The FDA is proposing new flavored vape product guidance for manufacturers that it says could make the authorization of some non-tobacco/non-menthol flavors more likely. But, in reality, it will probably change nothing.
The new guidance suggests that some non-tobacco/non-menthol flavors may pose a lower risk of youth uptake than others, and that it may be less difficult to convince the FDA that they meet the Tobacco Control Act standard of being “appropriate for the protection of public health” (APPH). The FDA specifically mentions mint, coffee, tea, and spice as flavors that may have an easier path through the review process.
The guidance is scheduled to be published in the Federal Register on March 11. At that point, a 60-day public comment period will open. Instructions for commenting are on the Federal Register page.
FDA guidance is not product standards
The first thing to understand is that FDA guidance isn’t the same as a rule or a set of standards. It doesn't set specific benchmarks to meet, and it isn’t binding—either on manufacturers or on the FDA.
Guidance merely represents the agency’s “current thinking,” which may turn on a dime. And every sentence in the guidance that contains a “may,” “might,” “probably,” or even a “should,” is not to be counted upon. After all, the Supreme Court has upheld the FDA’s right to mislead manufacturers with weasel words.
The FDA says determining whether a product meets the APPH standard includes “evaluating the risks and benefits, considering all relevant evidence and circumstances associated with the new product to the population as a whole. To show that the marketing of an ENDS is APPH, an applicant must show that the benefits, including those to adults who smoke combusted cigarettes, outweigh the risks, including those to youth, resulting in a net benefit to the public health.”
And potential sellers of flavored vapes must go even further, providing evidence that their flavored product provides additional benefits to adults that make up for the supposed greater risk to youth. That means expensive randomized controlled trials or longitudinal cohort studies that small manufacturers simply don’t have the resources to conduct.
No PMTA submitted for a non-tobacco/non-menthol product has yet been successful.
All the new FDA guidance does is propose that some non-tobacco/non-menthol flavors may present a lower risk to youth than the dreaded “fruit and candy/dessert/other sweet” flavor categories. So, they're telling manufacturers, go ahead and convince us.
However, the only way to know for sure if the highly subjective APPH standard has been met is still to do the research, file a PMTA, and wait 1-6 years for an answer. You have no more assurance of getting an authorization for your coffee-flavored vape than you did yesterday.
Flavors don’t drive youth vaping
The FDA cites “coffees, teas, or spices” as the kinds of flavors that might have a better chance of authorization. However, manufacturers will still be responsible for proving to the agency’s satisfaction that they meet the APPH standard. And the FDA notes that the apparent low youth popularity of these flavors on its surveys “may be a function of other factors such as the way the survey was conducted or more limited distribution of the product.”
In reality, flavors have had little to no effect on youth uptake of vapes. The same fruit and dessert flavors that were popular before and during the peak years of teen vaping are available now. Middle and high school vaping has fallen by over 70 percent since its 2019 high-water mark—but not because flavors are no longer available.
Kids who vape use whatever products are available, which means the same range of products popular among adults. And adults prefer fruit, dessert and candy flavors above all others. If the FDA manages through enforcement actions to rid the market of all flavored vapes except tobacco and menthol, those are what youth vapers will use.
The majority of currently popular vape products are not FDA-authorized, and that will remain true until the FDA Center for Tobacco Products gets serious about being a regulator, and provides clear and achievable written standards that allow vape manufacturers to participate in an open market for a wide range of legal products.