for immediate RELEASE:

Today, the US Food and Drug Administration issued Marketing Denial Orders (MDOs) for two menthol e-cigarette products currently marketed by RJ Reynolds Vapor Company. Products currently sold include Wooz Vibe Tank Menthol 3.0% and Wooz Syro Cartridge Menthol 1.5%. The company must not market or distribute these products in the US or they risk FDA enforcement action. The company may re-submit or file fresh applications to rectify the deficiencies in the products covered under these MDOs.

Brian King, Ph.D. “Consistent with the authorizations provided by Congress, FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product as a whole,” it said. ., MPH, director of the FDA’s Center for Tobacco Products. “Applications for these products do not present sufficient scientific evidence to demonstrate that the potential benefits to adult smokers outweigh the risks of youth initiation and use.”

When reviewing premarket tobacco product applications (PMTAs), the agency evaluates, among other things, the components, ingredients, additives, components, design, harmful and potentially harmful components and health risks of a tobacco product, as well as the product How to manufacture, packaging. and labelled. After reviewing the company’s PMTA, the FDA determined that there was not sufficient evidence in the applications to demonstrate that allowing marketing of the products would be appropriate to protect public health, which was mandated by the 2009 Family Smoking Cessation and Tobacco Act. Legally required is the applicable standard. control act.

Existing evidence indicates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with respect to youth attraction, use, and use; In contrast, the data indicates that tobacco-flavored e-cigarettes do not hold the same appeal for youth and therefore do not carry the same level of risk. Given these existing differences in youth exposure, applicants need to provide strong evidence to demonstrate that use of their menthol flavored e-cigarette products is likely to promote a complete switch or beyond that facilitated by tobacco. The potential to significantly reduce the use of flameless cigarettes in adult smokers are flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported “usually” using.

“Today’s decision pertains to the specific application submitted for review by the FDA,” said Dr. King. “The onus is on the applicant to provide scientific evidence strong enough to demonstrate that the required public health standard has been met. In this case, the evidence presented did not meet that standard.”

These products cannot legally be offered in interstate commerce in the US without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as is usually the case with unauthorized products, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact RJ Reynolds Vapor Company with any questions regarding the products in their inventory.

Issuing these MDOs today is one of many actions FDA has taken to ensure that any tobacco product that is marketed undergoes a science-based review and receives marketing authorization by FDA. The agency has completed a review and determination of more than 99% of the approximately 6.7 million deemed products for which applications were submitted by the court-ordered deadline of September 9, 2020. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that can currently be legally sold in the US

related information

,

boilerplate

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, regulating cosmetics, dietary supplements, electronic radiation products, and tobacco products.