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Wednesday, March 13, 2019

Proposed FDA Policy Will Make It Harder for Vapers to Get the Flavors They Prefer

By Jacob Sullum - March 13, 2019 at 04:10PM

Moving forward with its plan to restrict sales of e-cigarettes in the name of preventing underage vaping, the Food and Drug Administration today unveiled a "draft compliance policy" that effectively bans all flavors except tobacco, mint, and menthol but prioritizes enforcement against products "offered for sale in ways that pose a greater risk for minors." What that means is not completely clear, although it is bound to create headaches for manufacturers and retailers while making it harder for both former smokers and people interested in quitting to obtain the vaping products they prefer.

The FDA plans to "end current compliance policy" for e-cigarettes, except the three exempted flavors. That policy gave manufacturers until August 2022 to get FDA approval for their products, four years later than the original deadline. In the interim, they were allowed to continue selling products that were on the market as of August 8, 2016. The FDA intends to move the deadline up by a year for the disfavored flavors (i.e., nearly all of them) and end its policy of preapproval forbearance as it applies to those products. But the agency suggests that it won't take immediate action against them unless they are sold in a way that implicates its enforcement priorities.

The FDA lists four of those priorities: 1) "products sold in locations that minors are able to enter at any time," 2) "products sold through retail establishments and online retail locations that have sold to minors after issuance of the guidance," 3) "products sold online with no limit on the quantity that a customer may purchase within a given period of time," and 4) "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."

Although the list is not necessarily exhaustive, it seems reasonable to surmise that flavored e-cigarettes, pods, and e-liquids won't be subject to immediate enforcement action if they are sold by stores that do not admit minors or by online vendors with age verification and quantity limits. Theoretically, a convenience store could get away with selling such products if it restricted them to a separate section where minors are not allowed, but the cost of doing that surely will be prohibitive in most cases. (That option seems to be aimed mainly at evading a provision of the Family Smoking Prevention and Tobacco Control Act that says the FDA may not "prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.") The upshot is that adults who like the disfavored flavors will have to get them from vape shops, tobacconists, or websites with FDA-approved policies, as opposed to the thousands of other stores where they were heretofore available.

"We expect that some flavored e-cigarette products will no longer be sold at all," says FDA Commissioner Scott Gottlieb. "We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021." Retailers would be well-advised not to take Gottlieb at his word here, since they will be subject to enforcement action if they let customers younger than 18 enter their stores, even if they are scrupulous about checking IDs and never sell e-cigarettes to minors.

Gottlieb, who recognizes that e-cigarettes offer a "tremendous public health opportunity" as a harm-reducing alternative to the combustible kind, justifies the FDA's flavor discrimination by observing that the restricted varieties are especially popular with teenagers. Yet they are also undeniably popular with adults. According to survey data cited by the FDA in its draft compliance policy, 63 percent of adult vapers prefer flavors other than mint or menthol. "E-cigarettes are appealing to both youth and adults because of the variety of flavors that allow for customization," the authors of that study observed. "Findings indicate that the wide variety of flavors available and the freedom to 'mix-and-match' flavors may maintain use of e-cigarettes among youth and adults."

Will every vaper who likes a variety of flavors backslide once they are harder to get than the cigarettes he used to smoke? Will every smoker who tries vaping be deterred by the lack of flavor variety in the vast majority of stores? No, but there are bound to be some people in both categories, and they will face much greater health hazards than they otherwise would. The FDA is effectively encouraging smoking by trying to curb adolescent vaping with measures that go far beyond enforcing the minimum purchase age.

"This could have been worse," says Liz Mair of Vapers United. "But we do not consider the debate surrounding vapor regulation to be anywhere near settled, and we would urge FDA to provide further clarity as soon as possible, while continuing to bear in mind that the priority here should be enabling existing smokers to try vaping as a method [of] quitting and/or reducing harm...rather than restricting the marketplace in a way that could inadvertently keep smoking rates where they are now or even lead to them rising again."

The FDA will be accepting comments on its proposed policy for the next 30 days.


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