FDA Issues 22 Warning Letters Over Illegal Flavored Vape Sales

On March 11, the FDA announced that it had issued 22 warning letters to online and brick-and-mortar e-cigarette retailers and manufacturers across the United States, stating that the sale of flavored e-cigarette products based on cartridge systems is illegal.

This is the first time the FDA has publicly issued warning letters following the new e-cigarette regulations that took effect on February 5.

The e-cigarette manufacturers that received warning letters include Apollo E-Cigarettes, and retailers include companies like 7-11 and Shell.

Full text as follows:

Today, the U.S. Food and Drug Administration issued 22 warning letters to online and brick-and-mortar retailers and manufacturers of e-cigarette products across the United States, stating that the sale of cartridge-based flavored electronic nicotine delivery system (ENDS) products is illegal as they are being sold without market authorization.

The warning letters were sent to some well-known institutions, such as 7-11 and Shell, marking the first step in a series of follow-up actions related to the FDA's recent enforcement priority policy for e-cigarettes.

As announced earlier this year, the FDA is prioritizing enforcement against the following unauthorized ENDS products:

1) Flavored, cartridge-based ENDS products (excluding tobacco or menthol flavors);

2) All other ENDS products for which manufacturers have failed to take adequate measures to prevent minors from accessing them;

3) Any ENDS products that are targeted at youth or may promote youth use.

Under this policy, companies that do not cease the production, distribution, and sale of these unauthorized tobacco products may face FDA regulatory actions, ranging from warning letters to bans, seizures, or civil fines.

FDA Commissioner Dr. Stephen M. Hahn stated that the FDA's top priority remains to protect youth from the dangers of tobacco use, particularly in combating the epidemic of youth e-cigarette use that affects children, families, schools, and communities. We are committed to holding retailers and manufacturers accountable for marketing and sales practices that have led to increased accessibility and appeal of e-cigarettes to young people. We will utilize regulatory authorities to address youth e-cigarette use by focusing on the most popular products among children, and we will not hesitate to take action against bad actors, expecting more actions soon. Our policies are designed to be flexible so that we can prioritize issues as needed to address youth use concerns.

Manufacturers that received warning letters include:

ProSmoke in Illinois (prosmokestore.com)

Apollo Future Technologies in California

Global Tobacco LLC in Texas

Highland Manufacturing in Virginia

White Lightning in Florida

Georgia United Tobacco Vapor Group

Retailers that received warning letters include:

7-11 (#35433J)

7-11 (#27905E)

7-11 in Baltimore, Maryland

7-11 in Hialeah, Florida (#34577)

Chevron/Food Mart in Houston, Texas

Citgo/Gas Station in Waupaca, Wisconsin

Citgo/Quik Mart in Stone Mountain, Georgia

Confi in Aurora, Colorado

Cavinton Food Mart/Shell in Lithonia, Georgia

Marathon in Arlington, Tennessee

Mobil in Mundelein, Illinois

Pilot Travel Center 149 in Stanton, Tennessee

Shell in Houston, Texas

Shell in Stone Mountain, Georgia

Sunoco/Food Mart in Fort Myers, Florida

Tiger Mart in Columbia, Missouri

The warning letters notify retailers and manufacturers that selling or distributing ENDS products to U.S. customers without market authorization is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. Retailers and distributors are encouraged to communicate with suppliers to discuss possible options for unauthorized products in their inventory.

Additionally, as part of the agency's efforts, the FDA recently issued import alerts for certain unauthorized ENDS products based on the agency's enforcement priorities, describing products that would violate the FD&C Act if imported. These import alerts are issued before any specific product is detained.

The agency has also separately sent letters to nine manufacturers and importers seeking information about their ENDS products, including requests for evidence that the products were legally sold and that they were not introduced or modified after the effective date of the final rule on August 8, 2016.

As of March 10, 2020, the FDA has sent letters to over 100 companies seeking information about more than 140 ENDS products. Many companies have since removed products from the market.

Ultimately, manufacturers intending to sell any of these products (including flavored e-cigarettes or e-liquids) must submit applications to the FDA demonstrating that the products meet applicable standards under the law, such as whether the products are appropriate for the protection of public health. If a company can demonstrate to the FDA that a specific product meets the applicable standards set by Congress, including considering how the marketing of the product affects youth use, the agency may authorize the product for sale. While the FDA will prioritize enforcement against certain ENDS products more quickly, manufacturers of new products that are considered to lack premarket authorization must submit premarket applications by May 12, 2020.

All these efforts, along with the recent law raising the minimum age for federal tobacco sales from 18 to 21, and the FDA's expanded public education campaign, including videos of youth sharing their stories about e-cigarette addiction, aim to remove these products from the hands of young people.

In the coming days, the agency also plans to release new resources for middle and high school educators and school administrators.

The FDA will continue to monitor youth use of all e-cigarette products and will continue to expand its public education efforts, utilizing the agency's regulatory authorities (changing course as necessary) to further ensure that all tobacco products, especially e-cigarette products, are not marketed, sold, or used by young people.