NDI draft guidance

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The 18 things we learned from the IPA’s DC Workshop 2017

By Stephen Daniells

From market sizing to the need for global probiotics standards at Codex, the International Probiotic Association’s second DC workshop in collaboration with the US Pharmacopeia succeeded in providing a venue for sharing knowledge and expertise.

FDA continuing to drill down to provenance of ingredients

FDA continuing to drill down to provenance of ingredients

By Hank Schultz

Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...

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Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

By Hank Schultz

A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’ membership.

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.

Linnea requests FDA to withdrawal vinpocetine notice

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.

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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.

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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.

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