I 

116TH CONGRESS 

1ST SESSION H. R. 5005 

To amend the Federal Food, Drug, and Cosmetic Act to require a recall 

of electronic nicotine delivery systems that have not been subject to 

premarket review, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 8, 2019 

Mr. DESAULNIER introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require a recall of electronic nicotine delivery systems 

that have not been subject to premarket review, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preventing Vape Use 

5 Act’’. 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 5005 IH

1 SEC. 2. INCLUSION OF ENDS IN DEFINITION OF TOBACCO 

2 PRODUCT. 

3 (a) CONFIRMATION OF INCLUSION OF ENDS IN

4 DEFINITION OF TOBACCO PRODUCT.—Section 201(rr)(1) 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 321(rr)(1)) is amended by adding at the end the following: 

7 ‘‘Such term includes an electronic nicotine delivery sys8 tem.’’. 

9 (b) ENDS DEFINED.—Section 201 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amend11 ed by adding at the end the following: 

12 ‘‘(ss) The term ‘electronic nicotine delivery system’ 

13 means a tobacco product that is an electronic device that 

14 delivers nicotine, flavor, or another substance via an aero15 solized solution to the user inhaling from the device (in16 cluding e-cigarettes, e-hookah, e-cigars, vape pens, ad17 vanced refillable personal vaporizers, and electronic pipes) 

18 and any component, liquid, part, or accessory of such a 

19 device, whether or not sold separately.’’. 

20 SEC. 3. MANDATORY RECALL OF ENDS PENDING PRE21 MARKET REVIEW. 

22 Section 908(c) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 387h(c)) is amended by adding at 

24 the end the following: 

25 ‘‘(4) MANDATORY RECALL OF ENDS PENDING

26 PREMARKET REVIEW.— 


kjohnson on DSK79L0C42 with BILLS
3 

•HR 5005 IH

1 ‘‘(A) ISSUANCE OF ORDER.—Notwith2 standing paragraphs (1) and (2), in the case of 

3 a tobacco product that is an electronic nicotine 

4 delivery system with respect to which, as of the 

5 date of the enactment of this subparagraph, an 

6 order under section 910(c)(1)(A)(i) has not 

7 been issued, the Secretary shall, not later than 

8 60 days after such date of enactment, issue an 

9 order requiring— 

10 ‘‘(i) the appropriate person (including 

11 the manufacturers, importers, distributors, 

12 or retailers of the tobacco product) to im13 mediately cease distribution of such to14 bacco product; and 

15 ‘‘(ii) the recall of such tobacco prod16 uct. 

17 ‘‘(B) HEARING.—The order under sub18 paragraph (A) shall provide the person subject 

19 to the order with an opportunity for an infor20 mal hearing, to be held not later than 10 days 

21 after the date of the issuance of the order, on 

22 the actions required by the order and the terms 

23 of the recall required by such order. 

24 ‘‘(C) CONTENTS OF ORDER.—An order 

25 issued under subparagraph (A) shall specify a 


kjohnson on DSK79L0C42 with BILLS
4 

•HR 5005 IH

1 timetable in which the tobacco product recall 

2 will occur and shall require periodic reports to 

3 the Secretary describing the progress of the re4 call. 

5 ‘‘(D) NOTICE.—An order under subpara6 graph (A)— 

7 ‘‘(i) shall not include recall of a to8 bacco product from individuals; and 

9 ‘‘(ii) shall provide for notice to per10 sons subject to the risks associated with 

11 the use of such tobacco product. 

12 ‘‘(E) ASSISTANCE ALLOWED.—In providing 

13 the notice required by subparagraph (D)(ii), the 

14 Secretary may use the assistance of retailers 

15 and other persons who distributed such tobacco 

16 product. If a significant number of such per17 sons cannot be identified, the Secretary shall 

18 notify such persons under section 705(b). 

19 ‘‘(F) WITHDRAWAL OF ORDER.—The Sec20 retary may only withdraw an order issued 

21 under subparagraph (A) with respect to a to22 bacco product described in such subparagraph 

23 upon the issuance of an order section 

24 910(c)(1)(A)(i) with respect to that product.’’. 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 5005 IH

1 SEC. 4. NO EXEMPTIONS ALLOWED FOR ENDS. 

2 Section 910(a) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 387j(a)) is amended— 

4 (1) in paragraph (2), by adding at the end the 

5 following: 

6 ‘‘(C) APPLICATION TO ENDS.—Notwith7 standing clauses (i) and (ii) of subparagraphs 

8 (A) and (B), beginning on the date that is 60 

9 days after the date of the enactment of this 

10 subparagraph— 

11 ‘‘(i) electronic nicotine delivery sys12 tems are deemed to be not substantially 

13 equivalent to any predicate tobacco prod14 uct; and 

15 ‘‘(ii) the requirement for premarket 

16 review under subparagraph (A) shall apply 

17 to a tobacco product that is an electronic 

18 nicotine delivery system.’’; and 

19 (2) in paragraph (3)(C)— 

20 (A) by striking ‘‘equivalent to a predicate’’ 

21 and inserting the following: ‘‘equivalent— 

22 ‘‘(A) to a predicate’’; 

23 (B) by striking ‘‘adulterated.’’ and insert24 ing ‘‘adulterated; or’’; and 

25 (C) by adding at the end the following: 


kjohnson on DSK79L0C42 with BILLS
6 

•HR 5005 IH

1 ‘‘(B) beginning on the date that is 60 days 

2 after the date of the enactment of this subpara3 graph, if the tobacco product is an electronic 

4 nicotine delivery system.’’. 

Æ 


kjohnson on DSK79L0C42 with BILLS