Title: Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017
Policy area: Health

Summary:
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration (FDA) to regulate electronic cigarettes through regulation of e-liquids (solutions used in electronic cigarettes) and personal electronic vaporizers (products that convert e-liquids into inhalable vapor).
E-liquids and personal electronic vaporizers are excluded from the definition of tobacco products.
The bill sets forth requirements for the sale and manufacturing of e-liquids and personal electronic vaporizers including: (1) prohibiting sales to persons younger than 18, (2) establishing manufacturing standards, and (3) requiring certification of compliance with manufacturing standards.
The FDA may prohibit advertising of e-liquids and vaporizers to minors. The Office of E-Liquid and Personal Vaporizer Standards Compliance is created in the FDA's Center for Tobacco Products and Tobacco Harm Reduction.
State and local laws on e-liquids and personal electronic vaporizers are preempted by this bill.
The FDA shall provide Congress a comparative health risk assessment of tobacco products and other nicotine delivery alternatives and rank them based on morbidity and mortality risk as compared to smoking cigarettes.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2194 Introduced in House (IH)]

<DOC>






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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Cigarette Smoking 
Reduction and Electronic Vapor Alternatives Act of 2017''.
    (b) Table of Contents.--The table of contents of 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.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Cigarette smoking is the practice of burning tobacco 
        rolled in a paper and inhaling the smoke. According to the 
        Department of Health and Human Services--
                    (A) the burning of tobacco produces a chemical 
                mixture of more than 7,000 compounds;
                    (B) cigarette smoking causes cancer, heart disease, 
                stroke, lung diseases, diabetes, and chronic 
                obstructive pulmonary disease, and harms nearly every 
                organ of the body;
                    (C) cigarette smoking causes more than 480,000 
                deaths each year, including nearly 42,000 deaths due to 
                secondhand tobacco smoke;
                    (D) the economic cost of cigarette smoking is more 
                than $300 billion a year, including nearly $170 billion 
                in direct medical care, and more than $156 billion in 
                lost productivity; and
                    (E) nearly 7 in 10 adult cigarette smokers want to 
                quit smoking.
            (2) Electronic vapor products, also known as ``electronic 
        cigarettes'' or ``e-cigarettes'', are battery-operated devices 
        that use low heat to turn e-liquid, which generally contains 
        nicotine, into a vaporized aerosol which is inhaled--there is 
        no burning of tobacco or generation of smoke for inhalation.
            (3) Evidence from numerous studies strongly suggests that 
        electronic vapor products are magnitudes safer than 
        traditional, combustible cigarettes. Studies have found that 
        several million regular vapers in the United States no longer 
        regularly smoke cigarettes.
            (4) Studies of cigarette smokers who switched to vapor 
        found significant improvements in lung function, including a 
        study finding asthmatic smokers who switched to vapor had 
        significant improvements in spirometry data, asthma control, 
        airway hyperresponsiveness, and lower blood pressure.
            (5) The Royal College of Physicians 2016 report on e-
        cigarettes titled, ``Nicotine without smoke: Tobacco harm 
        reduction'' issued the following findings:
                    (A) The available evidence to date indicates that 
                e-cigarettes are being used almost exclusively as safer 
                alternatives to smoked tobacco, by confirmed smokers 
                who are trying to reduce harm to themselves or others 
                from smoking, or to quit smoking completely.
                    (B) The hazard to health arising from long-term 
                vapor inhalation from the e-cigarettes available today 
                is unlikely to exceed 5 percent of the harm from 
                smoking tobacco.
                    (C) E-cigarettes are marketed as consumer products 
                and are proving much more popular than Food and Drug 
                Administration-approved nicotine replacement therapies 
                (NRT) as a substitute and competitor for tobacco 
                cigarettes.
            (6) ``E-liquid'' is the liquid that is heated into vapor. 
        It contains, principally, propylene glycol, vegetable glycerin, 
        in some cases food flavoring, in some cases nicotine, and in 
        some cases water; propylene glycol and vegetable glycerin are 
        designated as ``generally recognized as safe'' by the Food and 
        Drug Administration (FDA) as food additives.
            (7) Surveys have found that a significant majority of 
        regular users of electronic vapor products had previously tried 
        FDA-approved smoking cessation drugs to quit smoking without 
        success.
            (8) An expert independent evidence review published by 
        Public Health England (PHE) concluded that--
                    (A) the use of vapor products is about 95 percent 
                less harmful than cigarette smoking;
                    (B) nearly half the population doesn't realize 
                vapor is much less harmful than smoking; and
                    (C) there is no evidence suggesting electronic 
                vapor products act as a route into smoking for children 
                or nonsmokers.
            (9) Electronic vapor product sales in the United States 
        have increased from an estimated $100 million in 2010 to $4 
        billion in 2016 while cigarette consumption in the United 
        States declined from $307 billion in 2010 to an estimated $265 
        billion in 2016.
            (10) On May 10, 2016, the Food and Drug Administration 
        issued its ``Deeming Regulation'' to deem e-cigarettes or 
        electronic vapor products to be subject to its authority. The 
        regulation will, as a practical matter, because of its 
        significant compliance costs and poorly articulated standard 
        for protecting public health, ban the sale of all electronic 
        vapor products by August 2018.
            (11) The Food and Drug Administration's Deeming Regulation, 
        by effectively banning electronic vapor products, will push 
        vapers who have quit or reduced cigarette smoking by switching 
        to electronic vapor products back to smoking deadly cigarettes.
            (12) The 2015 Monitoring the Future survey of the National 
        Institute on Drug Abuse found past-30-day use of an electronic 
        vapor product by 8th, 10th, and 12th graders combined declined 
        from 13.9 percent in 2014 to 9.9 percent in 2016; however, that 
        survey found that fewer than 20 percent of teens who used an 
        electronic vapor product in the past 30 days reported using a 
        product containing nicotine.
            (13) Electronic vapor products show tremendous promise in 
        reducing cigarette smoking, and cigarette smoking attributable 
        morbidity, mortality, and health care costs.
            (14) According to an April 13, 2017, Centers for Disease 
        Control and Prevention study, more Americans who are trying to 
        quit smoking use vapor products (35.3 percent) than any other 
        smoking cessation tool. This includes using a nicotine patch or 
        gum (25.4 percent), getting help from a doctor or other health 
        professional (15.2 percent), using smoking cessation 
        medications approved by the Food and Drug Administration (12.2 
        percent), and getting help from a website (7.1 percent) or a 
        telephone quitline (5.4 percent).
            (15) Since the Food and Drug Administration was granted 
        authority to regulate tobacco products in 2009, the agency has 
        failed to grant market approval to any modified risk tobacco 
        product.

