FDA Issues MDOs for Multiple E-Cigarette Products

According to a report from American media CSNews on January 23rd, the US Food and Drug Administration (FDA) has recently issued Market Denial Orders (MDOs) for multiple products from companies such as Bidi Vapor, Shenzhen Youmi Information Technology Co., Ltd., Fontem US, and Shenzhen IVPS Technology Co., Ltd. These products include Bidi Stick Classic e-cigarettes, Suorin Air rechargeable e-cigarettes, Suorin empty pods, blu PLUS+ e-cigarette batteries, seven types of pre-filled e-liquid for blu PLUS+ e-cigarettes, and 22 different SMOK brand e-cigarette products.

The FDA emphasized public health standards that consider the risks and benefits to the entire population when evaluating Pre-Market Tobacco Product Applications (PMTA). After reviewing PMTAs from companies like Bidi Vapor, the FDA determined that these applications lacked sufficient evidence to demonstrate that allowing these products on the market would be beneficial for public health, thus violating the legal standards set by the 2009 Family Smoking Prevention and Tobacco Control Act. 

Brian King, director of the FDA's Center for Tobacco Products, stated, "Thorough scientific review is a key pillar of FDA regulation. It is the responsibility of applicants to ensure that PMTAs contain sufficient scientific evidence to meet statutory public health standards, and in these cases, such evidence was lacking."

Bidi Vapors, a company well-known for its e-cigarette products, expressed disappointment with the recent decision made by the Food and Drug Administration (FDA), while emphasizing that the impact is limited to just one of their products. Bidi CEO, Niraj Patel stated, "Bidi Vapor is currently evaluating this opinion based on its essence. In the meantime, this decision only affects our 'Classic' or tobacco-flavored product. The remaining 10 flavors are still under scientific review and available for sale. At present, we are exploring legal remedies and expect to provide updates within the next few days. In the meantime, we urge our wholesalers and retail partners to reach out to our sales representatives for any queries they may have.

Due to MDO, Bidi, or other companies are prohibited from selling or distributing the products listed in the United States market without FDA risk enforcement action. The FDA may require distributors or retailers to comply with regulations as part of its recent efforts to strengthen enforcement of illegal tobacco products.