FDA Begins Issuing Warning Letters to Retailers & Manufacturers Selling Unauthorized Flavored E-Cigarette Products

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FDA Begins Issuing Warning Letters to Retailers & Manufacturers Selling Unauthorized Flavored E-Cigarette Products

03/11/2020
FDA headquarters

SILVER SPRING, Md. — One month after the new policy banning the sale of unauthorized flavored vapor cartridge- and pod-based products went into effect, the Food and Drug Administration (FDA) is taking notice of those retailers still selling the products.

On March 10, the agency issued 22 warning letters to online and brick-and-mortar retailers and manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system (ENDS) products advising them that selling these products, which lack marketing authorization, is illegal.

The warning letters are the first step in a series of ongoing actions consistent with the FDA's recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market, according to the agency.

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.

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.

"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," he added.

The retail locations that received warning letters are:

  • 7-Eleven (#35433J), Washington, D.C.
  • 7-Eleven (#27905E), Washington, D.C.
  • 7-Eleven, Baltimore
  • 7-Eleven (#34577), Hialeah, Fla.
  • Chevron/Food Mart, Houston
  • Citgo/The Filling Station, Waupaca, Wis.
  • Citgo/Quik Mart, Stone Mountain, Ga.
  • Conoco, Aurora, Colo.
  • Covington Food Mart/Shell, Lithonia, Ga.
  • Marathon, Arlington, Tenn.
  • Mobil, Mundelein, Ill.
  • Pilot Travel Center 149, Stanton, Tenn.
  • Shell, Houston
  • Shell, Stone Mountain, Ga.
  • Sunoco/Food Mart, Fort Myers, Fla.
  • Tiger Mart, Columbia, Mo.

The manufacturers that received warning letters are ProSmoke in Illinois, Apollo Future Technology Inc. in Calif., Global Tobacco LLC in Texas, Premium Manufacturing Facility in Virginia, WhiteLightning USA in Florida, and United Tobacco Vapor Group in Georgia.

According the agency, retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.

The FDA announced the policy shift regarding the sale of flavored vapor cartridges and pods — other than tobacco or menthol — in early January and it went into effect on Feb. 6. The change does not affect e-liquid flavors used in open vaping systems and in disposable, single-use vape products, as Convenience Store News previously reported. 

However, companies must file premarket tobacco applications for its vapor products by the FDA's May 12, 2020 deadline in order to remain on the market during the review process.