SEC. 3. PURPOSES OF THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL 
              ACT.

    Section 3 of the Family Smoking Prevention and Tobacco Control Act 
(21 U.S.C. 387 note) is amended by amending paragraph (9) to read as 
follows:
            ``(9) to promote--
                    ``(A) cessation to reduce disease risk and the 
                social costs associated with tobacco-related diseases; 
                and
                    ``(B) harm reduction strategies; and''.

SEC. 4. REGULATION OF ELECTRONIC VAPOR PRODUCTS.

    (a) Center for Tobacco Products and Tobacco Harm Reduction.--
Section 901(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387a(e)) is amended--
            (1) in the subsection heading, by striking ``Center for 
        Tobacco Products'' and inserting ``Center for Tobacco Products 
        and Tobacco Harm Reduction'';
            (2) by striking ``Center for Tobacco Products'' and 
        inserting ``Center for Tobacco Products and Tobacco Harm 
        Reduction''; and
            (3) by striking ``this chapter'' and inserting ``this 
        chapter and chapter X''.
    (b) FDA Authority Over Electronic Vapor Products.--
            (1) Exclusion from definition of tobacco product.--Section 
        201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(rr)) is amended--
                    (A) in paragraph (2), by inserting ``an e-liquid 
                (as defined in section 1001), a personal electronic 
                vaporizer (as defined in section 1001),'' before ``or a 
                combination product''; and
                    (B) in paragraph (3), by inserting after ``The 
                products described in paragraph (2)'' the following: 
                ``(other than an e-liquid or personal electronic 
                vaporizer)''.
            (2) Combination products.--Section 503(g) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A), by striking ``or 
                        biological product'' and inserting ``, 
                        biological product, e-liquid, or personal 
                        electronic vaporizer''; and
                            (ii) in subparagraph (D)--
                                    (I) in clause (ii), by striking 
                                ``or'' at the end;
                                    (II) in clause (iii), by striking 
                                the period at the end and inserting ``; 
                                or''; and
                                    (III) by adding at the end the 
                                following:
            ``(iv) an e-liquid or personal electronic vaporizer, the 
        agency center charged with regulating e-liquids and personal 
        electronic vaporizers shall have primary jurisdiction.''; and
                    (B) in paragraph (9)--
                            (i) by redesignating subparagraphs (C) and 
                        (D) as subparagraphs (D) and (E), respectively; 
                        and
                            (ii) by inserting after subparagraph (B) 
                        the following:
            ``(C) The terms `e-liquid' and `personal electronic 
        vaporizer' have the meanings given to such terms in section 
        1001.''.
            (3) Regulatory authority.--The Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
                    (A) by redesignating chapter X as chapter XI;
                    (B) by redesignating sections 1001 through 1014 as 
                sections 1101 through 1114, respectively;
                    (C) in section 505(n)(2), by striking ``1004'' and 
                inserting ``1104'';
                    (D) in sections 523(b)(2)(D) and 704(g)(13), by 
                striking ``1003(g)'' and inserting ``1103(g)'';
                    (E) in section 1109(a)(5)(A), as redesignated by 
                paragraph (4), by striking ``1008'' and inserting 
                ``1108''; and
                    (F) by inserting after chapter IX the following:

                 ``CHAPTER X--ELECTRONIC VAPOR PRODUCTS

``SEC. 1001. DEFINITIONS.

