The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to Fontem US, LLC for several of its myblu electronic nicotine delivers system (ENDS) products, according to an FDA press release.

The applications for the products in question “lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health”, said the FDA. Usually, information regarding premarket applications would be considered confidential commercial information (CCI), however the FDA has listed some of the products that have received MDOs on its website saying: “The FDA has determined that these products are currently marketed based on communication with the applicant during the development of the publicly available Deemed New Tobacco Product Application List, and therefore the applicant has acknowledged the submission of these premarket applications.”
The press release went on to say that further myblu products have received MDOs however they do not appear on the publicly available list. The agency suggests reaching out to the company with any questions on products that may have received MDOs and are not on the list.
Tobacco products that receive an MDO are not allowed to be sold, distributed or marketed in the US. If the products are already on the market they must be removed.