I 

115TH CONGRESS 

1ST SESSION H. R. 2194 

To protect the public health by providing the Food and Drug Administration 

with certain authority to regulate e-liquids and personal electronic vaporizers, to reduce the morbidity and mortality resulting from cigarette 

smoking through the responsible regulation of e-liquids and personal 

electronic vaporizers as a tobacco harm reduction strategy, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 27, 2017 

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

Committee on Energy and Commerce 

A BILL 

To protect the public health by providing the Food and 

Drug Administration with certain authority to regulate 

e-liquids and personal electronic vaporizers, to reduce 

the morbidity and mortality resulting from cigarette 

smoking through the responsible regulation of e-liquids 

and personal electronic vaporizers as a tobacco harm 

reduction strategy, 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, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Cigarette Smoking Reduction and Electronic Vapor Al4 ternatives Act of 2017’’. 

5 (b) TABLE OF CONTENTS.—The table of contents of 

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Purposes of the Family Smoking Prevention and Tobacco Control Act. 

Sec. 4. Regulation of electronic vapor products. 

Sec. 5. Joint comparative health risk assessment. 

7 SEC. 2. FINDINGS. 

8 The Congress finds the following: 

9 (1) Cigarette smoking is the practice of burning 

10 tobacco rolled in a paper and inhaling the smoke. 

11 According to the Department of Health and Human 

12 Services— 

13 (A) the burning of tobacco produces a 

14 chemical mixture of more than 7,000 com15 pounds; 

16 (B) cigarette smoking causes cancer, heart 

17 disease, stroke, lung diseases, diabetes, and 

18 chronic obstructive pulmonary disease, and 

19 harms nearly every organ of the body; 

20 (C) cigarette smoking causes more than 

21 480,000 deaths each year, including nearly 

22 42,000 deaths due to secondhand tobacco 

23 smoke; 


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1 (D) the economic cost of cigarette smoking 

2 is more than $300 billion a year, including 

3 nearly $170 billion in direct medical care, and 

4 more than $156 billion in lost productivity; and 

5 (E) nearly 7 in 10 adult cigarette smokers 

6 want to quit smoking. 

7 (2) Electronic vapor products, also known as 

8 ‘‘electronic cigarettes’’ or ‘‘e-cigarettes’’, are battery9 operated devices that use low heat to turn e-liquid, 

10 which generally contains nicotine, into a vaporized 

11 aerosol which is inhaled—there is no burning of to12 bacco or generation of smoke for inhalation. 

13 (3) Evidence from numerous studies strongly 

14 suggests that electronic vapor products are mag15 nitudes safer than traditional, combustible ciga16 rettes. Studies have found that several million reg17 ular vapers in the United States no longer regularly 

18 smoke cigarettes. 

19 (4) Studies of cigarette smokers who switched 

20 to vapor found significant improvements in lung 

21 function, including a study finding asthmatic smok22 ers who switched to vapor had significant improve23 ments in spirometry data, asthma control, airway 

24 hyperresponsiveness, and lower blood pressure. 


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1 (5) The Royal College of Physicians 2016 re2 port on e-cigarettes titled, ‘‘Nicotine without smoke: 

3 Tobacco harm reduction’’ issued the following find4 ings: 

5 (A) The available evidence to date indi6 cates that e-cigarettes are being used almost ex7 clusively as safer alternatives to smoked to8 bacco, by confirmed smokers who are trying to 

9 reduce harm to themselves or others from 

10 smoking, or to quit smoking completely. 

11 (B) The hazard to health arising from 

12 long-term vapor inhalation from the e-cigarettes 

13 available today is unlikely to exceed 5 percent 

14 of the harm from smoking tobacco. 

15 (C) E-cigarettes are marketed as consumer 

16 products and are proving much more popular 

17 than Food and Drug Administration-approved 

18 nicotine replacement therapies (NRT) as a sub19 stitute and competitor for tobacco cigarettes. 

20 (6) ‘‘E-liquid’’ is the liquid that is heated into 

21 vapor. It contains, principally, propylene glycol, veg22 etable glycerin, in some cases food flavoring, in some 

23 cases nicotine, and in some cases water; propylene 

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1 erally recognized as safe’’ by the Food and Drug Ad2 ministration (FDA) as food additives. 

