FDA Provides Updated Report to Congress Regarding Regulatory Pathways for CBD-Infused Products

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FDA Provides Updated Report to Congress Regarding Regulatory Pathways for CBD-Infused Products

Thursday, 02 April 2020
Washington, DC: Representatives from the US Food and Drug Administration (FDA) have recently provided a report to members of Congress with respect to the safety and marketing of commercially available CBD products.

The report reiterates the agency's longstanding position that the majority of commercially available CBD-infused products are marketed in a manner that is inconsistent with the Food, Drug & Cosmetics Act. Specifically, the agency states, "It is not currently lawful to add CBD to human or animal food, ... [and] CBD products cannot be lawfully sold as dietary supplements." The agency additionally states that CBD-infused vape products "cannot be marketed without FDA-approved drug applications." It issued similar guidance for CBD-branded cosmetic and topical products that are "intended to affect the structure or function of the body, or [that are] intended for therapeutic use."

The FDA acknowledged that many commercially available products are of variable quality and potency, and may contain contaminants or elevated levels of heavy metals. It stated, "FDA intends to continue monitoring the marketplace, and to initiate and expand appropriate compliance and enforcement actions against unlawful CBD products that pose the greatest risk harm to the public."

The agency said that it is continuing to evaluate safety information regarding CBD consumption. Specifically, it "is actively evaluating what and how much data would be sufficient to support a conclusion that CBD can be safely allowed in dietary supplements under certain conditions." The FDA acknowledged that CBD products could ultimately be permitted to be marketed in such a manner, but that allowing such activities would require explicit changes to the agency's current rules.

It concluded, "We recognize the high level of interest in dietary supplements as potential pathways for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements." The agency added, however, that doing so would present "certain challenges," including potentially discouraging clinical investigations of the cannabinoid by drug development companies.

In 2018, Congress enacted explicit language amending the US Controlled Substances Act so that hemp plants containing no more than 0.3 percent THC and/or cannabinoids extracted from said plants, are no longer federally prohibited by the CSA.

Full text of the FDA report is available online. Additional information is available from the NORML fact-sheet, "FAQs About Cannabidiol (CBD)."


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