Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Compliance Policy for Limited
Modifications to Certain Marketed
Tobacco Products
Guidance for Industry
Comments may be submitted at any time for Agency consideration. Electronic comments may
be submitted to https://www.regulations.gov. Alternatively, submit written comments to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. All comments should be identified with the docket number
listed in the notice of availability that publishes in the Federal Register.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-
877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. ET.
Additional copies are available online at
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. You
may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy of
this guidance. You may send a request for hard copies to U.S. Food and Drug Administration,
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
November 2019

i
Table of Contents
I. INTRODUCTION……………………………………………………………………….1
II. DISCUSSION…………………………………………………………………………….2
A. Battery Injury Concerns…………………………………………………...………..2
B. Nicotine Exposure Concerns …………………………………………...…………...3
III. REFERENCES…………………………………………………………………………...5

1
Compliance Policy for Limited
Modifications to Certain Marketed
Tobacco Products
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I. INTRODUCTION
In this guidance, FDA sets out its compliance policy for premarket review requirements for two
types of limited modifications to new tobacco products that were on the market as of August 8,
2016: (1) modifications to battery-operated tobacco products solely to comply with UL 8139;
and (2) modifications to liquid nicotine products solely to comply with the Child Nicotine
Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine
containers. This compliance policy provides that FDA does not intend to enforce violations of
the premarket review requirements against such modified products on the basis of the
modifications described in this guidance.2 In light of their potential safety risks, FDA strongly
encourages manufacturers to remove the currently marketed unmodified tobacco products from
the market prior to introducing the modified tobacco products to the market.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required.
1 This guidance was prepared by the Office of Compliance and Enforcement, Office of Science, and Office of
Regulations in the Center for Tobacco Products at FDA.
2 FDA may take enforcement action against these products for violating the premarket review requirements for other
reasons.

2
II. DISCUSSION
A. Battery Injury Concerns
From 2009-2017, government agencies and news outlets received reports of injuries and other
adverse experiences resulting from the failures of batteries used in electronic nicotine delivery
systems (ENDS) products and many more were reported on social media. Despite the likelihood
that the true number of incidents was under-reported since the information provided was
primarily self-reported and voluntary, all sources identified a growing trend in the number and
severity of these incidents. In particular,
· The number of battery-related injury and damage reports associated with ENDS products
increased nearly 100-fold during that time period (Ref. 1, 2, 3). With respect to severe
injuries since 2014, this increase correlated well with the ENDS product sales trend
during that period (Ref. 2).
· ENDS battery fires and explosions have resulted in serious, disfiguring or disabling
injuries (Ref. 2, 4).
· Representative sampling of hospital data from 2015-2017 indicates that battery-related
injuries associated with ENDS may have been responsible for approximately 678
emergency room visits per year (Ref. 4, 5).
Data received after 2017 indicates that battery-related adverse experiences (AEs) remain a
serious issue. FDA recorded 63 battery-related AEs through its Safety Reporting Portal (SRP)3
between 2017 and mid-2019:
· 2017: 12
· 2018: 42
· 20194: 9
ENDS battery explosions reportedly caused one death in 2018 (Ref. 6) and one death in early
2019 (Ref. 7), although the latter has not been reported to SRP.
UL (formerly known as Underwriters Laboratories) is a global safety certification company. It
tests and certifies cells and batteries, chargers, and adapters to UL Standards, as well as key
international, national, and regional regulations. UL also contributes to the development and
international harmonization of industry safety and performance standards.
UL, along with the U.S. Consumer Product Safety Commission (CPSC), FDA, Health Canada,
the American National Standards Institute (ANSI), and industry stakeholders, developed a
voluntary industry standard, ANSI/CAN/UL 8139 Standard for Safety for Electrical Systems of
Electronic Cigarettes and Vaping Devices (UL 8139),5 to help manufacturers address battery
hazards for electronic cigarettes and other battery-operated tobacco products. The standard
3 https://www.safetyreporting.hhs.gov
4 Number of AEs reported January-June 2019
5 https://ctech.ul.com/en/news-new/ul-8139-electrical-systems-of-electronic-cigarettes/

