WASHINGTON – On Tuesday, the U.S. Food and Drug Administration (FDA) announced it has issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products following scientific review.
Read more Federal judge blocks Postal Service from carrying out Trump mail-in ballot order
With this issuance, these ZYN nicotine pouch products – which have been authorized for sale in the United States since January 2025 – may now be marketed with the following risk modification claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
FDA authorizes 20 ZYN nicotine pouches be marketed with modified risk claim
Dig deeper:
An order permitting the sale of a modified risk tobacco product (MRTP) refers to specific products, not an entire class of tobacco products.
Advertising for Zyn smokeless nicotine pouches, a Swedish Match AB product, at a smoke shop in the East Village neighborhood of New York. (Credit: Bing Guan/Bloomberg via Getty Images
The products receiving modified risk granted orders include the following, each with two nicotine strengths (3 milligram and 6 milligram):
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
What they’re saying:
“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” Bret Koplow, the acting director of the FDA’s Center for Tobacco Products, said in a statement. “Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
FDA conducts scientific review of products
The backstory:
FDA’s scientific review of Swedish Match USA, Inc.’s MRTP applications, included the relative health risks of the products to individuals who use tobacco, consumer understanding and perception of the products marketed with the modified risk claim, data regarding youth risk, and the potential impact to the population.
The FDA concluded that Swedish Match had demonstrated that the specific modified risk claim was scientifically accurate with respect to these ZYN products, that consumers understood the claim, and that marketing the products with the claim would benefit the population as a whole.
Read more Records claim Katy Tesla crash suspect overrode ‘self-driving’ mode before fatal incident
Following a review, FDA originally authorized the marketing of these products through the premarket tobacco product application (PMTA) pathway on January 16, 2025.
The authorization requires Swedish Match USA, Inc. to conduct postmarket surveillance and studies that include an assessment of the MRTP users’ behaviors and their understanding of the risk-related information. These orders will expire in five years, before which time the company may request and receive FDA authorization to continue marketing the products as MRTPs.
To date, the FDA has authorized 26 nicotine pouch products.
All forms of tobacco use are harmful
Big picture view:
According to the World Health Organization, tobacco damages nearly every organ in the body, causing cancer, heart disease, stroke, lung disease, reduced fertility, weakened immunity and premature death.
Tobacco also kills more than 7 million people each year, including over 1.6 million non-smokers who are exposed to second-hand smoke. All forms of tobacco use are harmful, and there is no safe level of exposure.
RELATED: Cigarette smoking rates in US hit historic low among adults
“There is no safe tobacco product, and those who do not use tobacco products should not start,” the FDA noted in its press release on Tuesday. “For adults who currently smoke cigarettes, fully quitting the use of all forms of tobacco products would most benefit their health.”
The agency added, “However, switching completely from cigarettes to FDA-authorized nicotine pouches may reduce exposure to many harmful chemicals found in cigarettes.”
Read more Mother mourns daughter killed in Atascocita bakery crash hours after college acceptance