marketing_granted_order_ltr_rjrv_sep_2020_b1_redacted.pdfVUSE Alto Tobacco PMTA MGO Letter
July 18, 2024
46 months from submission to decision
Summary of Marketing Restrictions in the MGO:
Prohibited Marketing Practices:
The applicant is restricted from using several marketing practices to reduce youth appeal and exposure:
Broadcast or digital radio advertising
Television advertising
Outdoor advertising
Print advertising
Direct mail advertising
Search engine advertising
Online display advertising
Paid or unpaid product placements
Citation: "Not utilizing the following marketing practices: o Broadcast or digital radio advertising, o Television advertising, o Outdoor advertising, o Print advertising, o Direct mail advertising, o Search engine advertising, o Online display advertising, o Paid or unpaid product placements" (p. 2 of 18, Appendix A).
Youth Access Restrictions:
The applicant is required to implement measures to restrict youth access to the products and limit youth exposure to labeling, advertising, marketing, and promotion.
Citation: "Specifically, you stated you intend to use the following measures to help reduce youth appeal of your marketing materials, restrict youth access to your products, and limit youth exposure to your labeling, advertising, marketing, and promotion" (p. 2 of 18, Appendix A).
Potential for Modification Post-Authorization:
It is noted that the applicant could alter its marketing plans following authorization. To address this concern, the marketing restrictions and reporting requirements described in section V of the OHCE consult are incorporated.
Citation: "However, it is noted that the applicant could alter its marketing plans following authorization. OHCE noted that if the products are authorized, this concern may be addressed by incorporating the marketing restrictions and reporting requirements described in section V of OHCE consult" (p. 2 of 18, Appendix A).
Monitoring and Compliance:
The FDA will closely monitor how these products are marketed and will act if the company fails to comply with statutory or regulatory requirements, or if there is a notable increase in youth initiation.
Citation: "The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products" (p. 2 of 18, Appendix A).
pmta_tpl_rev_rjrv_sep_2020_b1_c2_redacted.pdfVUSE Alto Tobacco Technical Project Lead Memo
July 18, 2024
Summary:
Product Characterization:
The e-liquids contain nicotine salt formulations that may be easier to inhale at high amounts of nicotine, facilitating initiation and use of ENDS with high nicotine concentrations (p. 7).
Abuse Liability:
The abuse liability of the new products is lower than combusted cigarettes and is similar to, or lower than, that of other ENDS (p. 27).
Toxicant Exposure:
The overall toxicological risk to users of the new products is lower compared to cigarettes due to significant reductions in aerosol HPHCs (Harmful and Potentially Harmful Constituents) of the new products compared to cigarettes (p. 27).
Population and Public Health:
The applicant demonstrated that current adult smokers are particularly interested in the new products to assist in intended switching, and these products have the potential to benefit that group as compared to continued exclusive cigarette use (p. 4, 27).
Statutory Requirements:
FDA's evaluation determined that there are adequate process controls and quality assurance procedures to help ensure both the device and e-liquids are manufactured consistently (p. 27).
Youth Use Considerations:
The review discusses the potential for youth use of the electronic nicotine delivery system (ENDS) by highlighting that the applicant did not provide direct data on youth (p. 29).
Toxicology:
The new products and the ENDS comparison product, Vuse Alto Original 5%, aerosols demonstrated no cytotoxicity (neutral red uptake [NRU] assay) at the concentrations and under the conditions tested (p. 47).
The applicant provided supporting data from published in vitro and in vivo toxicology literature on respiratory effects, carcinogenicity, cardiovascular effects, mutagenicity and genotoxicity effects, reproductive/developmental effects, immunotoxicity, neurotoxicity effects, and other systemic effects (p. 47).
Comparative Analysis:
The applicant tested and provided mainstream aerosol HPHC yields from Vuse Alto (Original flavor pod, 5% w/w nicotine, Menthol, 5% w/w nicotine), Blu PLUS+ (Classic Tobacco, 2.4% w/w nicotine, Menthol, 2.4% w/w nicotine), and NJOY Ace (Classic Tobacco, 5% w/w nicotine, Mint 5% w/w nicotine) for comparison (p. 9).
The rationale for selecting combustible cigarettes and other commercially available ENDS as comparison products is reasonable given their general product composition and design (p. 9).
