Washington, D.C. — Senators Ted Budd (R-NC), Thom Tillis (R-NC), and Martin Heinrich (D-NM) have sent a letter to Food and Drug Administration Commissioner Robert Califf concerning “the continued presence of unauthorized electronic nicotine delivery systems (ENDS) and illicit vaping products among vendors at large trade shows across the country.”
We remain concerned about the continued presence of unauthorized electronic nicotine delivery systems (ENDS) and illicit vaping products among vendors at large trade shows across the country. Vendors display and sell illicit products in the presence of Food and Drug Administration (FDA) personnel despite their lack of market authorization. These concerns were brought to the FDA’s attention on January 25, 2024 and again on June 6, 2024, but the FDA has not provided a satisfactory, substantive response. Meanwhile, manufacturers, mostly from China, continue to pour their illicit vapes into the United States with few, if any, consequences. For this reason, we urge you to utilize enforcement actions against illicit products at 2025 trade shows, namely events hosted by the Total Products Expo (TPE) and the Alternative Products Expo (APE), across the country at locations in Florida, Nevada, Tennessee, and Texas.
As mentioned in a letter dated June 6, FDA personnel were present at the 2024 TPE in Las Vegas, Nevada and were distributing educational materials—in the presence of unauthorized vendors—and yet did not utilize enforcement actions. Simply staffing a booth alongside illicit products is negligence. If illicit products are displayed in the presence of FDA personnel, they must enforce the law.
Many of the companies present at these trade shows have received warning letters from your agency and therefore should not be selling their products at all. On September 13, 2024, the FDA issued six new warning letters to manufacturers of illicit products that were present at the 2024 TPE.
Given that these products and distributors are likely to appear at the 2025 Total Products and Alternative Products Expos, please respond to the below questions.
- Aside from the initial formation of a federal, multi-agency task force, what concrete steps has FDA taken with federal partners, including the U.S. Department of Justice (DOJ) and U.S. Customs and Border Protection (CBP), to ensure illicit products exhibited at the 2024 expos are not present at the 2025 expos?
- What metrics are currently utilized across agencies to assess the efficiency of FDA’s federal collaboration on illicit vaping products and ENDS?
- Has DOJ historically rejected FDA’s requests for enforcement actions such as civil monetary penalties or product seizures? If yes, please provide specific details of each instance.
- Considering FDA’s two recent import alerts announced this year,5 please provide details about the implementation of ‘detention without physical examination.’ Will the FDA keep record of violators at the point of detention for the purpose of future federal joint operations? If yes, will this list be made public for law enforcement in all jurisdictions?
- How does FDA, with federal partners, implement admission refusal and/or product destruction in cases such as the 53,700 ENDS seized by Chicago CBP?
Please respond to this letter no later than January 24, 2025.
###
