Tuesday, December 01, 2020 5:15:36 PM
FDA CBD Regulations
The Senate Appropriations report also asks the FDA to temporarily back off its enforcement of CBD until more of a regulatory structure has been put in place. "Within 90 days of enactment of [the appropriations bill], the FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp …. Such enforcement discretion shall be in effect until the FDA establishes a process for stakeholders to notify the FDA of use of CBD in products that include safety studies for intended use per product and makes a determination about such product."
Miller says that this language is an important step to address the FDA's position that it is illegal to sell ingestible hemp-derived CBD products. "I'm encouraged by it because … it demonstrates bipartisan congressional support" for the sale of CBD products. However, he doubts that this will have much immediate effect because the report language is not binding. The FDA has also historically not paid much attention to such Congressional pronouncements.
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