The FDA announced today it has issued warning letters to 20 companies the agency says have continued to sell products that should have been removed from the market. The products were submitted to the agency for premarket review and rejected with Marketing Denial Orders (MDOs).
The FDA has so far issued MDOs to 323 vaping manufacturers, mostly for products in flavors other than tobacco and menthol. The FDA announced on Aug. 26 that flavored vaping products would not be considered for authorization unless manufacturers could show “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
The FDA has stated that products remaining on the market after receiving MDOs are among the agency’s highest enforcement priorities. Receiving a warning letter is the first step of FDA enforcement, and can be followed with more severe sanctions, including fines and seizures of products. The agency also announced additional warning letters to companies marketing products without first submitting Premarket Tobacco Applications (PMTAs).
Although the FDA’s most recent MDO list was published Sept. 22, the agency hasn’t actually issued a new MDO since Sept. 17—nearly three weeks ago. Companies receiving MDOs have 30 days to challenge the orders in court or through administrative appeal.
Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy