FDA makes key decision on Zyn nicotine pouches

For the first time, the Food and Drug Administration has authorized the marketing and sale of popular nicotine patches, saying the products could help some smokers kick the habit.

In a statement, the FDA said it has authorized the marketing and sale of Philip Morris International’s Zyn nicotine pouches. The pouches, which are placed between the lip and gum, are tobacco-free but contain nicotine. They come in different strengths and a variety of flavors such as citrus, coffee, peppermint and berry.

Dr. Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, said marketing authorization requires “sufficient evidence that the new products offer greater benefits to population health than risks.”

“In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products,” Farrelly said.

The agency said the pouches met the public health standards required by the 2009 Family Smoking Prevention Tobacco Control Act which considers the risks vs. the benefits of a product. It found Zyn contained “substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products” and posed a “lower risk of cancers and other serious health conditions.”

The he agency cautioned it would closely monitor any upswing in Zyn use by youth.

“While today’s actions permit these specific tobacco 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.” There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start,” the agency said.

Marketing for the products will be targeted at those 21 and older, including not using actors or models younger than 35 in advertising and avoiding any content specifically designed to appeal to teens, such as the use of characters or themes.