3
includes all battery chemistries and types. UL 8139 prescribes an approach to evaluate the safety
of the electrical, heating, cell, battery, and charging systems of these products. UL 8139 testing
includes battery management system evaluation for normal use and foreseeable misuse,
mechanical stress testing, accidental activation, compatibility with interconnected systems, and
environmental resilience. This testing enhances consumer safety, minimizes battery-related
injuries, and mitigates potential risks. As of August 27, 2019, UL has certified 14 e-cigarettes as
complying with this standard.
FDA believes that battery-operated tobacco products that comply with UL 8139 have a
significantly reduced risk of battery-related AEs.
FDA recognizes that, to comply with UL 8139, manufacturers of battery-operated tobacco
products may need to change certain aspects of their product. For battery-operated tobacco
products that were on the market as of August 8, 2016 and that are then modified solely and only
to the extent necessary to comply with UL 8139, FDA does not intend to initiate enforcement
action against such modified products on the basis of these modifications.6 For such products
modified before the submission of a marketing application for the non-modified product, FDA
recommends that manufacturers submit a single marketing application that describes both the
product that was on the market as of August 8, 2016 and the modified product. For such
products modified after the submission of a marketing application for the non-modified product,
FDA recommends that manufacturers submit an amendment to the original application that
describes the modifications implemented for UL 8139 compliance.7
These types of changes to the product to comply with UL 8139 may include but are not limited
to: addition of protective circuits and controls; use of a different battery or cell; changes to the
wiring, terminals, fuses, or insulation; modifying the product to incorporate 2-step activation;
changes to the housing material or construction to meet flammability, crush resistance, water
exposure, venting, and temperature test requirements; changes to the battery compartment to
prevent user access to the battery or cells; changes to the product design so that venting is away
from the mouthpiece; changes to the printed wiring boards to meet flame and temperature
ratings; and any changes recommended under UL 8139. Changes to the product that are not
necessary to comply with UL 8139, include, but are not limited to: changes to the coil design or
other heating element (e.g., number of coils, material, resistance, length, or diameter); changes in
the wicking material or amount; changes in the power supplied to the product (i.e., no changes to
the number of batteries or cells); and changes to the method of aerosolization of the e-liquid.
B. Nicotine Exposure Concerns
Accidental exposure to e-liquids that contain nicotine can cause toxicity, sometimes resulting in
death, particularly in children (Ref. 8, 9, 10, 11). While e-liquids contain numerous chemicals at
6 The compliance policy in this guidance provides that FDA does not intend to enforce violations of the premarket
review requirements against such modified products solely on the basis of the modifications described in this
guidance. FDA may take enforcement action against these products for violating the premarket review requirements
for other reasons.
7 This amendment should refer to the FDA-assigned submission tracking number (STN) provided to the applicant in
the Acceptance letter of the original application for the product(s) of which these modifications apply.

4
various levels, nicotine itself raises the greatest toxicological concern in the context of accidental
exposure to the liquid due to its acute toxicity profile and the concentrated amounts found in
some e-liquids. In 2018, an expert committee of the National Academies of Sciences,
Engineering, and Medicine determined there is “conclusive evidence that oral, dermal, or ocular
exposures to e-liquids containing nicotine can cause adverse health effects, including seizures,
anoxic brain injury, vomiting, lactic acidosis, and can even be fatal” (Ref. 11).
Infants and children are uniquely vulnerable to acute nicotine toxicity because their natural
curiosity and normal gains in mobility and fine motor skills put them at risk for accidental
exposure. Additionally, their low body weight and naivety to nicotine make them especially
prone to toxicity if exposed.
Epidemiological data from poison control centers have described accidental exposure in children
to e-liquids. Between 2001 and 2016, there were 7,707 calls to U.S. poison centers regarding
exposure to e-cigarettes and e-liquids for children younger than five years old (Ref. 12). An
analysis of calls to U.S. poison centers between 2010 and 2014 indicates that incidents related to
e-cigarettes were more likely to involve adverse health effects than those related to cigarettes
(Ref. 13). Fatalities in children under three years old after accidental ingestion of liquid nicotine
have been reported (Ref. 14, 15, 16, 17).
Effective July 26, 2016, the CNPPA requires that liquid nicotine containers that are “accessible
through normal and foreseeable use by a consumer” comply with the “special packaging”
standards defined in the Poison Prevention Packaging Act (PPPA). Special packaging is defined
as packaging that is “significantly difficult for children under age five to open or obtain a toxic
or harmful amount of the substance contained therein within a reasonable time and not difficult
for normal adults to use properly” (16 CFR 1700.1). The CNPPA does not apply to sealed, pre-
filled, and disposable containers inserted directly into ENDS devices. CPSC staff have issued
letters to industry providing that any liquid nicotine product, including existing inventory,
covered by the CNPPA must be in special packaging that meets the standards in 16 CFR
1700.15, as determined through testing in accordance with the methods described in 16 CFR
1700.20.
Commonly used types of special packaging, such as child-resistant caps, are reasonably
protective when used correctly but require active re-engagement after each use in order to work
(Ref. 18). Flow restrictors, on the other hand, are a passive secondary line of protection. Flow
restrictors are typically adapters added to the neck of a bottle to limit the release of a liquid and
are intended to limit the amount of a liquid substance to which a child can gain access (Ref. 19).
The use of flow restrictors as a secondary barrier may mitigate the risk of toxicity from
accidental exposures to e-liquids in children. A study to assess the efficacy of flow restrictors in
limiting children’s access to liquid medicines showed that the addition of flow restrictors to
bottles decreased the proportion of children who accessed the liquid, decreased the amount of
liquid accessed, and increased the amount of time required to empty a bottle (Ref. 19). A study
analyzed poison center data to assess the association of adding flow restrictors to liquid
acetaminophen products and subsequent rate of pediatric accidental unsupervised ingestions and

