Week of July 7 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee - Regulations.gov

The FDA is seeking to fill five vacancies on the committee with individuals who are knowledgeable in fields such as medicine, medical ethics, science, or technology related to tobacco products. Specifically, the FDA is looking for physicians, dentists, scientists, or health care professionals with expertise in areas like oncology, pulmonology, cardiology, toxicology, pharmacology, and addiction. Of the five vacancies, one is designated for a representative of the general public and another for a government employee at the state, local, or federal level.

Nominations were initially requested by June 25, 2025, for first consideration, with a later deadline of August 25, 2025. A correction was later issued to a notice, changing a date from June 25, 2025, to August 25, 2025.

The following members' terms are set to expire:

• Mignonne Guy, Ph.D.: Term ends on January 31, 2026. Dr. Guy serves as an Associate Professor and Chair.

• Adam Leventhal, Ph.D.: Term ends on January 31, 2026. Dr. Leventhal is the Director and a Professor at the University of Southern California's Keck School of Medicine.

• Risa Robinson, Ph.D.: Term ends on January 31, 2026. Dr. Robinson is a Professor and the Department Head of Mechanical Engineering.

• Scout, Ph.D., M.A.: Term ends on January 31, 2026. Dr. Scout serves as an Executive Director.

• Dona Upson, M.D., M.A.: Term ends on January 31, 2026. Dr. Upson is a physician and a Regular Government Employee.

Other members with terms ending in the coming years include:

• Sven-Eric Jordt, Ph.D.: Term ends on April 23, 2027.

• Nancy Rigotti, M.D.: Term ends on June 17, 2027.

• Maria Gogova, M.D., Ph.D.: Term ends on December 1, 2027.

The committee's chair, Cristine Delnevo, Ph.D., MPH, along with members William Andy Bailey, Ph.D., and Lucy Popova, Ph.D., have longer terms, all ending on January 31, 2029.

• FDA Embraces Radical Transparency by Publishing Complete Response Letters - FDA

Today (July 10), the FDA CDER published more than 200 decision letters, known as complete response letters or CRLs.

CRLs are issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form.

By making these CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved. (See Analysis Below)

• Johnny Copper L.L.C. vs US FDA - PETITIONER’S REPLY BRIEF

This brief challenges a final marketing denial order issued by the respondents, the United States Food and Drug Administration (FDA) and others, in the U.S. Court of Appeals for the Eleventh Circuit under Case No. 24-13302. The petition seeks review of the FDA's denial of marketing authorization for the petitioner's non-tobacco flavored open-system electronic nicotine delivery systems (ENDS) products, following a remand and re-review of the initial 2021 denial. In its reply brief filed on July 9, 2025, Johnny Copper argues that the denial violates constitutional doctrines, is based on an unconstitutionally vague standard, imposes a de facto ban without proper rulemaking, and arbitrarily ignores updated data on youth usage and the petitioner's marketing plan, requesting the court to vacate and remand the order.

• Krishnamoorthi leads demand on FDA ban of flavored vapes targeting teens - Office of Raja Krishnamoorthi

A bipartisan group of lawmakers is calling on the Food and Drug Administration to take stronger action against the flood of illegal flavored e-cigarettes that are hooking millions of teens on nicotine.

Led by Rep. Raja Krishnamoorthi, a Democrat from Illinois, and Rep. Celeste Maloy, a Republican from Utah, the lawmakers sent a letter urging FDA Commissioner Dr. Marty Makary to prioritize enforcement. They say the growing youth vaping crisis is being driven by thousands of unauthorized products that remain on store shelves and online marketplaces. Letter here.

• Veratad Technologies Powers Haypp Group's Industry-Leading Age and Identity Verification Program Across U.S. E-commerce Platforms - Veratad Technologies

Veratad Technologies, a global leader in age and identity verification, today announced a new partnership with Haypp Group — the world's largest online retailer of nicotine pouches — to deliver a next-generation compliance solution now live across Haypp's U.S. platforms, Nicokick.com and Northerner.com.

Operating in over seven markets worldwide, Haypp Group brings a strong foundation of trust, regulatory alignment, and transparency. Through its integration of Veratad's real-time orchestration platform for age and identity verification, Haypp is ensuring that transactions on Nicokick and Northerner meet rigorous standards for age assurance, identity verification, and customer trust — while scaling seamlessly to serve Haypp's diverse and growing U.S. customer base.

• Just How Harmful Is Vaping? More Evidence Is Emerging. - NYTimes

When vapes started to become popular in the mid-2010s, the tiny cartridges carried big promises. They were presented as a healthier alternative to cigarettes and a path to quit smoking.

Now, researchers are coming to understand the hazards of vapes themselves. In a study from last month, for example, a team of scientists analyzed the mist from popular vapes and found such high levels of heavy metals that one researcher thought their machine had malfunctioned. Other studies have suggested that vaping can affect the heart, lungs and brain.

Even so, “common sense tells you — your mom would tell you — that a superheated chemical inhaling right into your lungs isn’t going to be good,” said Dr. James H. Stein, a professor of cardiovascular medicine at the University of Wisconsin School of Medicine. Increasingly, research is pointing to the reality that while vapes do not contain the same dangerous chemicals as cigarettes, they come with their own harms.

• 22nd Century Provides Corporate Update On Its VLN® MRTP Renewal Process - The First and Only Combustible Tobacco Product Authorized by the FDA Specifically to Help Smokers Smoke Less - GlobeNewswire

Originally authorized in December 2021 and due for renewal in December 2026, a growing list of brands are using VLN® tobacco containing 95% less nicotine than conventional, highly addictive cigarettes.

The renewal process is part of 22nd Century’s ongoing R&D programs that continue to advance reduced nicotine content in tobacco and support the introduction of additional VLN® based products that give tobacco users further health oriented non-addictive alternatives to conventional tobacco products, as well as to new nicotine delivery products that are designed to create and sustain nicotine addiction.