Ingredient Disclosures for Vapor Products and E-Cigarettes
Pursuant to New York Public Health Law Article 17
Notice: The information on this website is provided solely for purposes of compliance with the ingredient disclosure requirements of New York as set forth in N.Y. Pub. Health Law § 1701 and 10 N.Y.C.R.R. §1006.2. Disclosures are provided for vapor products and e-cigarettes that are currently distributed, sold, or offered for sale in the state of New York. In the event that the U.S. Food and Drug Administration (FDA) issues marketing granted orders for additional vapor products or e-cigarettes that will be distributed, sold, or offered for sale in the state of New York, this website will be updated. Disclaimer: None of the information on this website is provided for the purposes of advertising, marketing, or promoting any tobacco product. The information displayed below must be made publicly available pursuant to N.Y. Pub. Health Law § 1701 and does not constitute explicit or implicit representations, claims, or statements of reduced harm or human health risk related to the use of any tobacco product.
Background
R.J. Reynolds Vapor Company (RJRV) manufactures several series of non-refillable cartridge-based electronic nicotine delivery system (ENDS) products that are currently distributed, sold, and offered for sale in the state of New York under the brand names Vuse Solo, Vuse Vibe, Vuse Ciro, and Vuse Alto. The Vuse Alto products available in the state of New York are currently under scientific review by the FDA. The FDA has completed review of premarket tobacco product applications (PMTAs) for the Vuse Solo, Vuse Ciro, and Vuse Vibe products available in the state of New York and determined that the marketing of these products is appropriate for the protection of the public health.
Vapor Products and E-Cigarettes Subject to Disclosure
The Vuse-branded vapor products and e-cigarettes listed below are currently distributed, sold, or offered for sale in the state of New York and are thus subject to the disclosure requirements of N.Y. Pub. Health Law § 1701 and 10 N.Y.C.R.R. §1006.2.
Vuse Solo:
- Vuse Solo Power Unit
- Vuse Solo Original Cartridges
Vuse Vibe:
- Vuse Vibe Power Unit
- Vuse Vibe Original Cartridges
Vuse Alto:
- Power Unit (Various Colors)
- Golden Tobacco Pods (1.8%, 2.4%, 5.0% nicotine)
- Rich Tobacco Pods (1.8%, 2.4%, 5.0% nicotine)
Vuse Alto Prismatic Series:
- Golden Spark Tobacco (5%)
- Dusk Glow Tobacco (5%)
1. E-Liquid Constituent Disclosures
Table 1-1: Vuse Solo Original E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h) | Ingredient Function** | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier; Aerosol Forming Agent |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier; Aerosol Forming Agent |
| Water | 7732-18-5 | Intentionally added | No | Carrier; Aerosol Forming Agent |
| Nicotine | 54-11-5 | Intentionally added | Yes | Nicotine Source |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-2: Vuse Vibe Original E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier; Aerosol Forming Agent |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier; Aerosol Forming Agent |
| Water | 7732-18-5 | Intentionally added | No | Carrier; Aerosol Forming Agent |
| Nicotine | 54-11-5 | Intentionally added | Yes | Nicotine Source |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-3: Vuse Alto Golden Tobacco 5.0% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-4: Vuse Alto Golden Tobacco 2.4% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-5: Vuse Alto Golden Tobacco 1.8% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-6: Vuse Alto Rich Tobacco 5.0% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-7: Vuse Alto Rich Tobacco 2.4% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-8: Vuse Alto Rich Tobacco 1.8% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-9: Vuse Alto Prismatic Series Golden Spark Tobacco 5.0% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
Table 1-10: Vuse Alto Prismatic Series Dusk Glow Tobacco 5.0% E-Liquid Intentionally Added Ingredients
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | Ingredient Function | |
| Glycerin | 56-81-5 | Intentionally added | Yes | Carrier |
| Propylene Glycol | 57-55-6 | Intentionally added | Yes | Carrier |
| Nicotine | 54-11-5 | Intentionally added | Yes | Active |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Note: Other intentionally added ingredients are withheld from public disclosure as proprietary and confidential business information pursuant to 10 NYCRR 1006.3
2. Aerosol Constituent Disclosures
Table 2-1: Vuse Solo Original Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium*** | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead*** | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| NNN | 16543-55-8 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
***Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.
Table 2-2: Vuse Vibe Original Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium*** | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead*** | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
***Although sometimes measured in aerosol above the limit of quantitation, values were comparable to the air blank levels collected in the study.
