not have a certification in effect as required by sec-
tion 1004(c). 
‘‘(c) MISBRANDING.—An e-liquid or personal elec-
tronic vaporizer shall be treated as misbranded if its label-
ing (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 sec-
tion 1004(e). 
‘‘(d) PENALTIES.—Any person who violates a provi-
sion 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 VA-
PORIZERS; COMPLIANCE. 
‘‘(a) REQUIREMENT.—Beginning on the date that is 
1 year after the date of enactment of the Cigarette Smok-
ing Reduction and Electronic Vapor Alternatives Act of 
2017, any e-liquid or personal electronic vaporizer intro-
duced or delivered for introduction into interstate com-
merce 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.— 
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‘‘(1) E-LIQUIDS.—The manufacturing stand-
ards for e-liquids under this subsection shall consist 
of the following: 
‘‘(A) INTERIM STANDARDS.—The e-liquid 
manufacturing standards issued by the Amer-
ican E-Liquid Manufacturing Standards Asso-
ciation (version 2.3.2) on March 8, 2017 (in-
cluding 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 pe-
riod beginning on the date described in sub-
section (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 re-
vision to such standards made in accordance 
with paragraph (3)) apply to the introduction 
or delivery for introduction into interstate com-
merce 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 
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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 Inter-
national Electrotechnical Commission, as in ef-
fect on the date of enactment of the Cigarette 
Smoking Reduction and Electronic Vapor Alter-
natives 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 mech-
anism to ensure user and battery safety in the 
event of a short circuit of the heating element. 
‘‘(C) DISCHARGE
MONITORING.—A re-
chargeable 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 
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these to safe levels. A personal electronic vapor-
izer that contains multiple battery cells in series 
shall monitor the cells individually. 
‘‘(E) SERIAL AND LOT NUMBERS.—A per-
sonal electronic vaporizer shall include a serial 
or lot number on the label that allows the va-
porizer to be traced to its time and place of 
manufacture. Notwithstanding the preceding 
sentence, a single-use personal electronic vapor-
izer 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 con-
structed 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 man-
ufacturer of a personal electronic vaporizer 
shall record all shipments of one or more per-
sonal electronic vaporizers by the manufacturer 
to a distributor, retailer, or end user, and cor-
relate each such shipment to serial or lot num-
bers, to enable batch tracking and recalls. 
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‘‘(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 per-
sonal electronic vaporizer are limited to ap-
proved medical or food contact grade prod-
ucts with established safety and biocompat-
ibility characteristics; and 
‘‘(ii) components of a personal elec-
tronic vaporizer which are expected to be 
subject to heat are appropriate for the ex-
pected temperatures. 
‘‘(3) REVISIONS.—Before issuing a revision to 
the standards applicable under paragraph (1)(A), 
(1)(B), or (2)(A), the American E-Liquid Manufac-
turing Standards Association, the American Na-
tional Standards Institute, or the International Elec-
trotechnical 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 qual-
ity of e-liquid products or personal electronic vapor-
izers, as applicable. If the Secretary determines that 
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the proposed revision does enhance the safety and 
quality of e-liquid products or personal electronic va-
porizers, as applicable, the Secretary shall give no-
tice 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 appli-
cable. 
‘‘(c) CERTIFICATION OF COMPLIANCE WITH MANU-
FACTURING 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 manufac-
turer 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 va-
porizers, as applicable, are manufactured, labeled, and 
otherwise in compliance with the standards under sub-
section (b). 
‘‘(d) INSPECTIONS FOR COMPLIANCE WITH MANU-
FACTURING STANDARDS.—E-liquid and personal elec-
tronic vaporizer manufacturers shall provide the Secretary 
with access to their facilities used in manufacturing e-liq-
uids or personal electronic vaporizers, as applicable, for 
inspection. 
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retary’s satisfaction that such noncompli-
ance 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 noncompli-
ance with the standards under subsection (b), and 
that such noncompliance presents an immediate dan-
ger to public health, the Secretary may issue an 
order requiring the manufacturer to suspend produc-
tion of such e-liquid or personal electronic vaporizer 
until the Secretary determines that such noncompli-
ance is corrected. 
‘‘SEC. 1005. PROHIBITION AGAINST ADVERTISING OR PRO-
MOTING TO MINORS. 
‘‘(a) PROHIBITION.—The Secretary may by regula-
tion 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 prohi-
bition 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). 
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‘‘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 require-
ment with respect to the manufacture, warning require-
ments, 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 disclo-
sure 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 ELEC-
TRONIC VAPORIZER STANDARDS COMPLI-
ANCE. 
‘‘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 To-
bacco Products and Tobacco Harm Reduction an Office 
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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 Di-
rector of such Center; and 
‘‘(2) provide technical and other nonfinancial 
assistance to e-liquid and personal electronic vapor-
izer 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 cat-
egory of products on a scale according to the reasonable 
expectation for morbidity and mortality risk when com-
pared to smoking cigarettes based on laboratory studies 
and existing scientific data. For purposes of such assess-
ment, tobacco and nicotine delivery alternative product 
categories shall include at a minimum— 
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‘‘(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 elec-
tronic 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, patch-
es, and other tobacco and nicotine products intended 
for transdermal consumption (treated collectively as 
a single category); 
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‘‘(15) tobacco and nicotine sprays, droplets, and 
mists intended for nasal consumption (treated as a 
single category); and 
‘‘(16) other nicotine-containing products (treat-
ed 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 Sec-
retary shall report to the Committee on Energy and Com-
merce 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.’’. 
Æ 
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