FDA rejects about 6,500 flavored e-cigarettes

Time： 2023-05-13

According to an announcement on the FDA's official website, the FDA has issued Marketing Denial Orders (MDOs) to 10 companies that collectively produce and...

According to an announcement on the FDA's official website, the FDA has issued Marketing Denial Orders (MDOs) to 10 companies that collectively produce and sell about 6,500 flavored e-liquids and vaping products. These companies are not permitted to sell or distribute these products in the United States, and retailers selling these illegal products could be at risk of FDA enforcement action.

The premarket tobacco product application (PMTA) for various flavored e-cigarette products does not provide sufficient evidence that allowing the sale of these products is appropriate to protect public health. Some of the rejected product flavors included citrus, strawberry cheesecake, cool mint and menthol.

Since the spring of 2020, the FDA has received more than 26 million applications for new tobacco products, the majority of which are e-cigarette products, and today’s action furthers FDA’s ongoing progress in its review and publication decisions.

To date, FDA has completed review and acted on more than 99 percent of applications.

"Science is the cornerstone of the FDA's tobacco product review process," said Dr. Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products. "Today's decision to reject approximately 6,500 products was based on insufficient scientific evidence presented in the application. We will continue to ensure that all new tobacco products undergo a robust, scientific premarket assessment to determine whether they meet appropriate public health standards for legal sale. ""

FDA evaluates PMTAs against public health criteria, which consider the risks and benefits of the product to the population as a whole. As part of reviewing these companies' PMTAs, FDA considered whether the products in the application demonstrate additional benefits for adult smokers compared to tobacco-flavored e-liquid and vaping products, which may outweigh the known significant risk profile of the flavorings. E-liquids and vaping products for teens. The evidence submitted by the applicant was insufficient to demonstrate this benefit, resulting in today's denial order.

"The onus is on the applicant to provide sufficient scientific evidence that marketing a new tobacco product is appropriate to protect public health," said Brian King, director of the Center for Tobacco Products. "To date, no flavored vaping product has met the standard of scientific adequacy, including in this case. But if the applicant is to meet that standard, the FDA will approve the product."

Companies receiving MDOs include:

Imperial Vapors LLC

Savage Enterprises

Big Time Vapes

SWT Global Supply Inc.

Great Lakes Vapor

DNA Enterprise LLC dba Mech Sauce

Absolute Vapor Inc.

ECBlend LLC

The FDA did not disclose the names of the other two companies that received MDOs to protect potentially confidential commercial information (CCI).

FDA remains committed to ensuring that all members of the industry—manufacturers, importers, distributors, and retailers—are in compliance with the law. Tobacco products subject to a negative determination, including tobacco products subject to an MDO, may not be sold, distributed, or marketed in the United States. Such products shall not be introduced or delivered for introduction into interstate commerce. If a product is already on the market, the product must be withdrawn from the market or face enforcement risks.

Today's action takes the FDA one step further by ensuring that all identified new tobacco products are scientifically reviewed and receive FDA marketing authorization before they can be legally sold. To learn more about tobacco products that FDA has authorized to be manufactured, sold and/or distributed in the United States, visit the Tobacco Products Marketing Order webpage.

Prev : British smokers have huge trust in e-cigarettes

Next : TikTok e-cigarette promotion news

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen

Language：简体中文 | >

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen Website