FDA Issues Multiple Warnings to Companies Illegally selling CBD Products
On December 22, 2020 the U.S. Food and Drug Administration (FDA) issued warning letters related to the sale of CBD products to Bee Delightful, G&L Wellness (C Better Daily), New Leaf Pharmaceuticals, NextL3vel Services Group LLC as This Stuff is Good For You and Wellness BioSciences. The individual letters can be found through links in the original memo posted by the FDA.
The FDA made note that the products in question were especially concerning due to their method of administration whether through inhalation or eye treatment. The FDA cites the Food, Drug and Cosmetic Act (FD&C Act) in determining the legality of selling and marketing CBD Products. The FD&C outlines the strict regulations for gaining approval for the sale of CBD products that claim to prevent, diagnose, mitigate, treat or cure diseases. Here, special attention was given to the methods of ingestion and further violations were identified in some cases due to CBD being added to food and potentially marketed as dietary supplements.
The FDA considers drugs to be all products intended to diagnose, cure, mitigate, treat or prevent a disease while also possibly affecting the structure or function of the body. Therefore, all products falling under this description are subject to FDA regulation and those that have not gone through the official approval process are considered unapproved new drugs. Currently the FDA has only approved of one prescription drug that contains CBD that is used specifically for the treatment of seizures associated with particular illnesses.
The FDA has requested responses from the five companies that have been issued warnings. The FDA is requesting that the companies provide an action plan for addressing the issues identified in the warnings or an explanation as to why the companies believe that they may not be in violation of the FDA regulations.
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