“Today’s marketing authorizations confirm that rigorous and efficient standards of scientific review are not mutually exclusive,” said Bret Koplow, Ph.D., J.D., Acting Director of the FDA’s Center for Tobacco Products. “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 is actively reviewing several applications as part of the nicotine pouch pilot program and will publicly communicate updates as appropriate. The FDA intends to evaluate the effectiveness of the process changes once the nicotine pouch pilot program is completed and potentially incorporate identified process improvements to the overall PMTA review program as appropriate.

The products authorized are made by Helix Innovations LLC and are sold under the on! PLUS brand. The authorized products come in several flavors and nicotine levels, and include:

on! PLUS nicotine pouches Mint, 6 mg

on! PLUS nicotine pouches Mint, 9 mg

on! PLUS nicotine pouches Tobacco, 6 mg

on! PLUS nicotine pouches Tobacco, 9 mg

on! PLUS nicotine pouches Wintergreen, 6 mg

on! PLUS nicotine pouches Wintergreen, 9 mg

Following a scientific review, the FDA determined that evidence provided by the company demonstrates that these nicotine pouch products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the U.S. This standard requires FDA to consider the risks and benefits to the U.S. population as a whole—including the benefits to adults who currently use tobacco products and switch to a potentially lower risk product that are sufficient to outweigh the risks of the product, including to any youth and adults who are not current users of tobacco products.

Among the key findings in the FDA’s evaluation is that the new products:

Contain lower levels of most harmful and potentially harmful constituents (HPHCs) when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products.

Do not contain measurable levels of several carcinogenic HPHCs, including those shown to be important drivers of excess oral cancer risk among adult smokeless tobacco users.

Have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth.

Primary packaging will consist of a certified child-resistant can and safety lid. FDA has previously urged manufacturers to use child-resistant packaging or other measures to mitigate the risk of accidental poisoning in young children for their nicotine pouches.

FDA will closely monitor the marketing and use of these products:

To reduce the potential for youth exposure to advertising of these products, the authorizations impose marketing restrictions for digital, TV, and radio media which require the company to ensure ads are carefully targeted to adults ages 21 and older.

The company must also track, measure, and report to FDA the effectiveness of its youth prevention measures and provide analyses of the demographics of the audiences reached by its advertising, marketing, and promotional activities.

While today’s actions permit these specific nicotine pouch products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they “FDA approved.” Importantly, today’s actions are specific to these 6 products only; the authorizations do not apply to any other Helix Innovations LLC products. There is no safe tobacco product. Those who do not currently use tobacco products should not start. Youth should never use tobacco products. The use of any tobacco product, including nicotine pouches, is not risk-free.