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NDI draft guidance

NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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.

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Workshop to explore the impact of NDI draft guidance, final GRAS rule for probiotics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

More NDI training needed: A pulse on the dietary supplements industry

More than half (56%) of dietary supplement professionals said they haven’t read the Aug. 11 NDI guidance—and 6% said they haven’t read it, but told their boss that they did.

Innovation hot spot lies at overlap of 'natural,' science and sustainability, expert says

The drive toward shorter, cleaner labels and the oft-mentioned dearth of innovation in the supplement sphere are both factors of the maturation of the dietary supplement  and functional foods industries,...

From nanotechnology to master files, 5 things to think about from FDA's new NDI draft guidance

From ingredient combinations to supercritical CO2 extraction to nanotechnology, here are some things to note from the new NDI draft guidance FDA released Aug. 11.

Guest article

NDIs: When to file, what FDA wants to see, and how companies can protect themselves

Over the last few years, the FDA has zeroed in on the dietary supplement industry.  It has taken numerous actions against dietary supplements where it believes the ingredients pose health...

FDA rules vinpocetine not a legal dietary ingredient despite successful NDI filings

In what has been called an ‘unprecedented’ move, the Food and Drug Administration has initiated a proceeding to take vinpocetine off the market despite a number of successful NDI notifications...

NPA asks for NDI comment period extension

The Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.

UNPA on the NDI draft guidance: ‘The economic cost to industry could be billions of dollars’

In addition to the areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the...

Self-affirmed GRAS omitted from new NDI draft guidance

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...

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