FDA Authorizes First-Ever Fruit-Flavored ENDS Products, Marking Major Policy Shift

The FDA has authorized the marketing of 4 Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway, the agency announced on May 5, 2026, marking the first time it has authorized nontobacco, nonmenthol flavored vaping products for sale in the US.^1,2

The authorized products are e-liquid pods, each containing 50 mg/mL (5%) of tobacco-derived nicotine, marketed under the names Classic Menthol, Fresh Menthol, Gold, and Sapphire. Gold and Sapphire correspond to mango and blueberry flavors, respectively, according to the FDA release.^1,2

The authorization came the same day The Wall Street Journal reported that President Donald J. Trump rebuked FDA Commissioner Marty Makary, MD, MPH, for not moving quickly enough to approve flavored vapes and nicotine products. Earlier this year, The Wall Street Journal reported that Makary was opposing the authorization of the 4 Glas products after FDA scientific advisers had authorized them. Now, the company has been authorized to legally market its products to users 21 years or older.^3,4

A Historic First for Flavored ENDS

Prior to the May 6 announcement, the FDA had only granted permission to tobacco- or menthol-flavored vaping products. With the Glas authorizations, the agency now has 45 ENDS products approved for marketing in the US—and for the first time, fruit flavors are among them.^1,5

The decision is certain to be opposed by health groups and parent organizations that have long pointed to flavors as a primary driver of underage vaping in the US; however, the action comes as teen vaping rates have dropped to a 10-year low, and manufacturers have intensified pressure on the administration to loosen restrictions on their products.⁶

A key element of the agency's authorization was Glas' digital age-verification system. The technology requires users to verify their age and identity with a government-issued ID and pair the device with a smartphone via Bluetooth; following verification, the device will not operate if separated from the registered phone. The app also conducts random biometric check-ins to confirm the registered user is the one using the device.¹

"By helping to prevent youth use, device access restrictions are a potential game changer," Bret Koplow, PhD, JD, acting director of the FDA's Center for Tobacco Products, said in the FDA news release. "This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke."¹

What the FDA Says

In a statement provided to Pharmacy Times, the FDA defended the rigor of its review process. "FDA follows a rigorous scientific review process for PMTAs in which FDA considers the risks and benefits to the US population to determine whether the benefits outweigh the risks, including considerations of risk to youth and adults who are not current users of tobacco products," the agency said. "Today's actions permit these specific ENDS products to be legally marketed in the US to adults 21 [years of age] and older."

The agency also noted that it "is responsible for protecting the public—especially youth—from the harms associated with the use of tobacco products” and that its "processes include many levels of clearances and opportunities for discussion and review before significant regulatory decisions are made."

The FDA added that it will closely monitor how the products are marketed and may suspend or withdraw authorization if the company fails to comply with applicable requirements—including if youth use increases or evidence emerges that the products' benefits no longer outweigh their risks.¹

Implications for Pharmacy Practice

The authorization of fruit-flavored ENDS products carries meaningful implications for pharmacists, particularly those engaged in tobacco cessation counseling. With new legally marketed products entering the landscape, pharmacists may encounter patients who ask whether flavored vaping devices represent a safer alternative to combustible cigarettes or a viable cessation tool.

The FDA emphasized that there is no safe tobacco product and that people who do not use tobacco should not start. Pharmacists play a critical role in reinforcing this message while helping patients who smoke navigate evidence-based cessation strategies, including FDA-approved pharmacotherapies such as varenicline (Champix; Pfizer), bupropion (Zyban; GSK), and nicotine replacement therapy.¹

Pharmacists, as some of the most accessible health care providers, are well positioned to counsel patients—particularly adolescents and young adults—on the risks of nicotine use and dependence, regardless of the delivery device. As the regulatory landscape continues to evolve under the current administration, pharmacy teams should remain attentive to FDA guidance updates and be prepared to address patient questions about newly authorized ENDS products with accurate, evidence-based information.

REFERENCES

1. FDA expands market access, authorizes new ENDS products. News release. FDA. May 5, 2026. Accessed May 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-market-access-authorizes-new-ends-products

2. Fruit-flavored e-cigarettes for adults OK'd by FDA in major shift under Trump. CBS News. Updated May 6, 2026. Accessed May 6, 2026. https://www.cbsnews.com/news/fruit-flavored-e-cigarettes-fda-major-shift-trump/

3. Whyte LE, Andrews N. Trump pressures FDA commissioner to approve flavored vapes. Wall Street Journal. Updated May 5, 2026. Accessed May 6, 2026. https://www.wsj.com/politics/policy/trump-pressures-fda-commissioner-to-approve-flavored-vapes-9dad81ee?st=jCMo1n&reflink=desktopwebshare_permalink

4. Whyte LE, Cooper L. White House pushes for flavored vapes blocked by FDA head. Wall Street Journal. Updated April 17, 2026. Accessed May 6, 2026. https://www.wsj.com/politics/policy/white-house-pushes-for-flavored-vapes-blocked-by-fda-head-2f8f0138

5. Juul can keep selling tobacco and menthol e-cigarettes, FDA decides. CBS News. Updated July 17, 2025. Accessed May 6, 2026. https://www.cbsnews.com/news/juul-sell-tobacco-menthol-e-cigarettes-fda-decides/

6. Birdsey J, Cornelius M, Jamal A, et al. Tobacco product use among U.S. middle and high school students—National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(44):1173-1182. doi:10.15585/mmwr.mm7244a1