FDA expands ENDS market access with first authorization of non-tobacco and non-menthol products

The Food and Drug Administration on May 5 authorized four Glas ENDS products, marking its first authorization of non-tobacco and non-menthol electronic nicotine delivery system products.

The agency said the products may be sold legally in the United States to adults 21 and older. The authorized products are Classic Menthol, Fresh Menthol, Gold and Sapphire.

The decision came through the FDA’s premarket tobacco application, or PMTA, process. In its announcement, the agency said its review considered factors including the company’s device-level age-verification and access controls.

AP and Reuters both reported the authorization and described it as a first for non-tobacco or fruit-flavored e-cigarettes. The move expands market access for a narrow set of products while leaving the broader regulatory framework for vaping products in place.

The FDA’s action is likely to draw close scrutiny from public-health groups and the industry alike. For now, the key development is that the agency has opened the door for limited marketing of these products while emphasizing adult-only access and regulatory oversight.