    ``In this chapter:
            ``(1) The term `e-liquid' means any liquid solution that--
                    ``(A) may or may not contain nicotine; and
                    ``(B) is intended to be converted into an aerosol, 
                vapor, or vapor-like mist for users to inhale through 
                the mouthpiece of a personal electronic vaporizer.
            ``(2) The term `personal electronic vaporizer' means an 
        electronic device that employs a heating element or atomizer 
        that converts an e-liquid into an aerosol, vapor, or vapor-like 
        mist through a noncombustive process.
            ``(3) The terms `e-liquid' and `personal electronic 
        vaporizer' exclude--
                    ``(A) a drug as defined in section 201(g)(1);
                    ``(B) a device as defined in section 201(h); and
                    ``(C) a biological product as defined in section 
                351 of the Public Health Service Act.

``SEC. 1002. EXCLUSIVE AUTHORITY FOR REGULATING E-LIQUIDS AND PERSONAL 
              ELECTRONIC VAPORIZERS.

    ``The authorities vested by this chapter constitute the exclusive 
authorities of the Secretary to regulate e-liquids and personal 
electronic vaporizers, except to the extent e-liquids and personal 
electronic vaporizers are within combination products regulated 
pursuant to section 503(g).

``SEC. 1003. PROHIBITED ACTS; PENALTIES.

    ``(a) Prohibitions.--
            ``(1) In general.--The following acts and the causing 
        thereof are hereby prohibited:
                    ``(A) The sale of an electronic vapor product or e-
                liquid to any person younger than 18 years of age.
                    ``(B) The manufacture of an e-liquid or personal 
                electronic vaporizer in noncompliance with the 
                standards under section 1004(b) in violation of an 
                order issued under section 1004(e).
                    ``(C) The offering of e-liquids or personal 
                electronic vaporizers for sale in interstate commerce 
                by an e-liquid or personal electronic vaporizer 
                manufacturer that does not have a certification in 
                effect as required by section 1004(c).
                    ``(D) The failure by an e-liquid or personal 
                electronic vaporizer manufacturer to provide access for 
                inspection as required by section 1004(d).
                    ``(E) The introduction or delivery for introduction 
                in interstate commerce of an e-liquid or personal 
                electronic vaporizer by any person that is adulterated 
                or misbranded, as described in subsection (b) or (c) 
                respectively.
            ``(2) Retailers.--Notwithstanding subparagraphs (A) and (E) 
        of paragraph (1), a retailer may be found to be in violation of 
        either such subparagraph (with respect to sale or introduction 
        or delivery for introduction in interstate commerce at retail) 
        only if the violation occurs knowingly.
    ``(b) Adulteration.--An e-liquid or personal electronic vaporizer 
shall be treated as adulterated if--
            ``(1) it was manufactured in noncompliance with the 
        standards under section 1004(b) in violation of an order issued 
        under section 1004(e); or
            ``(2) it was manufactured by an e-liquid or personal 
        electronic vaporizer manufacturer that does not have a 
        certification in effect as required by section 1004(c).
    ``(c) Misbranding.--An e-liquid or personal electronic vaporizer 
shall be treated as misbranded if its labeling (as such term is defined 
in section 201 with respect to drugs) is in noncompliance with the 
standards under section 1004(b) in violation of an order issued under 
section 1004(e).
    ``(d) Penalties.--Any person who violates a provision of subsection 
(a) shall be imprisoned not more than 3 years, fined not more than 
$10,000 (notwithstanding section 3571(e) of title 18, United States 
Code) for each day on which the violation continues, or both.

