Preventing Vape Use Act

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Preventing Vape Use 4 Act’’. 5 VerDate Sep 11 2014 04:04 Nov 16, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS 2 •HR 5005 IH SEC. 2. INCLUSION OF ENDS IN DEFINITION OF TOBACCO 1 PRODUCT. 2 (a) CONFIRMATION OF INCLUSION OF ENDS IN 3 DEFINITION OF TOBACCO PRODUCT.—Section 201(rr)(1) 4 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5 321(rr)(1)) is amended by adding at the end the following: 6 ‘‘Such term includes an electronic nicotine delivery sys- 7 tem.’’. 8 (b) ENDS DEFINED.—Section 201 of the Federal 9 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amend- 10 ed by adding at the end the following: 11 ‘‘(ss) The term ‘electronic nicotine delivery system’ 12 means a tobacco product that is an electronic device that 13 delivers nicotine, flavor, or another substance via an aero- 14 solized solution to the user inhaling from the device (in- 15 cluding e-cigarettes, e-hookah, e-cigars, vape pens, ad- 16 vanced refillable personal vaporizers, and electronic pipes) 17 and any component, liquid, part, or accessory of such a 18 device, whether or not sold separately.’’. 19 SEC. 3. MANDATORY RECALL OF ENDS PENDING PRE- 20 MARKET REVIEW. 21 Section 908(c) of the Federal Food, Drug, and Cos- 22 metic Act (21 U.S.C. 387h(c)) is amended by adding at 23 the end the following: 24 ‘‘(4) MANDATORY RECALL OF ENDS PENDING 25 PREMARKET REVIEW.— 26 VerDate Sep 11 2014 04:04 Nov 16, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS 3 •HR 5005 IH ‘‘(A) ISSUANCE OF ORDER.—Notwith- 1 standing paragraphs (1) and (2), in the case of 2 a tobacco product that is an electronic nicotine 3 delivery system with respect to which, as of the 4 date of the enactment of this subparagraph, an 5 order under section 910(c)(1)(A)(i) has not 6 been issued, the Secretary shall, not later than 7 60 days after such date of enactment, issue an 8 order requiring— 9 ‘‘(i) the appropriate person (including 10 the manufacturers, importers, distributors, 11 or retailers of the tobacco product) to im- 12 mediately cease distribution of such to- 13 bacco product; and 14 ‘‘(ii) the recall of such tobacco prod- 15 uct. 16 ‘‘(B) HEARING.—The order under sub- 17 paragraph (A) shall provide the person subject 18 to the order with an opportunity for an infor- 19 mal hearing, to be held not later than 10 days 20 after the date of the issuance of the order, on 21 the actions required by the order and the terms 22 of the recall required by such order. 23 ‘‘(C) CONTENTS OF ORDER.—An order 24 issued under subparagraph (A) shall specify a 25 VerDate Sep 11 2014 20:11 Nov 20, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS 4 •HR 5005 IH timetable in which the tobacco product recall 1 will occur and shall require periodic reports to 2 the Secretary describing the progress of the re- 3 call. 4 ‘‘(D) NOTICE.—An order under subpara- 5 graph (A)— 6 ‘‘(i) shall not include recall of a to- 7 bacco product from individuals; and 8 ‘‘(ii) shall provide for notice to per- 9 sons subject to the risks associated with 10 the use of such tobacco product. 11 ‘‘(E) ASSISTANCE ALLOWED.—In providing 12 the notice required by subparagraph (D)(ii), the 13 Secretary may use the assistance of retailers 14 and other persons who distributed such tobacco 15 product. If a significant number of such per- 16 sons cannot be identified, the Secretary shall 17 notify such persons under section 705(b). 18 ‘‘(F) WITHDRAWAL OF ORDER.—The Sec- 19 retary may only withdraw an order issued 20 under subparagraph (A) with respect to a to- 21 bacco product described in such subparagraph 22 upon the issuance of an order section 23 910(c)(1)(A)(i) with respect to that product.’’. 24 VerDate Sep 11 2014 04:04 Nov 16, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS 5 •HR 5005 IH SEC. 4. NO EXEMPTIONS ALLOWED FOR ENDS. 1 Section 910(a) of the Federal Food, Drug, and Cos- 2 metic Act (21 U.S.C. 387j(a)) is amended— 3 (1) in paragraph (2), by adding at the end the 4 following: 5 ‘‘(C) APPLICATION TO ENDS.—Notwith- 6 standing clauses (i) and (ii) of subparagraphs 7 (A) and (B), beginning on the date that is 60 8 days after the date of the enactment of this 9 subparagraph— 10 ‘‘(i) electronic nicotine delivery sys- 11 tems are deemed to be not substantially 12 equivalent to any predicate tobacco prod- 13 uct; and 14 ‘‘(ii) the requirement for premarket 15 review under subparagraph (A) shall apply 16 to a tobacco product that is an electronic 17 nicotine delivery system.’’; and 18 (2) in paragraph (3)(C)— 19 (A) by striking ‘‘equivalent to a predicate’’ 20 and inserting the following: ‘‘equivalent— 21 ‘‘(A) to a predicate’’; 22 (B) by striking ‘‘adulterated.’’ and insert- 23 ing ‘‘adulterated; or’’; and 24 (C) by adding at the end the following: 25 VerDate Sep 11 2014 04:11 Nov 20, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS 6 •HR 5005 IH ‘‘(B) beginning on the date that is 60 days 1 after the date of the enactment of this subpara- 2 graph, if the tobacco product is an electronic 3 nicotine delivery system.’’. 4 Æ VerDate Sep 11 2014 04:04 Nov 16, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H5005.IH H5005 kjohnson on DSK79L0C42 with BILLS