Calls for Major Efforts to Remove Illegal E-Cigarettes in the US

An independent review of the tobacco regulatory agency of the Food and Drug Administration (FDA) found that they are overwhelmed, slow to react, and exhausted due to the heavy workload associated with electronic cigarettes. The review called on several departments of the Biden administration to make significant efforts to remove millions of illegal electronic cigarette products from the United States.

The report, written by the Reagan-Udall Foundation for the FDA, states that the agency's Center for Tobacco Products, established in 2009 under federal law, failed to establish clear priorities and has been plagued by lawsuits from tobacco and e-cigarette companies on one hand, and public health groups on the other.

The review states that there are millions of illegal electronic cigarette products on the market - involving companies that should have applied for FDA authorization but have not done so, or companies whose applications have been rejected - that need to make significant efforts to remove them.

Although criticism has been directed at the FDA for its lack of enforcement, the agency has acknowledged that it does not have the authority to remove millions of illegal products from the market on its own - with much of the power belonging to the Department of Justice.

A review team led by Lauren Silvis, former Chief of Staff to ex-FDA Commissioner Scott Gottlieb, is calling on the Biden administration to establish an inter-agency task force to prioritize enforcement of tobacco laws, particularly in addressing the risks posed by illegal tobacco products and teenage use.

In addition, the group stated that the FDA should develop a priority roadmap and explain how it will be implemented, including standards for authorizing electronic cigarettes. The group recommended this, but there were dissenting opinions.

FDA Commissioner Robert M. Califf has authorized a review following sharp criticism from Congress and supporters of the agency's handling of electronic cigarettes. He stated that the agency will review the report and provide updated information on future action steps before the beginning of February.

In the 13 years since Congress authorized the FDA to regulate tobacco products, we have made significant strides and have based regulatory decisions on science across a wide range of products," said Califf. However, he added that greater challenges still lie ahead.

The report has received praise from both sides of the e-cigarette debate, but for different reasons. Anti-tobacco groups applaud its emphasis on law enforcement and compliance, while pro-vaping advocates argue that the report confirms their view that the center is not operating effectively.

The most important outcome of this is that if it leads to effective enforcement of laws within the government, it will clear the market of FDA unauthorized products," said Matthew Myers, president of the tobacco control group Free Kids. He also stated that the FDA should take action to prohibit the sale of electronic cigarette products that have not been reviewed by the agency.

Products submitted prior to the fall of 2020 are allowed to remain on the market during their project review period.

The legislative and foreign affairs director of the industry trade organization, the American Boiler Manufacturers Association, Gregory Conley, said, "Time and time again, the policy deficiencies that we have repeatedly raised have been confirmed in the report. However, the problem is that the report does not seem to have any mechanism to enforce the correction of these issues, except for the new presidential administration.

In July, Califf requested a review of the FDA's tobacco activities. Shortly after, the agency ordered the removal of vaping products from the US market and suspended orders from Juul Labs, citing a need for more time to investigate "unique scientific issues" specific to Juul's application. This reversal has been seen as embarrassing for the agency.

The Reagan-Udall Foundation, which closely collaborates with the agency, receives funding from the FDA, industry, non-profit organizations, and private donors.

Mitch Zeller, who served as director of the Tobacco Center until his retirement in April, stated that the report accurately highlights the challenge faced by the FDA and the Center, which is their lack of authority. While the FDA can take some enforcement actions on its own, such as sending warning letters to companies, "when it comes to using tools like seizure and injunction, the decision-makers are not lawyers from the FDA or HHS, but from the Department of Justice," he said.

Califf has called for a review of both tobacco regulations and food safety regulations, in response to the anger sparked by shortages of infant formula earlier this year. The Reagan-Udall Foundation recently criticized the food safety structure and culture of the agency, recommending major restructuring, citing inadequate oversight of foodborne illnesses and sluggish decision-making. In a statement, Califf announced the formation of a leadership group to advise him on how to implement the review findings and pledged to share these efforts with the public in early 2017.

The FDA has been under immense pressure from congressional members and tobacco control advocates to more actively remove flavored tobacco products, including e-cigarettes, from the market. This year, Congress granted the agency additional regulatory powers so that it can track flavored products made with synthetic nicotine.

The FDA has received millions of applications and now says that it won't be able to complete the review process until next year. The agency has already reviewed the majority of the applications, rejecting millions of them while approving some applications for tobacco flavored e-cigarettes. However, it has not completed the review of the largest companies' applications that dominate the market.

Zeler stated that the agency's time frame, set in 2017, was reduced from four years to 10 months after losing a lawsuit. He mentioned that this has significantly decreased the amount of time the agency has to prepare for a large number of applications.

The FDA has strengthened enforcement efforts this fall. In October, the agency announced that the Justice Department, representing the FDA, is seeking permanent injunctions against six e-cigarette manufacturers in federal court. The government accuses these companies of selling new tobacco products without obtaining FDA marketing authorization. This marks the first time the FDA has initiated such proceedings to enforce pre-market review requirements for new tobacco products.

This month, the Supreme Court refused to block California's law prohibiting flavored tobacco. In the November 8th vote, voters overwhelmingly supported the ban on the sale of all flavored tobacco products, including e-cigarettes and menthol cigarettes. The law was passed in 2020, but implementation was delayed due to opposition led by tobacco companies, who collected enough signatures to put it on the ballot.