BAT’s Vuse E-Cigarette Gets PMTA, Becomes First FDA-Authorized Brand

On October 13, news suddenly came from the U.S. e-cigarette market!

The world's first e-cigarette brand to pass the PMTA in the United States has been born, which are the three e-cigarette products of RJ Reynolds, a subsidiary of British American Tobacco.

British American Tobacco's Vuse took the lead

The U.S. Food and Drug Administration (FDA) said on Tuesday it authorized legal sales of e-cigarette products in the U.S. market for the first time in history, allowing RJ Reynolds to sell three of its Vuse e-cigarette products.

These three products are:

#p#Pagination Title #e#

Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2

Vuse Solo became the first e-cigarette product authorized by the FDA.

The US Food and Drug Administration (FDA) has issued its first marketing authorization for e-cigarette products. On Tuesday afternoon, the FDA's Center for Tobacco Products posted marketing authorization orders (MGO) for the first generation of Vuse Solo e-cigarettes and two tobacco-flavored replacement cartridges on its website.

In addition to obtaining authorization, the FDA also announced that it had issued marketing denial orders (MDOs) for 10 non-tobacco flavors of Vuse Solo refill cartridges-further evidence that the FDA has no intention of authorizing any flavored product other than menthol. It's unclear whether the FDA rejected the PMTA for Vuse's peppermint cigarette bombs.

In October 2019, a premarket tobacco application (PMTA) for Vuse Solo and multi-flavor cigarettes was submitted to the FDA. The manufacturer of the Vuse brand is RJ Reynolds Vapor Company, which is a subsidiary of Reynolds American Inc. A division of Reynolds American Inc. A subsidiary of British American Tobacco.

#p#Pagination Title #e#

Vuse Solo is a so-called cigar-a small stick battery that uses a pre-charged disposable atomizer. The product is similar to a cigarette, but the Solo battery is silver and the cigarette cartridge is black. Cigarette cartridges only provide 4.8% (48 mg/mL) of nicotine strength.

The device is very low-power and requires a high nicotine intensity to provide a reasonably satisfactory blow to the user. Compared to pod-based devices such as Vuse Alto, JUUL and NJOY Ace, it is considered a product for transitional smokers.

Vuse Solo was one of the first products to be submitted for review, but it was an extremely cautious choice by the FDA. Among mass-market e-cigarette products, cigar products like Solo will be the least popular in 2021. The FDA may choose Solo as the first authorized product to assess the response of tobacco control and medical organizations that the agency has been seeking to please.

Vuse Solo was one of the first products submitted for review and appeared to be an extremely cautious choice by the FDA.

firstWas it approved first because it looked like a cigarette?

The FDA approved a product that was not a hot product on the market and was probably asking for directions. Solo was selected as the first authorized product to assess the response of tobacco and medical organizations.

Although we allow e-cigarette products to be sold in the United States, that does not mean that these products are safe or FDA approved, the FDA said in a statement. All tobacco products are harmful and addictive, and those who do not use tobacco products should not use them.# p#pagination title #e#

The FDA said it had denied VUSE's license to sell 10 flavoring products, but did not say what they were.All three authorized products that passed the review are tobacco-flavoredThe FDA says they are unlikely to appeal to children and adolescents and are more likely to be used by smokers to reduce their risk of harm.

Mitch Zeller, head of the FDA's Tobacco Products Center, said in a statement: Today's authorization is an important step towards ensuring that all new tobacco products pass the FDA's strong, scientific premarket evaluation.

Data from e-cigarette manufacturers suggest that by reducing exposure to harmful chemicals, their tobacco-flavored products can benefit addicted adult smokers who switch to these products, completely or significantly reducing cigarette consumption.

Matthew Myers, president of the Campaign for Tobacco Free Children, a public health advocacy group, was also dissatisfied with the FDA's decision, and Raja Krishnamoorthi, chairman of the Economic and Consumer Policy Subcommittee of the U.S. House Oversight Committee, also expressed concerns.

FDA said it will pay close attention to the marketing of the product.

The largest players in the e-cigarette market have not yet been decided, including Juul.

#p#Pagination Title #e#FDA attitude: allowing the sale of e-cigarettes for the first time, suitable for protecting public health

The U.S. Food and Drug Administration announced today that it has authorized the sale of three new tobacco products, marking the first electronic nicotine delivery system product to receive FDA authorization through the Premarket Tobacco Product Application (PMTA) path.

Under the PMTA pathway, e-cigarette manufacturers must demonstrate to the agency, among other things, that marketing of new tobacco products is appropriate to protect public health. The products were found to meet this criterion because, among several key considerations, the agency determined that study participants who only used authorized products were exposed to less harmful and potentially harmful ingredients (HPCs) than users who burned cigarettes.

Based on existing data comparisons and the results of non-clinical studies, the toxicological assessment also found that the aerosol of the authorized product was significantly less toxic than that of burning cigarettes.In addition, the FDA considers the risks and benefits to the entire population, including users and non-users of tobacco products. Importantly, this includes reviewing available data on the likelihood of young people using the product. For these products, the FDA determined that if applicants follow postmarket requirements designed to reduce youth exposure and exposure to products, the potential benefits to smokers who completely or significantly reduce cigarette use will outweigh the risks to adolescents.

Conclusion:

As Vuse's three products have passed the PMTA review by the US FDA, it means that the electronic atomization category of e-cigarettes has a new identity.

It is worth noting that the FDA's first authorization is of profound significance.# p#pagination title #e#

First of all, only the approval of tobacco flavors means that all flavored e-cigarettes cannot be passed. Tobacco is passed to give adult smokers a choice. Flavoring is refused to refuse teenagers to be interested in e-cigarettes. This is an iron principle. All subsequent flavors will not be passed.

Secondly, the mint flavor is up in the balance. This also makes people worry that if there are no fruit-flavored cigarettes, mint flavor may become the next best choice for smokers. If mint is also banned, it will be a real pain for smokers.

Third, FDA authorization of Vuse may cause Vuse's market share to soar. Nielsen data shows that Anglo-American companies 'Vuse U.S. e-cigarette market is 32.3%, which may be higher in the later period.

The U.S. e-cigarette policy will be a great reference for global e-cigarette regulation and can be said to be the vane of the e-cigarette market.

The FDA's first e-cigarette authorization is a good thing for the entire e-cigarette industry. It means that e-cigarettes have legal status. Strict supervision is not a bad thing. One size fits all is the most terrible thing.