References:
Technical Project Lead (TPL) Memo for Vuse Alto Marketing Granted Order. July 18, 2024
2022-05-12 RJRV-MGO-MultipleSTNs.pdfVUSE Vibe and Ciro PMTA MGO Letter
May 12, 2022
25 months from submission to decision
Vuse Vibe Ciro TPL.pdfVUSE Vibe and Ciro Technical Project Lead Memo
May 12, 2022
The following are the key points from each scientific review discipline that contributed to the rationale for the marketing granted order:
Product Characterization:
The products' design and manufacturing processes meet the manufacturer's specifications p. 48.
Labeling and Advertising:
Environmental Decision:
The environmental assessments for all PMTAs contain sufficient information to determine the impact on the human environment p. 48
Social Science:
Conclusion and Recommendation:
The toxicology assessment of the premarket tobacco applications (PMTAs) highlighted several key findings:
Toxicant Exposure:
The assessment indicated significant reductions in harmful and potentially harmful constituents (HPHCs) in the new product aerosols compared to combusted tobacco comparison products p. 35.
It was noted that the observed levels of vegetable glycerin (VG) and propylene glycol (PG) in new product aerosols were comparable to levels normally seen in other ENDS market comparison products p. 35.
Nonclinical Studies:
Results from in vitro toxicology studies demonstrated that the aerosols of the tested new products or ENDS market comparison products were not mutagenic or genotoxic and exhibited minimal cytotoxicity p. 39.
The toxicology review indicated that the new product aerosols consistently resulted in substantially lower nonclinical toxicity and histopathological changes compared to combusted cigarette smoke p. 39.
Health Effects:
The assessment concluded that no definitive health conclusions could be drawn about the new products' impact on human health based on the clinical data and health effects literature submitted by the applicant p. 41.
It was noted that the overall toxicological risk to the user population was evaluated to be lower than that of combusted cigarettes and higher than that of 4mg nicotine replacement therapy (NRT) gum p. 49.
The review of the premarket tobacco applications (PMTAs) provided several specific mentions about youth usage of the product:
Youth Appeal and Initiation:
The review emphasized the substantial evidence regarding the impact of youth exposure to marketing on youth appeal and initiation of tobacco use p. 7p. 49.
The marketing authorization for the new products should include post-market requirements to help ensure that youth exposure to tobacco marketing is limited p. 7p. 49.
Youth Perceptions:
The review highlighted that the appeal of the tobacco-flavored new products is low in adult non-users, and non-users view the new products as a risk to developing poorer health p. 7.
Existing evidence consistently indicates that use of tobacco-flavored electronic nicotine delivery systems (ENDS) is less common than non-tobacco flavored ENDS among youth p. 49.
Marketing Restrictions:
Recommendations were made to place restrictions on digital, TV, and radio marketing to protect youth p. 26p. 31.
The review emphasized the need for post-market requirements aimed at reducing youth exposure and access to the products p. 49.
2021-10-12 RJReynolds-MGO-Ltr-PM0000551-553-560.pdfVUSE Solo PMTA MGO Letter
October 12, 2021
24 months from submission to decision
RJReynold-Vuse Solo-TPL-PM0000551-553-560 (1).pdfVUSE Solo Technical Project Lead Memo
The rationale for issuing a marketing granted order for Vuse Solo is based on the scientific review of various disciplines:
Product Characterization: The e-liquids contain nicotine salt formulations that may be easier to inhale at high amounts of nicotine, facilitating initiation and use of ENDS with high nicotine concentrations p. 7.
Abuse Liability: The abuse liability of the new products is lower than combusted cigarettes and is similar to, or lower than, that of other ENDS p. 27.
Toxicant Exposure: The overall toxicological risk to the users of the new products is lower compared to cigarettes due to significant reductions in aerosol HPHCs of the new products compared to cigarettes p. 27.
Population and Public Health: The applicant has demonstrated that current adult smokers are particularly interested in the new products to assist in intended switching, and these products have the potential to benefit that group as compared to continued exclusive cigarette use p. 4p. 27.
Statutory Requirements: FDA's evaluation determined that there are adequate process controls and quality assurance procedures to help ensure both the device and e-liquids are manufactured consistently p. 27.
The review of Vuse Solo discusses the potential for youth use of the electronic nicotine delivery system (ENDS) by highlighting that the applicant did not provide direct data on youth p. 17. It also mentions that the evidence from the peer-reviewed literature demonstrates that while youth use of ENDS is common, the proportion of youth who report Vuse Solo as their usual brand is low p. 20. Additionally, the TPL emphasizes that the prevalence of youth use of tobacco-flavored ENDS is low and that tobacco-flavored ENDS are less likely to be used by youth who initiate or regularly use ENDS compared to non-tobacco flavors p. 18. However, it also points out that more data is needed to determine the overall appeal of cig-a-like ENDS to youth p. 18.