3 (7) Surveys have found that a significant ma4 jority of regular users of electronic vapor products 

5 had previously tried FDA-approved smoking ces6 sation drugs to quit smoking without success. 

7 (8) An expert independent evidence review pub8 lished by Public Health England (PHE) concluded 

9 that— 

10 (A) the use of vapor products is about 95 

11 percent less harmful than cigarette smoking; 

12 (B) nearly half the population doesn’t real13 ize vapor is much less harmful than smoking; 

14 and 

15 (C) there is no evidence suggesting elec16 tronic vapor products act as a route into smok17 ing for children or nonsmokers. 

18 (9) Electronic vapor product sales in the United 

19 States have increased from an estimated $100 mil20 lion in 2010 to $4 billion in 2016 while cigarette 

21 consumption in the United States declined from 

22 $307 billion in 2010 to an estimated $265 billion in 

23 2016. 

24 (10) On May 10, 2016, the Food and Drug Ad25 ministration issued its ‘‘Deeming Regulation’’ to 


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1 deem e-cigarettes or electronic vapor products to be 

2 subject to its authority. The regulation will, as a 

3 practical matter, because of its significant compli4 ance costs and poorly articulated standard for pro5 tecting public health, ban the sale of all electronic 

6 vapor products by August 2018. 

7 (11) The Food and Drug Administration’s 

8 Deeming Regulation, by effectively banning elec9 tronic vapor products, will push vapers who have 

10 quit or reduced cigarette smoking by switching to 

11 electronic vapor products back to smoking deadly 

12 cigarettes. 

13 (12) The 2015 Monitoring the Future survey of 

14 the National Institute on Drug Abuse found past15 30-day use of an electronic vapor product by 8th, 

16 10th, and 12th graders combined declined from 13.9 

17 percent in 2014 to 9.9 percent in 2016; however, 

18 that survey found that fewer than 20 percent of 

19 teens who used an electronic vapor product in the 

20 past 30 days reported using a product containing 

21 nicotine. 

22 (13) Electronic vapor products show tremen23 dous promise in reducing cigarette smoking, and cig24 arette smoking attributable morbidity, mortality, 

25 and health care costs. 


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1 (14) According to an April 13, 2017, Centers 

2 for Disease Control and Prevention study, more 

3 Americans who are trying to quit smoking use vapor 

4 products (35.3 percent) than any other smoking ces5 sation tool. This includes using a nicotine patch or 

6 gum (25.4 percent), getting help from a doctor or 

7 other health professional (15.2 percent), using smok8 ing cessation medications approved by the Food and 

9 Drug Administration (12.2 percent), and getting 

10 help from a website (7.1 percent) or a telephone 

11 quitline (5.4 percent). 

12 (15) Since the Food and Drug Administration 

13 was granted authority to regulate tobacco products 

14 in 2009, the agency has failed to grant market ap15 proval to any modified risk tobacco product. 

16 SEC. 3. PURPOSES OF THE FAMILY SMOKING PREVENTION 

17 AND TOBACCO CONTROL ACT. 

18 Section 3 of the Family Smoking Prevention and To19 bacco Control Act (21 U.S.C. 387 note) is amended by 

20 amending paragraph (9) to read as follows: 

21 ‘‘(9) to promote— 

22 ‘‘(A) cessation to reduce disease risk and 

23 the social costs associated with tobacco-related 

24 diseases; and 

25 ‘‘(B) harm reduction strategies; and’’. 


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1 SEC. 4. REGULATION OF ELECTRONIC VAPOR PRODUCTS. 

2 (a) CENTER FOR TOBACCO PRODUCTS AND TOBACCO

3 HARM REDUCTION.—Section 901(e) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 387a(e)) is amend5 ed— 

6 (1) in the subsection heading, by striking 

7 ‘‘CENTER FOR TOBACCO PRODUCTS’’ and inserting 

8 ‘‘CENTER FOR TOBACCO PRODUCTS AND TOBACCO

9 HARM REDUCTION’’; 

10 (2) by striking ‘‘Center for Tobacco Products’’ 

11 and inserting ‘‘Center for Tobacco Products and To12 bacco Harm Reduction’’; and 

13 (3) by striking ‘‘this chapter’’ and inserting 

14 ‘‘this chapter and chapter X’’. 

