FDA’s Proposed Nicotine Rule Sparks Concerns Over Black Market Surge

The FDA is advancing a controversial regulation to lower nicotine levels in cigarettes, drawing criticism for potential unintended consequences, including fueling black market activity. Experts warn that the move, championed by the Biden administration, could empower organized crime while undermining public health goals.

The FDA confirmed on January 3 that the Tobacco Product Standard for Nicotine Level of Certain Tobacco Products had passed regulatory review but is not yet finalized. The agency states the rule, if enacted, would represent a historic step in tobacco regulation, reducing nicotine to non-addictive levels to curb smoking. Critics, however, caution that such a shift could backfire, spurring illicit trade and increased smoking rates.

Rich Marianos, former ATF assistant director, labeled the proposal a “gift” to organized crime groups, including Mexican cartels, Chinese counterfeiters, and Russian mafias. Marianos predicts these entities would capitalize on demand for high-nicotine products, flooding U.S. streets with unregulated tobacco. Lawmakers have previously flagged tobacco trafficking as a national security risk, linking it to financing terrorism, money laundering, and narcotics smuggling.

Marianos criticized the administration for failing to consult law enforcement, healthcare providers, and regulators about potential repercussions. He warned that black market tobacco operations could mirror the existing smuggling of fentanyl, with devastating consequences for American communities.

Proponents of the nicotine cap, including FDA Commissioner Robert Califf, argue it would prevent youth addiction and encourage smokers to quit. Yet, Marianos countered that reducing nicotine levels could paradoxically increase cigarette consumption as smokers seek to satisfy cravings. He also highlighted concerns over workplace productivity, with more frequent smoke breaks resulting from weaker nicotine products.

Efforts to regulate tobacco have been ongoing since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority over the industry. A similar push under the Trump administration sought to cut nicotine levels, while the Biden administration previously attempted to ban menthol cigarettes. That proposal faced backlash for disproportionately targeting minority communities and fostering illicit sales, leading to its delay.

As the proposed rule awaits finalization, both Democrat and Republican lawmakers remain wary of its implications. Senator Bill Cassidy (R-LA) and others have cited evidence of criminal networks using tobacco smuggling to finance activities like human trafficking and narcotics trade. The FDA’s nicotine cap may inadvertently amplify these threats, critics warn, raising questions about the regulation’s effectiveness in achieving its goals.

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