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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Bill Steering Hemp In Supplements To NDI Notification Pathway Introduced For Third Time
Virginia Republican Morgan Griffith has same message for FDA he’s previously stated about hemp ingredients. Agency “has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” he says.
Is US Hemp Policy Heading For Farm Bill, Act III?
It could take next farm bill, on lawmakers’ 2023 to-do list, to extinguish inferno of disagreement between FDA and regulated industries over lawful use of hemp-based ingredients in supplements as well as food and non-drug topicals. Before 2018 bill de-scheduled hemp, 2014 bill expanded access to hemp for research.
Solving US Hemp Regulatory Problem Will Take Wider View Of FDA Rule – AHPA’s McGuffin
FDA, along with supplement and food industries, have looked to Congress to authorizing agency to waive exclusion rule for hemp ingredients. Instead, Michael McGuffin recommends amending DSHEA to clarify that the same ingredients at different concentrations can be allowed in supplements and drugs.