NDI draft guidance

PEAs harder to control than were steroids, experts say

PEAs harder to control than were steroids, experts say

By Hank Schultz

The presence and proliferation of phenylethylamines in sports nutrition products continues to be a thorn in the side of the dietary supplement industry.  But trying to regulate these ingredients away is not nearly as straightforward as was the case with...

© iStock/Jezperklauzen

IPA recommends expanded grandfathered list for probiotics

By Stephen Daniells

The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.

NPA urges FDA to back off in applying food additive standards

NPA urges FDA to back off in applying food additive standards

By Hank Schultz

The Natural Products Association has urged FDA to cease its attempt to apply  food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.

Algae Health Sciences gets NDI for high dose astaxanthin

Algae Health Sciences gets NDI for high dose astaxanthin

By Stephen Daniells

The US Food and Drug Administration has accepted a New Dietary Ingredient (NDI) notification from Algae Health Sciences, Inc., a subsidiary of BGG, for high-dose but limited duration astaxanthin dosing.

Vinpocetine is derived from vincamine obtained from the lesser periwinkle plant (Vinca minor L.). Image © Ryan Kaldari

Linnea requests FDA to withdrawal vinpocetine notice

By Stephen Daniells

Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.

© iStock / Jezperklauzen

13 things we learned from the IPA’s DC Workshop

By Stephen Daniells

From market sizing to the positions from FDA and FTC on NDIs and claims substantiation, the International Probiotic Association’s DC workshop succeeded in providing a venue for sharing knowledge and expertise.

Lesser Periwinkle Plant (Vinca minor). Image © Ryan Kaldari

Senator Hatch urges withdrawal of vinpocetine notice

By Stephen Daniells

Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.

© iStock / studioportosabbia

Ten things to change about DSHEA

By Stephen Daniells

If you could change one thing about the Dietary Supplements Health & Education Act, what would it be? Ten industry lawyers weighed in…

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.’

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.

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…

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