EMA, Other Groups Request Swift Release Of ENDS Nicotine Products List With Marketing Denial Orders
On September 10, EMA joined FMI (the Food Industry Association), NACS, NATSO and SIGMA in a letter to Janet Woodcock, M.D. Acting Commissioner of Food and Drugs, U.S. Food & Drug Administration (FDA), and Mitchell Zeller, JD, Director of the Center for Tobacco Products (CTP), FDA, urging swift announcement of the list of electronic nicotine delivery system (ENDS) products for which the Agency has issued marketing denial orders (MDOs).
Without the list, retail members, who make every effort to comply with the law, do not know which products must be removed from shelves.
Last August, our associations also sent a letter asking CTP to publish a list of products for which PMTAs had been submitted to know which products could legally be sold in stores during the FDA’s review process.
In May, CTP published this list providing needed clarity for retailers, distributors and wholesalers.
As the Agency takes action on PMTAs, it is imperative that there is continued transparency in the process and that stakeholders across the tobacco trade know all of the products that have had PMTAs rejected as well as all of the products that have had marketing orders granted.
Retail members who sell ENDS products take the responsibility of compliance and operating in accordance with the law seriously. Publicly available information noting the status of individual products is the only way retailers can ensure compliance.
The letter urged the FDA to, “Until such information is available, we respectfully ask CTP to focus enforcement on manufacturers who know the legal status of their own products and exercise enforcement discretion with respect to retailers selling ENDS products for which the status of their PMTAs has not been made publicly available.”