On January 22, 2024, the US FDA issued a Marketing Denial Order (MDO) to Vape manufacturer Bidi Vapor for its Bidi Stick – ClassicVape, a closed tobacco-flavored disposable Vape.
The FDA requires Bidi Vapor not to market or distribute this product in the United States or face FDA enforcement action. In addition to ensuring that manufacturers comply with the order, the FDA also intends to ensure that distributors and retailers comply with the order. Bidi Vapor may submit a new application to the FDA for review.
The FDA said that after reviewing the company’s PMTA application, it determined that the application lacked sufficient evidence to demonstrate that allowing the product to be marketed would be appropriate to protect public health, a standard required by law under the Family Smoking Prevention and Tobacco Control Act of 2009. Specifically, the evidence submitted by the applicant did not demonstrate that the product had an overall net benefit to people who use tobacco products and lacked sufficient evidence to address the health risks.
Since 2020, the FDA has received PMTAs for more than 26 million tobacco products, the vast majority of which are vapes, and made decisions on 99% of those applications. To date, the FDA has approved only 23 tobacco-flavored vape products and devices. The distribution or sale of illegally marketed products will be subject to compliance and enforcement actions, the FDA said.