15 (b) FDA AUTHORITY OVER ELECTRONIC VAPOR

16 PRODUCTS.— 

17 (1) EXCLUSION FROM DEFINITION OF TOBACCO

18 PRODUCT.—Section 201(rr) of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 321(rr)) is 

20 amended— 

21 (A) in paragraph (2), by inserting ‘‘an e22 liquid (as defined in section 1001), a personal 

23 electronic vaporizer (as defined in section 

24 1001),’’ before ‘‘or a combination product’’; and 

25 (B) in paragraph (3), by inserting after 

26 ‘‘The products described in paragraph (2)’’ the 


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1 following: ‘‘(other than an e-liquid or personal 

2 electronic vaporizer)’’. 

3 (2) COMBINATION PRODUCTS.—Section 503(g) 

4 of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 353(g)) is amended— 

6 (A) in paragraph (1)— 

7 (i) in subparagraph (A), by striking 

8 ‘‘or biological product’’ and inserting ‘‘, bi9 ological product, e-liquid, or personal elec10 tronic vaporizer’’; and 

11 (ii) in subparagraph (D)— 

12 (I) in clause (ii), by striking ‘‘or’’ 

13 at the end; 

14 (II) in clause (iii), by striking the 

15 period at the end and inserting ‘‘; or’’; 

16 and 

17 (III) by adding at the end the 

18 following: 

19 ‘‘(iv) an e-liquid or personal electronic vapor20 izer, the agency center charged with regulating e-liq21 uids and personal electronic vaporizers shall have 

22 primary jurisdiction.’’; and 

23 (B) in paragraph (9)— 


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1 (i) by redesignating subparagraphs 

2 (C) and (D) as subparagraphs (D) and 

3 (E), respectively; and 

4 (ii) by inserting after subparagraph 

5 (B) the following: 

6 ‘‘(C) The terms ‘e-liquid’ and ‘personal elec7 tronic vaporizer’ have the meanings given to such 

8 terms in section 1001.’’. 

9 (3) REGULATORY AUTHORITY.—The Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

11 seq.) is amended— 

12 (A) by redesignating chapter X as chapter 

13 XI; 

14 (B) by redesignating sections 1001 

15 through 1014 as sections 1101 through 1114, 

16 respectively; 

17 (C) in section 505(n)(2), by striking 

18 ‘‘1004’’ and inserting ‘‘1104’’; 

19 (D) in sections 523(b)(2)(D) and 

20 704(g)(13), by striking ‘‘1003(g)’’ and inserting 

21 ‘‘1103(g)’’; 

22 (E) in section 1109(a)(5)(A), as redesig23 nated by paragraph (4), by striking ‘‘1008’’ 

24 and inserting ‘‘1108’’; and 


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1 (F) by inserting after chapter IX the fol2 lowing: 

3 ‘‘CHAPTER X—ELECTRONIC VAPOR 

4 PRODUCTS 

5 ‘‘SEC. 1001. DEFINITIONS. 

6 ‘‘In this chapter: 

7 ‘‘(1) The term ‘e-liquid’ means any liquid solu8 tion that— 

9 ‘‘(A) may or may not contain nicotine; and 

10 ‘‘(B) is intended to be converted into an 

11 aerosol, vapor, or vapor-like mist for users to 

12 inhale through the mouthpiece of a personal 

13 electronic vaporizer. 

14 ‘‘(2) The term ‘personal electronic vaporizer’ 

15 means an electronic device that employs a heating 

16 element or atomizer that converts an e-liquid into an 

17 aerosol, vapor, or vapor-like mist through a non18 combustive process. 

19 ‘‘(3) The terms ‘e-liquid’ and ‘personal elec20 tronic vaporizer’ exclude— 

21 ‘‘(A) a drug as defined in section 

22 201(g)(1); 

23 ‘‘(B) a device as defined in section 201(h); 

24 and 


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1 ‘‘(C) a biological product as defined in sec2 tion 351 of the Public Health Service Act. 

3 ‘‘SEC. 1002. EXCLUSIVE AUTHORITY FOR REGULATING E4 LIQUIDS AND PERSONAL ELECTRONIC VA5 PORIZERS. 

