FDA Road To Decision On Expanding CBD Uses Starts With Weighing Impact On Existing And Future Use As Drug
At public hearing, FDA officials starting with acting Commissioner Sharpless emphasized CBD is approved only as a drug and deciding on allowing its use in any other type of FDA-regulated product will be done with potential impact on drug development foremost in agency's thinking. Also apparent from questions 12-member panel of FDA officials asked was a potential regulatory pathway for clearing hemp and CBD as dietary ingredients will require resolving concerns about the substances' dose or concentration levels and establishing ingredient identity standards.
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FDA warns BioLyte Laboratories and Honest Globe about making OTC drugs with cannabinoids. Firms also advised about GMP problems and that labeling cannabinoids as inactive ingredients doesn’t make their use compliant.
Legislation some states have passed is unclear and sometimes conflicts with state enforcement agencies’ policies, attorneys commented during recent FDLI conference. In states without a law, many marketers incorrectly assume sales of hemp-derived CBD in those states are legal under the 2018 farm bill.
CFSAN regulatory affairs chief Douglas Stearn says a regulatory pathway wouldn’t be an open door for CBD-containing food and supplements due to concerns about the ingredients’ safety. Legislation from Congress might "do something with CBD that’s different than the rest of the Food, Drug and Cosmetic Act," he says.