ALEXANDRIA, Va.—ITG Brands said it has appealed the Food and Drug Administration’s marketing denial orders (MDO) for certain myblu electronic nicotine delivery products and has informed NACS that these products can continue to be displayed and sold at retail outlets while the appeal is pending.
FDA issued the MDOs on April 8.
The affected 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%.
In the accompanying announcement issued today by 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.”