NDI draft guidance

FDA extends NDI comment period to Dec. 12

FDA extends NDI comment period to Dec. 12

By Hank Schultz

The Food and Drug Administration has extended the comment period on the updated draft version of the New Dietary Ingredients guidance. The new deadline for comments is Dec. 12.

© iStock / Thatpichai

NPA to develop ‘safe harbor’ list for dietary ingredients

By Stephen Daniells

In response to the recently re-released NDI draft guidance, the Natural Products Association (NPA) has said it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients.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Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.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Self-affirmed GRAS omitted from new NDI draft guidance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The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

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.’

Pressure mounts for regulatory clarity on CBDs

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.

Image: iStockPhoto / Lukatme

Looking Ahead at 2016? Be Prepared!

By Steve Mister, president & CEO, the Council for Responsible Nutrition (CRN)

What a difference a year makes! Last January at this time, who in the industry would have predicted the New York Attorney General (AG) debacle in February? Or Senator Dick Durbin’s dietary supplement amendments on the defense authorization bill in May?...

Image: iStockPhoto

The 10 key events of 2015… Our Editors’ selection

By Stephen Daniells

As we enter the twilight days of 2015 the editors of NutraIngredients-USA become a reflective bunch. A lot of things happened this year, and here is our top 10 of most important events of the year…

Image: iStockPhoto

Trade associations unanimous in support of DoJ/FTC/FDA crackdown

By Stephen Daniells

Dietary supplement trade associations have universally welcomed the Department of Justice’s nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.

Durbin, Blumenthal urge FDA to take action against BMPEA

Durbin, Blumenthal urge FDA to take action against BMPEA

By Hank Schultz

US Senators Dick Durbin and Richard Blumenthal sent a letter yesterday to the Food and Drug Administration asking the agency to take action against products containing the synthetic stimulant ingredient known as BMPEA, products which the pair called both “mislabeled...

Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA

Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA

By Hank Schultz

The dietary supplement industry received a welcome breath of fresh air in a meeting of industry representatives with Rep. Ted Lieu, the newly elected Democrat in California’s 33rd Congressional District.  The meeting was arranged by Jarrow Formulas and...

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