The U.S. Food and Drug Administration (FDA) has issued an update for consumers explaining its investigations into cannabis and cannabis-derived compounds, including cannabidiol (CBD). The agency indicates that it is “working to learn more about the safety of CBD and CBD products,” specifically: (i) “[t]he effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time”; (ii) “[t]he cumulative exposure to CBD if people access it across a broad range of consumer products”; (iii) “[t]he effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class)”; and (iv) “[t]he safety of CBD use in animals (e.g., species, breed, or class) including pets.”

FDA also advises that “unapproved CBD drug products have not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation regarding whether they are safe and effective to treat a particular disease, what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.” Further, “FDA has also tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. We have also heard reports of CBD potentially containing contaminants (e.g., pesticides, heavy metals); we are looking into this.”

Sen. Ron Wyden (D-Ore.) issued a letter urging FDA “to issue guidance announcing a formal enforcement discretion policy by August 1, 2019, and—pending publication of a permanent final rule—issue an interim final rule that ensures a regulatory pathway for lawful use of CBD as a food additive and as a dietary ingredient in dietary supplements.”

“I appreciate FDA’s current risk-based enforcement approach toward hemp-derived CBD products in the marketplace, which has focused on those firms making egregious disease claims not otherwise permitted for conventional foods or dietary supplements,” Wyden states. “I view this approach as absolutely critical for the advancement of this new and rapidly growing industry. However, absent formal enforcement discretion guidance, hemp producers and their customers will continue to be left in a regulatory gray zone. … I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable. The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time.”

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.