
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.
We welcome news tips, article submissions, interview requests, or comments on this piece.
Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn
Notice
1. This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.
2. The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.
3. This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.
4. Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.
Copyright
This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.
For copyright-related inquiries, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.
We welcome any corrections or feedback. Please contact us at: info@2firsts.com