5
found that the rate of pediatric accidental unsupervised ingestions decreased after adding flow
restrictors (Ref. 20).
On March 8, 2019, CPSC staff issued a letter to industry, “Nicotine Packaging Test Parameters,”
providing the testing parameters that CPSC staff will use to assess compliance with the restricted
flow requirement in 16 CFR 1700.15(d) (Ref. 21). 16 CFR 1700.15(d) requires “special
packaging from which the flow of liquid is so restricted that not more than 2 milliliters of the
contents can be obtained when the inverted, opened container is taken or squeezed once or when
the container is otherwise activated once.” CPSC staff considered the PPPA’s flow restrictor
provisions and recent draft American Society for Testing Materials International’s “Standard
Test Method for Assessing Non-Metered Restricted Delivery Systems for Liquid Consumer
Products.” The test methodology simulates a 5-year-old child gripping an inverted bottle for five
seconds (Ref. 21). This method relies on mechanical testing to ensure flow restrictors are
designed and manufactured to a consistent standard. The letter to industry further stated that
manufacturers may use the provided test protocol or an equivalent testing method to determine
compliance. On August 15, 2019, CPSC staff provided supplemental information on testing
liquid nicotine packaging for rigid containers (Ref. 22).
FDA recognizes that to comply with the CNPPA requirements for restricted flow, manufacturers
of liquid nicotine products may need to change certain aspects of their products. For liquid
nicotine products that were on the market as of August 8, 2016, and that are then modified solely
and only to the extent necessary to comply with the CNPPA requirements for restricted flow for
liquid nicotine containers, FDA does not intend to initiate enforcement action against such
modified products on the basis of these modifications.8 For such products modified before the
submission of a marketing application for the non-modified product, FDA recommends that
manufacturers submit a single marketing application that describes both the product that was on
the market as of August 8, 2016, and the modified product. For such products modified after the
submission of a marketing application for the non-modified product, FDA recommends that
manufacturers submit an amendment to the original application that describes the modifications
implemented for CNPPA compliance.9
III. REFERENCES
1. SF Rudy, EL Durmowicz; Electronic nicotine delivery systems: overheating fires and
explosions; Tob Control (2017) 26:10–18.
2. Electronic Cigarette Fires and Explosions in the United States 2009 – 2016; USFA FEMA;
July 2017.
8 The compliance policy in this guidance provides that FDA does not intend to enforce violations of the premarket
review requirements against such modified products solely on the basis of the modifications described in this
guidance. FDA may take enforcement action against these products for violating the premarket review requirements
for other reasons.
9 This amendment should refer to the FDA-assigned submission tracking number (STN) provided to the applicant in
the Acceptance letter of the original application for the product(s) of which these modifications apply.

