The FDA has authorized 30 nicotine pouch products in 2026. Public health groups, pediatricians and parents are suing to stop the agency's approach.

On July 14, 2026, a coalition including the Campaign for Tobacco-Free Kids and the American Heart Association filed a federal lawsuit in the U.S. District Court for the District of Maryland, challenging an FDA enforcement guidance issued in May 2026 that allows e-cigarette and nicotine pouch products to be marketed without completing the scientific review required by federal law.

Three weeks later, on August 4, the FDA authorized four more flavored on! nicotine pouch products — Rich Berry, Cappuccino and Autumn Spice — bringing the total number of FDA-authorized pouch products to 30. The American Heart Association issued a statement the same day saying the authorization "threatens to sustain youth nicotine use."

What the lawsuit challenges

The FDA's May 2026 enforcement guidance says the agency will not use its enforcement discretion against certain e-cigarette and nicotine pouch products that have not yet received marketing-granted orders — the formal authorization required under the Tobacco Control Act.

The lawsuit argues this guidance "permits potentially thousands of tobacco products to enter and remain on the market for an indefinite period of time without the [marketing granted order] required by the Tobacco Control Act." The plaintiffs include products the FDA itself has repeatedly found pose a substantial risk to youth, according to the Campaign for Tobacco-Free Kids.

The New York Times reported that the policy was finalized days after tobacco industry executives dined with President Trump at his golf club in Florida, and that Reynolds American donated $5 million to a Trump-backed super PAC two days before the lunch. The FDA said its approach reflects a streamlined review process aimed at moving products through the pipeline faster.

The ZYN modified-risk decision

On June 30, 2026, the FDA issued Modified Risk Tobacco Product orders for 20 ZYN nicotine pouch products — 10 flavors in both 3mg and 6mg strengths, manufactured by Swedish Match USA (a Philip Morris International subsidiary). The authorized marketing claim states: "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

These are the first MRTP orders granted for nicotine pouches. PMI called it "an important moment for the more than 45 million legal-age nicotine consumers in America."

The American Heart Association pushed back the next day. AHA CEO Nancy Brown said the decision "risks perpetuating nicotine addiction" and that the modified-risk claim could mislead consumers into believing pouches are safe rather than simply less harmful than cigarettes.

The on! authorization and AHA response

The August 4 authorization covers four flavored on! pouch products from Helix Innovations LLC, a subsidiary of Altria. The FDA said the products contain lower levels of most harmful constituents than traditional oral and smokeless tobacco.

The AHA statement was sharp. The organization said the basis for the FDA's pilot program — which streamlines the review process — was "never adequately explained to the public" and accused the agency of "allowing dangerous products" to reach the market. The AHA also noted that the authorized flavors — including Cappuccino and Rich Berry — are the kind that appeal to young users.

The Independent quoted experts warning that the move ignores "decades of evidence" about the tobacco industry's marketing practices. CBS News reported that the Trump administration has actively promoted the category, including a White House TikTok video showcasing ZYN that featured Joint Chiefs Chairman Dan Caine saying the U.S. military consumes "a lot of nicotine."

Why this matters for the pouch market

The FDA's 2026 actions — 30 authorized products, 20 with reduced-risk claims, a streamlined enforcement pathway — represent the most permissive regulatory environment nicotine pouches have seen in the United States. That is driving the market: U.S. pouch volumes surged in the first half of 2026, with Haypp reporting a 125% year-over-year increase in American sales.

But the lawsuit creates uncertainty. If the Maryland court sides with the plaintiffs, the enforcement guidance could be set aside — potentially requiring manufacturers to pull unauthorized products from the market while completing full scientific review. Even if the lawsuit fails, it signals that the public health community is prepared to litigate every expansion of the pouch category.

The parallel track is political. The White House has embraced nicotine pouches as part of a harm-reduction agenda, while public health groups see the same moves as deregulation that prioritizes industry access over youth protection. The court case will force a judge to decide whether the FDA's shortcut is legal.

What's next

The lawsuit is in its early stages. The plaintiffs are seeking to have the enforcement guidance set aside and to require the FDA to enforce the Tobacco Control Act's premarket review requirements as written. The FDA has not publicly commented on the litigation.

Meanwhile, more authorizations are expected. The FDA's pilot program is ongoing, and other manufacturers — including PMI for additional ZYN variants and Reynolds for Velo products — have applications in the pipeline. Each new authorization is likely to draw fresh opposition from the same coalition.

The core question the court will eventually answer: can the FDA let nicotine pouches reach the market through a streamlined pathway, or does federal law require full scientific review for every product? The answer will shape how fast the pouch category can grow in the United States — and how much pushback it will face along the way.

---

Compare nicotine pouch brands and prices at PouchFinder.

SOURCES:

• Campaign for Tobacco-Free Kids, "Public Health Groups, Pediatricians and Parents Sue FDA Over Policy Allowing the Marketing of Unauthorized E-Cigarettes and Nicotine Pouches." 14 Jul 2026. tobaccofreekids.org
• Bloomberg Law, "Health Groups Sue FDA Over Its New E-Cigarette Marketing Policy." 14 Jul 2026. Bloomberg Law
• New York Times, "Public Health Groups Sue F.D.A. Over Flavored E-Cigarette Policy." 14 Jul 2026. NYT
• American Heart Association, "FDA authorization of flavored nicotine pouches threatens to sustain youth nicotine use." 4 Aug 2026. AHA Newsroom
• American Heart Association, "Modified risk claim for 20 ZYN nicotine pouches risks perpetuating nicotine addiction." 1 Jul 2026. AHA Newsroom
• CBS News, "As FDA approves new marketing for nicotine pouches, some doctors sound alarms." 5 Aug 2026. CBS News
• The Independent, "Trump's FDA just approved new nicotine pouches. Experts warn the move ignores 'decades of evidence'." 5 Aug 2026. The Independent
• PMI press release, "FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products." 30 Jun 2026. PMI
• FDA, "Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products." Updated 15 Jul 2026. FDA.gov
• Tobacco Reporter, "FDA Issues MRTP Orders for 20 Zyn Products." 30 Jun 2026. Tobacco Reporter