March 25, 2020

Faegre Drinker Team Discusses Cannabidiol’s Safety Status With the FDA

As cannabidiol (CBD) products flood the dietary supplement market, the U.S. Food and Drug Administration (FDA) has been slow to enact a regulatory framework for lawful use.

As reported by Informa Pharma Intelligence, the FDA’s lag may be due to its belief that hemp-derived food and supplements aren’t unsafe.

Partners Heili Kim and Libby Baney, and counsel Kevin Boot, commented on the FDA’s approach to HBW Insight’s Informa Pharma Intelligence.

Ultimately, the FDA’s approach leaves consumers and the U.S. Congress idling. According to Baney, they’re waiting for, at minimum, a timeline from the FDA to address the substantive issues regarding regulatory frameworks.

But the FDA has been sitting around, according to Kim, who cited 15 warning letters from November 2019 to manufacturers of CBD products. The warnings targeted products that would most likely impact the elderly, children and terminally ill patients.

According to Boot, not all CBD-derived supplements and products are being treated equally. As reported by HBW, CBD transdermal patches are at high risk of regulation because of the way they deliver CBD to the consumer—through skin contact rather than through ingestion
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