Congress Responds to FDA Guidelines on Unlicensed Tobacco Products

Current and former congressional members, along with law enforcement officials, have commended President Donald Trump’s Food and Drug Administration (FDA) for its initiatives against unlicensed tobacco products.

In May, the FDA ramped up its efforts, announcing an increased focus on illegal tobacco sales. On May 8, the agency released a document outlining its enforcement priorities for certain tobacco products that lack premarket approval.

This guidance details the enforcement strategies for electronic nicotine delivery systems (ENDS) and nicotine pouch products that are being marketed without the necessary premarket authorization. The document clearly states:

All new tobacco products on the market without authorization, which includes ENDS and nicotine pouches, are illegal. This guidance outlines specific enforcement measures for these products lacking premarket approval.

Numerous congressional members have been actively opposing illegal tobacco imports.

Recently, Representative Ashley Hinson (R-Iowa) introduced the Ending the Malicious Distribution of Smuggled Chinese E-Cigarettes Act (ENDS), aimed at tackling the “influx of illegal and unregulated Chinese products targeting American youths.” Senator Tom Cotton (R-Ark.) has proposed a similar bill in the Senate.

In a statement, Hinson expressed her concerns:

China is inundating our country with illegal vaping products aimed at our kids, and as a mother, I can’t ignore this. These e-cigarettes contain harmful chemicals and dangerously high levels of nicotine, all while China prohibits their use at home. We can’t let this continue. This legislation will strengthen enforcement and ensure that those who target American children face severe repercussions.

The ENDS legislation includes stricter civil penalties for those importing illegal e-cigarettes into the U.S.:

• $500 per vape for standard negligence violations.
• $1,000 per vape for gross negligence violations.
• $5,000 per vape for intentional fraud or misrepresentation.

In March, Hinson and other lawmakers urged the Trump administration to act against illegal Chinese e-cigarettes.

Former Senator Richard Burr (R-North Carolina) remarked in an interview that this action was overdue, saying, “The illegal market emerged due to a lack of enforcement clarity. It’s complex because, while enforcement was absent, the illegal market grew significantly.” He appreciated the FDA’s recent clarity on what products can be sold and its commitment to targeting illegal items, particularly those from China.

Burr mentioned that shifting focus toward harm reduction is essential—moving away from traditional tobacco products to less harmful alternatives.

He reflected on past efforts, noting, “The Tobacco Control Act was meant to encourage companies to invest in technologies that lessen harm. Congress granted the FDA authority for a reason, and the industry has invested millions in new technologies.”

Diane Goldstein, a former police lieutenant and head of the Law Enforcement Action Partnership, offered a critical perspective. She pointed out the complexities of addressing the illicit market and emphasized the need for balanced enforcement strategies. Goldstein remarked, “A tiny fraction of products enter the country illegally; ultimately, consumer demand drives this issue. If the FDA doesn’t approve enough safe products, addressing combustion-related nicotine issues only provides a partial solution.”

Goldstein suggested that a sufficient supply of safe, regulated options is essential to change the market effectively. “There are over 12,000 FDA-approved tobacco products currently, with a minor number being nicotine products. Until we accept that e-cigarettes lower risk and actually have better public health benefits, we won’t resolve the illegal market problem. We need at least 4,000 approved alternative products available.”