FDA Issues Warning Letters on Flavored E-Cigs

The agency is conducting compliance checks to look for unauthorized vape products.

March 13, 2020

WASHINGTON—This week, the U.S. Food and Drug Administration (FDA) issued 22 warning letters to online and brick-and-mortar e-cigarette product 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 of what will be a series of ongoing actions consistent with the FDA’s recently issued notice of enforcement priorities for e-cigarettes and other deemed products on the market.

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 flavors)
  2. All other ENDS products for which the manufacturer has failed to take adequate measures to prevent underage access
  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., in a press release. “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.”