Week of October 13 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Retail media, nicotine pouches, protein and more abound at the NACS Show - CSP

While smoking rates are at historic lows, non-combustible product alternatives are on the rise, including nicotine pouches, which were widely on display at the trade floor at the NACS Show. OTP sales averaged $19,663 per store, per month in 2024, up 7% from 2023, according to NACS State of the Industry data for 2024.

“The profitability gap between cigarettes and other tobacco products (OTP) is closing,” said Emma Tainter, NACS research manager, analytics and programs, at Tuesday’s education session, The Evolving Tobacco and Vape Landscape.

Tobacco companies aren’t the only ones adapting to attract today’s nicotine shopper.

Jessica Starnes, CLMP, director of loyalty and tobacco category manager at Weigels Inc., said during an education session Tuesday that the Powell, Tennessee-based retailer has “rightsized the backbar to position ourselves to become the nicotine pouch destination.”

• ACHV Secures FDA Priority Voucher for Novel Vaping Cessation Therapy - GuruFocus News

Achieve Life Sciences (ACHV) announced that its innovative treatment for nicotine dependence, cytisinicline, has received a significant boost from the U.S. Food and Drug Administration. The FDA awarded the company a National Priority Voucher, a rare designation given to only nine therapies in the inaugural year of the program. This special status aims to enhance communication with the FDA and speed up the review process to one or two months, down from the typical 10 to 12 months, after all necessary documents are submitted.

• The FDA’s plan to fast-track nicotine pouches is long overdue. But why aren’t vapes included? - Reason.org

Currently, the expedited review for premarket tobacco applications (PMTAs) appears open only to nicotine pouches made by four companies, three of which are legacy tobacco firms. This comes as a gut-punch to e-cigarette makers, consumers, and advocates who have pleaded for a similar streamlined process for e-cigarettes since the FDA began regulating them in 2016. The agency’s failure to provide one has been catastrophic.

In 2018, Juul was the undeniable leader in the e-cig market, representing nearly 70 percent of all e-cigarette sales. Its nearest competitor, British American Tobacco’s Vuse, captured just 13 percent. That year, Juul submitted its PMTA to FDA, reportedly spending over $100 million to prepare the 125,000-page document. But, while the FDA was statutorily required to make a decision within 180 days, it took five years. Juul only received authorization for its tobacco and menthol products this past July.

In the interim, Juul faced massive litigation, nearly went bankrupt, and fell behind its competitors. Vuse, which was authorized by the FDA in 2021, is now the market leader among authorized products, with 35% of sales. Juul is a distant third with 19%, earning fewer sales than even GeekVape—an authorized Chinese import. The technology has also advanced, making the now-approved first-generation Juul outdated before it was authorized. The company’s next generation product, which features built-in age-verification technology, has been available in the U.K. since 2022. But at the FDA’s current glacial approval pace, it will take the agency until 2030 to authorize its sale in the U.S., if it ever does.

• Cotton Introduces Bill to Bar Adversarial Foreign Nationals from FDA - Office of Senator Tom Cotton (R-Arkansas)

Senator Tom Cotton (R-Arkansas) last week introduced legislation to protect American food and medicine from adversarial foreign nationals. The American Medicine Safety and Security Act will prohibit the Food and Drug Administration from employing individuals with ties to China, Russia, or Iran.

• CDC team running top survey on health and nutrition is laid off - StatNews

The CDC division within the National Center for Health Statistics (NCHS) that directs the National Health and Nutrition Examination Survey (NHANES) — a bellwether of the country’s health — lost all its planners in last weekend’s firings. Unlike the 600 out of 1,300 employees eliminated across disciplines but reinstated within 24 hours, the people in the branch that plans and disseminates the research informing public health policies from food to oral health to environmental exposures got no reprieve.