JUUL Labs Product Disclosures — NY Ingredient Disclosure

James V. McDonald, M.D., M.P.H.

Commissioner, New York State Department of Health

E-Mail: doh.sm.VapingIngredientDisclosure@health.ny.gov

Re: Ingredient Disclosures for Vapor Products and E-Cigarettes

Dear Commissioner McDonald:

In accordance with New York Public Health Law, Article 17, and the New York State Department of Health’s implementing regulations, (10 N.Y.C.R.R. Part 1006), Juul Labs, Inc. (“JLI”) submits the following information:

JLI is the manufacturer of the JUUL System, a closed, cartridge-based electronic nicotine delivery system (“ENDS”) product that utilizes heating technology to aerosolize and deliver nicotine. The JUUL System that is marketed and sold in New York comprises the following e-cigarette and vapor products:

JUUL Device;
JUULpods, Virginia Tobacco, 5.0% (59 mg/mL) nicotine concentration;
JUULpods, Virginia Tobacco, 3.0% (35 mg/mL) nicotine concentration;
JUULpods, Menthol, 5.0% (59 mg/mL) nicotine concentration; and
JUULpods, Menthol, 3.0% (35 mg/mL) nicotine concentration.

Since JLI’s original 2022 ingredient disclosures submission, the U.S. Food and Drug Administration (“FDA”) has issued marketing granted orders for JLI’s JUUL Device and JUULpods in Virginia Tobacco flavor (5% and 3% nicotine strength) and Menthol flavor (5% and 3% nicotine strength), determining that the marketing of these products is appropriate for the protection of public health.¹ Because JLI’s 2022 filing addressed only Virginia Tobacco products (the only products sold in New York at that time), JLI now supplements its prior submission with updated ingredient information, including information for menthol-flavored JUULpods.

For each e-liquid formulation marketed and sold in New York, JLI provides a list naming each “ingredient”, as defined in 10 N.Y.C.R.R. § 1006.1(c), in descending order of predominance by weight, as required by 10 N.Y.C.R.R. § 1006.2(b)(1)(ii). The tables below also indicate ingredients that are considered “chemicals of concern” as defined in 10 N.Y.C.R.R. § 1006.1(h) and required by 10 N.Y.C.R.R. § 1006.2(b)(1)(iv).

I. Ingredient Information – JUUL E-Liquids
Pursuant to N.Y. Pub. Health Law § 1701 and 10 N.Y.C.R.R. § 1006.2(b)(1)(ii)

Ingredient	CAS#	Category 10 NYCRR 1006.1(c)	Chemical of Concern	Ingredient Function
JUULpods Virginia Tobacco 5.0%*
Glycerin	56-81-5	Intentionally Added Ingredient	Yes	Carrier
Propylene Glycol	57-55-6	Intentionally Added Ingredient	Yes	Carrier
Nicotine	54-11-5	Intentionally Added Ingredient	Yes	Nicotine Source
Benzoic Acid	65-85-0	Intentionally Added Ingredient	No	pH Modifier
Acetaldehyde	75-07-0	Byproduct	Yes	N/A
Acrolein	107-02-8	Byproduct	Yes	N/A
Diacetyl	431-03-8	Byproduct	Yes	N/A
Formaldehyde	50-00-0	Byproduct	Yes	N/A
Glycidol	556-52-5	Byproduct	Yes	N/A
Nickel	7440-02-0	Contaminant	Yes	N/A
Nornicotine	494-97-3	Byproduct	Yes	N/A