6
3. SM Trigger, B Coleman. Social media mentions of electronic nicotine delivery systems
(ENDS) battery-related overheating, fires, and explosions: Findings from a pilot study. Int J
Environ Res Public Health (2019) 16(8):1308.
4. CJ Corey, JL Chang, BL Rostron; Electronic nicotine delivery system (ENDS) battery-
related burns presenting to US emergency departments,2016; Injury Epidemiology (2018)
5:4.
5. ME Rossheim, MD Livingston, EK Soule, HA Zeraye, DL Thombs, Electronic cigarette
explosion and burn injuries, US Emergency Departments 2015–2017; Tob Control (2018
0:1–3.
6. E Rosenberg; Exploding vape pen caused Florida man’s death, autopsy says; Washington
Post (Washington, DC) published May 17, 2018.
7. A Horton; Vape pen kills man after exploding in his mouth; Washington Post (Washington
D.C.) published 2/5/2019
8. Bassett, R. A., Osterhoudt, K., & Brabazon, T. (2014). Nicotine poisoning in an infant. New
England Journal of Medicine, 370, 2249-2250.
9. Chatham-Stevens, K., Law, R., Taylor, E., Melstrom, P., Bunnell, R., Wang, B., … Schier, J.
G. (2014). Notes from the field: Calls to Poison Centers for Exposures to Electronic
Cigarettes – United States, September 2010–February 2014. MMWR, 63, 292-293.
10. Forrester, M. B. (2015). Pediatric exposures to electronic cigarettes reported to Texas poison
centers. Journal of Emergency Medicine, 49, 136-142.
11. National Academies of Sciences, Engineering, and Medicine. 2018. Public health
consequences of e-cigarettes. Washington, DC: Tshe National Academies Press. doi:
https://doi.org/10.17226/24952.
12. Wang B, Rostron B. Tobacco-related poison events involving young children in the US,
2001-2016. Tob Regul Sci. 2017;3(4):525–535. doi: https://doi.org/10.18001/TRS.3.4.12.
13. Chatham-Stephens, K., Law, R., Taylor, E. et al. J. Med. Toxicol. (2016) 12: 350. doi:
https://doi.org/10.1007/s13181-016-0563-7.
14. Eggleston, W., N. Nacca, C. M. Stork, and J. M. Marraffa. 2016. Pediatric death after
unintentional exposure to liquid nicotine for an electronic cigarette. Clinical Toxicology
54(9):890–891.
15. Seo, A. D., D. C. Kim, H. J. Yu, and M. J. Kang. 2016. Accidental ingestion of e-cigarette
liquid nicotine in a 15-month-old child: An infant mortality case of nicotine intoxication.
Korean Journal of Pediatrics 59(12):490–493.
16. Winer, S. (2013, May). Police investigating toddler’s death from nicotine overdose. The
Times of Israel. Retrieved from http://www.timesofisrael.com/police-investigating-toddler-
death-from-nicotine-overdose/.
17. Moore, G. (2019, Jul 8). Mum’s nicotine kills Victorian toddler. Australian Associated Press.
Accessed 7/8/2019 from https://www.examiner.com.au/story/6262929/mums-nicotine-kills-
victorian-toddler/?cs=7.
18. Budnitz, D. S., & Salis, S. (2011). Preventing medication overdoses in young children: An
opportunity for harm elimination. Pediatrics, 127, e1597-9.
19. Lovegrove, M. C., Hon, S., Geller, R. J., Rose, K. O., Hampton, L. M., Bradley, J., &
Budnitz, D. S. (2013). Efficacy of flow restrictors in limiting access of liquid medications by
young children. Journal of Pediatrics, 163, 1134-1139.
20. Brass et al., Frequency of poison center exposures for pediatric accidental unsupervised
ingestions of acetaminophen after the introduction of flow restrictors. J Pediatr. 2018.

7
21. CPSC Letter to Industry, “Nicotine Packaging Test Parameters,” March 8, 2019, available at
https://www.cpsc.gov/s3fs-public/NoticeofRestrictedFlowTP.March82019.pdf.
22. CPSC Letter to Industry, “Supplemental Information on Liquid Nicotine Packaging for Rigid
Containers,” August 15, 2019, available at https://www.cpsc.gov/s3fs-
public/SupplementalInformationOnLiquidNicotinePackagingForRigidContainers08152019.p
df.