6 ‘‘The authorities vested by this chapter constitute the 

7 exclusive authorities of the Secretary to regulate e-liquids 

8 and personal electronic vaporizers, except to the extent e9 liquids and personal electronic vaporizers are within com10 bination products regulated pursuant to section 503(g). 

11 ‘‘SEC. 1003. PROHIBITED ACTS; PENALTIES. 

12 ‘‘(a) PROHIBITIONS.— 

13 ‘‘(1) IN GENERAL.—The following acts and the 

14 causing thereof are hereby prohibited: 

15 ‘‘(A) The sale of an electronic vapor prod16 uct or e-liquid to any person younger than 18 

17 years of age. 

18 ‘‘(B) The manufacture of an e-liquid or 

19 personal electronic vaporizer in noncompliance 

20 with the standards under section 1004(b) in 

21 violation of an order issued under section 

22 1004(e). 

23 ‘‘(C) The offering of e-liquids or personal 

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1 porizer manufacturer that does not have a cer2 tification in effect as required by section 

3 1004(c). 

4 ‘‘(D) The failure by an e-liquid or personal 

5 electronic vaporizer manufacturer to provide ac6 cess for inspection as required by section 

7 1004(d). 

8 ‘‘(E) The introduction or delivery for intro9 duction in interstate commerce of an e-liquid or 

10 personal electronic vaporizer by any person that 

11 is adulterated or misbranded, as described in 

12 subsection (b) or (c) respectively. 

13 ‘‘(2) RETAILERS.—Notwithstanding subpara14 graphs (A) and (E) of paragraph (1), a retailer may 

15 be found to be in violation of either such subpara16 graph (with respect to sale or introduction or deliv17 ery for introduction in interstate commerce at retail) 

18 only if the violation occurs knowingly. 

19 ‘‘(b) ADULTERATION.—An e-liquid or personal elec20 tronic vaporizer shall be treated as adulterated if— 

21 ‘‘(1) it was manufactured in noncompliance 

22 with the standards under section 1004(b) in viola23 tion of an order issued under section 1004(e); or 

24 ‘‘(2) it was manufactured by an e-liquid or per25 sonal electronic vaporizer manufacturer that does 


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1 not have a certification in effect as required by sec2 tion 1004(c). 

3 ‘‘(c) MISBRANDING.—An e-liquid or personal elec4 tronic vaporizer shall be treated as misbranded if its label5 ing (as such term is defined in section 201 with respect 

6 to drugs) is in noncompliance with the standards under 

7 section 1004(b) in violation of an order issued under sec8 tion 1004(e). 

9 ‘‘(d) PENALTIES.—Any person who violates a provi10 sion of subsection (a) shall be imprisoned not more than 

11 3 years, fined not more than $10,000 (notwithstanding 

12 section 3571(e) of title 18, United States Code) for each 

13 day on which the violation continues, or both. 

14 ‘‘SEC. 1004. STANDARDS FOR THE MANUFACTURING OF E15 LIQUIDS AND PERSONAL ELECTRONIC VA16 PORIZERS; COMPLIANCE. 

17 ‘‘(a) REQUIREMENT.—Beginning on the date that is 

18 1 year after the date of enactment of the Cigarette Smok19 ing Reduction and Electronic Vapor Alternatives Act of 

20 2017, any e-liquid or personal electronic vaporizer intro21 duced or delivered for introduction into interstate com22 merce shall conform to the e-liquid or personal electronic 

23 vaporizer (as applicable) manufacturing standards under 

24 subsection (b), including the labeling standards therein. 

25 ‘‘(b) MANUFACTURING STANDARDS.— 


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1 ‘‘(1) E-LIQUIDS.—The manufacturing stand2 ards for e-liquids under this subsection shall consist 

3 of the following: 

4 ‘‘(A) INTERIM STANDARDS.—The e-liquid 

5 manufacturing standards issued by the Amer6 ican E-Liquid Manufacturing Standards Asso7 ciation (version 2.3.2) on March 8, 2017 (in8 cluding any revision to such standards made in 

9 accordance with paragraph (3)), apply to the 

10 introduction or delivery for introduction into 

11 interstate commerce of e-liquids during the pe12 riod beginning on the date described in sub13 section (a) and ending on the date described in 

14 subparagraph (B). 

