Myblu, the fourth place in the United States, was rejected by the FDA for sale, and the application for the replacement product was in jeopardy

Blue Hole New Consumption reported today

April 9 news, the UNITED STATES e-cigarette supervision came heavy news, the first large international tobacco company e-cigarette product PMTA application was rejected by the FDA!

Fda today issued a Marketing Refusal Order (MDO) to Fontem US for its Myblu reloader and multiple flavors.

Myblu's PMTA rejection was the first announced MDO, which was released for a reload-based product produced by a large tobacco company.

Myblu is manufactured and sold by Fontem US, the e-cigarette products division of Imperial Brands, a large international tobacco company with a market capitalization of more than $20 billion.

This means that the United States is about to make a final decision on the fate of large e-cigarette companies, and the top three Juul, Vuse and Njoy are trembling.

Today's decision was a ruling on the fourth place in the market, and Myblu was unfortunately rejected.

According to Nielsen's latest analysis of convenience store retail data, in the four weeks covering the end of March 26, Juul market share was determined to be 35.7 percent, Vuse market share at 33.9 percent, NJoy at 3.2 percent, and Fontem Ventures' blu eCigs at 2.3 percent.

This rejection is significant.

The FDA is still reviewing PMTA based on reloading equipment submitted by other major companies, including Juul Labs' Juul equipment and smoke bombs, British American Tobacco's Vuse Alto and NJOY's Ace equipment. These devices and kits make up most of the retail sales of convenience stores and gas stations in the e-cigarette market.

The Rejection of Myblu may indicate that the FDA will also reject other reload-based products, possibly because their nicotine delivery is more efficient than the older generation of Vuse Solo and the two Logic e-cigarette products that have been marketed.

The FDA said in a statement that grounds for the rejection included a lack of "sufficient evidence of design features, fabrication and stability" in Fontem's Myblu application. No one can be sure what this means without seeing the actual refusal order, but it could almost involve anything related to the performance or physical structure of the device, smoke bomb, or e-cigarette oil.

In addition, the FDA said the applications did not demonstrate that the potential benefits for smokers who completely or significantly reduced smoking would outweigh the risks to young people.

The meaning of this sentence is that if such product applications are released, the disadvantages will be more than the benefits, that is, the risk and benefit of young people using e-cigarettes exceeds the possibility of reducing smoking for adult smokers.

Myblu products that receive marketing rejection orders are as follows:

myblu Device Kit, Device Kit

myblu Intense Tobacco Chill 2.5%, Strong Cool Tobacco, 2.5%

myblu Intense Tobacco Chill 4.0%, Strong Cool Tobacco, 4%

myblu Intense Tobacco 2.4%, Strong Tobacco, 2.4%

myblu Intense Tobacco 3.6%, Strong Tobacco, 3.6%

myblu Gold Leaf 1.2%, Gold Leaf, 1.2%, what is this flavor?

myblu Gold Leaf 2.4%, Gold Leaf, 2.4%

The FDA has also issued MDOs for some Myblu cartridges that are not currently on the market and are therefore not listed in the FDA's published PMTA submission list.

Fontem has not yet announced what additional flavors it will include in its April 2020 Myblu PMTA, but said at the time that the scope of submissions was broad.

Other Blu products, including Blu's disposable cigalikes and rechargeable PLUS+ cigalikes, are still under FDA review.

Curiously, two menthol Myblu cartridges are still under review, but they would be completely useless without the e-cigarette devices that have been rejected.

Under FDA regulations, Fontem must immediately stop selling products or face possible enforcement action.

The company now has 30 days to file a legal challenge with Myblu's MDO.

At present, more than 30 small independent e-cigarette companies have challenged their MDO in federal court, and other companies have filed administrative appeals with the FDA, which is also an option for Fontem.

Some manufacturers have received refusal orders, while the FDA has been forced to revoke the MDO of some others.

We expect Fontem to challenge, after all, being the fourth in the U.S. market.

When reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of these tobacco products to the population as a whole, including users and non-users of tobacco products, considering, among other things, the likelihood of those who do not.

According to the information and available evidence provided in the applications filed by Fontem US, LLC for these myblu products, these applications lack sufficient evidence in terms of design features, manufacturing, and stability.

In addition, these applications do not demonstrate that the potential benefits for smokers who completely or significantly reduce smoking outweigh the risks to adolescents.

Tobacco products subject to negative action as a result of premarket submissions, including those subject to the MDO, may not be sold, distributed, or marketed in the United States. Such products may not be introduced or delivered for the purpose of introducing interstate trade, and if the product has already been placed on the market, the product must be withdrawn from the market.

Currently, the FDA's highest enforcement priority is unappliced e-cigarette products, including, for example, those with an MDO or an unsubmitted application.

The FDA believes that today's action takes the FDA one step closer to its goal of ensuring that all new tobacco products identified are scientifically vetted and approved by the FDA before being legally marketed.

Of the nearly 6.7 million products that filed applications by the September 9, 2020 deadline, FDA has reviewed and decided on more than 99 percent.

In fact, global e-cigarette practitioners are currently very concerned about two categories of PMTA applications.

The first category is the fate of the top three in the US market, the results of Juul, Vuse and Njoy will affect the US e-cigarette market, and the current Myblu reload series has been completely destroyed, making people worry about the reload series.

The second category is PMTA applications related to Chinese companies, which may cover open cigarettes, reloading equipment and smoke oil.

At present, only two companies' e-cigarette products have obtained PMTA sales qualifications in the United States.

On March 25, the FDA authorized the sale of eight products, including two e-cigarette devices and tobacco flavor refills, manufactured by Logic Technology Development LLC, the e-cigarette products division of Japan Tobacco International (JTI), to pass the review, and also issued a marketing rejection order for a variety of other products to Logic.

These are the only e-cigarette products authorized by British American Tobacco since Vuse Solo, a subsidiary of British American Tobacco, became the first e-cigarette product in October 2021.

Logic is the second company to receive FDA approval to sell e-cigarette products.

In October 2021, Vuse Solo equipment and two tobacco-flavored smoke bombs of British American Tobacco's RJ Reynolds (RJR) Vapor Company received marketing permission for three obsolete steam products, all of which were rejected for flavoring other than tobacco flavors.

A background information supplement.

Robert Carleef, the current FDA director, and Xavier Becella, secretary of health and human services, are both skeptical and hostile to e-cigarettes. In recent years, both sides have advocated a complete ban on flavored products.

Therefore, the bitter days of the US e-cigarette market are still ahead.

In addition, Blue Hole looked at photos of the products obtained by the two companies and found commonalities.

Vuse Solo

Logic PRO

VAPE LEAD

What are the commonalities? Retro, ugly, frigid.

Look at the rejected Myblu reloader. What is the final conclusion? That is:

Good-looking ones are rejected! Ugly looking are approved!

Probably because the uglier the design, the more frigid it is, and the less efficient the transmission of nicotine, the less likely it is to attract minors to use!

Outrageous.

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