/>iOn July 17, 2025, the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders (MGOs) to JUUL Labs Inc. (JUUL), authorizing for sale JUUL’s tobacco- and menthol-flavored pod-based electronic nicotine delivery system (ENDS) products in the United States, reversing its previous position and marking a major regulatory milestone in the years-long evaluation of JUUL’s Premarket Tobacco Product Applications (PMTAs).
According to FDA’s press release, the agency finally granted marketing authorization for the following products — all of which have been commercially available since 2015 under FDA’s deferred enforcement policy for deemed tobacco products subject to timely-submitted PMTAs:
- JUUL device
- Virginia Tobacco-flavored JUULpod (3% nicotine)
- Virginia Tobacco-flavored JUULpod (5% nicotine)
- Menthol-flavored JUULpod (3% nicotine)
- Menthol-flavored JUULpod (5% nicotine)
The authorization was based on a rigorous scientific review of JUUL’s PMTAs, including hundreds of scientific studies, which FDA concluded demonstrated that these products are “appropriate for the protection of public health” (APPH) – the statutory standard under the Family Smoking Prevention and Tobacco Control Act for marketing a new tobacco product. As stated by FDA, “This standard requires FDA to consider the risks and benefits to the U.S. population as a whole – including the benefits to adults who currently smoke cigarettes and completely switch to a potentially less harmful product or significantly reduce their cigarette use – that is sufficient to outweigh the risks of the product, including to any youth and adults who are not current users of tobacco products. Regarding these specific products, the applicant submitted robust data—including a two-year longitudinal cohort study—demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored JUUL products.”
This development represents a dramatic shift from FDA’s original decision issued nearly three years ago on June 23, 2022, when the agency denied marketing authorization for these same products. At the time, FDA claimed JUUL’s applications lacked sufficient toxicological data, particularly regarding the potential genotoxicity and chemical leaching from the company’s proprietary e-liquid pods. As discussed in our prior blog post, JUUL quickly filed for an emergency administrative stay of the marketing denial orders (MDOs), which the U.S. Court of Appeals for the D.C. Circuit granted on June 24, 2022. Subsequently, on July 5, 2022, FDA administratively stayed the MDOs after determining that certain scientific issues warranted additional review. After nearly two years of re-review, on June 6, 2024, FDA rescinded the 2022 MDOs, restoring the PMTAs to pending status and signaling that a final decision was forthcoming.
FDA’s decision to now grant formal marketing authorization to the JUUL products is significant not only for JUUL Labs but for the broader vapor industry. This marks only the third time FDA has authorized menthol-flavored ENDS products through the PMTA pathway. The menthol-flavored NJOY Daily Extra disposable and the NJOY ACE Pod ENDS products were previously authorized by FDA. All other FDA authorized ENDS are tobacco-flavored. See E-Cigarettes Authorized by the FDA.
The agency justified its decision, in part, by citing behavioral data showing that JUUL’s tobacco and menthol products are more commonly used by adult smokers than by youth, and that these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette use. Of note, although youth vaping rates continue to decline and are now at their lowest levels in over a decade, JUUL still ranked among the top five brands used by students who reported vaping nicotine at least once in the past 30 days, according to the most recent National Youth Tobacco Survey.
FDA also emphasized that its decision was product-specific and does not signal a general policy shift regarding flavored ENDS products. “Today’s action is specific to these products and the applicant’s scientific evidence,” the agency stated. “Authorization does not mean these products are safe or FDA-approved, but that the evidence shows that these tobacco products meet the public health standard.”
