The Food and Drug Administration (FDA) is facing criticism for its tobacco and nicotine regulation under President Biden. Critics argue the agency's approach is ineffective, citing concerns about political pressure influencing decisions regarding vapes and e-cigarettes, while simultaneously allowing a surge of Chinese products into the US market.

The FDA's Center for Tobacco Products (CTP) is responsible for regulating tobacco products. However, its approach to electronic nicotine delivery systems (ENDS), including vapes and e-cigarettes, has drawn fire. While cracking down on ENDS, the FDA is also grappling with an influx of illicit and unregulated products, many originating from China.

The FDA has issued numerous warnings to companies selling illegal e-cigarettes containing tobacco-derived nicotine, but the effectiveness of these actions remains unclear. Reports suggest that vape companies frequently disregard FDA orders, continuing to produce and sell illicit products readily available in numerous stores and online. A key concern is the prevalence of Chinese-made disposable vapes with youth-appealing flavors, sold in various retail outlets across the US.

Former FDA Commissioner Scott Gottlieb has highlighted this issue, pointing out that synthetic nicotine products manufactured in China, like Puff Bar, are specifically targeting young people. He argues this contradicts Congressional public health efforts and disadvantages US tobacco companies complying with regulations.

In Congress, efforts are underway to address these concerns. Legislation has been introduced to close loopholes related to flavored ENDS attractive to children. Senate Majority Leader Chuck Schumer has called for an FDA investigation into Elf Bar, a Chinese e-cigarette heavily advertised on social media. Subsequently, the FDA issued an import alert for Elf Bar products.

A report by the Department of Health and Human Services' inspector general questions the FDA's effectiveness in preventing online youth access to tobacco products, citing limited actions and poor transparency. Rep. James Comer, Chairman of the House Oversight Committee, has requested documents from the FDA to investigate its tobacco and nicotine regulation. He expressed concerns about “enforcement failures” and “suspicions of political interference,” arguing the FDA’s regulatory system allows unsafe products to proliferate.

A Reagan-Udall Foundation report, commissioned by FDA Commissioner Robert Califf, echoes these concerns. The report found the CTP to be reactive and lacking a clear strategic plan. It criticized the agency's lack of transparency in decision-making, particularly regarding the balance between scientific evidence and policy judgments. The report also highlighted the FDA’s failure to clear the market of illegal products.

The FDA has responded by stating it will develop a new 5-year strategic plan, emphasizing health equity and proactive activities. However, it remains unclear how the agency will address concerns about politicized decision-making. Internal FDA comments suggest scientific disagreement is suppressed within the agency, with political agendas overriding scientific findings.

The FDA is also under pressure from Congress to restrict ENDS products, particularly those from Juul Labs Inc. Several Democratic lawmakers have urged the FDA to deny Juul's applications and remove its products from the market. Similar pressure has been exerted regarding menthol-flavored vaping products, despite the FDA previously stating that youth prefer other flavors. Following this pressure, the FDA issued marketing denial orders for menthol ENDS, reportedly reversing its own scientific recommendations.

A watchdog group has filed a complaint accusing the FDA of disseminating scientifically unfounded statements and overruling its scientists. The FDA maintains that no tobacco product is safe and has authorized only a limited number of tobacco-flavored e-cigarette products.

While adult smoking rates have declined, millions of Americans still smoke, leading to hundreds of thousands of deaths annually. Studies suggest e-cigarettes can be effective in helping smokers quit. However, the FDA’s approach to regulating these products continues to be a source of contention.