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Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path

Executive Summary

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

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Tests Show CBD Levels In Some Supplements Don't Match Labeling

Seven of 10 CBD-containing supplement products tested in a lab did not contain the levels of CBD advertised on the label, says hemp, CBD and natural health product information publisher Remedy Reviews. Most products also were found to contain heavy metals.

FDA Warns 15 CBD Product Marketers For Violations, Cautions Consumers: CBD May Harm You

The agency announces that it cannot conclude cannabidiol is GRAS, potentially heading off GRAS notifications and making NDI notifications a likelier future for CBD use in the supplement sector if any “lawful pathway” is to be found. In addition to a barrage of warning letters to marketers of CBD products, the FDA issued a stark warning to consumers about potential hazards.

FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks

There's a reason the FDA continues accepting comments on questions about using hemp- and cannabis-derived ingredients in products other than drugs months after the comment period closed. "It's safe to say say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on," says Sharon Mayl, senior advisor for policy in the commissioner's office.

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