,i #aaeth ,,congress #ast ,session ,h4 ,r4 #baid ,,in ,,the ,,house ,,of ,,representatives ,april #bg1 #bjag,mr4 ,hunter introduced the following bill2 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 vaporizers1 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 strategy1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,findings4 ,sec4 #c4 ,purposes of the ,family ,smoking ,prevention and ,tobacco ,control ,act4 ,sec4 #d4 ,regulation of electronic vapor products4 ,sec4 #e4 ,joint comparative health risk assessment4 #b4 ,findings ,the ,congress finds the following3 7#a7 ,cigarette smoking is the practice of burning tobacco rolled in a paper and inhaling the smoke4 ,according to the ,department of ,health and ,human ,services-- 7,a7 the burning of tobacco produces a chemical mixture of more than #g1jjj compounds2 7,b7 cigarette smoking causes cancer1 heart disease1 stroke1 lung diseases1 diabetes1 and chronic obstructive pulmonary disease1 and harms nearly every organ of the body2 7,c7 cigarette smoking causes more than #dhj1jjj deaths each year1 including nearly #db1jjj deaths due to secondhand tobacco smoke2 7,d7 the economic cost of cigarette smoking is more than #cjj billion a year1 including nearly #agj billion in direct medical care1 and more than #aef billion in lost productivity2 and 7,e7 nearly #g in #aj adult cigarette smokers want to quit smoking4 7#b7 ,electronic vapor products1 also known as electronic cigarettes or e-cigarettes1 are battery-operated devices that use low heat to turn e-liquid1 which generally contains nicotine1 into a vaporized aerosol which is inhaled--there is no burning of tobacco or generation of smoke for inhalation4 7#c7 ,evidence from numerous studies strongly suggests that electronic vapor products are magnitudes safer than traditional1 combustible cigarettes4 ,studies have found that several million regular vapers in the ,united ,states no longer regularly smoke cigarettes4 7#d7 ,studies of cigarette smokers who switched to vapor found significant improvements in lung function1 including a study finding asthmatic smokers who switched to vapor had significant improvements in spirometry data1 asthma control1 airway hyperresponsiveness1 and lower blood pressure4 7#e7 ,the ,royal ,college of ,physicians #bjaf report on e-cigarettes titled1 ,nicotine without smoke3 ,tobacco harm reduction issued the following findings3 7,a7 ,the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco1 by confirmed smokers who are trying to reduce harm to themselves or others from smoking1 or to quit smoking completely4 7,b7 ,the hazard to health arising from long-term vapor inhalation from the e-cigarettes available today is unlikely to exceed #e percent of the harm from smoking tobacco4 7,c7 ,e-cigarettes are marketed as consumer products and are proving much more popular than ,food and ,drug ,administration-approved nicotine replacement therapies 7,,nrt7 as a substitute and competitor for tobacco cigarettes4 7#f7 ,e-liquid is the liquid that is heated into vapor4 ,it contains1 principally1 propylene glycol1 vegetable glycerin1 in some cases food flavoring1 in some cases nicotine1 and in some cases water2 propylene glycol and vegetable glycerin are designated as generally recognized as safe by the ,food and ,drug ,administration 7,,fda7 as food additives4 7#g7 ,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 success4 7#h7 ,an expert independent evidence review published by ,public ,health ,england 7,,phe7 concluded that-- 7,a7 the use of vapor products is about #ie percent less harmful than cigarette smoking2 7,b7 nearly half the population doesn't realize vapor is much less harmful than smoking2 and 7,c7 there is no evidence suggesting electronic vapor products act as a route into smoking for children or nonsmokers4 7#i7 ,electronic vapor product sales in the ,united ,states have increased from an estimated #ajj million in #bjaj to #d billion in #bjaf while cigarette consumption in the ,united ,states declined from #cjg billion in #bjaj to an estimated #bfe billion in #bjaf4 7#aj7 ,on ,may #aj1 #bjaf1 the ,food and ,drug ,administration issued its ,deeming ,regulation to deem e-cigarettes or electronic vapor products to be subject to its authority4 ,the regulation will1 as a practical matter1 because of its significant compliance costs and poorly