Table 2-3: Vuse Alto Golden Tobacco 5.0% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| NNN | 16543-55-8 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-4: Vuse Alto Golden Tobacco 2.4% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-5: Vuse Alto Golden Tobacco 1.8% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-6: Vuse Alto Rich Tobacco 5.0% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Butyraldehyde | 123-72-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-7: Vuse Alto Rich Tobacco 2.4% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Butyraldehyde | 123-72-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-8: Vuse Alto Rich Tobacco 1.8% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Butyraldehyde | 123-72-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-9: Vuse Alto Prismatic Series Golden Spark Tobacco 5.0% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| NNN | 16543-55-8 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
Table 2-10: Vuse Alto Prismatic Series Dusk Glow Tobacco 5.0% Aerosol Byproducts and Contaminants
| CAS# | Category 10 NYCRR 1006.1(c) | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** | |
| Acetaldehyde | 75-07-0 | Byproduct | Yes |
| Acetone | 67-64-1 | Contaminant | Yes |
| Acetyl Propionyl | 600-14-6 | Byproduct | Yes |
| Acrolein | 107-02-8 | Byproduct | Yes |
| Butyraldehyde | 123-72-8 | Byproduct | Yes |
| Chromium | 7440-47-3 | Contaminant | Yes |
| Crotonaldehyde | 4170-30-3 | Byproduct | Yes |
| Diacetyl | 431-03-8 | Byproduct | Yes |
| Ethylene Glycol | 107-21-1 | Contaminant | Yes |
| Formaldehyde | 50-00-0 | Byproduct | Yes |
| Furfural | 98-01-1 | Byproduct | Yes |
| Glycidol | 556-52-5 | Byproduct | Yes |
| Lead | 7439-92-1 | Contaminant | Yes |
| Nickel | 7440-02-0 | Contaminant | Yes |
| NNK | 64091-91-4 | Byproduct | Yes |
| Toluene | 108-88-3 | Contaminant | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
3. Toxic Metals Disclosures
Table 3-1: Vuse Solo Heating Element
| Heating Element Composition | CAS# | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** |
| Aluminum | 7429‐90‐5 | Yes |
| Chromium | 7440‐47‐3 | Yes |
| Cobalt | 7440‐48‐4 | Yes |
| Copper | 7440‐50‐8 | Yes |
| Iron | 7439‐89‐6 | Yes |
| Manganese | 7439‐96‐5 | Yes |
| Nickel | 7440‐02‐0 | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
In addition, 10 NYCRR 1006.2(b)(2)(iii) requires a “list naming each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.” For this list, please refer to Table 2-1.
Table 3-2: Vuse Vibe Heating Element
| Heating Element Composition | CAS# | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** |
| Aluminum | 7429-90-5 | Yes |
| Chromium | 7440-47-3 | Yes |
| Iron | 7439-89-6 | Yes |
| Manganese | 7439-96-5 | Yes |
| Nickel | 7440-02-0 | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
In addition, 10 NYCRR 1006.2(b)(2)(iii) requires a “list naming each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.” For this list, please refer to Table 2-2.
Table 3-3: Vuse Alto Heating Element
| Heating Element Composition | CAS# | Chemical of Concern as Defined by 10 NYCRR 1006.1(h)** |
| Chromium | 7440-47-3 | Yes |
| Iron | 7439-89-6 | Yes |
| Nickel | 7440-02-0 | Yes |
**With respect to 10 N.Y.C.R.R. §1006.1(b)(1)(v) and §1006.1(b)(2)(v) relating to evaluations of the availability of alternative ingredients in vapor products or alternatives for constituents of any heating element in e-cigarettes, RAIS states that such evaluations have not been performed for any of the products.
In addition, 10 NYCRR 1006.2(b)(2)(iii) requires a “list naming each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.” For this list, please refer to Table 2-3, Table 2-4, Table 2-5, Table 2-6, Table 2-7, Table 2-8, Table 2-9, and Table 2-10.
Investigations and Research on Human Health Effects
Investigations and research concerning the human health effects of Vuse products are described below, pursuant to the requirements of N.Y. Pub. Health Law §§ 1701(1)(a)(ii) and (1)(b)(iii) as implemented by 10 N.Y.C.R.R. §§ 1006.2(b)(1)(iii) and (b)(2)(iv).
RJRV has conducted or sponsored a body of research to assess potential human health effects related to Vuse products and their ingredients. These investigations and research have been included in RJRV’s premarket tobacco product applications (PMTAs). The FDA has completed review of PMTAs for the Vuse Solo, Vuse Ciro, and Vuse Vibe products available in the state of New York and determined that the marketing of these products is appropriate for the protection of the public health.
