April 8, 2022
On April 8, FDA issued marketing denial orders (MDOs) to Fontem US, LLC for several myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. The currently marketed products receiving MDOs 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%
- myblu Gold Leaf 2.4%
Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose. However, FDA 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. Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products.
FDA is issuing MDOs for additional myblu products that do not appear on the publicly available list. FDA has publicly named only products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential CCI issues. Therefore, FDA recommends contacting the company with questions about their products that may have received MDOs but are not listed above.
In reviewing premarket applications for tobacco products, FDA evaluates the risks and benefits of those tobacco products to the population as a whole, including users and nonusers of the tobacco product, and takes into account, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products. Based on the information provided in the applications submitted by Fontem US, LLC for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
Tobacco products subject to a negative action regarding a premarket submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US. Such products may not be introduced or delivered for introduction into interstate commerce, and if the product is already on the market, the product must be removed from the market. Currently, FDA’s highest enforcement priorities are ENDS products for which no application is pending, including, for example, those with an MDO or those for which no application was submitted.
Today’s actions move FDA one step closer toward ensuring all deemed new tobacco products have undergone science-based review and received marketing authorization by FDA before they can be legally marketed. FDA has completed the review of and made determinations on more than 99 percent of the nearly 6.7 million products for which applications were submitted by the Sept. 9, 2020 deadline. More information about FDA’s tobacco product authorizations and marketing denial orders can be found on FDA’s website.