Little pouches of nicotine sold by the brand ZYN were given the green light for marketing this week through the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) pathway.
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What that means is that the 20 authorized ZYN products can be marketed, but with “stringent” restrictions for TV, radio and digital platforms. These restrictions are meant to ensure that advertisements are targeted to adults over age 21.
ZYN also intends to “implement additional measures to restrict youth access, reduce youth appeal and limit youth exposure to their labeling and advertising,” said the FDA. For example, the company does not plan to use mass-market advertising on radio and TV, to use actors and models that appear to be under the age of 35 or to use characters and themes in their advertising.
In the 1990s, Joe Camel – a cartoon character used to market camel cigarettes – was retired after complaints that it helped tobacco products appeal to children. Since that time, there has been increased concern about marketing potentially harmful products to young consumers.
ZYN’s products are described by the FDA as “small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.” The agency said this is the first time it has authorized nicotine pouches and that it comes “following an extensive scientific review.”
Overall, 10 flavors of the product – ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen – in 3 milligram and 6 milligram sizes have been approved by the FDA for marketing.
“The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the administration said. “This standard considers the risks and benefits of products to the population as a whole.”
One key consideration was an evaluation that determined the ZYN products have substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, including moist snuff and snus. Therefore, the FDA concluded that they pose lower risk of cancer and other serious health conditions than those other products.
However, the American Lung Association is wary of the FDA’s move.
“FDA’s granting of these marketing order to 20 flavored products is a gift to the tobacco industry. The American Lung Association sees FDA’s authorization ZYN Citrus, ZYN Cool Mint, ZYN Chill and other kid-appealing flavors is a green light to the industry to further lean in with their youth-focused marketing,” said ALA President and CEO Harold Wimmer. He also said the organization is “extremely disappointed,” about the authorization.
Last year, ALA Chief Medical Officer Dr. Albert Rizzo joined Audacy to discuss another controversial product related to nicotine: vapes. He said that, as of last spring, vaping was still an epidemic among middle school and high school students in the U.S.
Rizzo explained that nicotine is the addictive component of most tobacco products. Although it might not lead to inflammation like smoke or vapor inhalation alone, he said it also has effects on blood vessels.
Healthline reported on a social media trend involving ZYN. Instagram and TikTok users were calling it “O-Zyn-pic” in a reference to the medication Ozempic known to result in weight loss.
“Content creators are claiming the $5 doses of flavored nicotine have helped them lose up to 30 pounds,” said the outlet. According to the Daily Mail, nicotine pouches are “touted as ‘Gen Z’s favorite accidental weight loss drug.’”
Amy Reichelt, PhD, Chief Innovation Officer at PurMinds Neuropharma, told Healthline that the trend was concerning due to nicotine’s addictive qualities, though she did aknowledge that it is an effective appetite suppressant. She also noted that it can cause withdrawal when people stop using it.
High doses of nicotine can also have side effects such as nausea, headache, dizziness, throat irritation and gastrointestinal discomfort, Healthline said. It can also have acute cardiovascular effects and is associated with strokes and some types of cancer, the outlet added.
“While it has not been sold in the U.S. for long, we are already seeing very concerning levels of youth use, and troubling use of influencers and celebrities to promote the product, exactly like Juul was promoted previously,” said the ALA of ZYN. “One study found there has been a 641% increase in sales of the products between 2019 and 2022, but just 2.9% of U.S. adults had ever used a nicotine pouch. This shows an alarming rate of people younger than 21 using this product.”
At the same time, the FDA cited “evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products,” that was provided by the applicant.
“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,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products.
Audacy spoke with Bloomberg reporter Priya Anand about ZYN use among adults last spring.
“It’s something that office workers have described to me as something they can use while they’re at work because it’s very discreet,” she explained. With ZYN, they don’t have to leave the office for smoke breaks.
According to the FDA, it found that ZYN showed nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products. This benefit was sufficient enough to outweigh risks associated with the product, the FDA said.
“While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. The FDA also notes that “there is no safe tobacco product.”
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