The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by British American Tobacco-owned RJ Reynolds Vapor Company under the Vuse Solo brand.

In 2021, the Solo device and its tobacco-flavored refills become the first vaping products to receive marketing authorization from the FDA. The Solo is the original cigar-like e-cigarette, powered by a cigarette-shaped battery and using a screw-on preloaded cartomizer cartridge.

In an announcement, the FDA explained that Vuse Solo menthol refills did not meet the agency's criteria for suitability to protect public health because menthol e-cigarettes pose known significant risks to youth appeal, uptake and use.

The FDA has issued marketing denial orders (MDOs) for millions of flavored e-liquids and prefilled devices since it began rejecting premarket tobacco applications (PMTAs) in August 2021, but after appointing Brian King King, most menthol products are still under review.

He served as director of the FDA's Center for Tobacco Products last summer.

There has been speculation that the FDA will authorize some menthol products as lower-risk alternatives for people who smoke menthol cigarettes, which the agency intends to ban. Since King took office, however, the FDA has declined to request menthol refills for several previously authorized mass-market vaping devices, starting with Logic Pro and Logic Power refills.

Logic immediately challenged the FDA decision in court and was granted a temporary stay of the denial order by the Third Circuit Court of Appeals. CTP documents unearthed in Logic’s lawsuit show that the CTP Director’s Office pressured the CTP Office of Science (both before and after King took over) to reject Logic’s menthol supplements after the Office of Science’s initial recommendation for authorization.

In January, the agency released MDOs in mint refills of two previously authorized Vuse devices, the Vuse Ciro and Vuse Vibe. A day after issuing a Marketing Denial Order (MDO), the Fifth Circuit Court of Appeals granted Vuse maker RJ Reynolds the right to temporarily stay the order.

Reynolds may challenge Vuse Solo menthol MDO in court.

None of the three licensed Vuse products has been well-received by the market, but Reynolds may be concerned about future rejections of the Vuse Alto and its mint refills. Unlike the other three Vuse products, Alto is the leader in the convenience store/gas station segment of the vaping product market.

PMTA for Alto e-cigarettes is still under FDA review.

In its announcement, the FDA cited National Youth Tobacco Survey data showing that Vuse was the second most common brand youth vapers reported commonly using. All three of these FDA-authorized Vuse products (and their mint refills) are unpopular with users of all ages, and the agency knows it. The NYTS data primarily refers to the very popular Vuse Alto.

RJ Reynolds recently asked the FDA to crack down on the popular disposable e-cigarettes that currently dominate the convenience store/gas station vaping market.

The following is the full text of the announcement:

Today, the U.S. Food and Drug Administration issued Marketing Denial Orders (MDOs) for two menthol e-cigarette products currently marketed by RJ Reynolds Vapor Company under the Vuse Solo brand. Products currently on the market include Vuse Replacement Cartridge Menthol 4.8% G1 and Vuse Replacement Cartridge Menthol 4.8% G2. Companies must not sell or distribute these products in the United States, or they risk FDA enforcement action.

Companies may resubmit applications or submit new applications to address deficiencies in products subject to these MDOs.

FDA evaluates premarket tobacco product use (PMTA) against public health criteria, which consider a product's risks and benefits to the population as a whole. After reviewing the company's PMTA, FDA determined that the application lacked sufficient evidence that allowing the product to be marketed would be appropriate to protect public health, an applicable standard required by the Household Smoking Prevention and Tobacco Control Act of 2009.

Specifically, the applicant submitted evidence that did not demonstrate that its mint-flavored e-cigarettes provided additional benefits to adult smokers relative to tobacco-flavored e-cigarettes.

"The FDA is a data-driven agency, and science remains the cornerstone of our tobacco product regulatory activities," said Brian King, PhD, public health, director of the FDA's Center for Tobacco Products. "Science has guided -- and will always guide -- FDA's decisions on the use of premarket tobacco products, including today's marketing refusal order."

Available evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), suggests that non-tobacco flavored e-cigarettes, including menthol flavored e-cigarettes, carry known and significant risks with respect to youth attraction, uptake, and use.

In contrast, data suggest that tobacco-flavored e-cigarettes do not have the same appeal to young people and therefore do not pose the same level of risk. Given these existing differences in youth risk, applicants will need to provide strong evidence that use of their menthol-flavored e-cigarette products may promote complete switching or may significantly reduce adult smokers' use of combustible cigarettes, not just tobacco .

The NYTS data also found that Vuse was the second most common brand youth vapers reported commonly using.

These products cannot be legally introduced into U.S. interstate commerce without risking FDA enforcement. In addition to ensuring that manufacturers comply with this order, as with unauthorized products in general, FDA also intends to ensure compliance by distributors and retailers. Retailers should contact RJ Reynolds Vapor Company with any questions regarding product in stock.

Today's action is just one of many actions the FDA is taking to ensure that any tobacco product sold in the United States undergoes a science-based review and receives the agency's marketing authorization.

To date, the agency has received more than 26 million applications for deemed products and has made decisions on 99 percent of them.

To date, the FDA has authorized 23 tobacco-flavored vaping products and devices, the only ones that can currently be legally sold or distributed in the United States; this includes the Vuse Solo vaping device and two accompanying tobacco-flavored vaping devices.

The FDA also rejected millions of marketing applications for products that did not meet legal requirements, including 10 non-tobacco-flavored e-liquid pods under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Pods Menthol 1.5%.

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