FDA begins enforcement of synthetic nicotine vapes

On July 13, the Food and Drug Administration (FDA) announcement that it had sent two warning letters to manufacturers marketing synthetic nicotine products without permission, and more than 100 warning letters to retailers who had sold synthetic nicotine products to minors.

The press release, published on the FDA website, came the day the agency was granted the power to regulate and exercise its enforcement discretion over synthetic nicotine products. In March, President Joe Biden signed an omnibus spending bill which gave the FDA this authority, something it had previously eluded. (Law on the prevention of family smoking and the fight against smoking, signed by President Barack Obama in 2009only gave the FDA the power to regulate nicotine products derivative tobacco – although chemically, synthetic nicotine is essentially identical.)

Many anti-nicotine and prohibitionist lobby groups and legislators expect a major offensive on disposable e-cigarettes, many of which use synthetic nicotine and have become the favorite vapes of teenagers, although youth vaping rates have decreased over the years. It will be tricky, however, when many disposable products are made in China, beyond the regulatory arm of the FDA.

Vapor makers, many of whom switched to using synthetic nicotine after the FDA summarily denied their Premarket Tobacco Product Applications (PMTAs), had just months to submit new PMTAs for their synthetic nicotine products – a delay they repeatedly called unreasonable, as the required scientific and behavioral studies would take longer than the application process itself. Some companies have not filed a PMTA for these products.

“The FDA is working diligently to address the significant number of [PMTA] applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said Dr. Brian King, director of the Center for Tobacco Products (CTP). from the FDA, said in a press release. “We remain fully committed to taking all necessary steps to protect public health and to providing timely updates on our ongoing progress in regulating tobacco-free nicotine products.”

“The FDA is cracking down on companies that couldn’t meet a Sisyphean task.”

Vape makers and tobacco harm reduction advocates are highly critical of the FDAthe latest actions.

“After Congress set an impossible PMTA deadline for synthetic nicotine companies, it should come as no surprise that some companies were unable to submit the robust data and evidence requirements on time,” Amanda Wheeler, President of American Vapor Manufacturers (AVM), Told Filtered. “Companies had 60 days to present extensive, time-consuming and expensive research findings to the FDA. The limited number of labs has a minimum wait time of six months, and most tests take 12 to 24 months, but the FDA has completely ignored these facts. Now the FDA is cracking down on companies that couldn’t meet a Sisyphean task. »

“AVM and its members have pleaded with the FDA to use its discretion to allow the continued sale of open-system vaping products that adults use to quit smoking while the companies gather the required evidence,” she said. for follow-up. “But the agency’s sloppy regulatory decisions leave us with more questions about whether the agency is acting to benefit combustible cigarettes.” (MY V recently organized a citizen petition, urging the FDA to allow e-liquids containing synthetic nicotine used in open-system vaping products to remain on the market beyond July 13.)

The FDA came under intense political pressure. The day before the agency announcement, two notable senators – Dick Durbin, a Democrat from Illinois and longtime critic of the tobacco and vaping industries, and Susan Collins, a Republican from Maine –castigated the agency for failing to take substantial action, writing in a letter that they found it “deeply disappointing and unacceptable that the FDA appears to be on the verge of once again failing to protect our nation’s children from the dangers of addiction with nicotine”.

“Outside of the COVID era, the FDA and its state partners are still performing youth access compliance checks,” Greg Conley, president of the American Vaping Association, Told Filtered. “The FDA tends to issue press releases trumpeting their routine work following a month of bad press.”

“The weakest of the fruits at hand for the FDA are US-based companies that previously registered tobacco-derived nicotine products, but then switched to synthetic nicotine and did not file of PMTA,” he continued. “This is another instance of the FDA making tough decisions and instead targeting small-company manufacturers of open-system vaping products.”


Photograph by Felton Davis via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filteredreceived donations from the American Vaping Association. Filter’s editorial independence policy applies.

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