FDA's New “Flavor Ban Lite” Ignores May PMTA Deadline

As expected, the Trump administration announced new FDA guidance on enforcement priorities Thursday. The new plan will result in removal from the market of all prefilled pods in flavors other than tobacco and menthol. The FDA guidance was almost exactly as described in administration leaks on New Year’s Eve.

All vaping products are currently available only because the FDA has decided not to enforce provisions of its Deeming Rule. With the new guidance, the agency is now choosing to actively enforce its regulations as they apply to certain classes of vaping products:

Pod-based products sold unfilled, as well as mods, tanks, and bottled e-liquid, are not affected by the new guidance—unless the manufacturer uses “kid-appealing” imagery or encourages sales to those under 21. The goal of this “ban” is to eliminate the most popular products used by teenagers, although the evidence is slim that teens looking for a “nic buzz” or vaping out of curiosity won’t simply switch to tobacco flavors.

The guidance takes effect in 30 days. The products that will be most affected are flavored pods sold by tobacco companies RJ Reynolds (Vuse), Imperial Brands (Blu), and Japan Tobacco International (Logic), and iconic independent vape manufacturer NJOY. While these products are mainly sold in convenience stores, the prohibition extends to any seller, including vape shops.

Convenience store leader JUUL voluntarily stopped selling its popular mint flavored pods in November, and had already removed its other non-tobacco and non-menthol flavors a year ago. While much news coverage described the new flavored vape ban as hurting JUUL, it will in fact be beneficial to the controversial company.

In addition to removing legitimate competitors’ flavored products from store shelves, the new guidance will make enforcement actions against JUUL-compatible and clone products much easier for the FDA. Until now, authorities would have to show that the products were illegally introduced after Aug. 8, 2016—but now all flavored pods are prohibited, and offenders will be easy to identify.

Interestingly, the agency does not intend to enforce against “completely self-contained, disposable products.” That allows cigalike products like the NJOY Daily to remain in convenience stores, even though it’s available in flavors other than tobacco and menthol.

Although President Trump described the action as temporary, it isn’t. The products cannot return to the market without an approved premarket tobacco application (PMTA) from the FDA. While all vaping products will be forced to submit PMTAs by May 11, the flavored pods affected by today’s action will not receive a one-year grace period to sell products after their manufacturers submit PMTAs.They must be granted premarket approval before ever being sold again.

The FDA guidance has no effect on the May 11 PMTA deadline. Virtually all open system products currently being sold will become illegal on May 12. Only those that have a PMTA accepted for review will receive a one-year reprieve. No PMTA’s from independent vape companies have yet been accepted by the FDA, although RJ Reynolds’ Vuse PMTA is currently being reviewed by the agency, and Japan Tobacco is believed to have submitted an application for some Logic products.