15 ‘‘(B) SUBSEQUENT STANDARDS.—The e16 liquid manufacturing standards of the American 

17 National Standards Institute (including any re18 vision to such standards made in accordance 

19 with paragraph (3)) apply to the introduction 

20 or delivery for introduction into interstate com21 merce of e-liquids beginning on the date of the 

22 adoption of such standards by the American 

23 National Standards Institute. 

24 ‘‘(2) PERSONAL ELECTRONIC VAPORIZERS.— 

25 The manufacturing standards for personal electronic 


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1 vaporizers under this subsection shall consist of the 

2 following: 

3 ‘‘(A) BATTERY SAFETY.—Any battery used 

4 in a personal electronic vaporizer shall conform 

5 to the IEC 62133 standards of the Inter6 national Electrotechnical Commission, as in ef7 fect on the date of enactment of the Cigarette 

8 Smoking Reduction and Electronic Vapor Alter9 natives Act of 2017 and including any revision 

10 to such standards made in accordance with 

11 paragraph (3). 

12 ‘‘(B) SHORT CIRCUIT PROTECTION.—A 

13 personal electronic vaporizer shall have a mech14 anism to ensure user and battery safety in the 

15 event of a short circuit of the heating element. 

16 ‘‘(C) DISCHARGE MONITORING.—A re17 chargeable personal electronic vaporizer shall 

18 have a mechanism to prevent the battery from 

19 being discharged below a safe voltage during 

20 use or discharged faster than the battery can 

21 sustain safely. 

22 ‘‘(D) CHARGE MONITORING.—A personal 

23 electronic vaporizer that contains an onboard 

24 charger shall include circuitry to monitor the 

25 battery voltage and charge current and limit 


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1 these to safe levels. A personal electronic vapor2 izer that contains multiple battery cells in series 

3 shall monitor the cells individually. 

4 ‘‘(E) SERIAL AND LOT NUMBERS.—A per5 sonal electronic vaporizer shall include a serial 

6 or lot number on the label that allows the va7 porizer to be traced to its time and place of 

8 manufacture. Notwithstanding the preceding 

9 sentence, a single-use personal electronic vapor10 izer may have such serial or lot number on the 

11 packaging of the vaporizer other than the label. 

12 ‘‘(F) VERIFICATION AND VALIDATION.—A 

13 personal electronic vaporizer shall be con14 structed with sufficiently validated processes, or 

15 subject to sufficient verification and testing, to 

16 ensure that each individual vaporizer conforms 

17 to its specifications. 

18 ‘‘(G) TRACKING AND RECALLS.—The man19 ufacturer of a personal electronic vaporizer 

20 shall record all shipments of one or more per21 sonal electronic vaporizers by the manufacturer 

22 to a distributor, retailer, or end user, and cor23 relate each such shipment to serial or lot num24 bers, to enable batch tracking and recalls. 


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1 ‘‘(H) MATERIALS.—The manufacturer of a 

2 personal electronic vaporizer shall ensure that— 

3 ‘‘(i) materials that come in contact 

4 with e-liquids or vapor during manufacture 

5 or reasonably foreseeable use of the per6 sonal electronic vaporizer are limited to ap7 proved medical or food contact grade prod8 ucts with established safety and biocompat9 ibility characteristics; and 

10 ‘‘(ii) components of a personal elec11 tronic vaporizer which are expected to be 

12 subject to heat are appropriate for the ex13 pected temperatures. 

14 ‘‘(3) REVISIONS.—Before issuing a revision to 

15 the standards applicable under paragraph (1)(A), 

16 (1)(B), or (2)(A), the American E-Liquid Manufac17 turing Standards Association, the American Na18 tional Standards Institute, or the International Elec19 trotechnical Commission, as applicable, shall notify 

20 the Secretary in writing of the proposed revision. 

21 Not later than 90 days after the date of receipt of 

22 such notice, the Secretary shall determine whether 

23 the proposed revision enhances the safety and qual24 ity of e-liquid products or personal electronic vapor25 izers, as applicable. If the Secretary determines that 


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1 the proposed revision does enhance the safety and 

2 quality of e-liquid products or personal electronic va3 porizers, as applicable, the Secretary shall give no4 tice of such determination to the public for a period 

5 of 90 days and, effective at the end of such period, 

6 incorporate the revision into the standards applicable 

7 under paragraph (1)(A), (1)(B), or (2)(A), as appli8 cable. 