articulated standard for protecting public health1 ban the sale of all electronic vapor products by ,august #bjah4 7#aa7 ,the ,food and ,drug ,administration's ,deeming ,regulation1 by effectively banning electronic vapor products1 will push vapers who have quit or reduced cigarette smoking by switching to electronic vapor products back to smoking deadly cigarettes4 7#ab7 ,the #bjae ,monitoring the ,future survey of the ,national ,institute on ,drug ,abuse found past-#cj-;day use of an electronic vapor product by #hth1 #ajth1 and #abth graders combined declined from #ac4i percent in #bjad to #i4i percent in #bjaf2 however1 that survey found that fewer than #bj percent of teens who used an electronic vapor product in the past #cj days reported using a product containing nicotine4 7#ac7 ,electronic vapor products show tremendous promise in reducing cigarette smoking1 and cigarette smoking attributable morbidity1 mortality1 and health care costs4 7#ad7 ,according to an ,april #ac1 #bjag1 ,centers for ,disease ,control and ,prevention study1 more ,americans who are trying to quit smoking use vapor products 7#ce4c percent7 than any other smoking cessation tool4 ,this includes using a nicotine patch or gum 7#be4d percent71 getting help from a doctor or other health professional 7#ae4b percent71 using smoking cessation medications approved by the ,food and ,drug ,administration 7#ab4b percent71 and getting help from a website 7#g4a percent7 or a telephone quitline 7#e4d percent74 7#ae7 ,since the ,food and ,drug ,administration was granted authority to regulate tobacco products in #bjji1 the agency has failed to grant market approval to any modified risk tobacco product4 #c4 ,purposes of the ,family ,smoking ,prevention and ,tobacco ,control ,act ,section #c of the ,family ,smoking ,prevention and ,tobacco ,control ,act 7#ba ,u4,s4,c4 #chg note7 is amended by amending paragraph 7#i7 to read as follows3 7#i7 to promote-- 7,a7 cessation to reduce disease risk and the social costs associated with tobacco-related diseases2 and 7,b7 harm reduction strategies2 and 4 #d4 ,regulation of electronic vapor products 7a7 ,center for tobacco products and tobacco harm reduction ,section #ija7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chg;a7e77 is amended-- 7#a7 in the subsection heading1 by striking ,center for ,tobacco ,products and inserting ,center for ,tobacco ,products and ,tobacco ,harm ,reduction2 7#b7 by striking ,center for ,tobacco ,products and inserting ,center for ,tobacco ,products and ,tobacco ,harm ,reduction2 and 7#c7 by striking this chapter and inserting this chapter and chapter ,x4 7b7 ,,fda authority over electronic vapor products 7#a7 ,exclusion from definition of tobacco product ,section #bja7rr7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7rr77 is amended-- 7,a7 in paragraph 7#b71 by inserting an e-liquid 7as defined in section #ajja71 a personal electronic vaporizer 7as defined in section #ajja71 before or a combination product2 and 7,b7 in paragraph 7#c71 by inserting after ,the products described in paragraph 7#b7 the following3 7other than an e-liquid or personal electronic vaporizer74 7#b7 ,combination products ,section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a71 by striking or biological product and inserting 1 biological product1 e-liquid1 or personal electronic vaporizer2 and 7ii7 in subparagraph 7,d7-- 7,i7 in clause 7ii71 by striking or at the end2 7,,ii7 in clause 7iii71 by striking the period at the end and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7iv7 an e-liquid or personal electronic vaporizer1 the agency center charged with regulating e-liquids and personal electronic vaporizers shall have primary jurisdiction4 2 and 7,b7 in paragraph 7#i7-- 7i7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,d7 and 7,e71 respectively2 and 7ii7 by inserting after subparagraph 7,b7 the following3 7,c7 ,the terms e-liquid and personal electronic vaporizer have the meanings given to such terms in section #ajja4 4 7#c7 ,regulatory authority ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended-- 7,a7 by redesignating chapter ,x as chapter ,,xi2 7,b7 by redesignating sections #ajja through #ajad as sections #aaja through #aaad1 respectively2 7,c7 in section #eje7n77#b71 by striking #ajjd and inserting #aajd2 7,d7 in sections #ebc7;b77#b77;,d7 and #gjd7;g77#ac71 by striking #ajjc7;g7 and inserting #aajc7;g72 7,e7 in section #aaji7;a77#e77;,a71 as redesignated by paragraph 7#d71 by striking #ajjh and inserting #aajh2 and 7,f7 by inserting after chapter ,,ix the following3 ,x ,electronic ,vapor ,products #ajja4 ,definitions ,in this chapter3 7#a7 ,the term e-liquid means any liquid solution that-- 7,a7 may or may not contain nicotine2 and 7,b7 is intended to be converted into an aerosol1 vapor1 or vapor-like mist for users to inhale through the mouthpiece of a personal electronic vaporizer4 7#b7 ,the term personal electronic vaporizer means an electronic device that employs a heating element or atomizer that converts an e-liquid into an aerosol1 vapor1 or vapor-like mist through a noncombustive process4 7#c7 ,the terms e-liquid and personal electronic vaporizer exclude-- 7,a7 a drug as defined in section #bja7;g77#a72 7,b7 a device as defined in section #bja7;h72 and 7,c7 a biological product as defined in section #cea of the ,public ,health ,service ,act4 #ajjb4 ,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 vaporizers1 except to the extent e-liquids and personal electronic vaporizers are within combination products regulated pursuant to section #ejc7;g74 #ajjc4 ,prohibited acts2 penalties 7a7 ,prohibitions 7#a7 ,in general ,the following acts and the causing thereof are hereby prohibited3 7,a7 ,the sale of an electronic vapor product or e-liquid to any person younger than #ah years of age4 7,b7 ,the manufacture of an e-liquid or personal electronic vaporizer in noncompliance with the standards under section #ajjd7;b7 in violation of an order issued under section #ajjd7;e74 7,c7 ,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 #ajjd7;c74 7,d7 ,the failure by an e-liquid or personal electronic vaporizer manufacturer to provide access for inspection as required by section #ajjd7;d74 7,e7 ,the introduction or delivery for introduction in interstate commerce of an e-liquid or personal electronic vaporizer by any person that is adulterated or misbranded1 as described in subsection 7b7 or 7c7 respectively4 7#b7 ,retailers ,notwithstanding subparagraphs 7,a7 and 7,e7 of paragraph 7#a71 a retailer may be found to be in violation of either such subparagraph 7with respect to sale or introduction or delivery for introduction in interstate commerce at retail7 only if the violation occurs knowingly4 7b7 ,adulteration ,an e-liquid or personal electronic vaporizer shall be treated as adulterated if-- 7#a7 it was manufactured in noncompliance with the standards under section #ajjd7;b7 in violation of an order issued under section #ajjd7;e72 or 7#b7 it was manufactured by an e-liquid or personal electronic vaporizer manufacturer that does not have a certification in effect as required by section #ajjd7;c74 7c7 ,misbranding ,an e-liquid or personal electronic vaporizer shall be treated as misbranded if its labeling 7as such term is defined in section #bja with respect to drugs7 is in noncompliance with the standards under section #ajjd7;b7 in violation of an order issued under section #ajjd7;e74 7d7 ,penalties ,any person who violates a provision of subsection 7a7 shall be imprisoned not more than #c years1 fined not more than #aj1jjj 7notwithstanding section #cega7;e7 of title #ah1 ,united ,states ,code7 for each day on which the violation continues1 or both4 #ajjd4 ,standards for the manufacturing of e-liquids and personal electronic vaporizers2 compliance 7a7 ,requirement ,beginning on the date that is #a year after the date of enactment of the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag1 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 7as applicable7 manufacturing standards under subsection 7b71 including the labeling standards therein4 7b7 ,manufacturing standards 7#a7 ,e-liquids ,the manufacturing standards for e-liquids under this subsection shall consist of the following3 7,a7 ,interim standards ,the e-liquid manufacturing standards issued by the ,american ,e-,liquid ,manufacturing ,standards ,association 7version #b4c4b7 on ,march #h1 #bjag 7including any revision to such standards made in accordance with paragraph 7#c771 apply to the introduction or delivery for introduction into interstate commerce of e-liquids during the period beginning on the date described in subsection 7a7 and ending on the date described