FDA Warns Retailers Against Selling Philip Morris ZYN Nicotine Pouches to Minors

The U.S. Food and Drug Administration (FDA) announced Thursday, April 4, that it has sent warning letters and filed civil complaints seeking fines against retailers involved in selling Philip Morris International's (PMI) ZYN nicotine pouches to minors.[1].

The FDA sent 119 warning letters to retailers and filed 41 complaints seeking monetary penalties, totaling just over $55,000. The FDA also issued warning letters to three online retailers for unauthorized sales of ZYN flavored nicotine pouches, including Espressino, Black Cherry, Lemon Spritz and Cucumber Lime.

Nicotine pouches are tobacco products according to the FDA

The FDA said it is illegal for any retailer to sell any tobacco product — including cigarettes, e-cigarettes, cigars and nicotine pouches — to anyone under the age of 21 in the United States. The agency also added that nicotine pouches are classified as a type of tobacco product.

The data of thenational survey 2023 on youth smoking show that about 1.5% of middle and high school students reported currently using nicotine pouches. However, the FDA has since received reports of the potential growing popularity of these products among adolescents. These products are particularly popularized on social media with the help of influencers.

FDA typically issues warning letters the first time an investigation or inspection reveals a violation. To achieve voluntary compliance, recipients of warning letters have 15 business days to respond with steps they are taking to correct and prevent future violations. However, failure to promptly correct practices with ongoing violations may result in additional FDA action, including fines as in this case.

ZYN products are not authorized for sale

In order for a new tobacco and nicotine product to be legally marketed in the United States, it must receive FDA approval. To obtain this approval, an application must be submitted for the intended product. This application must be accompanied by sufficient scientific evidence demonstrating that the product complies with applicable health standards. To date, The FDA has authorized four oral tobacco products that meet the required standards and ZYN products are not among them.

The FDA reminds that the marketing authorizations issued for these four products allow them to be legally sold or distributed in the United States, but do not mean that the products are safe or "FDA approved."

In France, nicotine pouches are not covered by the provisions of the public health code concerning tobacco or vaping products. They are therefore sold completely illegally. The VELO pouches from the manufacturer British American Tobacco are the most popular due to aggressive marketing campaigns online and at tobacconists. The ZYN brand is currently only sold online.

Keywords: ZYN, nicotine pouch, Philip Morris, FDA, United States, sale to minors

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[1] Press release, FDA Issues Warning Letters to and Files Civil Money Penalty Complaints Against Retailers for Underage Sales of ZYN Nicotine Pouches, FDA, published April 4, 2024