Ingredient	CAS#	Category 10 NYCRR 1006.1(c)	Chemical of Concern	Ingredient Function
JUULpods Virginia Tobacco 3.0%*
Glycerin	56-81-5	Intentionally Added Ingredient	Yes	Carrier
Propylene Glycol	57-55-6	Intentionally Added Ingredient	Yes	Carrier
Nicotine	54-11-5	Intentionally Added Ingredient	Yes	Nicotine Source
Benzoic Acid	65-85-0	Intentionally Added Ingredient	No	pH Modifier
Acetaldehyde	75-07-0	Byproduct	Yes	N/A
Acrolein	107-02-8	Byproduct	Yes	N/A
Diacetyl	431-03-8	Byproduct	Yes	N/A
Formaldehyde	50-00-0	Byproduct	Yes	N/A
Glycidol	556-52-5	Byproduct	Yes	N/A
n-Butyraldehyde	123-72-8	Byproduct	Yes	N/A
Nornicotine	494-97-3	Byproduct	Yes	N/A

Ingredient	CAS#	Category 10 NYCRR 1006.1(c)	Chemical of Concern	Ingredient Function
JUULpods Menthol 5.0%*
Glycerin	56-81-5	Intentionally Added Ingredient	Yes	Carrier
Propylene Glycol	57-55-6	Intentionally Added Ingredient	Yes	Carrier
Nicotine	54-11-5	Intentionally Added Ingredient	Yes	Nicotine Source
Benzoic Acid	65-85-0	Intentionally Added Ingredient	No	pH Modifier
Acetaldehyde	75-07-0	Byproduct	Yes	N/A
Acrolein	107-02-8	Byproduct	Yes	N/A
Diacetyl	431-03-8	Byproduct	Yes	N/A
Formaldehyde	50-00-0	Byproduct	Yes	N/A
Glycidol	556-52-5	Byproduct	Yes	N/A
n-Butyraldehyde	123-72-8	Byproduct	Yes	N/A
Nornicotine	494-97-3	Byproduct	Yes	N/A

Ingredient	CAS#	Category 10 NYCRR 1006.1(c)	Chemical of Concern	Ingredient Function
JUULpods Menthol 3.0%*
Glycerin	56-81-5	Intentionally Added Ingredient	Yes	Carrier
Propylene Glycol	57-55-6	Intentionally Added Ingredient	Yes	Carrier
Nicotine	54-11-5	Intentionally Added Ingredient	Yes	Nicotine Source
Benzoic Acid	65-85-0	Intentionally Added Ingredient	No	pH Modifier
Acetaldehyde	75-07-0	Byproduct	Yes	N/A
Acrolein	107-02-8	Byproduct	Yes	N/A
Diacetyl	431-03-8	Byproduct	Yes	N/A
Formaldehyde	50-00-0	Byproduct	Yes	N/A
Glycidol	556-52-5	Byproduct	Yes	N/A
n-Butyraldehyde	123-72-8	Byproduct	Yes	N/A

*All other ingredients are withheld as trade secrets, proprietary flavorants, and confidential business information to protect the manufacturer's competitive position. None of the withheld information has prevented the identification and disclosure of any byproduct or contaminant required to be disclosed under N.Y.C.R.R. § 1006.2.²

JLI has evaluated the availability of potential alternatives for the ingredients identified as chemicals of concern in its vapor products, see 10 N.Y.C.R.R. § 1006.2(b)(1)(v), and determined none were appropriate for the JUUL1 System in light of the regulatory framework applicable to these products under the FDCA. In its premarket tobacco product applications (“PMTAs”), JLI provided FDA detailed information regarding the product’s ingredients, materials, and constituents, including the potential hazards posed by these products. After considering this evidence, FDA concluded that “the risks posed to public health by the new products … is outweighed by the significant benefit of adult smokers switching from [combustible cigarettes] to the new products” and, therefore, the marketing of the products “is appropriate for the protection of public health.”³ Any changes to these products must be reviewed by FDA under the statute.

II. Toxic Metal – JUUL Device Heating Element

Additionally, JLI provides this list naming any “toxic metal”, defined in 10 N.Y.C.R.R. § 1006.1(i), that is a constituent of any heating element of the JUUL Device, as required by 10 N.Y.C.R.R. § 1006.2(b)(2)(ii).

