The FDA announced Thursday it has rejected 800,000 of the approximately one million synthetic nicotine product marketing applications submitted by the May 14 filing deadline. Of the 800,000 receiving Refuse to Accept (RTA) letters, the FDA says more than 700,000 were rejected in the last month.
The agency now says 85 percent of submitted synthetic nicotine premarket tobacco applications (PMTAs) have been reviewed for basic filing requirements, which means about 150,000 PMTAs have yet to receive a determination of any kind.
The FDA also reported it has accepted “over 350” applications for further review—the same vague number it used in its Aug. 3 update. But the leading vaping industry group says “over 350” is deceptive and a gross understatement of the real number. That group also says the agency altered required PMTA forms close to the submission deadline to disqualify already-submitted applications.
According to American Vapor Manufacturers Association (AVM) President Amanda Wheeler, her organization’s member companies alone have received acceptance letters for 4,700 PMTA submissions. Wheeler thinks the FDA is misreporting the acceptance results to avoid criticism from tobacco control groups that seek prohibition of all vaping products.
“Once again the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”
To be clear, none of the submitted applications have yet been scientifically reviewed; that process comes later. The FDA has refused to accept 800,000 applications, meaning they are deemed unfit for further review. RTA letters are sent when manufacturers don’t meet the most basic requirements to move forward in the review process.
The 4,700 applications from AVM members have met the requirements to advance to the next step in the process.
By reporting that “over 350” products have passed the first stage of the PMTA process—instead of a number closer to 5,000—the agency may be attempting to stay off the radar of the Campaign for Tobacco-Free Kids and its allies. Wheeler says the FDA wants to show “the appearance of action” to keep those critics at bay.
Vaping360 contacted the FDA Thursday for comment on its reporting of synthetic PMTA results, but didn’t receive a reply in time to include it in this article. We will update if the agency responds.
As we reported on Aug. 3, the FDA has issued RTA letters to many manufacturers for technical errors, such as using the old version of a form that the agency updated two weeks before the submission deadline. The difference between the two versions was the addition of two checkboxes.
According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.” She says the application form switcheroo is “another outrageous example of how FDA has been underhandedly rigging the approval process.”
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If true, it will be difficult for the FDA to keep such unethical behavior secret. Wheeler says AVM expects the tactic “will be pointed out to the various federal courts now hearing litigation against the agency.” Dozens of manufacturers have challenged marketing denial orders (MDOs) for tobacco-derived nicotine vaping products in the courts, and the synthetic PMTA process is bound to wind up in front of federal judges too.
Congress granted the FDA regulatory authority over synthetic nicotine products in March. Manufacturers had till May 14 to submit PMTAs, and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement, although the agency hasn’t to our knowledge taken action against any company for products with submitted PMTAs.
The FDA has still not responded to a citizen petition filed by AVM in June. The citizen petition—a formal FDA process often used by pharmaceutical manufacturers—asked the agency to extend enforcement discretion beyond July 13 to small companies that submitted PMTAs for synthetic nicotine-based e-liquid. The petition has received almost 4,200 public comments so far.
The FDA also announced today it has issued 25 warning letters since Aug. 3 (44 total) to manufacturers selling synthetic nicotine-based products without first submitting PMTAs, and published a list of recent warning letters sent to retailers for underage sales violations involving synthetic products. The agency says it has sent more than 300 such letters to retailers so far.
You can stay up-to-date on the FDA’s latest reporting of synthetic nicotine-based product refusals, denials, warnings and other actions at the agency’s “non-tobacco nicotine” regulation and enforcement page.