Nicotine

The FDA Promises To Streamline the Dauntingly Complex Rules for Approving Nicotine Products

The planned reforms could promote harm reduction by addressing a huge backlog that has resulted in routine violations of a statutory deadline.

Jacob Sullum | 9.30.2026 4:00 PM

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(FDA/Wikimedia Commons/Iryna Piskova/Dreamstime)

The Food and Drug Administration (FDA) this week announced that it is reevaluating its approach to approving nicotine products such as vapes and pouches. The Wall Street Journal reports that FDA officials want to "smooth the way for more tobacco products such as flavored vapes to legally enter the market by changing the rules to speed up the authorization process."

That is good news for manufacturers of nicotine products, who for years have struggled with regulatory bottlenecks, burdensome requirements that do not apply to cigarettes, and long delays in processing their applications for "premarket" approval. It is also good news for current and former cigarette smokers, promising to preserve their access to a wide variety of alternatives that are far less hazardous than combusted tobacco.

The planned reforms would build on progress that the FDA has made during the last couple of years, including its approval of nicotine pouches and vapes in flavors that former smokers demonstrably prefer. Those decisions recognize that concerns about underage use should not override the interests of adults who might want to dramatically reduce their health risks by switching to nicotine habits that do not involve lighting vegetable matter on fire and inhaling the smoke. But if the FDA is serious about tobacco harm reduction, it needs to overhaul a dauntingly complex, expensive, time-consuming, and frustrating system that makes it extremely difficult to legally market such alternatives.

"The Trump administration is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets, and providing safer alternatives for adults who want to quit smoking cigarettes," a Department of Health and Human Services (HHS) spokeswoman told the Journal. Regulate Smarter, a trade group chaired by former U.S. Sen. Richard Burr (R–N.C.), welcomed the FDA's announcement in an emailed press release, calling it "an encouraging and long-overdue course correction."

The need for that correction is clear from a lawsuit that Helix Innovations, an Altria subsidiary that makes nicotine pouches, and NJOY, the company's vape business, filed this month in the U.S. District Court for the Northern District of Texas. The complaint, which was also joined by two Texas retailers and the Texas Food & Fuel Association, argues that the FDA has failed to "comply with its obligations" under the Family Smoking Prevention and Tobacco Control Act (TCA), the 2009 law that gave the agency regulatory authority over tobacco products.

That law "expressly requires the FDA to authorize the marketing of new tobacco products (including alternatives to cigarettes) as 'appropriate for the protection of the public health,'" Helix et al. note. "To facilitate such authorizations,........

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