A pilot program that aims to ease the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products launched this month, the Food and Drug Administration said on Thursday.
Calling it a “significant” step forward, details of the program include real-time communication between the FDA and applicants and shorter review timeframes, the agency said.
The FDA’s case-by-case review of individual applications “will increase efficiency by focusing review on the most critical elements for this product category to determine whether permitting the marketing of a product is appropriate for the protection of the public health,” the agency said.
The FDA said it also intends to have ongoing conversations with applicants to discuss missing information or request clarification with the hope to address issues sooner, or at least limit the number and severity of issues included in a deficiency letter at the conclusion of the evaluation.
“There is evidence that nicotine pouches can help some adults switch away from more harmful tobacco products, and adults who significantly reduce their cigarette use or fully switch from smoking cigarettes to using a lower-risk alternative tobacco product could generally reduce their health risks and exposure to toxic and cancer-causing chemicals,” the FDA said.
New tobacco products must submit a PMTA and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to 20 Zyn nicotine pouch products. Philip Morris International bought Zyn maker Swedish Match North America in 2022.
“We appreciate the FDA and the Trump administration for reinforcing that tobacco products exist on a continuum of risk with combustible cigarettes being by far the most harmful,” Sam Dashiell, manager, U.S. press office, PMI U.S., told CSP Daily News on Friday. “This pilot program is a step in the right direction to finally establish a timely scientific review for nicotine pouch products that are a better choice for legal-age adults who would otherwise use traditional tobacco products.”
Tobacco companies, including Helix Innovations LLC, a subsidiary of Altria, have voiced concerns on inconsistent standards and the FDA’s review timelines that have extended beyond the 180-day statutory requirement.
Helix Innovations LLC, a subsidiary of Altria, will be launching On Plus nicotine pouches this fall in North Carolina, Texas and Florida, the companyposted on X. The launch of the nicotine pouch brand is without having first received authorization from the FDA.
“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,” the company said on X.
Earlier this month, CSP Daily News reached out for FDA comment surrounding the agency’s plans to fast-track nicotine pouch authorizations, the Department of Health and Human Services (HHS) issued the following statement from Bret Koplow, acting director of the FDA’s Center for Tobacco Products:
“The FDA has long stated that the health risks of tobacco products differ by product type, with some products posing greater health risks than others. We’ve also stated that for adults who smoke, switching completely from cigarettes to nicotine pouch products authorized by FDA may reduce exposure to many harmful chemicals found in cigarettes. FDA is under no pressure—from the administration or agency leadership—to lower its scientific standard or compromise its commitment to protecting public health from the risks posed by tobacco products.”
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