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As indicated in our previous post, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) created a joint task force including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); Customs and Border Control (CBP) and the Federal Trade Commission (FTC). The task force has ramped up enforcement efforts to curb the importation, distribution and sale of unauthorized vaping products.
In a press release from September 25, the DOJ along with FDA announced recent enforcement actions targeting unauthorized vaping products resulted in the seizure of more than 2.1 million vaping products taken from five distributors and six retailers across seven different states.
Pursuant to the Family Smoking Prevention and Tobacco Control Act, vaping products manufacturers must obtain premarket review of new tobacco products, including vaping products, and FDA's marketing authorization before the products can be legally sold. Per the DOJ, the companies from which the vaping products were seized had received prior warnings from FDA that vaping product did not have the required premarket authorization from FDA; however, the impacted companies continued to sell and distribute unauthorized vaping products.
Attorney General Pamela Bondi indicated the unauthorized vapes are a "national security issue" and also commented "[t]hese dangerous and unauthorized vapes are often smuggled in from China to be sold near schools and military bases, putting our kids and service members directly at risk." Attorney General Bondi further noted the recent raids and seizures were "just the beginning" and "we will prosecute anyone participating in the illegal sale of these products."
On the heels of the recent raids and seizures, FDA Commissioner Marty Makary, M.D., M.P.H. issued a statement encouraging retailers to stop selling illegal vapes. Dr. Makary indicated FDA is "launching an initiative to increase voluntary compliance from retailers—including vape shops, convenience stores and gas stations—that play a key role in the distribution of both legal and illegal products into American communities."
Under the stop-sale initiative, FDA intends to mail the following materials over 300,000 retailers nationwide:
- A list of the 39 vapes and 20 nicotine pouch products that can be legally marketed in the United States, which features QR codes linked to the FDA real-time digital versions of these lists (www.fda.gov/authorizedecigs and www.fda.gov/authorizednicotinepouches);
- Information on accessing FDA's new Searchable Tobacco Product Database, a database of over 17,000 tobacco products—covering all categories, such as cigarettes, cigars, hookah and e-cigarettes—that may be legally marketed in the United States; and
- New tobacco retailer education materials, including a wall calendar of reminders focused on retailer requirements such as only selling tobacco products to those 21 and older and requiring a photo ID check of anyone under 30.
Buchanan's experienced and dedicated FDA & Biotechnology team will continue to monitor the increased enforcement activities by the joint federal task force. Should your business be impacted by a government seizure action or wish to discuss contingency planning, please do not hesitate to reach out.
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