It's Complicated: FDA Prohibits CBD In Supplements, Enforcement Priority On Disease Claims
This article was originally published in The Rose Sheet
As FDA announces its first-ever approval of a drug that contains a substance derived from marijuana, officials say the agency's policy that prohibits CBD's use in dietary supplements or food will not change. They also say, however, that FDA's priority for enforcement actions against dietary supplements containing CBD, an extract from cannabis and hemp plants, will remain on products marketed with drug or disease claims.
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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.
Everywhere In Supplements And Food, Is Hemp Safe Enough To Be Lawful? US FDA Wants Science Board's Help Solving Regulatory Conundrum
FDA says Science Board, “utilizing cannabinoids as a case study,” will consider challenges in evaluating safety of “ingredients with predicted pharmacological activity” used in supplements and food. Other ingredients also used in supplements and food also could be on its radar, but for good reason cannabinoids are focus of Science Board discussion.
Leading discussions on CBD safety as a dietary ingredient and developing best-practices guidance were natural steps for AHPA. "We were viewing it as another botanical product, another one of the type of products that we’ve been dealing with throughout our history," said program development director Jane Wilson.