Legal & Regulation
Former Head of FDA Scott Gottlieb Proposes Regulatory Plan for CBD
Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration, presented his potential regulatory scheme concerning CBD last week. During the presentation, he posed the question of whether the FDA can oversee the quality of the substance, along with its purity and potency.
Gottlieb first recommended generating regulations for CBD supplements. Although they have become widely available, the cannot be marketed because the FDA has not developed rules concerning their marketing. He also added that regulators could place the onus on CBD producers to ensure that the products are safe at low levels and that manufacturing standards, purity, and minimum levels are being adhered to.
He also touched upon the safety of the products, stating that it must be the first principle, and that appropriate claims must be grounded in science. He also added that CBD is not safe and has largely unproven benefits outside a small subset of carefully studied indications.
At this point, there is no indication as to whether the FDA will issue an interim final rule, or what regulations will be implemented at all.
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