The FDA announced on Wednesday that they have sent "refuse to accept" letters to manufacturers of over 88,000 products containing laboratory-made nicotine.
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Brian Kin, Director of the Center for Tobacco Products, revealed the progress of the FDA's regulation of non-tobacco nicotine sources (i.e. synthetic nicotine). The FDA was authorized earlier this year to regulate synthetic nicotine.
Regulatory gray area.
Brian King stated in a letter to unapproved makers of nasal snuff that "selling or distributing any new tobacco products without pre-market authorization in the U.S. market is illegal." The FDA has not approved any synthetic nicotine products for marketing.
According to regulations set by the FDA, as of July 13th, all unauthorized synthetic nicotine products are considered illegal. Therefore, technically, any manufacturer that has not received FDA approval cannot sell their products after that date.
However, the FDA also noted that it will continue to evaluate over 350 synthetic nicotine products. While many of these products (most of which are e-cigarettes) are technically not allowed to be sold, it is still unclear whether the FDA will remove them from the market upon evaluation. The FDA has exercised enforcement discretion for e-cigarettes containing tobacco-derived nicotine, allowing them to remain on shelves while continuing to weigh their sale.
A buildup process
Jonathan Foulds, a public health science professor specializing in tobacco addiction at Penn State College of Medicine, told Pulse that some manufacturers of synthetic nicotine electronic cigarettes are undoubtedly bad. They exploit regulatory loopholes to stay on the market, with their products mainly targeting teenagers.
Given the tight timeline for compiling evidence, other manufacturers may not have had the opportunity to submit applications to the FDA. "To be honest, I'd be surprised if any of them got authorization," he told Pulse. "It's a lot of work that requires a great deal of information and proper research, which simply can't be completed in just two months." He noted that even electronic cigarette manufacturers that use tobacco-derived nicotine have been unable to meet the FDA's evidence standards, despite having had years to apply for marketing orders.
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He added, "If they are to withdraw from the market during the review by the agency, it would be fine by me, but they should have enough time to tidy up their applications.
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