Toxic Metal	CAS#	Chemical of Concern 10 NYCRR 1006.1(h)
Nickel	7440-02-0	Yes
Chromium	7440-47-3	Yes
Manganese	7439-96-5	Yes
Iron	7439-89-6	Yes

JLI has evaluated the availability of potential alternatives for the constituents of the heating elements identified as a toxic metal and ingredients identified as a chemical of concern in the e-cigarette, see 10 N.Y.C.R.R. § 1006.2(b)(2)(vi), and determined none were appropriate for the JUUL1 System in light of the regulatory framework applicable to these products under the FDCA. In its PMTAs, JLI provided FDA detailed information regarding the product’s ingredients, materials, and constituents, including the potential hazards posed by these products. After considering this evidence, FDA concluded that “the risks posed to public health by the new products … is outweighed by the significant benefit of adult smokers switching from [combustible cigarettes] to the new products” and, therefore, the marketing of the products “is appropriate for the protection of public health.”⁴ Any changes to these products must be reviewed by FDA under the statute.

III. Byproducts Information – JUUL Aerosols

Finally, JLI provides a list of each “byproduct” that may be introduced into the vapor produced during normal use of the JUUL Device with each of the JUULpods marketed in New York, as required by 10 N.Y.C.R.R. § 1006.2(b)(2)(iii).

Byproduct	CAS#	Chemical of Concern 10 NYCRR 1006.1(h)
Aerosol: JUUL Virginia Tobacco 5.0%
Acetaldehyde	75-07-0	Yes
Acrolein	107-02-8	Yes
Chromium*	7440-47-3	Yes
Formaldehyde	50-00-0	Yes
Glycidol	556-52-5	Yes
Lead*	7439-92-1	Yes
Nornicotine	494-97-3	Yes

*Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.

Byproduct	CAS#	Chemical of Concern 10 NYCRR 1006.1(h)
Aerosol: JUUL Virginia Tobacco 3.0%
Acetaldehyde	75-07-0	Yes
Acrolein	107-02-8	Yes
Chromium*	7440-47-3	Yes
Formaldehyde	50-00-0	Yes
Glycidol	556-52-5	Yes
Lead*	7439-92-1	Yes
Nickel	7440-02-0	Yes
Nornicotine	494-97-3	Yes

*Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.

Byproduct	CAS#	Chemical of Concern 10 NYCRR 1006.1(h)
Aerosol: JUUL Menthol 5.0%
Acetaldehyde	75-07-0	Yes
Acrolein	107-02-8	Yes
Chromium*	7440-47-3	Yes
Diacetyl	431-03-8	Yes
Formaldehyde	50-00-0	Yes
Glycidol	556-52-5	Yes
Lead	7439-92-1	Yes
Nornicotine	494-97-3	Yes

*Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.

Byproduct	CAS#	Chemical of Concern 10 NYCRR 1006.1(h)
Aerosol: JUUL Menthol 3.0%
Acetaldehyde	75-07-0	Yes
Acrolein	107-02-8	Yes
Chromium*	7440-47-3	Yes
Diacetyl	431-03-8	Yes
Formaldehyde	50-00-0	Yes
Glycidol	556-52-5	Yes

*Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.

IV. Scientific Assessment/Studies

Nature and extent of investigations or research concerning the effects on human health of JUUL products or ingredients

JLI based its assessment of the potential effects on human health of the JUUL System on studies it conducted and/or commissioned, published literature, and reported complaints and adverse events. As part of its premarket tobacco product applications (“PMTAs”) for the JUUL System, JLI submitted to FDA more than 110 scientific studies spanning nonclinical, clinical, and behavioral research, supported by population and economic modeling. On July 17, 2025, FDA issued marketing granted orders for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavors, finding that the continued marketing of these products is appropriate for the protection of public health.

