Holding FDA Accountable for Regulation of New Tobacco Products

ACS CAN joined the Campaign for Tobacco-Free Kids, the American Heart Association, American Lung Association, American Academy of Pediatrics, Parents Against Vaping E-cigarettes, and the Truth Initiative, along with some individual plaintiffs in a lawsuit against the Food and Drug Administration (FDA) regarding the agency’s May 8, 2026, Guidance for Industry entitled “Enforcement Priorities for Certain New Tobacco Products Without Premarket Authorization” (Guidance). The Guidance marked an enormous shift in FDA enforcement policy that will result in thousands of e-cigarettes and nicotine pouches, including flavored products, entering and staying on the market without authorization as required by the Family Smoking Prevention and Tobacco Control Act (TCA). The lawsuit seeks to vacate the Guidance because it violates the TCA.

Background on FDA Issuance of Marketing Orders

The TCA requires manufacturers of all new tobacco products to submit a premarket tobacco product application (PMTA) for each new product before the product goes on the market. The TCA mandates that the FDA conduct a full scientific review to determine whether sale of the product is “appropriate for the protection of public health” (APPH). If FDA determines the new product is not APPH, it must issue a marketing denial order (MDO). If the product is found to be appropriate for the protection of public health, the agency issues a marketing granted order (MGO). The manufacturer is not permitted to market or sell a new tobacco product without an MGO. To date, FDA has only issued MGOs for 45 e-cigarette products, 30 nicotine pouches, 8 snus products, 10 heated tobacco products, and 2 very low nicotine cigarettes.

Products in these categories for sale without MGOs are unauthorized and illegally on the market. FDA is responsible for enforcement of the law, including seizing illegal products and fining manufacturers, distributors, and retailers (and not individual consumers) for the sale of illegal products. Federal agencies, including the FDA, can use “enforcement discretion” to determine how to prioritize their efforts. Enforcement discretion means the agency can choose whether and how to enforce regulation against specific violators in order to preserve resources, but it does not allow the agency to disregard the law and not enforce it against anyone. There are products on the market illegally that FDA has not yet enforced against, but the new Guidance would allow many products to stay on the market indefinitely as long as a PMTA had been submitted. And more importantly, it would also allow a flood of entirely new products to be introduced to and stay on the market if the manufacturer submitted a new PMTA.

ACS CAN’s Litigation on PMTAs

In 2020, ACS CAN, along with other public health groups, won a lawsuit against the FDA (initially filed in 2018), when the FDA violated the TCA by issuing guidance in 2017 that permitted e-cigarette and cigar products to stay on the market indefinitely without MGOs. Importantly, in deciding for public health groups, the judge in that case found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The judge ruled that the FDA’s delay gave “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”

May 8, 2026 Guidance

In the 2026 Guidance, FDA indicated it will not prioritize enforcement against an e-cigarette or nicotine pouch product that has a pending PMTA – meaning the PMTA was submitted but has not yet undergone a full scientific review by FDA with very limited exceptions. The Guidance also states that FDA will create a public-facing webpage to list the manufacturers and products not subject to FDA’s enforcement, despite not having an MGO.

The result of this action would mean thousands of illegal e-cigarette and nicotine pouch products, including flavored products, may be permitted to be sold in the U.S., similar to the result of the 2017 Guidance. Their lawsuit claims FDA is abdicating its responsibilities under the TCA by flipping the statutory requirements on PMTAs, essentially allowing all products to stay on the market while the PMTAs are pending instead of requiring authorization of the products before they can be legally sold.

The Lawsuit

The lawsuit seeks to vacate the 2026 Guidance on three grounds:  

• FDA lacked the authority, under the TCA, to allow the marketing of e-cigarettes and nicotine pouches without those products having been granted MGOs by FDA.
• FDA violated the Administrative Procedure Act (APA) by issuing the Guidance without notice to the public and the opportunity for public comment.
• The Guidance was “arbitrary and capricious” in violation of the APA.

Read the press statement.