FDA eases enforcement on unauthorized e-cigarettes

The Food and Drug Administration (FDA) issued new guidance stating that it does not intend to prioritize enforcement against many e-cigarettes and nicotine pouches marketed without FDA authorization.

• Why it’s important: The new policy could allow major tobacco and vape companies to begin selling flavored e-cigarettes, which pose particular risk to young people.

Reminder: In order to sell a tobacco product, manufacturers currently have to submit a Premarket Tobacco Application to FDA that demonstrates that the product they want to sell is “appropriate for the protection of public health” — meaning that the benefits to adults trying to quit smoking outweigh the risks of potential youth uptake of the products.

• Products that do not receive authorization from FDA are illegal to sell. FDA has approved just a handful of the applications it has received, with millions pending review.

The details: FDA will not prioritize enforcement if:

1. the manufacturer has a pending application that has been accepted and filed by FDA, and,
2. in the case of flavored vapes, FDA has determined the application includes data necessary to evaluate whether the product is appropriate for the protection of public health.

• • Yes, but: The FDA does not have to actually evaluate that data.

What’s next:

• FDA will create a publicly available list of products that it does not intend to prioritize enforcement against.
• FDA said it will continue to take action against products with “underage-appealing elements” such as depicting a cartoon-like fictional character, disguising its nature as a vaping product (e.g., making it look like a highlighter), or resembling a children’s toy, phone, or game.

The broader context:

• The plan makes an end run around the rules that set up a process to approve products shown to help cigarette smokers quit without attracting new nicotine users, which FDA had previously defended up to the Supreme Court.
• FDA skipped the process of first issuing a draft and allowing public comments before publishing its final draft.
• The move comes shortly after FDA issued guidance potentially opening the door to approving products in flavors such as coffee, teas, and spices, and after the agency authorized the first two flavored vapes.

The main point: Some say the move amounts to a “get-out-of-jail-free card” for companies that sell their products without FDA authorization. It is likely to result in more flavored vapes available on store shelves.

Read more: With Commissioner Under Pressure, F.D.A. Opens Door to Flavored Vapes; No FDA permission, no problem: New flavored vape policy worries experts