US FDA may implement synthetic nicotine regulation on July 13
The U.S. Food and Drug Administration is expected to officially close the loophole that allows the sale of synthetic nicotine tomorrow.
July 13 is the deadline for regulators to complete the approval process for synthetic nicotine products.
The FDA is unlikely to review premarket tobacco product applications (PMTAs) submitted before the May 14 deadline. The agency has yet to complete its review of many other electronic nicotine delivery system (ENDS) products using tobacco-derived nicotine that submitted PMTAs by the September 9, 2020 deadline.
Lawyers for the e-cigarette industry say Congress has set unrealistic deadlines for manufacturers to submit PMTA and FDA review of them. The law, which went into effect on April 14, requires companies to submit PMTAs by May 14, and all existing products that are not authorized must be taken off the market by July 13.
The FDA said last week that it was still reviewing the large number of applications it received for synthetic nicotine products, but declined to disclose the total number of submissions, according to media reports.
The agency said synthetic nicotine products on the market after July 13 without FDA marketing approval "would be considered a violation of federal law and "may be subject to FDA enforcement."
The FDA is expected to issue at least some marketing denial orders to companies that submit PMTAs but do not include required data, such as environmental impact assessments.
In March, the U.S. Senate approved by a bipartisan vote of 68-31 a $1.5 trillion piece of legislation that includes language that changes the definition of a tobacco product to include synthetic nicotine.
The rule becomes law 30 days after the passage of the bill. Congress further grants synthetic nicotine products a transition period, allowing such products to remain on the market until July 13, 2022, provided they submit the required PMTA by the May 14 deadline—unless the FDA has rejected non-admission Synthesize versions of the same product (meaning these manufacturers are subject to enforcement 30 days after the Act is passed).
The wording of the Tobacco Control Act was changed to define a tobacco product as "any product made or derived from tobacco, or containing nicotine from any source, for human consumption."
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA needs to act in accordance with Congress' rules on synthetic products.
"It would be outrageous if the FDA failed to enforce the law after Congress acted urgently to address a growing threat to our nation's children's health: E-cigarette makers use synthetic nicotine to evade FDA regulation and continue to sell flavored products Attractive and addicted kids," he said. “In recent years, more and more e-cigarette makers have turned to synthetic nicotine — nicotine made in a lab, rather than nicotine extracted from tobacco — and the FDA has put an end to its use in flavored products made from tobacco-derived nicotine. After taking action."
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