Week of August 18 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA Denies Marketing for blu Disposable E-Cigarette - FDA

The U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) for blu® Disposable Classic Tobacco 2.4%, an e-cigarette product manufactured by Fontem US, LLC. This means the company still must not market or distribute this product in the United States, or they risk enforcement action by FDA. The company may submit a new application for the product subject to this MDO.

The company did not provide sufficient evidence that adults who smoke will completely switch to the new product or significantly reduce their cigarette consumption. Instead, the application’s evidence suggests that people will likely use this product in addition to cigarettes, potentially exposing them to higher levels of toxicants than exclusive cigarette use. In general, long periods of using both e-cigarettes and cigarettes – often referred to as “dual use” – can result in harms to health similar to, or in addition to, the harms from exclusive use of cigarettes. See Analysis Below

• Battling unregulated vapes, Big Tobacco tries a new strategy: joining in - Reuters

Reynolds' disposable vape brand Vuse One uses laboratory-produced synthetic nicotine and has an application pending with the U.S. Food and Drug Administration. Pilot sales will start in late September or early October, Pinto told Reuters exclusively.BAT's new devices will initially go on sale in South Carolina, Florida and Georgia, and while they do not yet have an FDA licence, Pinto said they can be launched.

BAT acquired the device in April, but its previous owner applied for an FDA licence in 2022. That application has been pending long beyond the agency's 180-day mandate for reaching a decision.

Reynolds launched a nicotine pouch brand last year on the same basis. Pinto said it has never been challenged by the agency over this move.

Altria, which also previously considered synthetic nicotine products without FDA signoff as illegal, has shifted to a similar position, CEO William Gifford told investors in April.

"We're looking at all available opportunities to assess what's the right move in that direction," he said.

• Helix is excited to announce the launch of on! PLUS™ Nicotine Pouches - available this fall in North Carolina, Texas, and Florida. - @AltriaNews

on! PLUS™ is a spit-free, oral tobacco-derived nicotine pouch designed for adult tobacco consumers 21+ who are seeking smoke-free options they enjoy. on! PLUS™ is manufactured in Richmond, VA, and will be available in Mint, Wintergreen, and Tobacco flavors. Each pouch is offered in multiple nicotine strengths (6mg, 9mg, and 12mg) and features our proprietary NICOSILK™ mesh technology.

This launch reflects our commitment to harm reduction and responsible innovation. In June 2024, Helix submitted a comprehensive Premarket Tobacco Product Application (PMTA) to the FDA, comprising over 25,000 pages of scientific and regulatory documentation prepared by a team of more than 50 experts. We’ve met the requirements under the Tobacco Control Act and proactively notified the FDA of our intent to launch.

While the FDA’s review timelines have extended far beyond the 180-day statutory requirement, Helix has complied with all regulatory requirements to bring on! PLUS to market—disclosing ingredients, opening facilities for inspection, and submitting marketing materials for review.

• Oversight Committee Seeks DOJ Briefing on Illegal Chinese Vape Products Threatening American Consumers and Public Health - Committee on Oversight and Government Reform

House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) is continuing to investigate the influx of unregulated, illegal vapor products, primarily from China, available for sale in the United States. In a letter to U.S. Department of Justice (DOJ) Attorney General Pam Bondi, Chairman Comer emphasized that the supply of unauthorized vapor products in the U.S. has surged alarmingly over the past four years and is now requesting a staff-level briefing to gain a clearer understanding of how the DOJ is working to combat this illicit market effectively.

The Committee urges DOJ to continue to prioritize this critical issue. As a key part of the Trump Administration, which has emphasized strong border enforcement and combating the trafficking of illicit produces, DOJ plays a vital role in keeping harmful substances—particularly those targeting our youth—off the streets. To assist the Committee’s oversight of this matter, we request a staff-level briefing as soon as possible…”