FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations

FDA in Brief

• For Immediate Release: October 07, 2021

The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products:

“The FDA is responsible for ensuring that new tobacco products are put through the appropriate regulatory review process to determine if they meet the public health standards of the law before they can be marketed. If a product does not meet the particular standard then the agency issues an order denying the marketing application. It is illegal to market a new tobacco product in the United States that does not have marketing authorization from the FDA.

One of our top priorities is ensuring that manufacturers are held accountable for marketing unauthorized tobacco products. Today’s action shows that we’re prioritizing enforcement against tobacco product manufacturers who received a negative action on their application, such as a Marketing Denial Order or Refuse to File notification and continue to illegally sell those unauthorized products, as well as products for which manufacturers failed to submit a marketing application.

It is our responsibility to make sure that tobacco product manufacturers comply with the law to protect public health and we’ll continue to hold companies accountable for breaking the law.”

Additional Information

• Today, the U.S. Food and Drug Administration issued warning letters to 20 companies for continuing to unlawfully market electronic nicotine delivery system (ENDS) products that are the subject of Marketing Denial Orders (MDOs). These are the first warning letters issued for products subject to MDO determinations on their premarket tobacco product applications (PMTAs).
• The FDA also issued warning letters today for the unlawful marketing of tobacco products to one company that received Refuse to File (RTF) determinations on their PMTA, one company that received RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.
• Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA.
• As of Sept. 23, the FDA has issued a total of 323 MDOs, accounting for more than 1,167,000 flavored ENDS products.
• The FDA will continue to prioritize enforcement against companies that market ENDS products without the required authorization–especially those products with a likelihood of youth use or initiation.