A coalition of 18 conservative advocacy groups, led by Americans for Prosperity, is urging the new Food and Drug Administration commissioner to rein in tough tightening federal regulations on synthetic nicotine products.
Dr. Robert Califf returned as FDA commissioner on February 17. He held the same position during the last year of the Obama administration.
Anti-tobacco advocacy groups have expressed optimism that Califf will support additional tobacco and nicotine restrictions on traditional menthol cigarettes and synthetic nicotine products.
President Joe Biden signed into law United States House Resolution 2471, a $1.5 trillion federal funding bill in March that contained language placing the use of synthetic nicotine under the authority of the FDA. This aspect of the law will come into force on April 14.
Specifically, the federal Food, Drug, and Cosmetic (FD&C) Act “now includes specific language that makes it clear that the FDA may soon regulate tobacco products containing nicotine from any source, including synthetic nicotine. “, the FDA said in a press release.
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Currently, synthetic nicotine products may be sold in candy and fruit flavors not available for FDA-regulated tobacco and nicotine products.
Puff Bar has been a major distributor of flavored synthetic nicotine products, attracting the attention of anti-tobacco advocates as a preferred option for high school students. It receives similar scrutiny as the best-selling Juul e-cigarette in recent years.
In 2020, the FDA ordered Puff Bar to remove its flavored disposable e-cigarettes from the market due to their appeal to children. In 2021, Puff Bar re-entered the market as a synthetic nicotine product with kid-friendly flavors such as Banana Ice and Cool Mint.
The Conservative coalition said Califf should approve a delay in the enforcement of the new law because it will “effectively ban vapor products containing synthetic nicotine that are legally manufactured and sold in the United States.”
“Manufacturers of tobacco products containing non-tobacco-derived nicotine will soon be required to submit a premarket tobacco product application to the FDA and obtain agency clearance to market their product under the FD&C Act as amended by such legislation, or they will be subject to FDA enforcement.
“Unfortunately, the FDA itself has stated that acceptable applications typically require six months to prepare, making it a de facto ban on any small business that lacks the resources of multinational tobacco companies,” the coalition wrote. .
“As a result, this law deprives smokers and former smokers of a crucial tool to quit smoking in favor of healthier alternatives.”
More time needed
The coalition is calling on Califf to allow products to remain on the market beyond the 60-day period established by law so that manufacturers can have more time to prepare their applications.
“The FDA has done this before, and you should do it now,” the coalition wrote.
“Failure to do so will have disastrous consequences for former smokers who rely on synthetic vapor products to avoid cigarettes.”
“As the leading voices against government excesses, we believe that no regulator or legislator should be able to restrict consumer choice in this area, especially if it has direct health implications.”
The coalition warned Califf that by removing American synthetic nicotine products, it “re-opens the floodgates for illegal counterfeit products from China…which have formed a dangerous domestic black market that has prompted Americans to use these cheap counterfeits with unsafe and unregulated substances, resulting in multiple cases of illness and death.”
Barclays analyst Jain Gaurav said a knock-on effect of the new law is that “all synthetic nicotine e-cigarettes, or about 20% of the market, would likely be taken off the market.”
The FDA has requested the regulatory language due to concerns that e-cigarette makers are turning to synthetic nicotine products “in an attempt to evade FDA regulations (which) revealed a critical need to clarify FDA authority over these products.
“This has been accomplished, by ensuring that like products, except for the nicotine source, are regulated as tobacco products.”
Matt Myers, president of the Campaign for Tobacco-Free Kids, said the language was needed, saying synthetic nicotine “poses a new and growing threat to the health of children in our country.”
Amanda Wheeler, president of the American Vapor Manufacturers Association, said giving the FDA authority over synthetic nicotine would serve to slow adult smokers’ transition to vaping options.
“It’s bad enough that the FDA is banning adult American smokers from switching to vaping, but this legislation is so absurd that it will expand the FDA’s reach to products that have no real physical connection to tobacco,” said Wheeler said.