What does FDA marketing approval for Zyn nicotine pouches mean? : NPR

Federal health officials have authorized the marketing and sale of Zyn nicotine pouches, marking the first time the Food and Drug Administration has cleared these popular products, which are placed between a user’s gums and upper lip.

The FDA said an “extensive scientific review” found that these products pose a lower risk of cancer and other serious health conditions than cigarettes and smokeless tobacco products.

Matthew Farrelly, director of the Office of Science at the FDA’s Center for Tobacco Products, said in a statement: “To obtain marketing approval, FDA requires sufficient evidence that a new product offers greater benefits to the public’s health than risks.” said. “In this case, the data shows that these nicotine pouch products benefit and meet the criteria for adults who use cigarettes and smokeless tobacco products and switch to these products completely.”

The FDA’s decision covers 3-milligram and 6-milligram Zyn products in flavors such as cinnamon, citrus, coffee, cool mint, and menthol.

The agency’s action allows these products to be legally sold in the United States to adults 21 and older, but it does not mean that these products containing nicotine are considered safe or ” It doesn’t mean it’s FDA approved. The agency states that “no safe tobacco product exists” and that persons under the age of 21 should not use tobacco products.

Zyn’s popularity is growing, and so are its critics.

Zyn’s popularity exploded last year, with online fans influencing others to use the product. Zyn pouches have been on the market for about 10 years. However, it was only this summer that it became so popular that it became scarce.

This product contains powdered nicotine, which when placed in the user’s mouth along the upper gums dissolves and enters the bloodstream.

Owned by tobacco giant Philip Morris, Zyn was originally created to help existing nicotine users kick the habit. However, although Zyn does not contain harmful tobacco, it is still addictive. Zyn points out that the FDA requires a warning: “This product contains nicotine. Nicotine is an addictive chemical.”

Interest in the product exploded thanks to users on TikTok and other social media sites, drawing young people to it. Philip Morris previously told NPR that its research shows the average age of Zyn users is 39 years old, and that the company does not pay so-called “Zynfluencers” to promote its products online.

Last summer’s national shortage was triggered by the Washington, D.C., attorney general’s subpoena against Philip Morris, alleging that the company’s online sales violated the district’s flavored nicotine ban. It was something I put out. In response, the company suspended all online sales, and in December the attorney general announced that Zyn’s maker would pay $1.2 million to resolve the investigation.

The FDA said it will continue to monitor advertisements and product usage to ensure that advertisements are specifically targeted to adults 21 and older.