There are now 30 flavored nicotine pouch products authorized for sale by the FDA, but some health organizations have expressed concerns for potential youth adoption.
The USFDA authorized the marketing of four new flavored nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. The authorized products, made by Helix Innovations LLC, are sold under the “on!” brand name.
The review of these products was part of the agency’s nicotine pouch pilot program.
The FDA said its review process “considers the risks and benefits to the US population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products.”
The American Lung Association called the authorizations of flavored nicotine products a “gamble.”
“Every new flavored tobacco product authorized by FDA is another gamble with kids’ health,” said Ranjana Caple, Director of Federal Advocacy at the American Lung Association. “We know flavors drive youth tobacco use. Over 90% of young people who use nicotine pouches use flavored products, and nicotine pouches are already the second most commonly used tobacco product among youth. These products are attracting kids who otherwise may never have used a tobacco product. FDA should be protecting kids—not authorizing more flavored products. Kids deserve better.”
The American Heart Association echoed those concerns.
“The American Heart Association is deeply concerned by the FDA’s decision today to authorize four new flavored on! nicotine pouch products manufactured by Helix Innovations. Nicotine pouches are already the second most popular tobacco product among youth, and flavored tobacco products have long appealed to kids.
“Today’s authorization of Helix products was made under an ill-defined nicotine pouch ‘pilot program’ that the FDA announced it was ending earlier this year. The FDA had stated that the program, which was never adequately explained to the public, was intended to increase efficiency and streamline review of nicotine pouch applications. Yet key questions about the program remain unanswered, including how it differed from the existing premarket tobacco application process and whether any changes were made to the standards used to evaluate these products under the pilot program.
“By authorizing these flavored nicotine pouch products while leaving key questions about the review process unanswered, the FDA appears to be ignoring decades of evidence that the tobacco industry has used flavored products and other tactics to attract and addict youth to its harmful products. The tobacco industry cannot be trusted with the health of our nation’s children. Rather than allowing dangerous products on the market, the FDA should protect children’s health by prohibiting the sale of all flavored tobacco products, including menthol.”
According to the FDA, it has authorized a total of 30 nicotine pouches. All 30 are flavored products. Despite authorizing the products, the FDA warns:
While these products are authorized to be sold in the United States, it does not mean these products are safe, nor are they “FDA approved.” All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.
