According to foreign reports, NACs and other retail associations in Alexandria, Virginia, once again promote the U.S. Food and Drug Administration (FDA) to improve the transparency of its marketing refusal order (MDO).
On behalf of convenience stores, the organization requested Janet Woodcock, FDA food and drug agency Commissioner, and Mitch Zeller, director of the tobacco products center, to announce the name of RJ Reynolds vapor Co. products accepting MDO in a letter on October 14.
This letter was issued after the approval of the company’s VUSE solo electronic nicotine delivery system (ends) equipment and related tobacco flavored e-cigarettes, which were submitted under the pre marketing tobacco product application (PMTA) process. FDA also released 10 MDOs for flavoring ends products submitted by RJR under the brand VUSE solo, but FDA will not publicly disclose specific flavoring products due to potential confidential business information.
RJR did not immediately respond to the request for comment.
“The FDA is working to update the public list of products, including information on products that have received MDO,” an FDA spokesman said on Friday, “Given the large number of products involved, sharing this information requires additional time and resources. Please note that FDA does not include all products that obtain MDO in this list due to potential problems of confidential business information. Retailers should contact the manufacturer about any problems with their inventory products.”
NACs states that its members do not need any confidential or detailed information about the product – but they need to know the name of the rejected product so that they can identify and exit the market.
“Requiring hundreds of thousands of tobacco retailers to verify the PMTA status of ends products to each manufacturer does not fulfill the responsibility of the agency to inform regulated enterprises of its decisions. There is no guarantee that manufacturers will provide such information in a timely, complete or accurate manner,” said the national convenience store association (NACs), which was also supported by the American Association of energy marketers (EMA, formerly oil marketers); American Association or PMAA; Food Marketing Association (FMI), National Association of truck stop operators (natso), and American Association of independent gasoline Marketers (sigma).
The organization also sent a letter to FDA in September asking it to publish a public list of ends products for which the agency has released MDOs. FDA has released more than 300 MDOs for products submitted through PMTA.
Although FDA lists companies that have received MDO or marketing license orders and other status updates on its website, the MDO list publicly provided by FDA only includes the name of the company receiving the letter, not the specific products rejected.