Reynolds is selling fruity new vapes unauthorized by FDA

At a GetGo gas station in suburban Ohio, Reynolds American is advertising four new flavors of Vuse Pro vapes—peach, berry, watermelon, and fresh mint—now on sale in Ohio and other states despite lacking FDA authorization. The products arrive shortly after the FDA softened its enforcement guidance in May, which critics say effectively invited companies like Reynolds to push unauthorized flavored products onto the market.

Mitch Zeller, former head of the FDA's Center for Tobacco Products, called the guidance 'wrongheaded' both as public health policy and as law. Cristine Delnevo, director of the Rutgers Institute for Nicotine and Tobacco Studies, warned that the move could spur other large manufacturers to follow suit and 'encourage broader noncompliance across the marketplace.' Tobacco giant Altria last week sued the FDA over the timeliness of its review process, reflecting growing industry frustration.

Reynolds American is owned by British American Tobacco, which highlighted the planned Vuse fruit-flavor rollout in its midyear results presentation, including a slide noting that 'Regulatory and enforcement actions support U.S. New Category growth.' Reynolds spokesperson Luis Pinto said the sales are 'consistent with applicable state regulations' and are paired with 'enhanced youth access prevention measures' such as ID requirements and purchase limits. Some states, including California, Massachusetts, New York, and New Jersey, have bans on flavored vapes, and Pinto emphasized the company's focus on expanding adult choices while preventing underage access.

The U.S. legal framework requires new nicotine and tobacco products to obtain FDA authorization before sale; so far only 48 e-cigarettes have been approved. In a notable shift, the FDA in May authorized fruit-flavored vapes for the first time, citing confidence in new age-gating technology from the company Glas to reduce youth uptake. The current rollout of fruit-flavored Vuse Pro products raises questions about whether the FDA's enforcement approach is keeping pace with industry actions.