By Stacy Ehrlich & Will Woodlee
On March 13, 2019, FDA published a Draft Guidance entitled “Modifications to Compliance Policy for Certain Deemed Tobacco Products” (Draft Guidance). A summary of the Draft Guidance follows.
Background
• The Draft Guidance relates to FDA’s compliance policy for deemed tobacco products (i.e., regulated tobacco products other than cigarettes, smokeless tobacco, RYO tobacco, and components, parts, and accessories of such products) that qualify as “new tobacco products” (i.e., tobacco products not commercially marketed in the U.S. “as of” February 15, 2007, or physically modified after that date). While such products generally require premarket authorization from FDA, the Agency’s current compliance policy for the premarket review requirements permits deemed “new tobacco products” that were on the U.S. market on August 8, 2016, to remain marketed until at least one of two compliance dates: (i) August 8, 2021 (for combustible products); or (ii) August 8, 2022 (for non-combustible products). The current compliance policy would allow the continued marketing of such a product after the applicable compliance date, provided that the marketer submitted a marketing application for the product by the applicable compliance date and such application remains pending with FDA. If the application’s review concludes without the issuance of a marketing authorization, FDA’s enforcement discretion policy would cease to apply to the subject product. If the application’s review concludes with the issuance of a marketing authorization, the product could remain on the market, subject to other applicable requirements under federal law. The Draft Guidance proposes to modify the current compliance policy in several significant respects for certain electronic nicotine delivery system (ENDS) products and flavored cigar products.
• FDA would not implement any changes to the compliance policy proposed in this Draft Guidance until 30 days after FDA issues a final version of the guidance.
• Stakeholders should submit comments on the Draft Guidance by April 12, 2019, to ensure that the Agency considers the comments before it begins work on any final version of the guidance.
• FDA states that, although prior notice is not required, the Agency generally seeks voluntary compliance by issuing a warning letter to a manufacturer or retailer before initiating an enforcement action. The Draft Guidance suggests that, in implementing any finalized version of the guidance, FDA would generally send a manufacturer or retailer a warning letter for a violation of the modified compliance policy before initiating any more-punitive enforcement action.
• Under the proposed modified compliance policy, FDA’s would make a decision to prioritize enforcement of the premarket review authorities against a manufacturer or retailer on a case-by-case basis.
• How, if at all, the resignation of FDA Commissioner Scott Gottlieb will impact this initiative, including whether FDA will eventually finalize the Draft Guidance, remains unclear at this time. However, the Commissioner’s statement announcing the availability of the Draft Guidance states that this policy change has “the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump” and that FDA’s “pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump Administration.”
ENDS products
• Importantly, under the proposed modified compliance policy, FDA would change the compliance date for filing a marketing application for flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) from August 8, 2022, to August 8, 2021.
• In the Draft Guidance, FDA does not define what would qualify as a “flavored” ENDS product.
• Under the proposed modified compliance policy, and beginning 30 days after the issuance of any final version of the Draft Guidance, FDA would prioritize enforcement regarding the lack of marketing authorization against:
1. Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) offered for sale in ways that pose a greater risk for minors to access such products. For example:
- Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) sold in locations that minors are able to enter at any time (e.g., the entire establishment or an area within the establishment);
- Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) sold through retail establishments and online retail locations that have sold to minors after issuance of the final guidance (information about sales to minors identified by FDA is publicly available on FDA’s searchable retailer inspection database);
- Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) sold online with no limit on the quantity that a customer may purchase within a given period of time; or
- Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) sold online without independent, third-party age- and identity-verification services that compare customer information against third-party data sources, such as public records. (Contrary to FDA’s previous statements, the Agency has not provided additional guidance on what would constitute appropriate age-verification procedures for online sales (e.g., signature or age-verification upon delivery).)
2. Flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) that are offered for sale in the United States after August 8, 2021, without the manufacturer submitting (and FDA receiving) a premarket application (or after action by FDA on that application, as described below); and/or
3. All ENDS products that are targeted to minors or likely to promote use of ENDS by minors. FDA seems to provide the following examples:
- Use of social media to market products to minors;
- Use of youth-appealing cartoons or minors or people who appear to be minors in advertising; and
- Products that resemble kid-friendly foods and drinks or resemble other non-ENDS products that are often consumed by youth.
• Under the proposed modified compliance policy, after August 8, 2021, FDA would prioritize enforcement for lack of a marketing authorization against flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) offered for sale in the United States and for which the manufacturer has not submitted (and FDA has not received) a marketing application. FDA states that, notwithstanding submission (and FDA receipt) of a marketing application, the enforcement priorities described elsewhere in the Draft Guidance would continue to apply.
• FDA requests comment on whether there are any technologies or other measures that would also be well tailored to address youth access to ENDS products, as well as any additional data that would be relevant to FDA’s formulation of its enforcement priorities.
• FDA requests comments on whether to adjust the premarket review compliance date to August 8, 2021, for all ENDS products, including tobacco-flavored, mint-flavored, and menthol-flavored ENDS products.
Cigars
• Under the proposed modified compliance policy, and beginning 30 days after the issuance of any final version of the Draft Guidance, FDA would prioritize enforcement actions with respect to flavored cigars (other than tobacco-flavored cigars) that were on the market on August 8, 2016, and that meet the definition of a “new tobacco product.”
• Under the proposed modified compliance policy, FDA would prioritize enforcement with respect to mint- and menthol-flavored cigars that qualify as “new tobacco products” even though the Agency plans to continue to exercise its discretion not to take enforcement action with respect to mint- and menthol-flavored ENDS products under most aspects of the modified compliance policy. FDA states that, unlike with respect to ENDS products, there is no similar potential public health benefit to new mint- and menthol-flavored cigars remaining on the market.
• FDA does not define what would qualify as a “flavored” cigar product.
• All tobacco-flavored cigars would continue to be subject to the extended compliance dates announced in the August 2017 Compliance Policy (summarized above).
• FDA requests comments and/or data on the number of currently marketed flavored cigars that were on the U.S. market as of February 15, 2007 (i.e., flavored cigars that are not considered “new tobacco products”).
• FDA has not proposed any changes in the current compliance policy that would apply to hookah or waterpipe tobacco, pipe tobacco, or dissolvables.