NDI draft guidance

NPA asks for NDI comment period extension

NPA asks for NDI comment period extension

By Hank Schultz

The Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.

© iStock / Olgaorly

Self-affirmed GRAS omitted from new NDI draft guidance

By Stephen Daniells

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

AMA warns members about rise of nootropics

AMA warns members about rise of nootropics

By Hank Schultz

A new policy by the American Medical Association on nootropics once again highlights the blurred edges of what can legitimately be called a ‘dietary supplement.’

Image: © iStockPhoto / Zzvet

Pressure mounts for regulatory clarity on CBDs

By Hank Schultz

The recent spate of FDA warning letters on the use of CBD as an ingredient in dietary supplements seems to have done little to dampen formulators’ enthusiasm for its use in new products. The situation is unprecedented in the herbal products sphere, observers...

FDA seizes $400,000 worth of kratom products in Illinois

FDA seizes $400,000 worth of kratom products in Illinois

By Hank Schultz

Despite an import ban on the substance, kratom-containing products continue to find their way into the country. In the latest action, the Food and Drug Administration has seized 90,000 bottles at a facility in Illinois.

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