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:
- Any flavored, pod- or cartridge-based product (other than tobacco- or menthol-flavored products)
- All other products for which the manufacturer has failed to take adequate measures to prevent access by minors
- Any product that is targeted to minors or whose marketing is likely to promote use of vaping products by minors
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 issue is that 99.9% of the companies that make the refillable, “open tank” systems that FDA says are used by adult smokers cannot afford the PMTA’s. This needs to be addressed so these companies are able to remain on the market and users aren’t forced to the black market. https://t.co/i0IrJcCEos— Matt From SMM (@SuckMyMod) January 3, 2020
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 guidance 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.
Today, the Trump Administration released a new enforcement policy to stem the crisis of youth e-cigarette use and protect public health. Under @POTUS's leadership, we’ve arrived at a smart, balanced policy, built on a careful examination of the latest data https://t.co/MgPv0b5Jj6— Secretary Alex Azar (@SecAzar) January 2, 2020
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.
A new federal policy is a win for JUUL and e-cig makers — flavors like unicorn vomit & gummy bear will stay on the market. The policy puts politics & profits ahead of young people’s and gives the green light for the youth e-cig epidemic to continue. https://t.co/bIUiWzDdfN— Truth Initiative (@truthinitiative) January 2, 2020
It’s unclear if President Trump understands that the pushback he has gotten from vapers over the past four months will be mild compared to what will happen in May if the PMTA requirements haven’t changed by then. A four-month reprieve is unlikely to change the minds of vapers who consider themselves single-issue voters. The new FDA guidance will do nothing to save Trump from vapers outraged by a ban on their preferred products in May. And vape shop employees and owners will never forget the President who is in office when their livelihoods are destroyed.
Nor will the “flavor ban” appease tobacco control activists, who have already announced they will double down on efforts to pass a full ban of all flavors—including in vape shops—in Congress and in state legislatures. Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a press release that the new FDA guidance is “a capitulation to both Juul and vape shops and gives a green light to the e-cigarette industry to continue to target and addict kids with flavored products.”