States Cloud US CBD Supplement Market With Patchwork Of Laws While Waiting For FDA To Act
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.
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Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.
Latest warning letters published by FDA include not only two more about claims for supplements to prevent or treat the disease caused by the novel coronavirus, but also warnings about good manufacturing practices violations and noncompliant claims for CBD-containing products and for a detoxification line.
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.