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August 3, 2022

Warning Letters Can't Paper Over FDA’s Terrible Month

With its regulatory processes in chaos and its reputation in freefall, the FDA Center for Tobacco Products is doing what it always does in challenging times: bragging about enforcement actions against small businesses.

Today, new CTP Director Brian King issued an update on the review process for synthetic nicotine products and the agency’s actions against manufacturers and sellers.

More warning letters for synthetic products

On July 13—the last day of the two-month grace period allowing sales of synthetic nicotine products after the May 14 premarket tobacco application (PMTA) deadline—the FDA announced its first warning letters to companies selling synthetic nicotine-based products without authorization (there were just two), and named over a hundred retailers cited for selling synthetic nicotine products to minors.

See: FDA and Synthetic Nicotine: All You Need to Know

Now, two weeks later, the agency has sent warnings to 17 more manufacturers, including premium e-liquid pioneer Five Pawns. The warning letters give manufacturers 15 working days to respond to the FDA and describe actions taken to “bring your tobacco products into compliance with the [Food, Drug and Cosmetic] Act.”

Along with the letters to manufacturers, the FDA provided a list of 102 additional stores warned for selling to underage customers. Nearly all are convenience stores, smoke shops or gas stations, and the purchases all seem to be disposable vapes.

Refuse-to-Accept (RTA) letters: checkboxes matter

In his statement, King repeated that the CTP has received nearly a million PMTAs for synthetic nicotine products from more than 200 manufacturers, and brags that “In the past three weeks alone, FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products in applications that do not meet the criteria for acceptance.”

RTA is the first (and simplest) step in the PMTA process—a quick look to be sure the application itself meets statutory and regulatory requirements.

Some of the RTA letters King describes were issued because manufacturers used an old version of a required form, which had been changed just two weeks before the synthetic product PMTA submission deadline. Some manufacturers had used the old form, because small vape manufacturers don’t have government compliance offices.

The only difference between the old and new versions of the form was a pair of added checkboxes for tobacco or menthol flavors (the company checks one box), according to American Vapor Manufacturers Association (AVM) President Amanda Wheeler.

“Applications are required to provide important information needed for processing and reviewing,” writes King. “Without the required information, applications cannot proceed past the acceptance phase of the review process.”

At the CTP—a federal regulatory office with a $700 million budget—tripping up tiny businesses with paperwork tricks is a source of pride. More important for the FDA, the more manufacturers that exit the process before reaching the stage at which their applications must be denied, the fewer legal challenges the agency will have to answer.

King also announced the CTP has accepted 350 applications. But as far as the FDA is concerned, any synthetic-based vaping product currently being sold is illegal and subject to enforcement. The agency has not yet responded to a citizen petition from AVM asking for an extension of enforcement discretion to small companies that submitted PMTAs for synthetic nicotine-based e-liquid.

In trouble? Get out the “tough on tobacco” playbook

The FDA followed the same playbook in the months following the Sept. 9, 2020 PMTA submission deadline. Beginning in January 2021, and then every few weeks thereafter, the agency issued statements about its tough enforcement actions, along with a list of warning letters sent to tiny e-liquid manufacturers and retailers.

The first 2021 enforcement announcement arrived two days after Senator Dick Durbin and 11 colleagues sent a letter to then-FDA commissioner Stephen Hahn, demanding the agency ignore its mandate to evaluate PMTAs individually and instead simply institute a wholesale ban of flavored products.

Today’s communiqué from King also seems intended to distract from recent missteps caused by—you guessed it—pressure from Sen. Durbin and his allies in Congress. However, it’s doubtful that any number of warning letters could paper over the FDA’s awful July.

FDA’s terrible, awful, really no good July

On June 23, the FDA issued a marketing denial order (MDO) to Juul Labs, demanding all Juul products be immediately removed from the market. A day earlier, the news that the agency would ban Juul was mysteriously leaked to the Wall Street Journal. The leak came just a day after Sen. Durbin had suggested in a press release that FDA Commissioner Robert Califf should resign if he couldn’t “protect our children” from vaping products.

Less than two weeks later, on July 5, the FDA was forced to back down and issue a stay of the Juul Labs MDO. The agency supposedly missed 6,000 pages of Juul’s PMTA that contained evidence about the toxicology issues upon which the FDA had based its denial. Judging by recent evidence, this “error” could keep Juul out of the FDA’s hair for years.

Soon after the Juul fiasco, Califf announced he was asking the Reagan-Udall Foundation—a semi-independent FDA partner organization—to review the agency’s tobacco “processes and procedures, resourcing, and organizational structure.” This almost certainly is intended to give Califf cover in his dealings with Congress, but you just never know when some rogue consultant will start looking too closely at the TPS Reports. Vape trade group AVM has already announced Reagan-Udall has agreed to a meeting.

Following that came the most embarrassing news of all: CTP Office of Science Director Matthew Holman was leaving the agency to join tobacco giant Philip Morris International. That of course raised the usual revolving door complaints, but more damning for the CTP was the implication that its respected science chief believed he would do more good for public health by helping PMI sell IQOS and other new nicotine products than he would at the CTP.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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David Priddy
David Priddy
10 months ago

Somehow, I find this a bit unbelievable. I’d like to see proof where stores are selling to underage (minors). Not really buying their BS!

9 months ago

Has any synthetic nicotine been approved? Or would technically every single product be illegal as of today?

9 months ago
Reply to  Jim McDonald

When do you expect the first MDO or approval to be granted for synthetic nic?