By Timothy S. Donahue

Top Takeaways:

• FDA framework: The agency published a sweeping environmental assessment covering nicotine pouches, gums, lozenges, discs, and dissolvable nicotine products.
• Manufacturer implications: FDA signaled that manufacturers will be expected to address environmental controls, waste handling, child-resistant packaging, and disposal risks in PMTA reviews.
• Retail relevance: The assessment reinforces FDA concerns about child exposure, product disposal and rising sales volumes as oral nicotine products rapidly expand in the U.S. market.

The U.S. Food and Drug Administration has released a major new environmental assessment of oral nicotine products that could shape future premarket tobacco product application (PMTA) reviews for nicotine pouches, gums, lozenges, discs, and other modern oral products.

The 26-page Programmatic Environmental Assessment, published on March 10, gives the nicotine industry one of its clearest looks yet at how the FDA plans to evaluate environmental impacts associated with the rapidly growing oral nicotine category.

While the agency ultimately concluded that the products generally pose “minimal” environmental risks compared with combustible products, the document also outlines several expectations and pressure points likely to become increasingly important for manufacturers and retailers navigating the PMTA process.

The assessment applies to products the FDA categorizes as “other,” including tobacco-derived and synthetic nicotine pouches, lozenges, discs, tablets, gums, nicotine-infused products, and dissolvable tobacco products. Traditional smokeless products such as dip, snuff, snus, and chewing tobacco are excluded.

FDA repeatedly emphasized that any future marketing authorization decisions will remain product-specific. “Product specific environmental effects of new products will be evaluated when their premarket applications are submitted for FDA review,” the agency wrote.

Still, the document offers substantial insight into what regulators are watching. One of the biggest takeaways for manufacturers is the FDA’s focus on environmental compliance related to nicotine extraction and production expansion.

The agency warned that extracting nicotine from tobacco may require additional environmental controls, permitting, and waste-management systems because of the solvents and chemicals used in manufacturing. “Tobacco manufacturers may need additional environmental controls, permits, and new waste management facilities to stay in compliance with existing environmental laws,” FDA said.

The agency also noted that oral nicotine manufacturing is “water intensive” and said that expanded production capacity will likely increase water use and wastewater discharge.

The FDA said manufacturers will be expected to comply with local, state, and federal environmental regulations as part of PMTA-related reviews. The report also strongly reinforces how central nicotine pouches have become within the broader oral nicotine category.

FDA said nicotine pouches “presently represent almost the entire market share” within the “other” category. According to the assessment, nicotine pouch sales in the United States surged from fewer than 1 billion units in 2019 to nearly 14 billion units in 2024; the agency cited Euromonitor data.

FDA also acknowledged that the broader category is expected to continue expanding beyond pouches to gums, gummies, lozenges and tablets. For retailers, the assessment underscores FDA’s growing concern about child safety and accidental exposure risks. “There is a potential risk of inadvertent exposure to nicotine from contact with the new products,” FDA wrote.

The agency specifically cited reports of children swallowing used nicotine pouches and said the risks “can be mitigated with childproof container closure systems and proper use of the new products.” That language could become increasingly important as the FDA continues to scrutinize product packaging, disposal instructions and child-resistant design expectations during PMTA reviews.

The assessment also offers the clearest signal yet that the FDA views oral nicotine products differently from combustible products from an environmental perspective. “The products are free of airborne emissions and therefore will not affect air quality in the vicinity of use,” FDA said.

The agency added that effects on non-users are expected to be “minimal, given the lack of secondhand or thirdhand exposure to airborne emissions during use.” The FDA similarly concluded that environmental risks associated with disposal appear low.

The agency conducted a screening environmental risk assessment of nicotine, phenol, acetophenone, nickel, chromium, and N’-nitrosonornicotine and concluded that the chemicals posed “low or negligible environmental risks” to aquatic systems under modeled scenarios.

FDA also said that packaging waste from oral nicotine products currently accounts for “less than 1%” of overall municipal solid waste streams. Still, the agency acknowledged several limitations and unresolved concerns.

The assessment specifically noted that it did not fully evaluate risks associated with plastics and microplastics from pouch materials. It also warned that future increases in market size could alter environmental exposure assumptions as sales continue to grow.

Importantly for the nicotine industry, the FDA again referenced the agency’s broader public health framework for smoke-free products. “Oral nicotine products within the ‘Other’ product category may benefit public health by reducing the exposure to harmful chemicals for users who completely switch from combusted tobacco,” FDA wrote.

The assessment does not authorize any products or establish binding new regulations.