FDA Enforces E-Cigarette Marketing Denial Orders

FDA | E-cigarette Regulations

The following update was provided by the National Association of Tobacco Outlets (NATO).

The FDA issued an announcement from Center for Tobacco Products Director Mitch Zeller regarding enforcement actions being taken by the agency against manufacturers that have been issued Marketing Denial Orders (MDOs) denying their pre-market tobacco applications to sell flavored electronic cigarette/nicotine vapor products. The text of the announcement is below:

“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.”

In addition, the FDA announcement included the following information about enforcement actions being taken:

  • Warning letters were issued to 20 companies for continuing to unlawfully market electronic nicotine delivery system (ENDS) products that are the subject of Marketing Denial Orders. These are the first warning letters issued for products subject to MDO determinations on their premarket tobacco product applications (PMTAs).
  • Warning letters have also been issued to eight other companies that either continue to unlawfully market tobacco products after a Refuse to File determination was made by the agency denying the filing of its PMTA or did not submit any pre-market tobacco applications.
  • Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA.
  • As of Sept. 23, 2021, the FDA has issued a total of 323 MDOs accounting for more than 1,167,000 flavored ENDS products. Additional PMTAs continue to be reviewed by the agency.

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.