FDA Denies Marketing Approval to 65 MNGO Disposable Sticks

The U.S. Food and Drug Administration’s list of vapes that have been denied marketing approval continues to grow, as the agency stamps the PMTAs for 65 different products under the MNGO Disposable Stick brand with a big fat “No” this week. 

The products, all MNGO disposables with nicotine strengths between 2% to 6%, featured flavors like pink lemonade, strawberry mango, watermelon freeze, and iced banana, as well as more traditional tobacco and menthol varieties. As no flavored disposables have been authorized for sale in the United States, it is unsurprising that these also failed to be approved. 

Several of the denied flavors were labeled as “Clear” and described as flavorless, seemingly something that would have a good chance of being approved. However, the applications to the FDA showed that they contained flavor enhancers or ingredients known to impart an ice or menthol flavor. They were ultimately classed as “products with a characterizing flavor.”

Concerning the products overall, the FDA says that a scientific review determined that the “applications lacked sufficient evidence to show that marketing of the products would be appropriate for the protection of the public health.” This is the standard that so many vape brands have been unable to meet over the past several years, and probably the reason why only a handful of vapes have been authorized in the last 12 months or more. Despite 26 million applications being submitted, mostly for e-cigarette products, since 2020. 

Aside from being unable to show that the e-cigarette flavors could offer an added benefit to adults who use cigarettes, the applications did not provide adequate evidence of product stability, manufacturing methods, or design features that could prevent product tampering or misuse. Director of the FDA’s Center for Tobacco Products. Brian King, Ph.D., M.P.H., is quoted as saying: 

“The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products. In this case, the applicant did not meet the necessary bar.”

Shenzhen Yibo Technology Co. Ltd., the company behind the MNGO brand, can resubmit PMTAs again (as many times as they wish) but, in the meantime, cannot legally ship these products to stores. Retailers who currently hold stock of the affected MNGO disposables have been advised to contact the company about what to do with them. Selling any of these products could now land retailers with fines of over $20,000.