``SEC. 1004. STANDARDS FOR THE MANUFACTURING OF E-LIQUIDS AND PERSONAL 
              ELECTRONIC VAPORIZERS; COMPLIANCE.

    ``(a) Requirement.--Beginning on the date that is 1 year after the 
date of enactment of the Cigarette Smoking Reduction and Electronic 
Vapor Alternatives Act of 2017, any e-liquid or personal electronic 
vaporizer introduced or delivered for introduction into interstate 
commerce shall conform to the e-liquid or personal electronic vaporizer 
(as applicable) manufacturing standards under subsection (b), including 
the labeling standards therein.
    ``(b) Manufacturing Standards.--
            ``(1) E-liquids.--The manufacturing standards for e-liquids 
        under this subsection shall consist of the following:
                    ``(A) Interim standards.--The e-liquid 
                manufacturing standards issued by the American E-Liquid 
                Manufacturing Standards Association (version 2.3.2) on 
                March 8, 2017 (including any revision to such standards 
                made in accordance with paragraph (3)), apply to the 
                introduction or delivery for introduction into 
                interstate commerce of e-liquids during the period 
                beginning on the date described in subsection (a) and 
                ending on the date described in subparagraph (B).
                    ``(B) Subsequent standards.--The e-liquid 
                manufacturing standards of the American National 
                Standards Institute (including any revision to such 
                standards made in accordance with paragraph (3)) apply 
                to the introduction or delivery for introduction into 
                interstate commerce of e-liquids beginning on the date 
                of the adoption of such standards by the American 
                National Standards Institute.
            ``(2) Personal electronic vaporizers.--The manufacturing 
        standards for personal electronic vaporizers under this 
        subsection shall consist of the following:
                    ``(A) Battery safety.--Any battery used in a 
                personal electronic vaporizer shall conform to the IEC 
                62133 standards of the International Electrotechnical 
                Commission, as in effect on the date of enactment of 
                the Cigarette Smoking Reduction and Electronic Vapor 
                Alternatives Act of 2017 and including any revision to 
                such standards made in accordance with paragraph (3).
                    ``(B) Short circuit protection.--A personal 
                electronic vaporizer shall have a mechanism to ensure 
                user and battery safety in the event of a short circuit 
                of the heating element.
                    ``(C) Discharge monitoring.--A rechargeable 
                personal electronic vaporizer shall have a mechanism to 
                prevent the battery from being discharged below a safe 
                voltage during use or discharged faster than the 
                battery can sustain safely.
                    ``(D) Charge monitoring.--A personal electronic 
                vaporizer that contains an onboard charger shall 
                include circuitry to monitor the battery voltage and 
                charge current and limit these to safe levels. A 
                personal electronic vaporizer that contains multiple 
                battery cells in series shall monitor the cells 
                individually.
                    ``(E) Serial and lot numbers.--A personal 
                electronic vaporizer shall include a serial or lot 
                number on the label that allows the vaporizer to be 
                traced to its time and place of manufacture. 
                Notwithstanding the preceding sentence, a single-use 
                personal electronic vaporizer may have such serial or 
                lot number on the packaging of the vaporizer other than 
                the label.
                    ``(F) Verification and validation.--A personal 
                electronic vaporizer shall be constructed with 
                sufficiently validated processes, or subject to 
                sufficient verification and testing, to ensure that 
                each individual vaporizer conforms to its 
                specifications.
                    ``(G) Tracking and recalls.--The manufacturer of a 
                personal electronic vaporizer shall record all 
                shipments of one or more personal electronic vaporizers 
                by the manufacturer to a distributor, retailer, or end 
                user, and correlate each such shipment to serial or lot 
                numbers, to enable batch tracking and recalls.
