As announced earlier this year, the FDA is prioritizing enforcement against the following unauthorized ENDS products: 1) flavored, cartridge-based ENDS products (other than tobacco or menthol flavored); 2) all other ENDS products for which the manufacturer has failed to take adequate measures to prevent underage access; and 3) any ENDS product that is targeted to youth or likely to promote use by youth. Under this policy, companies that do not cease manufacture, distribution and sale of these unauthorized tobacco products risk FDA regulatory actions ranging from warning letters to injunction, seizure and/or civil money penalty actions.
“A top priority for the FDA remains protecting youth from the dangers of tobacco use, and in particular, combating the concerning youth e-cigarette use epidemic that is affecting children, families, schools and communities. We are committed to holding retailers and manufacturers accountable for marketing and sales practices that have led to increased youth accessibility and appeal of e-cigarettes. We will be using our regulatory authority to address youth e-cigarette use by focusing on the products that are most popular among kids,” said FDA Commissioner Stephen M. Hahn, M.D. “We will not hesitate to aggressively pursue bad actors and expect to take more actions soon. Our policy is designed to be flexible, so we can focus our priorities as warranted to tackle youth use.”
The following manufacturers received a warning letter.
- ProSmoke (prosmokestore.com), IL
- Apollo Future Technology Inc., CA
- Global Tobacco LLC, TX
- Premium Manufacturing Facility, VA
- WhiteLightning USA, FL
- United Tobacco Vapor Group, GA
The following retailers received a warning letter:
- 7-Eleven (#35433J), DC
- 7-Eleven, (#27905E), DC
- 7-Eleven, Baltimore, MD
- 7-Eleven (#34577), Hialeah, FL
- Chevron/Food Mart, Houston, TX
- Citgo/The Filling Station, Waupaca, WI
- Citgo/Quik Mart, Stone Mountain, GA
- Conoco, Aurora, CO
- Covington Food Mart/Shell, Lithonia, GA
- Marathon, Arlington, TN
- Mobil, Mundelein, IL
- Pilot Travel Center 149, Stanton, TN
- Shell, Houston, TX
- Shell, Stone Mountain, GA
- Sunoco/Food Mart, Fort Myers, FL
- Tiger Mart, Columbia, MO
The warning letters notify the retailers and manufacturers that selling or distributing ENDS products without a marketing authorization order to customers in the U.S. is prohibited under the Food, Drug and Cosmetic (FD&C) Act. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
Additionally, as part of the agency’s efforts, the FDA recently issued import alerts for certain unauthorized ENDS products offered for import into the U.S. based on the agency’s enforcement priorities. These import alerts describe products that, if imported, would violate the FD&C Act. These import alerts were issued in advance of any specific products being detained.
The agency also recently issued separate letters to nine manufacturers and importers seeking information about their ENDS products, including requesting evidence that the product is legally marketed and was not introduced or modified after Aug. 8, 2016, the effective date of the final rule that extended the FDA’s tobacco product authorities to all tobacco products. As of March 10, 2020, the FDA has sent letters to more than 100 companies seeking information about more than 140 ENDS products. A number of companies have now removed products from the market.
Ultimately, manufacturers that intend to market any of these products—including flavored e-cigarettes or e-liquids—must submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the agency may authorize that product for sale. Although the FDA is prioritizing enforcement against certain ENDS products sooner, manufacturers of deemed new products that lack premarket authorization must submit premarket applications by May 12, 2020.
All of these efforts, in addition to the recent law raising the federal minimum age for sale of tobacco products from 18 to 21 years and the recent expansion of the FDA’s public education campaign to include videos featuring teenagers sharing cautionary tales about their e-cigarette addiction, are aimed at keeping these products out of the hands of youth. In the coming days, the agency also plans to release new resources with ScholasticExternal Link Disclaimer for middle and high-school educators and school administrators.
The FDA continues to monitor youth use of all e-cigarette products and will continue to expand its public education efforts and use the agency’s regulatory authority—changing course as necessary—to further ensure all tobacco products, and e-cigarette products in particular, are not marketed to, sold to or used by youth.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.