FDA Lowers Risk Profile for RFK Jr.’s Preferred Nicotine Pouches

Zyn can market its nicotine pouches as less harmful to human health than cigarettes, the Food and Drug Administration announced Tuesday.

It’s the first product of its kind to get this classification, and a favorite across President Donald Trump’s administration — including Health and Human Services Secretary Robert F. Kennedy Jr., who sparked the president’s interest in authorizing more pouches and has overseen a series of exits from the FDA over the issue.

Zyn pouches contain nicotine but no tobacco, and are consumed by placing the product between the user’s gum and lip. First authorized for sale in January 2025, they are the fastest-growing nicotine product in the U.S.

Twenty types of Zyn nicotine pouches, manufactured by tobacco producer Philip Morris, can 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.”

The flavors approved by the “modified risk” order do not include fruity varieties, which are seen as popular among teens.

In the Tuesday news release, the FDA said there is no “safe” tobacco product, and that those who do not use tobacco products should not start.

“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,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products,. “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.”

Kennedy, who appeared to place a pouch in his mouth during his Senate confirmation hearing, last year called the pouches “probably the safest way” to consume nicotine. But easing restrictions on nicotine products, including Zyn pouches and vapes, has created notable moments of friction within the FDA over health concerns, particularly surrounding children.

Former commissioner Marty Makary was ousted in May in part over his reluctance to approve flavored vapes because of the health risks they might pose to children. Shortly after NOTUS first reported Makary’s poor standing with the White House, the agency announced it was approving four new flavored vape products. Kennedy’s senior spokesperson resigned in May over the regulatory changes that made flavored e-cigarettes and vapes more widely available.

Meanwhile, the president has grown his stock holdings in Philip Morris to as much as $1.64 million, and he has holdings in other leading tobacco companies. In 2025, tobacco interests donated a collective $6 million to MAGA Inc., the pro-Trump super PAC, and the president’s inauguration.

The FDA has also asked Zyn manufacturer Swedish Match USA to study how its customers perceive risks, also requiring the company to monitor upticks in youth usage.