Breaking: FDA Orders Imperial Tobacco to Remove myblu Vaping Products From the Market, Affecting Dis

On July 10, the FDA released a press release titled "FDA Denies Marketing of myblu Menthol E-Cigarette Product," stating that the FDA has issued a Marketing Denial Order (MDO) for the e-cigarette product myblu Menthol 2.4% produced by Fontem US, LLC. The company is prohibited from marketing or distributing this product in the United States, or it will face enforcement actions from the FDA. The company can resubmit a new application to address the issues related to the MDO.

myblu Menthol 2.4% is a pod compatible with the myblu device from Imperial Tobacco, with a nicotine content of 2.4%. Each box contains 2 pods (1.5 ml each), and the series includes nicotine strengths of 1.2% and 2.4%.

Regarding this ban, Dr. Matthew Farrelly, Director of the FDA's Center for Tobacco Products Science Office, stated that the application lacked the necessary scientific evidence to demonstrate that the benefits of the product to public health outweigh the known risks. In other words, the FDA's ban on the myblu brand from Imperial Tobacco is not because it has not applied for a PMTA, but because it believes the application materials are insufficient.

In this press release, the FDA also emphasized that in addition to ensuring manufacturers comply with the ban, the FDA intends to ensure that distributors and retailers comply with the order—meaning that merely wholesaling the aforementioned myblu e-cigarettes will also fall under the FDA's enforcement scope, which is not commonly mentioned in previous press releases regarding bans.

As usual, the FDA emphasized in the press release that as of now, only 23 SKUs of vaporized e-cigarettes have had their PMTA applications approved, receiving Marketing Grant Orders (MGO) issued by the FDA, including some products from NJOY, Vuse, and Logic.

This is not the first time myblu has received an MDO. On April 8, 2022, the FDA issued bans on 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%. Currently, the aforementioned products are still in litigation and are not legally sellable.

With the latest MDO issued on July 10, most of myblu's products are now under MDO status. According to Nielsen's convenience store data released in May, the market share of pod-based e-cigarettes in the U.S. market is 41.8% for Vuse, 26% for JUUL, 2.7% for NJOY, and 1.4% for blu. It seems that myblu will face even greater sales pressure in the U.S. market.

In fact, Vuse is already the market leader, but the newly appointed CEO of British American Tobacco is dissatisfied with the current pace of the company's transition to new tobacco products, and last month announced the dismissal of executives responsible for British American Tobacco's U.S. subsidiary Reynolds American and its new categories department (which includes the Vuse brand).

On the other hand, Altria announced last month that it had completed the acquisition of NJOY after shedding the burden of Juul, and stated that it would introduce NJOY into Altria's 70,000 stores in the U.S. market. The NJOY brand is likely to experience rapid growth similar to that of Juul after Altria's investment.

Ge Wu previously pointed out in a tweet titled "FDA's 'Lightning War' Effect Begins to Show: Brands Applying for PMTA in the U.S. Are Crazy to Grab Market Share" that after the FDA strengthened its supervision of retail channels, many channels that previously sold products without submitted PMTAs would face enforcement risks, leading to a reduction or even cessation of sales of related products. This means that there may be a gap in the channels, and products that have submitted PMTAs will rush to seize the territory.

Considering the current MDO issued to myblu, the uncertainty in the market has further increased. Even products that have submitted PMTAs may receive MDOs due to incomplete materials. It seems that Altria, which already holds MGO for several NJOY products, may see growth in the near future.

This also suggests that the legal e-cigarette market in the U.S. is about to trend towards concentration among leading brands. At the same time, from the FDA's previous rare mention in MDO press releases that it would "ensure distributors and retailers comply with MDO," we can see that the FDA's "lightning action" targeting sales channels is still ongoing, and myblu will face even more difficulties ahead.