The Food and Drug Administration on Friday issued marketing granted orders to six On Plus nicotine pouch products. They are the first authorizations under a pilot program launched in September to streamline the agency’s review process while maintaining its scientific standards, the FDA said.
The products are made by Helix Innovations LLC, a subsidiary of Altria, Richmond, Virginia. They are available in two nicotine strengths (6 milligrams and 9 milligrams). They include On Plus Mint, On Plus Wintergreen and On Plus Tobacco, with each flavor offered in both strengths.
“Today’s marketing authorizations confirm that rigorous and efficient standards of scientific review are not mutually exclusive,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP). “As a result of the FDA’s nicotine pouch pilot program, adults who smoke cigarettes and would like to switch to a lower-risk alternative tobacco product will now have an expanded array of options.”
The FDA said Friday’s actions apply only to the six authorized products and do not apply to any other Helix Innovations products.
The agency said it determined the products met the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The move allows the products to be legally sold in the United States but does not mean they are safe or FDA approved, the agency said.
In its evaluation, the FDA found the products contain lower levels of most harmful and potentially harmful constituents compared with other oral and smokeless tobacco products, with many constituents too low to be quantified. The agency also said the products do not contain measurable levels of several carcinogenic constituents linked to oral cancer risk and could provide a benefit to adult smokers or smokeless tobacco users that outweighs the risks, including risks to youth. The products will be sold in certified child-resistant packaging with a safety lid.
The FDA said it will closely monitor how these products are marketed. Helix Innovations must track, measure and report to the FDA the effectiveness of its youth prevention measures and provide analyses of the demographics reached by its advertising, marketing and promotional activities, the FDA said.
In January the agency issued marketing granted orders to 20 Zyn flavored nicotine pouches. Tobacco company Philip Morris International (PMI) bought Zyn maker Swedish Match North America in 2022.
A full list of the 26 nicotine pouch products authorized by the FDA is available on the agency’s website.
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