                    ``(H) Materials.--The manufacturer of a personal 
                electronic vaporizer shall ensure that--
                            ``(i) materials that come in contact with 
                        e-liquids or vapor during manufacture or 
                        reasonably foreseeable use of the personal 
                        electronic vaporizer are limited to approved 
                        medical or food contact grade products with 
                        established safety and biocompatibility 
                        characteristics; and
                            ``(ii) components of a personal electronic 
                        vaporizer which are expected to be subject to 
                        heat are appropriate for the expected 
                        temperatures.
            ``(3) Revisions.--Before issuing a revision to the 
        standards applicable under paragraph (1)(A), (1)(B), or (2)(A), 
        the American E-Liquid Manufacturing Standards Association, the 
        American National Standards Institute, or the International 
        Electrotechnical Commission, as applicable, shall notify the 
        Secretary in writing of the proposed revision. Not later than 
        90 days after the date of receipt of such notice, the Secretary 
        shall determine whether the proposed revision enhances the 
        safety and quality of e-liquid products or personal electronic 
        vaporizers, as applicable. If the Secretary determines that the 
        proposed revision does enhance the safety and quality of e-
        liquid products or personal electronic vaporizers, as 
        applicable, the Secretary shall give notice of such 
        determination to the public for a period of 90 days and, 
        effective at the end of such period, incorporate the revision 
        into the standards applicable under paragraph (1)(A), (1)(B), 
        or (2)(A), as applicable.
    ``(c) Certification of Compliance With Manufacturing Standards.--
Beginning not later than 1 year after the date of enactment of the 
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 
2017, each e-liquid and personal electronic vaporizer manufacturer 
offering e-liquids for sale in interstate commerce shall have in effect 
a certification filed with the Secretary in writing that all such e-
liquids or personal electronic vaporizers, as applicable, are 
manufactured, labeled, and otherwise in compliance with the standards 
under subsection (b).
    ``(d) Inspections for Compliance With Manufacturing Standards.--E-
liquid and personal electronic vaporizer manufacturers shall provide 
the Secretary with access to their facilities used in manufacturing e-
liquids or personal electronic vaporizers, as applicable, for 
inspection.
    ``(e) Failure To Comply With Manufacturing Standards.--
            ``(1) In general.--If the Secretary finds that an e-liquid 
        or personal electronic vaporizer manufacturer is in 
        noncompliance with the standards under subsection (b)--
                    ``(A) the Secretary shall not take any enforcement 
                action based on such noncompliance unless--
                            ``(i) the Secretary gives the manufacturer 
                        notice of, and a period of 90 days to correct, 
                        such noncompliance; and
                            ``(ii) the manufacturer fails, by the end 
                        of such 90-day period, to correct such 
                        noncompliance; and
                    ``(B) if the manufacturer fails to correct such 
                noncompliance, as described in paragraph (1)(A)(ii), 
                the Secretary may issue an order requiring the 
                manufacturer--
                            ``(i) to suspend any commercial activity 
                        that the Secretary finds to be in 
                        noncompliance; and
                            ``(ii) to not resume such activity until 
                        the manufacturer demonstrates to the 
                        Secretary's satisfaction that such 
                        noncompliance has been corrected.
            ``(2) Immediate danger to public health.--Notwithstanding 
        paragraph (1), if the Secretary determines that an e-liquid or 
        personal electronic vaporizer manufacturer is in noncompliance 
        with the standards under subsection (b), and that such 
        noncompliance presents an immediate danger to public health, 
        the Secretary may issue an order requiring the manufacturer to 
        suspend production of such e-liquid or personal electronic 
        vaporizer until the Secretary determines that such 
        noncompliance is corrected.

``SEC. 1005. PROHIBITION AGAINST ADVERTISING OR PROMOTING TO MINORS.

