ALEXANDRIA, Va.—The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to Fontem U.S. for several myblu electronic nicotine delivery system (ENDS) products, according to a news release. The FDA has determined that the company’s applications did not show enough evidence that allowing these products on the market would be beneficial to public health.
The products include myblu Device Kit, myblu Intense Tobacco Chill 2.5%, myblu Intense Tobacco Chill 4.0%, myblu Intense Tobacco 2.4%, myblu Intense Tobacco 3.6%, myblu Gold Leaf 1.2% and myblu Gold Leaf 2.4%.
The FDA is issuing MDOs for additional myblu products not included in the above list. The FDA is only releasing publicly named products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential confidential commercial information (CCI) issues.
The FDA recommends that retailers contact Fontem U.S. if they have questions about products that may have received MDOs but are not listed above.
Fontem U.S.’s products were denied by the FDA because the information provided in its applications for the products did not show enough evidence of public benefit regarding design features, manufacturing and stability. Additionally, the applications did not show a potential benefit to smokers who switch completely to myblu products or significantly reduce their cigarette use would outweigh the risk to youth, according to the agency.
FDA said the products that the agency denied can’t be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The affected companies may have submitted other premarket applications for additional tobacco- or menthol-flavored products, and those applications remain under review.
In a statement NACS received from ITG Brands, the company states the following response to the FDA issuance of the MDOs:
“As part of the marketing regulations for all vapor products in the United States, the U.S. Food and Drug Administration (FDA) required manufacturers to file applications by September 2020. Since that time, the agency has been conducting scientific reviews of those applications. The FDA has been issuing its decisions regarding these products on a rolling basis since late last year. On April 8, the FDA issued marketing denial orders (MDOs) for a number of ITG Brands myblu pod-based vapor products.”
“We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached. We believe our products meet the regulatory requirements and plan to use the administrative appeals process to convince the agency that approval should be granted. Based on past practice, we expect the FDA will not seek to enforce the MDOs while this appeal remains ongoing, and we therefore expect the products to remain in the market during this period. We do not believe that there will be any short-term impact on the business,” the statement indicates.
“All of our products remain available for sale and there is no legal prohibition against continuing to market the myblu vapor portfolio. Rest assured that we will indemnify and hold harmless all of our customers and business partners against any loss incurred related to the sales of our products—including actions taken by the FDA.”
In January, the FDA formally responded to a request from NACS and other groups that asked the agency to publish the names of vapor products for which it has taken action in their premarket tobacco application review. In their letters to FDA, the associations expressed the critical nature of this list for their retail members who need to know which products are legal to sell and which are not.
In its letter response to the associations, the FDA states that it understands the retail groups’ request for specific names of deemed products and that the agency is working to update the list with final actions taken on individual products, including those that received MDOs.
“Given the large number of products involved, sharing this information requires additional time and resources so that the agency does not disclose confidential commercial information about products that are not yet marketed,” FDA stated.
The FDA’s response explains that the agency does not have the authority to disclose CCI of products that are not on the market or whose marketing status is unclear. However, FDA’s website does disclose the names of companies that have received marketing denial orders. Until the list is updated, FDA encourages retailers to contact manufacturers and/or suppliers with any questions about specific products.
NACS will notify members when FDA updates the PMTA product list with actions taken.
(This article is updated from the original version published 04/11/22 with new information from ITG Brands.)