FDA Issues New Guidance Allowing Some Unauthorized Nicotine Products

The Food and Drug Administration published six-page guidelines earlier this month that permit certain nicotine products to remain on the market without full authorization. Senior staff in the agency's tobacco center learned of the changes the night before publication.

The guidelines were issued before the resignation of former FDA Commissioner Marty Makary. They allow companies to introduce some nicotine-based products without completing the agency's standard scientific review process.

Two anonymous agency employees told The Associated Press that staff responsible for enforcing vaping regulations were not consulted. Agency officials have since held meetings to determine how to implement the memo. Mitch Zeller, who retired as the FDA's tobacco director in 2022, questioned the process.

"It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway," Zeller stated. The guidelines bypassed the required public comment period. The FDA issued the policy after months of complaints from industry lobbyists.

The FDA has authorized vaping products from only five companies over more than a decade. It has rejected millions of other applications, mainly over flavors that appeal to children. Unauthorized vapes with fruit and candy flavors remain widely available.

U.S. teenagers has fallen to its lowest level in over 10 years. The new guidance will create a list of products subject to "enforcement discretion," allowing them to be sold without removal actions. The FDA plans to focus enforcement on products with youth-appealing designs rather than flavors alone.

Brian King said the approach will benefit larger tobacco companies that have resources to advance through the review process. Lobbyists for smaller importers have expressed concern about being excluded.