠—
(I)  roll-your-own tobacco (as defined in section 5702 of title 26); and
(II)  an electronic nicotine delivery system.
(B) 
 Exception
The term “cigarette” does not include a cigar (as defined in section 5702 of title 26).

15 U.S.C. 375(7) (PACT Act / Jenkins Act Sec. 1(7)), Definition of electronic nicotine delivery system [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(7) 
 Electronic nicotine delivery system
The term “electronic nicotine delivery system”⁠—
(A)  means any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device;
(B)  includes⁠—
(i)  an e-cigarette;
(ii)  an e-hookah;
(iii)  an e-cigar;
(iv)  a vape pen;
(v)  an advanced refillable personal vaporizer;
(vi)  an electronic pipe; and
(vii)  any component, liquid, part, or accessory of a device described in subparagraph (A), without regard to whether the component, liquid, part, or accessory is sold separately from the device; and
(C)  does not include a product that is⁠—
(i)  approved by the Food and Drug Administration for⁠—
(I)  sale as a tobacco cessation product; or
(II)  any other therapeutic purpose; and
(ii)  marketed and sold solely for a purpose described in clause (i).

18 U.S.C. 1716E(a)(1), Tobacco products as nonmailable [OLRC release point 119-136 (U.S. Code current through Pub. L. 119-136, 2026-10-22)]

(a) 

Prohibition.⁠—
(1) 

In general
.⁠—
All cigarettes and smokeless tobacco (as those terms are defined in section 1 of the Act of October 19, 1949, commonly referred to as the Jenkins Act) are nonmailable and shall not be deposited in or carried through the mails. The United States Postal Service shall not accept for delivery or transmit through the mails any package that it knows or has reasonable cause to believe contains any cigarettes or smokeless tobacco made nonmailable by this paragraph.