VTA RESPONDS TO FDA ANNOUNCEMENT
Today’s announcement makes one thing abundantly clear: FDA has heard our message.
First, flavored ENDS products must be treated differently than dangerous combustible cigarettes. We applaud Commissioner Gottlieb’s recognition that combustible cigarettes and flavored cigars must be treated differently than live-saving ENDS products. ENDS products – specifically flavors – are fundamental to improving public health through transitioning adult smokers to less harmful alternatives.
Second, from the first time that we met with the Commissioner we heralded the importance of vape shops. Today, we are pleased to see FDA’s recognition of the hard work from vape shops around the country in being responsible stewards and representatives of our industry. We are proud to represent vape shops in nearly 30 states, and today’s announcement vindicates the hard work our retailers do every single day to ensure proper distribution and strong enforcement of age verification to keep these products out of the hands of minors.
Third, FDA indicated its intent to continue to crack down on the improper marketing of ENDS products, rather than simply ban flavors in ENDS. This was the single most important message we left with the Commissioner, and his actions to date and again today demonstrates that he is dedicated to eliminating those improper marketing practices as we are.
As FDA finalizes a framework around certain aspects of today’s action – including third party online verification – we’ll continue to keep you informed of developments related to today’s announcement. We will also provide a deeper dive into the announcement later.
Here is the summary of the major points in FDA’s announcement:
- Flavored ENDS products that are not sold in an age-restricted, in-person location.
- Have all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations. All ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint and menthol, would be included. For instance, the proposed policy would apply to flavors such as cherry, vanilla, crème, tropical, melon and others.
- To advance this goal, the FDA is revisiting the compliance policy on PMTA authorization for such flavored products sold in physical locations where people under the age of 18 are permitted.
- The FDA is not revisiting the compliance policy with respect to ENDS products sold exclusively in age-restricted locations – for instance, a stand-alone tobacco retailer (such as a vape shop) that adequately prevents persons under the age of 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under the age of 18 and the flavored ENDS products are not visible or accessible to persons under the age of 18 at any time.
- At this time, ENDS products with tobacco, mint or menthol flavors, as well as any non-flavored ENDS products, sold in any location, would not be included in any policy revisions. This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age-restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking.
- The FDA, however, will not ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids. We will continue to use all available surveillance resources to monitor the rates and use patterns among youth and adults for these products, and we will reconsider our policies with respect to these products, if appropriate.
- Flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online.
- In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes.
- The FDA will be working to identify these heightened measures for age verification and other restrictions to prevent youth access via online sales. These best practices would be available soon, so sites can quickly adopt them.
- Because no tobacco products should be sold to kids (including non-flavored ENDS products or those with tobacco, mint and menthol flavors), the FDA will continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products.
- Flavored cigars.
- Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people.
- Given these public health concerns, I believe flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold.
- The FDA’s proposal to revisit the compliance policy for flavored cigars that are new tobacco products does not apply to the entire product category, as some products were considered “grandfathered.” Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars.
- In July, the comment period for our ANPRM on flavors in tobacco products closed. The FDA has expedited review and analysis of these comments, and we intend to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule.
- ENDS products that are marketed to kids.
- The FDA will pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth. This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda.
- Menthol in combustible tobacco products.
- Informed by the comments from our ANPRM, the FDA will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.
- The FDA started this process several years ago with an ANPRM. That ANPRM issued alongside the FDA’s preliminary scientific evaluation, which suggested menthol use is likely associated with increased smoking initiation by youth and young adults.
- Now, armed with the additional years of data, comments from the public – and with the perspective of our Comprehensive Plan and its implementation – the FDA will accelerate the proposed rulemaking process to ensure that our policies on flavored tobacco products protect public health across the continuum of risk.
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