Nonclinical Research. JLI’s nonclinical research examined the JUUL System through analytical chemistry, in vitro studies, and toxicological assessment:

Chemical Characterization and Evaluation: JLI conducted chemical analyses to quantify harmful and potentially harmful constituents (“HPHCs”) and other constituents in the JUUL System e-liquids and aerosols, non-targeted analyses to evaluate compounds not captured by the targeted analyses, and comparisons of aerosol constituent yields to those generated by comparator products, including combustible cigarettes. These analyses demonstrate that aerosols from the JUUL System contain fewer and substantially lower levels of HPHCs than combustible cigarette smoke.
Nonclinical Toxicity Studies: JLI conducted in vitro and in vivo nonclinical toxicity studies to assess cytotoxicity, mutagenicity, and genotoxicity, as well as inhalation studies to assess potential toxicity, conducted in accordance with applicable international guidelines. These studies demonstrate that JUUL System aerosol condensate is not cytotoxic, mutagenic, or genotoxic under the conditions of the studies, and is comparable to or lower in toxicity than comparator vapor products and less toxic than combustible cigarette smoke.

Clinical Research. JLI’s clinical research program, supported by published literature, evaluated how the JUUL System delivers nicotine and how exposure to toxicants changes among adults who switch from cigarettes. These studies fell into the areas of nicotine pharmacokinetics (PK), biomarkers of exposure (BOE), puffing topography, and environmental exposure, using comparator products including combustible cigarettes, other ENDS products, heated tobacco products, and nicotine gum. Pharmacokinetic studies demonstrate that the JUUL System delivers nicotine at a rate and level competitive with, but lower than, combustible cigarettes, and within the range of other vapor products. Biomarker of exposure studies demonstrate that adults who switch completely from smoking cigarettes to the JUUL System substantially reduce their exposure to HPHCs associated with smoking-related diseases. Puffing topography studies demonstrated that average puff topography parameters when using JUUL products fell within the range of similar ENDS products. Environmental exposure studies demonstrated that secondhand exposure to HPHCs from the JUUL System was substantially lower than from combustible cigarette smoke.

JLI clinical studies were performed in accordance with the ethical principles and international standards for human clinical studies, including International Council for Harmonization Good Clinical Practice and Organization for Economic Cooperation and Development Good Clinical Practice guidelines, including obtaining written informed consent from study subjects and ethical oversight from an authorized and properly constituted Institutional Review Board.

Risk Assessment. JLI applied a stepwise health-risk evaluation approach, beginning with product characterization, progressing to identification of potential hazards based on the available evidence — including review of ingredients, materials extractables and leachables, and aerosol HPHCs and other chemicals identified in the aerosols — and integrating actual-use data into a whole-product risk assessment. Integrating the chemical, toxicological, and clinical data, JLI’s whole-product risk assessment supports that the individual health risks of the JUUL System are expected to be lower than combustible cigarettes and within the range of currently marketed vapor products.

Behavioral Research. JLI maintained a behavioral research program to evaluate how the JUUL System is used in the population as a whole, including adults who smoke and those who do not use tobacco products. This research included cross-sectional and longitudinal studies, assessments of consumer response to product labeling and advertising, abuse liability and dependence assessments, and analysis of national survey data, including a multi-year longitudinal cohort study of U.S. adults who purchased the JUUL System. The research demonstrated that adult cigarette smokers who used the JUUL System switched away from cigarettes at rates substantially higher than those observed with unaided quitting or nicotine replacement therapy, and those who did not completely switch substantially reduced their daily cigarette consumption.

Population and Economic Modeling. JLI conducted quantitative analyses of the net population impact of the JUUL System using statistical population modeling, which support that the marketing of the authorized products provides a net benefit to the population as a whole when adult smokers switch completely to, or reduce their cigarette consumption through use of, these products.

