Week of September 1 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Exclusive: US FDA to fast-track nicotine pouch reviews amid White House pressure - Reuters

The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms' nicotine pouches in a pilot program launching on Monday, amid pressure from the Trump administration to speed up approvals, according to meeting transcripts seen by Reuters.

The FDA aims to finish reviewing the pouches from Philip Morris International, Altria, Reynolds American - part of British American Tobacco and Turning Point Brands by December, according to one transcript of an agency meeting held on Friday. Some of the products selected for the pilot, such as an updated version of PMI's pouches, Zyn Ultra, are not yet on the market as producers wait for the FDA's greenlight. Rivals have gained market share with more competitive products in the meantime.

The pilot could provide a route to a far quicker legal launch for those selected to participate. For other products already on the market without permission, FDA authorisation would remove questions over their legality and the threat of potential enforcement from the agency.

An FDA official told staff last month that the agency had been pressured by leadership, including at the White House, to review nicotine pouches more efficiently, according to a transcript of a second meeting.

The FDA said in Friday's meeting that the products will be subject to an application process featuring streamlined and reduced reviews, more frequent communication between FDA staff and applicants, and expedited clearance.

Reviewers will focus only on information essential to start the scientific review of nicotine pouches, core product characterization, manufacturing consistency and stability, and abuse-liability data, according to the transcript.

• Juul’s CEO discusses the future of the vapor category - CSP

Adam: C-store operators are going to be listening to this podcast. How can they best merchandise products equipped with age-gated technology? 

Crosthwaite: Well, I will humbly give my advice to c-store operators that I have a great deal of respect for, but I have been around one way or another the nicotine landscape for call it 28 years now and what I’ve seen in the last several years is a pace of change in the United States like no other. If I was on the other side in a retailing environment, the rate of cigarette declines at double digit and the pace of consumers transitioning off combustion to non-combustion formats, I don't think that's going to slow down. And in fact, with a better structure to the regulated system, I believe the innovation is there for this pace of change to even increase.

My advice would be to really embrace that strategy. Thinking about how they’re going to differentiate their business and win with this pace of change, I think, is a critically important topic. You mentioned things like age-gating, responsible retailing of nicotine is essential to the future of the category. There really is no room for underage sales to be permitted and I think with the way technology has evolved at the product level and the way technologies evolved at the retail level with scanning information identification, I think you can remove a lot of the friction for consumers. I would be very focused on the pace of change right now if I was in the retailer’s shoes.

• FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure - FDA 

The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.

“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.”

• Governor Hochul Announces Largest Criminal Vape Enforcement Action in New York History - New York State

Governor Kathy Hochul today announced the largest criminal vape enforcement action in New York State history, resulting in over a dozen arrests and a total of 38 criminal charges for illegally shipping vaping products in violation of state law. The sweeping crackdown on the vape industry in New York, led by the New York State Department of Health in partnership with the New York State Police, targeted businesses and their owners that operate online vape shops and distribution networks located across the state, from Western New York to Long Island.

Based on a months-long investigation by the Department of Health’s Bureau of Investigations that included undercover online buys, the New York State Police charged the vape dealers with Unlawful Shipment and Transport of Vapor Products, a class A misdemeanor. According to the Public Health Law, any second or subsequent unlawful shipment and transport of vapor products following a conviction would be a class E felony. Many of the illicit shipments included bright-colored disposable e-cigarettes and e-liquids in flavors that appeals to adolescents, such as fruit, candy, soda and dessert flavors, marketed through websites, social media and mobile apps. Some included disposable vapes that come equipped with digital display screens and other tech-savvy features similar to smart phones, handheld video games and other electronic devices popular among children, teens and young adults. (See additional analysis below)