    ``(a) Prohibition.--The Secretary may by regulation prohibit any 
manufacturer of an e-liquid or personal electronic vaporizer from 
advertising or promoting the e-liquid or personal electronic vaporizer 
to individuals who have not attained 18 years of age.
    ``(b) Penalty.--If a manufacturer violates a prohibition 
established under subsection (a), the Secretary may refuse to accept 
for filing or renewal, and may revoke, the manufacturer's certification 
under section 1004(c).

``SEC. 1006. PREEMPTION OF CERTAIN STATE AND LOCAL REQUIREMENTS.

    ``(a) In General.--No State or political subdivision of a State may 
establish or continue in effect any requirement with respect to the 
manufacture, warning requirements, marketing, distribution, or sale of 
an e-liquid or personal electronic vaporizer which is different from, 
or in addition to, any requirement under the provisions of this chapter 
or pursuant to section 503(g), including the exclusion of e-liquids and 
personal electronic vaporizers from the definition of a tobacco product 
under section 201.
    ``(b) Exception.--Information disclosed to a State consistent with 
subsection (a) that is exempt from disclosure under section 552(b)(4) 
of title 5, United States Code, shall be treated as a trade secret and 
confidential information by the State.

``SEC. 1007. OFFICE FOR E-LIQUID AND PERSONAL ELECTRONIC VAPORIZER 
              STANDARDS COMPLIANCE.

    ``Not later than 90 days after the date of enactment of the 
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 
2017, the Secretary shall establish within the Food and Drug 
Administration's Center for Tobacco Products and Tobacco Harm Reduction 
an Office of E-Liquid and Personal Electronic Vaporizer Standards 
Compliance. The Office shall--
            ``(1) be responsible for the implementation of this chapter 
        and related matters assigned by the Director of such Center; 
        and
            ``(2) provide technical and other nonfinancial assistance 
        to e-liquid and personal electronic vaporizer manufacturers to 
        assist them in complying with the requirements of this Act.''.

SEC. 5. JOINT COMPARATIVE HEALTH RISK ASSESSMENT.

    Chapter X of the Federal Food, Drug, and Cosmetic Act, as added by 
section 4, is further amended by adding at the end the following:

``SEC. 1008. TOBACCO PRODUCTS AND NICOTINE DELIVERY ALTERNATIVES: 
              COMPARATIVE HEALTH RISK ASSESSMENT.

    ``(a) Assessment.--The Secretary shall undertake a tobacco products 
and other nicotine delivery alternatives comparative health risk 
assessment and rank each category of products on a scale according to 
the reasonable expectation for morbidity and mortality risk when 
compared to smoking cigarettes based on laboratory studies and existing 
scientific data. For purposes of such assessment, tobacco and nicotine 
delivery alternative product categories shall include at a minimum--
            ``(1) cigarettes;
            ``(2) loose tobacco for roll-your-own tobacco products;
            ``(3) little cigars;
            ``(4) cigars;
            ``(5) pipe tobacco;
            ``(6) moist snuff;
            ``(7) dry snuff;
            ``(8) chewing tobacco;
            ``(9) snus;
            ``(10) vaporized tobacco, meaning `heat not burn' 
        technology intended for inhalation;
            ``(11) vapor produced by a personalized electronic 
        vaporizer containing e-liquid with nicotine;
            ``(12) shisha and other tobacco products that are heated 
        and inhaled via a hookah, water pipe, or other type of pipe 
        (treated collectively as a single category);
            ``(13) dissolvable, chewable, drinkable, and other tobacco 
        and nicotine products intended for oral ingestion (treated 
        collectively as a single category);
            ``(14) tobacco and nicotine skin creams, patches, and other 
        tobacco and nicotine products intended for transdermal 
        consumption (treated collectively as a single category);
            ``(15) tobacco and nicotine sprays, droplets, and mists 
        intended for nasal consumption (treated as a single category); 
        and
            ``(16) other nicotine-containing products (treated 
        collectively as a single category).
    ``(b) Report.--Not later than 18 months after the date of enactment 
of the Cigarette Smoking Reduction and Electronic Vapor Alternatives 
Act of 2017, the Secretary shall report to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate on the results of the 
comparative health risk assessment under subsection (a). Based on such 
results, such report shall include recommendations on--
            ``(1) new or improved tobacco harm reduction strategies; 
        and
            ``(2) the possible need for additional legislative 
        authorities to implement such strategies.''.
                                 <all>