Draft Guidance

Jarrow challenges FDA on probiotics

Jarrow challenges FDA on probiotics

By Hank Schultz

Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.

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Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.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Self-affirmed GRAS omitted from new NDI draft guidance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The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

House committee admonishes FDA to pick up pace on NDI issue

House committee admonishes FDA to pick up pace on NDI issue

By Hank Schultz

The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance.  The message in a nutshell: Get a move on.

FDA: Inflammation and diabetes raising red flags for tainted products

FDA: Inflammation and diabetes raising red flags for tainted products

By Stephen Daniells in Laguna Beach

Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of CFSAN at FDA.

NDI Draft Guidance Comments in brief

Atrium Innovations on NDIs: The system isn’t broken, so why fix it?

By Stephen Daniells

The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.

Trade to FDA: Don’t leave us in limbo on NDI guidance

Trade to FDA: Don’t leave us in limbo on NDI guidance

By Elaine Watson

While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...

Special Edition: SupplySide West

Special Edition: SupplySide West

By Stephen Daniells

NDI draft guidance, market opportunities, adulteration, a perceived lack of innovation, and the specter of ‘dry labbing’ all got people talking at this year’s SupplySide West show in Las Vegas.

The wait is over: FDA releases NDI draft guidance

Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

By Stephen Daniells

The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.

Quality of nano toxicity data is ‘not great’, says expert

Quality of nano toxicity data is ‘not great’, says expert

By Elaine Watson

The limited nature of many toxicity studies into engineered nanoparticles used in the food and dietary supplements industry makes it very difficult to draw firm conclusions about their safety, according to one expert in the field.

AHPA opposes FDA's CAM guidance

AHPA opposes FDA's CAM guidance

By Clarisse Douaud

In a case that furthers the polemic surrounding regulatory
structure of the dietary industry, the American Herbal Products
Association (AHPA) has issued comments to the US Food & Drug
Administration (FDA) urging the agency to...

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