in subparagraph 7,b74 7,b7 ,subsequent standards ,the e-liquid manufacturing standards of the ,american ,national ,standards ,institute 7including any revision to such standards made in accordance with paragraph 7#c77 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 ,institute4 7#b7 ,personal electronic vaporizers ,the manufacturing standards for personal electronic vaporizers under this subsection shall consist of the following3 7,a7 ,battery safety ,any battery used in a personal electronic vaporizer shall conform to the ,,iec #fbacc standards of the ,international ,electrotechnical ,commission1 as in effect on the date of enactment of the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag and including any revision to such standards made in accordance with paragraph 7#c74 7,b7 ,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 element4 7,c7 ,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 safely4 7,d7 ,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 levels4 ,a personal electronic vaporizer that contains multiple battery cells in series shall monitor the cells individually4 7,e7 ,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 manufacture4 ,notwithstanding the preceding sentence1 a single-use personal electronic vaporizer may have such serial or lot number on the packaging of the vaporizer other than the label4 7,f7 ,verification and validation ,a personal electronic vaporizer shall be constructed with sufficiently validated processes1 or subject to sufficient verification and testing1 to ensure that each individual vaporizer conforms to its specifications4 7,g7 ,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 distributor1 retailer1 or end user1 and correlate each such shipment to serial or lot numbers1 to enable batch tracking and recalls4 7,h7 ,materials ,the manufacturer of a personal electronic vaporizer shall ensure that-- 7i7 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 characteristics2 and 7ii7 components of a personal electronic vaporizer which are expected to be subject to heat are appropriate for the expected temperatures4 7#c7 ,revisions ,before issuing a revision to the standards applicable under paragraph 7#a77;,a71 7#a77;,b71 or 7#b77;,a71 the ,american ,e-,liquid ,manufacturing ,standards ,association1 the ,american ,national ,standards ,institute1 or the ,international ,electrotechnical ,commission1 as applicable1 shall notify the ,secretary in writing of the proposed revision4 ,not later than #ij days after the date of receipt of such notice1 the ,secretary shall determine whether the proposed revision enhances the safety and quality of e-liquid products or personal electronic vaporizers1 as applicable4 ,if the ,secretary determines that the proposed revision does enhance the safety and quality of e-liquid products or personal electronic vaporizers1 as applicable1 the ,secretary shall give notice of such determination to the public for a period of #ij days and1 effective at the end of such period1 incorporate the revision into the standards applicable under paragraph 7#a77;,a71 7#a77;,b71 or 7#b77;,a71 as applicable4 7c7 ,certification of compliance with manufacturing standards ,beginning not later than #a year after the date of enactment of the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag1 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 vaporizers1 as applicable1 are manufactured1 labeled1 and otherwise in compliance with the standards under subsection 7b74 7d7 ,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 vaporizers1 as applicable1 for inspection4 7e7 ,failure ,to comply with manufacturing standards 7#a7 ,in general ,if the ,secretary finds that an e-liquid or personal electronic vaporizer manufacturer is in noncompliance with the standards under subsection 7b7-- 7,a7 the ,secretary shall not take any enforcement action based on such noncompliance unless-- 7i7 the ,secretary gives the manufacturer notice of1 and a period of #ij days to correct1 such noncompliance2 and 7ii7 the manufacturer fails1 by the end of such #ij-;day period1 to correct such noncompliance2 and 7,b7 if the manufacturer fails to correct such noncompliance1 as described in paragraph 7#a77;,a77ii71 the ,secretary may issue an order requiring the manufacturer-- 7i7 to suspend any commercial activity that the ,secretary finds