FDA Warns Four Companies for Selling Unapproved Animal Drugs That Contain CBD

FDA Warns Four Companies for Selling Unapproved Animal Drugs That Contain CBD
Cannabtimes

<![CDATA[A handful of companies have landed in the crosshairs of the U.S. Food and Drug Administration (FDA) for illegally selling unapproved CBD products intended for use in food-producing animals.The FDA announced May 26 that it had issued warning letters to four businesses—Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest—for violating the Federal Food, Drug, and Cosmetic (FD&C) Act.“Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug,” FDA officials wrote in the announcement. “The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children.”That prescription drug, Epidiolex, was approved in 2018, and the FDA considers all other CBD products that are intended for use as a drug as unapproved drugs that remain illegal to sell, according to the agency’s release.RELATED: DEA Greenlights Epidiolex. What’s Next for CBD and the Cannabis Industry?The companies that received the warning letters claim that their CBD products help “farm animals with stress, anxiety, pain, inflammation [and] injuries,” and provide “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, [and] maintain a normal inflammatory response,” according to the FDA’s announcement.These claims, FDA officials said, establish the indented use of the products as drugs.“Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved…

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Source : FDA Warns Four Companies for Selling Unapproved Animal Drugs That Contain CBD

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