Health-Related Documents and Post-Submission Research. The investigations and research described above encompass the health-related documents JLI has submitted to FDA, including documents relating to the health, toxicological, behavioral, and physiological effects of the JUUL System within the meaning of 21 U.S.C. § 387d(a)(4). Non-confidential publications and presentations reflecting this research, including research developed since JLI’s original health-document submissions to FDA, are available on JLI’s Science website (https://www.juullabsscience.com), which JLI updates as it reports additional results. Consistent with the conditions of FDA’s marketing granted orders, JLI continues to monitor the scientific literature and report postmarket information to FDA as required, including the results of any studies it conducts.

Additionally, a detailed analysis of JLI’s product-specific studies submitted to FDA in support of its PMTAs can be found in FDA’s Technical Project Lead review, available on FDA’s website. See FDA Authorizes Marketing of Tobacco- and Menthol-Flavored JUUL E-Cigarette Products, U.S. Food & Drug Admin. (July 17, 2025), https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-marketing-tobacco-and-menthol-flavored-juul-e-cigarette-products, and a link to these materials also appears on Juul Labs’ corporate page at https://www.juullabs.com/juul-labs-statement-on-fda-marketing-authorizations/.

V. Corporate/Product Information

In accordance with the Department of Health’s Guidance for Vapor Product and E-cigarette Manufacturers Regarding Ingredient Disclosure, JLI submits the following:

Manufacturer information, including the complete name of the manufacturer of the final product and the final domestic distributor of the product (if they are different)

Juul Labs, Inc.

Name, title, email address, telephone number and mailing address for the manufacturer,

domestic distributor, or agent submitting ingredient information on behalf of a manufacturer or

domestic distributor

Juul Labs, Inc.
1000 F. Street, NW
Washington, D.C. 20004

Point of Contact: Elizabeth Copeland, VP, U.S. FDA Regulatory Compliance
Email: elizabeth.copeland@juul.com
Phone: (804) 572-8356
Address: 1000 F. Street, NW, Washington, D.C. 20004

The facility establishment identifier (FEI) number assigned to your establishment by the U.S. Food and Drug Administration (FDA)

Juul Labs, Inc. (DUNS Number: 602486339)
Philips Medisize St. Croix Meadows (FEI: 3015491749)
Durham Exchange Club Industries (FEI: 042087361)

A link to the webpage where manufacturers are providing disclosure to the public of the ingredients for each product and any investigations or research into the effects on human health of such products or ingredients

Free Standing Website: www.JLproductdisclosures.com

Link from Corporate Website: https://www.juullabs.com/about/health-effects/

FDA Authorizes Marketing of Tobacco- and Menthol-Flavored JUUL E-Cigarette Products, U.S. Food & Drug Admin. (July 17, 2025), https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-marketing-tobacco-and-menthol-flavored-juul-e-cigarette-products.↩︎
JLI hereby claims the legal protections, including exemption from public disclosure, provided to such proprietary information under any and all applicable provisions of United States and New York law. See, e.g., Federal Food, Drug, and Cosmetic Act (“FDCA”) § 916(a)(2)(B) (21 U.S.C. § 387p(a)(2)(B)), the New York Freedom of Information Law (N.Y. Pub. Officer Law § 87(2)(a), (d)), and Department of Health’s implementing regulations, 10 N.Y.C.R.R. §§ 50-1.6(a)(1) & (a)(4), 1006.3(a)–(c). Moreover, federal law expressly requires New York and other States to accord equivalent protection to trade secrets and other confidential business information they receive from manufacturers. Specifically, Section 916(a)(2)(B) of the FDCA states: “Information disclosed to a State . . . that is exempt from disclosure under [§] 552(b)(4) of title 5 [i.e., Exemption 4 of the Federal Freedom of Information Act (FOIA)], shall be treated as a trade secret and confidential information by the State.↩︎
Food & Drug Admin., Technical Project Lead (TPL) Review of PMTAs for Juul Labs, Inc. 81 (July 17, 2025), https://www.accessdata.fda.gov/static/searchtobacco/juul/TPL_Rev_Multiple_STNs_JUL2025_Redacted.pdf.↩︎
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