9 ‘‘(c) CERTIFICATION OF COMPLIANCE WITH MANU10 FACTURING STANDARDS.—Beginning not later than 1 

11 year after the date of enactment of the Cigarette Smoking 

12 Reduction and Electronic Vapor Alternatives Act of 2017, 

13 each e-liquid and personal electronic vaporizer manufac14 turer offering e-liquids for sale in interstate commerce 

15 shall have in effect a certification filed with the Secretary 

16 in writing that all such e-liquids or personal electronic va17 porizers, as applicable, are manufactured, labeled, and 

18 otherwise in compliance with the standards under sub19 section (b). 

20 ‘‘(d) INSPECTIONS FOR COMPLIANCE WITH MANU21 FACTURING STANDARDS.—E-liquid and personal elec22 tronic vaporizer manufacturers shall provide the Secretary 

23 with access to their facilities used in manufacturing e-liq24 uids or personal electronic vaporizers, as applicable, for 

25 inspection. 


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1 ‘‘(e) FAILURE TO COMPLY WITH MANUFACTURING

2 STANDARDS.— 

3 ‘‘(1) IN GENERAL.—If the Secretary finds that 

4 an e-liquid or personal electronic vaporizer manufac5 turer is in noncompliance with the standards under 

6 subsection (b)— 

7 ‘‘(A) the Secretary shall not take any en8 forcement action based on such noncompliance 

9 unless— 

10 ‘‘(i) the Secretary gives the manufac11 turer notice of, and a period of 90 days to 

12 correct, such noncompliance; and 

13 ‘‘(ii) the manufacturer fails, by the 

14 end of such 90-day period, to correct such 

15 noncompliance; and 

16 ‘‘(B) if the manufacturer fails to correct 

17 such noncompliance, as described in paragraph 

18 (1)(A)(ii), the Secretary may issue an order re19 quiring the manufacturer— 

20 ‘‘(i) to suspend any commercial activ21 ity that the Secretary finds to be in non22 compliance; and 

23 ‘‘(ii) to not resume such activity until 

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1 retary’s satisfaction that such noncompli2 ance has been corrected. 

3 ‘‘(2) IMMEDIATE DANGER TO PUBLIC

4 HEALTH.—Notwithstanding paragraph (1), if the 

5 Secretary determines that an e-liquid or personal 

6 electronic vaporizer manufacturer is in noncompli7 ance with the standards under subsection (b), and 

8 that such noncompliance presents an immediate dan9 ger to public health, the Secretary may issue an 

10 order requiring the manufacturer to suspend produc11 tion of such e-liquid or personal electronic vaporizer 

12 until the Secretary determines that such noncompli13 ance is corrected. 

14 ‘‘SEC. 1005. PROHIBITION AGAINST ADVERTISING OR PRO15 MOTING TO MINORS. 

16 ‘‘(a) PROHIBITION.—The Secretary may by regula17 tion prohibit any manufacturer of an e-liquid or personal 

18 electronic vaporizer from advertising or promoting the e19 liquid or personal electronic vaporizer to individuals who 

20 have not attained 18 years of age. 

21 ‘‘(b) PENALTY.—If a manufacturer violates a prohi22 bition established under subsection (a), the Secretary may 

23 refuse to accept for filing or renewal, and may revoke, the 

24 manufacturer’s certification under section 1004(c). 


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1 ‘‘SEC. 1006. PREEMPTION OF CERTAIN STATE AND LOCAL 

2 REQUIREMENTS. 

3 ‘‘(a) IN GENERAL.—No State or political subdivision 

4 of a State may establish or continue in effect any require5 ment with respect to the manufacture, warning require6 ments, marketing, distribution, or sale of an e-liquid or 

7 personal electronic vaporizer which is different from, or 

8 in addition to, any requirement under the provisions of 

9 this chapter or pursuant to section 503(g), including the 

10 exclusion of e-liquids and personal electronic vaporizers 

11 from the definition of a tobacco product under section 

12 201. 

