Following a March 15th legislation, the FDA has been granted the authority to regulate tobacco products containing nicotine from any source, which has led to the alleged ban on synthetic nicotine.
Synthetic nicotine vaping products, had until recently been exempt from FDA regulations because they contain nicotine made in a lab, rather than extracted from a tobacco leaf. However, following a legislation enacted on March 15th, the FDA has been granted the authority to regulate tobacco products containing nicotine from any source, which has led to an alleged ban on synthetic nicotine.

After the passing of the ban, the Vapor Trade Association (VTA) had immediately began working on a strategy to ensure a viable path for companies which are selling the products. Moreover, the VTA’s Board of Directors and members met with the FDA Center for Tobacco Products (CTP) to discuss the ban.

The FDA personnel in attendance included over 35 senior leaders, representing seven different offices inside CTP. The VTA held presentations by three Ph.D’s in Organic Chemistry and Physical Analytical Chemistry, in order to frame critical scientific and public policy issues that we believe had not previously been presented to or considered by the FDA.

Synthetic nicotine manufacturers had to submit PMTAs by May 14th

Meanwhile, the March legislation required synthetic nicotine manufacturers to submit premarket applications by May 14, 2022, and any brand which had not submitted these documents would be considered illegal. However, this was not enforced in any way until recently.

This led to the FDA being heavily criticised. In a letter, which cited STAT’s reporting on the agency’s lack of action, Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine), said that the FDA “appears to be on the brink of failing yet again at protecting our nation’s children.”

Similarly, president of the Campaign for Tobacco-Free Kids Matt Myers, highlighted that given the FDA should exercise its authority to pull the products off the market. “All unauthorized synthetic nicotine products are now illegal and by law must be removed from the market now, not at some undetermined date in the future.”

Finally, on July 13th the FDA announced that it had sent two warning letters to manufacturers marketing non-authorized synthetic nicotine products and over 100 warning letters to retailers who sold synthetic nicotine products to minors.

The FDA revealed that while AZ Swagg Sauce LLC and Electric Smoke Vapor House have listed a combined total of approximately 10,000 products with the FDA, they have not submitted any PMTAs for their synthetic nicotine products. However, the agency did not address the most popular synthetic tobacco product on the market, Puff Bar, which is currently causing quite a stir due to an increase in popularity among teens.

“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said director of the FDA’s Center for Tobacco Products, Brian King in a statement.

Read Further: The Hill

Why The Ban on Synthetic Nicotine is Counterproductive to Public Health

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