The investigations and research submitted in RJRV’s PMTAs draw from a range of scientific disciplines including chemical analyses, preclinical toxicology, clinical studies, survey research, and population modeling to estimate the health effects of Vuse products. RJRV has conducted or sponsored studies including:
Chemical Analyses: RJRV has conducted and submitted to FDA chemical analyses of Vuse aerosols to determine what constituents are present and at what levels, including how such constituents change over the shelf life of the products. RJRV’s studies also include analyses to determine what elements or organic compounds may leach into Vuse e-liquids over time from materials used in Vuse products that have contact with the e-liquid or aerosol. Levels of constituents in Vuse products were compared to those in other marketed vapor products, as well as to levels in combustible cigarette smoke. The results of these studies show what constituents users may be exposed to and in what quantities, and are important for estimating the potential health risks of vapor product use.
The results of these studies demonstrate that overall levels of aerosol constituents in the studied products were lower than those found in combustible cigarette smoke and similar to other closed e-cigarette ENDS products marketed in the U.S.
Preclinical Studies: RJRV has conducted and submitted to FDA nonclinical toxicological analyses of Vuse aerosols to determine their effects on living cells. These include the Ames mutagenicity assay, which is used to test whether a chemical can cause various types of DNA mutations; the neutral red uptake cytotoxicity assay, which is used to test whether chemicals or mixtures cause toxic responses that may lead to cell death; and the in vitro micronucleus genotoxicity assay, which detects whether chemicals or mixtures disrupt chromosomal structure or replication. These types of in vitro evaluations are established and integral components of FDA oversight across the agency’s historically regulated product sectors, and were conducted in accordance with ICH and OECD guidelines as available.
The results of these in vitro evaluations demonstrate that aerosols from the studied products are non-mutagenic, non-genotoxic, and either non-cytotoxic or markedly less cytotoxic than combustible cigarettes.
Clinical Studies: RJRV has conducted and submitted to FDA human studies of Vuse product use in clinical settings to assess abuse liability and nicotine pharmacokinetics, biomarkers of exposure and potential harm, adverse events, and user topography. These studies, which are based on actual human use of the products, are important for understanding the potential impact of Vuse products on both users and nonusers. The clinical studies sponsored by RJRV include assessments of:
- Nicotine Pharmacokinetics, to understand how Vuse products deliver nicotine over time and how such delivery compares to other vapor products, combustible cigarettes, and FDA-approved nicotine replacement therapy medications;
- Abuse Liability, defined by FDA as the likelihood that individuals will develop physical and/or psychological dependence on a tobacco product;
- Biomarkers of Exposure, which allow measurement of systemic exposures to nicotine and other chemicals during tobacco product use;
- Biomarkers of Potential Harm, to assess early biological effects related to tobacco product exposure that could eventually lead to the development of disease;
- Adverse Events, which are unfavorable changes in health that occur during a clinical trial and include determinations by independent clinicians of whether such adverse events were related or unrelated to use of the trial product; and
- User Topography, to understand how people actually use Vuse products, including measurements of how many puffs users take, the length of each puff, and the intensity of puffing.
With regard to nicotine pharmacokinetics and abuse liability, these studies demonstrate that the studied products deliver nicotine over time at a rate and level that is slower and lower than the delivery of combustible cigarettes, quicker and higher than the delivery of nicotine replacement therapy medications, and similar to other other closed e-cigarette ENDS products marketed in the U.S.
Biomarker studies demonstrate that adult cigarette smokers who switch completely to use of the studied products likely leads to decreased exposure to tobacco smoke constituents in users.
Adverse events observed in clinical studies of the studied products were generally mild in severity, resolved prior to completion of the studies, and the majority were not deemed related to use of the trial products.
Studies of use topography of these products support the selected non-intense and intense puffing regimens as representative of low and high use conditions. Specifically, the topography study results demonstrated that, in users of the product, the mean puff duration is similar to, or lower than, the puff duration for the non-intense puffing regimen. Therefore, it is likely that the levels of toxicants from a machine-generated study are overestimations of the toxicants to which the user may be exposed during the use of these products.
Statistical Modeling: RJRV has also conducted and submitted to FDA statistical modeling of the population health effects of Vuse products. This modeling integrates estimates of individual health risk based on other types of evidence, as well as observed rates of product adoption, product switching, and other use behaviors, to provide a robust estimate of the effects of Vuse products on the population as a whole.
The results of these statistical models demonstrate that the marketing of these products likely provides a net positive benefit to the population as a whole when current adult smokers reduce their cigarette consumption or switch completely to use of these products.