13 ‘‘(b) EXCEPTION.—Information disclosed to a State 

14 consistent with subsection (a) that is exempt from disclo15 sure under section 552(b)(4) of title 5, United States 

16 Code, shall be treated as a trade secret and confidential 

17 information by the State. 

18 ‘‘SEC. 1007. OFFICE FOR E-LIQUID AND PERSONAL ELEC19 TRONIC VAPORIZER STANDARDS COMPLI20 ANCE. 

21 ‘‘Not later than 90 days after the date of enactment 

22 of the Cigarette Smoking Reduction and Electronic Vapor 

23 Alternatives Act of 2017, the Secretary shall establish 

24 within the Food and Drug Administration’s Center for To25 bacco Products and Tobacco Harm Reduction an Office 


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1 of E-Liquid and Personal Electronic Vaporizer Standards 

2 Compliance. The Office shall— 

3 ‘‘(1) be responsible for the implementation of 

4 this chapter and related matters assigned by the Di5 rector of such Center; and 

6 ‘‘(2) provide technical and other nonfinancial 

7 assistance to e-liquid and personal electronic vapor8 izer manufacturers to assist them in complying with 

9 the requirements of this Act.’’. 

10 SEC. 5. JOINT COMPARATIVE HEALTH RISK ASSESSMENT. 

11 Chapter X of the Federal Food, Drug, and Cosmetic 

12 Act, as added by section 4, is further amended by adding 

13 at the end the following: 

14 ‘‘SEC. 1008. TOBACCO PRODUCTS AND NICOTINE DELIVERY 

15 ALTERNATIVES: COMPARATIVE HEALTH RISK 

16 ASSESSMENT. 

17 ‘‘(a) ASSESSMENT.—The Secretary shall undertake a 

18 tobacco products and other nicotine delivery alternatives 

19 comparative health risk assessment and rank each cat20 egory of products on a scale according to the reasonable 

21 expectation for morbidity and mortality risk when com22 pared to smoking cigarettes based on laboratory studies 

23 and existing scientific data. For purposes of such assess24 ment, tobacco and nicotine delivery alternative product 

25 categories shall include at a minimum— 


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1 ‘‘(1) cigarettes; 

2 ‘‘(2) loose tobacco for roll-your-own tobacco 

3 products; 

4 ‘‘(3) little cigars; 

5 ‘‘(4) cigars; 

6 ‘‘(5) pipe tobacco; 

7 ‘‘(6) moist snuff; 

8 ‘‘(7) dry snuff; 

9 ‘‘(8) chewing tobacco; 

10 ‘‘(9) snus; 

11 ‘‘(10) vaporized tobacco, meaning ‘heat not 

12 burn’ technology intended for inhalation; 

13 ‘‘(11) vapor produced by a personalized elec14 tronic vaporizer containing e-liquid with nicotine; 

15 ‘‘(12) shisha and other tobacco products that 

16 are heated and inhaled via a hookah, water pipe, or 

17 other type of pipe (treated collectively as a single 

18 category); 

19 ‘‘(13) dissolvable, chewable, drinkable, and 

20 other tobacco and nicotine products intended for oral 

21 ingestion (treated collectively as a single category); 

22 ‘‘(14) tobacco and nicotine skin creams, patch23 es, and other tobacco and nicotine products intended 

24 for transdermal consumption (treated collectively as 

25 a single category); 


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25 

•HR 2194 IH

1 ‘‘(15) tobacco and nicotine sprays, droplets, and 

2 mists intended for nasal consumption (treated as a 

3 single category); and 

4 ‘‘(16) other nicotine-containing products (treat5 ed collectively as a single category). 

6 ‘‘(b) REPORT.—Not later than 18 months after the 

7 date of enactment of the Cigarette Smoking Reduction 

8 and Electronic Vapor Alternatives Act of 2017, the Sec9 retary shall report to the Committee on Energy and Com10 merce of the House of Representatives and the Committee 

11 on Health, Education, Labor, and Pensions of the Senate 

12 on the results of the comparative health risk assessment 

13 under subsection (a). Based on such results, such report 

14 shall include recommendations on— 

15 ‘‘(1) new or improved tobacco harm reduction 

16 strategies; and 

17 ‘‘(2) the possible need for additional legislative 

18 authorities to implement such strategies.’’. 

Æ 


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