Four Blu disposable vape products and one My Blu vape product have been issued a Marketing Denial Order (MDO) by the U.S. Food and Drug Administration to Fontem U.S. The MDOs mean that the company is not allowed to market or distribute these flavored blu vape products in the United States. However, Fontem U.S. does have the option to submit new applications for these flavored blu vape products.
The denied flavored blu products include a closed menthol e-liquid and several flavored blu vape products. The specific products that received MDOs are Blu Disposable Menthol 2.4 percent; flavored blu disposable Vanilla 2.4 percent; flavored blu disposable Polar Mint 2.4 percent; flavored blu Disposable Cherry 2.4 percent; and MyBlu Menthol 1.2 percent.
Why the FDA Will Deny Flavored Blu Vape?
The FDA reviewed Fontem U.S.’s premarket tobacco product applications and found that they did not provide enough evidence to demonstrate that marketing these flavored blu disposable products would be in the best interest of public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act. The applications lacked sufficient evidence on harmful ingredients in the aerosol of one product and battery safety for several products. Additionally, the applications did not show enough data to prove that these new products could benefit adult smokers in terms of completely switching from traditional cigarettes or significantly reducing cigarette use. The potential risk to youth also outweighed any potential benefits for adult smokers, according to the FDA.
