On April 15th, the FDA issued a Marketing Denial Order (MDO) to Shenzhen Yibo Technology Co. Ltd (深圳市绎柏科技有限公司), effectively banning the sale of 65 variants of their “MNGO Disposable Stick” e-cigarettes in the United States.
Details of the FDA Ban
Affected Flavors and Nicotine Concentrations:
- The order encompasses a variety of flavors including tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, and iced banana.
- These products are offered in nicotine concentrations ranging from 2% to 6%.
Special Note on “Clear” Flavor:
- Among the flavors included in the ban is a line described as flavorless or unscented, known as “Clear.”
- Investigations revealed that these “Clear” products contain ingredients that enhance taste or impart mint or menthol flavors. Based on these findings, the FDA determined that these products have characteristic flavors, which contributed to the ban.
Background and Previous Controversies
This is not the first time Shenzhen Yibo Technology has been involved in regulatory disputes. In October 2018, Juul Labs initiated a Section 337 investigation against the company, signaling ongoing concerns about compliance and product standards in the vaping industry.
Implications of the MDO
The FDA’s decision to issue an MDO against Shenzhen Yibo Technology underscores a stringent approach to regulating the e-cigarette market, particularly concerning product flavors that may appeal to younger demographics. This action reflects the agency’s commitment to enforcing existing regulations to prevent misleading practices and ensure consumer safety in the vaping sector.
As the situation develops, companies in the industry must navigate these regulatory landscapes carefully to align their products with FDA standards and avoid similar punitive actions. For consumers, it remains crucial to stay informed about the legal status of the products they choose to use.
