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Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller & Heckman LLP Partners Eric Gotting and Azim Chaudhry, filed 11 petitions.th The Court of Appeals for the Circuit will review the Food and Drug Administration’s (FDA) order denying a Premarket Tobacco Product Application (PMTA) for BIDI® Stick, a non-tobacco flavored disposable electronic nicotine delivery system (ENDS) device. On August 23, 2022, 11th Although the circuit court granted Bidi’s request for review and reversed and remanded the MDO in a landmark 2-1 majority opinion, the court found that the FDA had not previously reviewed relevant evidence, particularly Bidi’s aggressive and comprehensive marketing. The MDO was deemed arbitrary and capricious. and sales access restriction plans.
Regarding Bidi’s application, the agency did not consider the data and evidence that has long been shown to be critical to the PMTA’s “appropriate to protect public health” (APPH) analysis, particularly “product information.” , scientific safety testing, literature review, consumer insight research, and details about the company’s anti-youth access measures, distribution channels, and adult marketing practices,” and includes “existing adult vaping smokers, including current adult smokers. For product users only.” Also included is Bidi’s retail store surveillance program and state-of-the-art anti-counterfeit authentication system. “An agent’s actions are lawful only if based on a consideration of relevant factors,” and the MDO was deemed arbitrary and capricious because the agent did not consider the marketing and sales access restriction plan. I did.
Accordingly, the court reversed Bidi’s MDO and remanded it to FDA for further review. Since the MDO was published, Bidi has continued to supplement its comprehensive application with additional science, including clinical and behavioral studies that support his product’s APPH status.
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