Week of September 15 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA Launches Program to More Efficiently Review Nicotine Pouch Applications - FDA

This month, FDA launched a pilot program that aims to increase efficiency and streamline the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products. This initiative represents a significant step forward in FDA's commitment to improving regulatory efficiency while upholding the agency’s rigorous scientific standards for tobacco product review.

The pilot program is based on the understanding that the health risks for different tobacco products exist on a spectrum – sometimes referred to as a “continuum of risk.” For example, existing data indicate that products that are combusted (such as cigarettes) are typically the most harmful to health, while non-combusted tobacco products (such as FDA authorized nicotine pouches) can generally pose lower health risks.

The pilot program is an example of FDA’s ongoing commitment to ensuring all new tobacco products marketed in the United States undergo science-based review. For adults who smoke and want to switch to a nicotine pouch product, this pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose. (See analysis below)

• HHS Makes Push to Stop Youth Vaping - HHS

The U.S. Department of Health and Human Services (HHS) Office of the Surgeon General today announced its Youth Vaping Resource Guide [PDF, 7.94 MB] to combat the ongoing youth vaping epidemic. Despite recent declines in use, e-cigarettes remain the most commonly used tobacco product among middle and high school students, with more than 1.6 million youth reporting current use in 2024.

“Vaping directly threatens children’s brain development, mental health, and long-term well-being,” Secretary Kennedy said. “We’re acting now to protect the next generation—giving families, schools, and communities the clear warnings they need to keep kids safe from nicotine addiction and illegal products.”

• Certain Disposable Vaporizer Devices; Notice of Request for Submissions on the Public Interest - Federal Register (Patent application filed by RAI Strategic Holdings Inc on 3-31-2023)

The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation, specifically: a general exclusion order directed to certain disposable vaporizer devices imported, sold for importation, and/or sold after importation that infringe claims 4 and 12 of U.S. Patent No. 11,925,202; and cease and desist orders directed to Maduro Distributors Inc. d/b/a The Loon; American Vape Company, LLC (AVC), Shenzhen Kangvape Technology Co., Ltd., Thesy, LLC d/b/a Element Vape, SV3 LLC d/b/a Mi-One Brands, Price Point Distributors Inc. d/b/a Price Point NY, Breeze Smoke LLC, Social Brands, LLC, LCF Labs., Inc., Flawless Vape Shop Inc., Flawless Vape Wholesale & Distribution, Inc., and VICA Trading Inc. d/b/a Vapesourcing.

• BLUMENTHAL & MERKLEY URGE FDA TO FINALIZE BIPARTISAN RULE CAPPING NICOTINE LEVELS FOR COMBUSTIBLE TOBACCO PRODUCTS - Merkley Office

U.S. Senators Richard Blumenthal (D-CT) and Jeff Merkley (D-OR) this week led a letter to U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Tobacco Products Acting Director Bret Koplow to urge FDA to finalize a bipartisan rule that would establish maximum nicotine levels in cigarettes and other combusted tobacco products. U.S. Senators Dick Durbin (D-IL), Kirsten Gillibrand (D-NY), Jack Reed (D-RI), and Andy Kim (D-NJ) joined Blumenthal and Merkley in calling on the FDA to move swiftly to finalize the proposed rule to protect public health by capping nicotine levels at 95 percent less than products currently on the market. [Full letter]