Breeze Smoke, LLC v. FDA
Breeze Smoke, LLC v. FDA (U.S. Court of Appeals, 6th Circuit, Nov. 12, 2021): The 6th Circuit rejected a vape company’s request to block the FDA’s denial of their application and to be permitted to continue to sell their products. Because the application, which is required by federal law, was rejected, the company may no longer sell its products. The company claimed the FDA’s review of its application was inadequate and that denial of the application contradicted the agency’s 2019 statement that they would consider evidence of products’ public health implications that did not include long-term studies. The court concluded that the FDA’s review of the company’s application, while “possibly insufficient,” did not rise to the level of inadequacy warranting judicial action. Further, the court determined that the FDA’s 2019 statement was not binding and did not commit the agency to considering marketing applications without long-term studies. It only suggested that FDA might consider such applications. The 6th Circuit in this case expressly rejected a 5th Circuit decision against the FDA on similar facts, generating the possibility of Supreme Court Review. Read the full decision here.