The FDA's new enforcement guidance on tobacco products has drawn sharp criticism from public health advocates who say it effectively allows unauthorized e-cigarettes, nicotine pouches and other nicotine delivery devices to be sold before completing the required scientific review process.
Under federal law, tobacco companies must submit products for FDA review before selling them. The new guidance, according to critics, permits companies to sell products while applications are pending without significant enforcement action.
The Campaign for Tobacco-Free Kids said the guidance amounts to a gift to the tobacco industry. The group also noted the guidance was issued without a public comment period, departing from the agency's historical transparency standards.
Data shows that nearly four of five young people who have used tobacco started with a flavored product. Almost nine of ten youth e-cigarette users report using flavored versions, according to public health research.
Enforcement on unauthorized tobacco products has largely stalled, with no substantive FDA actions since last summer, according to reports. More than 1.4 million middle and high school students currently use e-cigarettes, and nicotine pouch use among young people is climbing.
Reports indicate the White House has pressured the FDA to authorize more flavored e-cigarettes. Public health advocates argue that federal enforcement should resume across the entire supply chain, including manufacturers, distributors, importers and retailers. They also call for the Department of Justice and U.S. Customs and Border Protection to increase efforts to stop illegal products from reaching the market.
