Recent FDA activity meets ongoing regulatory uncertainty

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In 2026, the Food and Drug Administration (FDA) has a real opportunity to move forward with tobacco harm-reduction policies. As more adult consumers move from cigarettes to less harmful, smoke-free options like vapor and pouches, the FDA needs to authorize more products for these adult consumers seeking alternatives, thus increasing options in the legal marketplace. By authorizing more legal and regulated products, the FDA can help build on recent progress and create a framework that supports a responsible, common sense regulatory approach that meets the needs of modern adult consumers.

The FDA continues to move forward—albeit gradually—on premarket tobacco product applications (PMTAs), issuing a limited number of marketing granted orders (MGOs).  Before the end of 2025, the FDA authorized six On Plus nicotine pouch products. In March, the FDA handed MGOs to a Glas G2 device and a Blonde Tobacco 50 mg/mL pod, bringing the total number of authorized vapor products in the U.S. to 41. This authorization was noteworthy because Glas is the first and only independent vape company—not affiliated with major tobacco companies—to secure FDA authorization. These recent authorizations reinforce what retailers have long recognized: not all nicotine products present the same level of risk.

However, it should also be noted that the recent vapor authorizations still do not include any flavored products. It is widely accepted that flavors play an important role in helping adult smokers migrate away from cigarettes. The FDA recently released draft guidance titled, “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.” The document outlines how the agency intends to evaluate PMTAs for flavored vaping products and clarifies the type of evidence manufacturers must provide to address concerns about youth appeal and usage. The draft guidance explains that when reviewing PMTAs for flavored ENDS products, the FDA evaluates whether the benefits to adult smokers in terms of quitting or significantly reducing cigarette use outweigh the risks of youth initiation and use. 

Newly released National Youth Tobacco Survey (NYTS) data support flavored product authorizations, as the data show that youth tobacco use continues to decline sharply. Youth vapor use has dropped significantly, and overall tobacco use among middle and high school students is now at its lowest level in 25 years. Additionally, nicotine pouch use among youth remains comparatively low and statistically stable.

Nicotine pouches have emerged as one of the most promising reduced-risk categories, with relatively low youth usage and growing adoption among adult consumers. FDA’s recent authorizations in this space are a positive step, signaling that the agency recognizes their potential role in harm reduction.

However, reports that FDA may be pausing or slowing its nicotine pouch pilot review program introduce new uncertainty. For manufacturers and retailers alike, inconsistent regulatory pathways make it more difficult to plan, invest, and bring compliant products to market.

A predictable and transparent review process is essential—not only for industry stability, but also to ensure adult consumers have access to regulated, science-backed alternatives.

For retailers, the path forward is clear: policies should support a well-regulated market that prioritizes youth prevention while preserving access to lower-risk alternatives for adults. Harm reduction is not a theory—it is a measurable public health opportunity.

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