On July 13, the Food and Drug Administration (FDA) announced that it had sent two warning letters to manufacturers marketing synthetic nicotine products without authorization, and more than 100 warning letters to retailers that had sold synthetic nicotine products to minors.
The press release, issued on the FDA’s website, arrived on the day the agency was granted the power to regulate and exercise its enforcement discretion on synthetic nicotine products. In March, President Joe Biden signed an omnibus spending bill that gave the FDA this authority, something that had previously eluded it. (The Family Smoking Prevention and Tobacco Control Act, signed by President Barack Obama in 2009, only gave the FDA the power to regulate nicotine products derived from tobacco—although chemically, synthetic nicotine is essentially identical.)
Many anti-nicotine and prohibitionist-minded lobbying groups and legislators now expect a significant offensive on disposable e-cigarettes—many of which use synthetic nicotine and have become teenagers’ vapes of choice, although youth vaping rates have decreased over the years. That will be tricky, however, when many disposables are manufactured in China—beyond the FDA’s regulatory arm.
Vapor manufacturers, many of whom switched to using synthetic nicotine after the FDA summarily denied their premarket tobacco product applications (PMTAs), had only a few months to submit new PMTAs for their synthetic nicotine products—a time frame that they repeatedly called unreasonable, as the required scientific and behavioral studies would take longer than the application process itself. Some of the companies did not file PMTAs for these products.
“FDA is working diligently to process the substantial 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,” Dr. Brian King, the director of the FDA’s Center for Tobacco Products (CTP), said in a statement. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”
“The FDA is cracking down on companies who could not meet a Sisyphean task.”
Vape manufacturers and tobacco harm reduction advocates are highly critical of the FDA’s latest actions.
“After Congress set an impossible-to-meet PMTA deadline for synthetic nicotine companies, it should not be surprising that some companies could not submit the robust data and evidentiary requirements in time,” Amanda Wheeler, the president of American Vapor Manufacturers (AVM), told Filter. “Companies had 60 days to present extensive, time-consuming, and expensive research findings to the FDA. The limited number of labs have a minimum six-month wait time, and most analyses take 12 to 24 months to complete, yet the FDA has wholly ignored these facts. Now the FDA is cracking down on companies who could not meet a Sisyphean task.”
“AVM and its members have pleaded with the FDA to use its enforcement discretion to allow the continued sale of open system vaping products that adults use to quit smoking while companies collect the required evidence,” she continued. “But the agency’s slipshod regulatory decisions leave us with more questions about whether the agency is acting to the benefit of combustible cigarettes.” (AVM recently organized a citizen petition, urging the FDA to allow e-liquids with synthetic nicotine used in open-system vaping products to stay on the market beyond July 13.)
The FDA has been under intense political pressure. The day before the agency’s announcement, two notable senators—Dick Durbin, a Democrat from Illinois and longtime critic of the tobacco and vape industries, and Susan Collins, a Republican from Maine—chastised 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 brink of failing yet again at protecting our nation’s children from the dangers of nicotine addiction.”
“Outside of COVID times, the FDA and its state partners are always conducting youth access compliance checks,” Greg Conley, the president of the American Vaping Association, told Filter. “The FDA tends to put out media releases trumpeting their routine work in the aftermath of a bad press month.”
“The lowest of low-hanging fruit for the FDA are US-based companies that previously registered tobacco-derived nicotine products, but later switched to synthetic nicotine and did not file PMTAs,” he continued. “This is another case of the FDA punting on tough decisions and instead targeting small business manufacturers of open-system vaping products.”
The Influence Foundation, which operates Filter, has received donations from the American Vaping Association. Filter’s Editorial Independence Policy applies.