to be in noncompliance2 and 7ii7 to not resume such activity until the manufacturer demonstrates to the ,secretary's satisfaction that such noncompliance has been corrected4 7#b7 ,immediate danger to public health ,notwithstanding paragraph 7#a71 if the ,secretary determines that an e-liquid or personal electronic vaporizer manufacturer is in noncompliance with the standards under subsection 7b71 and that such noncompliance presents an immediate danger to public health1 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 corrected4 #ajje4 ,prohibition against advertising or promoting to minors 7a7 ,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 #ah years of age4 7b7 ,penalty ,if a manufacturer violates a prohibition established under subsection 7a71 the ,secretary may refuse to accept for filing or renewal1 and may revoke1 the manufacturer's certification under section #ajjd7;c74 #ajjf4 ,preemption of certain ,state and local requirements 7a7 ,in general ,no ,state or political subdivision of a ,state may establish or continue in effect any requirement with respect to the manufacture1 warning requirements1 marketing1 distribution1 or sale of an e-liquid or personal electronic vaporizer which is different from1 or in addition to1 any requirement under the provisions of this chapter or pursuant to section #ejc7;g71 including the exclusion of e-liquids and personal electronic vaporizers from the definition of a tobacco product under section #bja4 7b7 ,exception ,information disclosed to a ,state consistent with subsection 7a7 that is exempt from disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 shall be treated as a trade secret and confidential information by the ,state4 #ajjg4 ,office for e-liquid and personal electronic vaporizer standards compliance ,not later than #ij days after the date of enactment of the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag1 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 ,compliance4 ,the ,office shall-- 7#a7 be responsible for the implementation of this chapter and related matters assigned by the ,director of such ,center2 and 7#b7 provide technical and other nonfinancial assistance to e-liquid and personal electronic vaporizer manufacturers to assist them in complying with the requirements of this ,act4 4 #e4 ,joint comparative health risk assessment ,chapter ,x of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #d1 is further amended by adding at the end the following3 #ajjh4 ,tobacco products and nicotine delivery alternatives3 comparative health risk assessment 7a7 ,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 data4 ,for purposes of such assessment1 tobacco and nicotine delivery alternative product categories shall include at a minimum-- 7#a7 cigarettes2 7#b7 loose tobacco for roll-your-own tobacco products2 7#c7 little cigars2 7#d7 cigars2 7#e7 pipe tobacco2 7#f7 moist snuff2 7#g7 dry snuff2 7#h7 chewing tobacco2 7#i7 snus2 7#aj7 vaporized tobacco1 meaning heat not burn technology intended for inhalation2 7#aa7 vapor produced by a personalized electronic vaporizer containing e-liquid with nicotine2 7#ab7 shisha and other tobacco products that are heated and inhaled via a hookah1 water pipe1 or other type of pipe 7treated collectively as a single category72 7#ac7 dissolvable1 chewable1 drinkable1 and other tobacco and nicotine products intended for oral ingestion 7treated collectively as a single category72 7#ad7 tobacco and nicotine skin creams1 patches1 and other tobacco and nicotine products intended for transdermal consumption 7treated collectively as a single category72 7#ae7 tobacco and nicotine sprays1 droplets1 and mists intended for nasal consumption 7treated as a single category72 and 7#af7 other nicotine-containing products 7treated collectively as a single category74 7b7 ,report ,not later than #ah months after the date of enactment of the ,cigarette ,smoking ,reduction and ,electronic ,vapor ,alternatives ,act of #bjag1 the ,secretary shall report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on the results of the comparative health risk assessment under subsection 7a74 ,based on such results1 such report shall include recommendations on-- 7#a7 new or improved tobacco harm reduction strategies2 and 7#b7 the possible need for additional legislative authorities to implement such strategies4 4