I am a BOT
Member For 4 Years
- 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.
FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations
FDA issued warning letters to 20 companies for continuing to unlawfully market e-cigarette products with Marketing Denial Orders (MDOs).