First enforcement action seeking court enforcement through the Food, Drug, and Cosmetic Act.
Six e-cigarette manufacturers are illegally making, selling, and distributing their products, despite previous warnings about legal repercussions, according to federal regulators.
The U.S. Department of Justice (DOJ) and the Food and Drug Administration (FDA) filed complaints asking federal courts for permanent injunctions to block sales. In a news release, the federal agencies said the cases are the first time they have gone to court seeking enforcement through the federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for new tobacco products.
The enforcement actions “represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in a news release. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
The federal agencies claimed the defendants made and sold new tobacco products without first obtaining marketing authorization from the FDA. The defendants could agree to consent degrees to stop manufacturing, selling, or distributing the items until they meet prerequisites such as FDA marketing authorizations, facility inspections, and FDA official notices of legal compliance.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA usually issues a warning letter to achieve voluntary compliance with the FD&C Act. If FDA documents continuing violations, the agency may request DOJ pursue enforcement actions, and FDA can issued fines for tobacco product violations.
Between January 2021 through Sept. 9, 2022, the FDA issued nearly 300 warning letters to firms that failed to submit timely premarket applications. Collectively they have more than 17 million e-cigarettes listed with the agency, and after receiving warning letters, a majority of those companies complied and removed their products from the market, according to FDA.
FDA and DOJ filed the lawsuits in the respective U.S. District Courts appropriate for these companies:
The first-time FD&C Act enforcement marks at least the fourth significant action involving cigarettes, tobacco, or electronic nicotine delivery systems by federal regulators this year.
In July, FDA announced the agency was effectively banning the sale of JUUL e-cigarettes, drawing positive responses from medical groups who criticized that company’s health effects and marketing that appeared aimed at young people. JUUL has argued its products help adult smokers “transition away from combustible cigarettes” and its products remain available for sale while the company is in an FDA review process.
In June, the White House published plans for future regulatory actions with FDA plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes.
In April, FDA proposed banning menthol cigarettes and flavored cigars to prevent youths from starting smoking and reduce tobacco-related disease and death. Menthol adds a minty taste and aroma to cigarettes, while adding flavors such as strawberry, grape, cocoa and fruit punch appeal to youths and young adults and make cigars easier to use, according to FDA. A final ruling on menthol cigarettes remains pending.