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NDI draft guidance

NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy. NutraIngredients-USA has collected analysis and insights from the leading players in the industry, from the trade associations to leading manufacturers and the FDA itself.

FDA continues to ‘carefully review’ vinpocetine comments

The US Food and Drug Administration has received over 800 comments about vinpocetine, as the agency continues to assess the regulatory status of the ingredient. 

NDI guidance would over regulate, weaken supplement industry, Jarrow asserts

The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently...

IPA recommends expanded grandfathered list for probiotics

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.

Sen McCaskill calls on FDA to quickly finalize NDI guidance

Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.

UNPA brands FDA's finished product focus in NDI guidance as unworkable and unlawful

Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products...

NPA urges FDA to back off in applying food additive standards

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,...

Experts recommend kratom & CBD players file NDIs first, before asking for new product category

Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those...

FDA open to notion that new fermentation medium doesn't change probiotic identity, expert says

A recent presentation to FDA that was well received made the case that simple changes in fermentation media would not result in the creation of a New Dietary Ingredient.

Bodybuilding.com urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

Dietary supplement retailer bodybuilding.com  has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master...

Algae Health Sciences gets NDI for high dose astaxanthin

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

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....

‘Pro business’ is best guess when looking at character of Trump administration

Donald Trump’s historic victory leaves dietary supplement industry observers wrestling with the question of what will be the character of his administration, when the candidate himself has taken so many...

13 things we learned from the IPA’s DC Workshop

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...

Ten things to change about DSHEA

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

Senator Hatch urges withdrawal of vinpocetine notice

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.

Workshop to explore the impact of NDI draft guidance, final GRAS rule for probiotics

A workshop hosted by the International Probiotics Association (IPA) in Washington, DC will tackle some of the key issues facing the probiotics sector, including positions from FDA and FTC on...

NDI innovation 'pause' looks more like a freeze, UNPA chief says

According to UNPA president Loren Israelsen there has been plenty of recent innovation within the dietary supplement despite complaints to the contrary. But the NDI draft guidance could bring that...

DEA ends emergency kratom listing, begins more protracted proceeding

Under the combined pressure of industry and lawmakers, the federal Drug Enforcement Administration has backed off its emergency listing of kratom to the schedule 1 list of controlled substances.

‘Several points in the NDI draft guidance should not apply to probiotics’: Expert

The NDI draft guidance contains several points that are potentially issues for probiotics, and there appears to be a disconnect with the GRAS (generally recognized as safe) process, says a...

ChromaDex CEO says new NDI guidance could be tool to clean up marketplace

The NDI draft guidance offers a workable road map for companies willing to provide the safety information already called for by law, according to one ingredient supplier.

Panel explores issue of how best to live with NDI provisions

The consensus of a recent industry session on NDIs was this: The draft guidance is here to stay. You’d best learn to deal with it.

FDA extends NDI comment period to Dec. 12

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.

Guest article

New Dietary Ingredients (NDI)– A Better Solution

“Antagonistic cooperation is the principle of all markets and many marriages.” - Mason Cooley

Special edition: botanicals

NDI guidance will dampen innovation in botanicals, experts say

The NDI draft guidance as written will squelch innovation in botanical ingredients, experts have said.

NPA to develop ‘safe harbor’ list for dietary ingredients

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...

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