FDA says CBD not recognized as safe in food, warns manufacturers

November 26, 2019

FDA cites 15 companies making unsubstantiated health claims.

In a new Consumer Update, FDA said it cannot conclude that cannabidiol (CBD) in food products is safe, and warned 15 companies for illegally selling products with CBD.

The agency’s revised Consumer Update lists safety concerns about CBD products, including liver injury, drug interactions, and male reproductive toxicity.

“Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food,” FDA said in a statement.

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Animal studies have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males, FDA said. “Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.”

FDA also warned 15 companies that are making unsubstantiated claims that their products will cure or treat diseases. Some of the products are marketed at infants and children.

The companies that received warning letters include: Koi CBD LLC, Noli Oil, Natural Native LLC, Whole Leaf Organics LLC, Infinite Product Company, Bella Rose Labs, Apex Hemp Oil, Sunflora, Healthy Hemp Strategies LLC dba Curapure, and Organix Industries.

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“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the statement.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety-including reports of products containing contaminants, such as pesticides and heavy metals-and there are real risks that need to be considered,” Abernathy added.

FDA has previously warned other companies illegally selling CBD products in that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act.

For example, FDA warned Phoenix-based Signature Formulations, about its manufacturing violations as well as marketing CBD-containing products as drugs.Signature claimed that that its Herbal Muscle Gel and Herbal Muscle Mist helps reduce inflammation, arthritis, and back pain, and can be used to treat fibromyalgia, Carpal Tunnel Syndrome, sciatica and other conditions.

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Christine Blank is a contributing writer based out of Florida.