FDA Denies Several Myblu ENDS Products

Others that received MDOs were not made public
Fontem Ventures

SILVER SPRING, Md. — Convenience-store retailers must remove several myblu electronic nicotine delivery system (ENDS) products from shelves following a ruling from the U.S. Food and Drug Administration (FDA).

The FDA on Friday issued marketing denial orders (MDOs) to Fontem U.S. LLC for myblu products because their premarket tobacco product applications (PMTAs) lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health, according to the agency.

Products on the market that received 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%

The FDA released this product information because the agency determined the products are currently marketed. 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), which the FDA would not disclose; therefore, the FDA issued MDOs for additional myblu products, but those will not appear on the publicly available list.

Retailers should contact the company directly with questions about their products that may have received MDOs but are not listed above, the FDA said.

When evaluating PMTA for tobacco products, the FDA evaluates the risk and benefits of the products to the population, including users and nonusers of the product.

“Based on the information provided in the applications submitted by Fontem 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,” the FDA said.

Products that received an MDO may not be sold, distributed or marketed in the United States.

“We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached," ITG Brands Director of External Communications Alexandra Wich told CSP. "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 FDA is still reviewing several other ENDS products that submitted timely PMTAs. It has made determinations on more than 99% of the nearly 6.7 million products for which applications were submitted by the Sept. 9, 2020, deadline.

The blu brand is owned by Fontem Ventures, a subsidiary of the Imperial Brands Group, Bristol, U.K. ITG Brands, Greensboro, N.C., is the U.S. affiliate of Fontem U.S., which sells blu electronic cigarettes.

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