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NDI draft guidance
The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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.
Plant proteins, ‘pill fatigue’ and ‘abominable’ weight loss ads: A year in supplements…
Could 2012 be the year for canola protein to shine? Will a dietary solution to the ticking time bomb of type 2 diabetes finally make it big in the supplement...
ABC: Solvents white paper could help inform NDI debate
An authoritative new guide to 23+solvents used in the production of botanical extracts for dietary ingredients could help inform the debate on ‘chemical alteration’ at the heart of the FDA’s...
The agony and the ecstasy: A year in the life of the trade association…
Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as...
USPLabs hit with class action over DMAA in Jack3d and OxyELITE
The regulatory status and safety of DMAA, a stimulant used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, has been...
News in brief
Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response
While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law...
Jarrow: FDA's talk of spiked supplements in context of NDI debate is 'highly disingenuous'
Food and Drug Administration (FDA) references to safety concerns over supplements spiked with drugs in the context of the debate on new dietary ingredients (NDIs) are “highly disingenuous”, Jarrow Formulas...
News in brief
UNPA webinar to explore NDIs ‘what now?’ with FDA
The United Natural Products Alliance (UNPA) will host a webinar on Wednesday December 21 with FDA’s Daniel Fabricant, PhD, to discuss the 7,000+ comments filed on the new dietary ingredients...
NDI draft guidance comments
Lawyer: NDI draft guidance raises ‘significant intellectual property issues’
Requiring supplement manufacturers to submit new dietary ingredient (NDI) notifications will force them to seek confidential information from suppliers in order to file submissions, according to law firm Amin Talati.
NDI comments review: Industry urges FDA back to the drawing board
One week on from the deadline for submission of comments on the FDA’s new dietary ingredients (NDI) draft guidance, we review the comments.
NDI draft guidance comments
IPA: We do not see NDI draft guidance as 'death sentence' for probiotics industry
The only probiotics that should be subject to new dietary ingredient (NDI) notifications should be “new probiotics derived from GM engineering which have little to no history of safe use”,...
Novel extraction method should not trigger automatic NDI notification, says USP
Botanical extracts that have been on the market for years should not automatically be treated as new dietary ingredients (NDIs) just because extraction methods have changed, according to the United...
NDI Draft Guidance Comments
Trade associations united in calls for ‘substantial overhaul’ of NDI draft guidance
The five main trade associations for the dietary supplements industry are united in their calls for a ‘timely’ and ‘substantial overhaul’ of the draft guidance, according to a joint statement.
!["The Draft Guidance, in its current form, [...] is tantamount to obtaining FDA approval for dietary supplement products" Atrium](/var/plain_site/storage/images/publications/food-beverage-nutrition/nutraingredients-usa.com/regulation/atrium-innovations-on-ndis-the-system-isn-t-broken-so-why-fix-it/5911059-1-eng-GB/Atrium-Innovations-on-NDIs-The-system-isn-t-broken-so-why-fix-it_dnm_thumb.jpg "\"The Draft Guidance, in its current form, [...] is tantamount to obtaining FDA approval for dietary supplement products\" Atrium")
NDI Draft Guidance Comments in brief
Atrium Innovations on NDIs: The system isn’t broken, so why fix it?
The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.
NDI Draft Guidance Comments
UNPA: NDI draft guidance is ‘needlessly burdensome’ & does not advance overall safety of dietary supplements
The new dietary ingredient (NDI) draft guidance, as it stands, will not help achieve the objective of full and efficient implementation and enforcement of DSHEA, says the United Natural Products...
NDI draft guidance comments
ANH-USA: 'Unworkable and irrational’ NDI guidance is rulemaking by the backdoor
Health advocacy group the Alliance for Natural Health USA (ANH-USA) is exploring all available “legal remedies” should the Food and Drug Administration (FDA) fail to ditch or substantially revise its...
NDI draft guidance comments
FDA history of safe use definition is ‘arbitrary and unfounded’, says pre/probiotics group
The International Scientific Association for Probiotics and Prebiotics (ISAPP) has urged the Food and Drug Administration (FDA) to rethink its approach to live microbial dietary ingredients.
NDI draft guidance comments
Citizens for Health NDI guidance withdrawal petition signatures approach 15,000
Health advocacy group Citizens for Health (CFH) has delivered a petition to the House of Representatives, the Senate and the Food and Food and Drug Administration (FDA) signed by more...
NDI draft guidance comments
AHPA to FDA: Tear up NDI draft guidance and start again
The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American...
NDI draft guidance comments
ABC: Expert panel should clarify list of grandfathered dietary ingredients
The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert...
NDI draft guidance comments
CRN on NDI draft guidance: ‘A choir has many voices but we’re all singing the same song ‘
There will be differences in emphasis in comments submitted to the FDA on its draft guidance on new dietary ingredients (NDIs), but the overall message from the supplements industry is...
Trade to FDA: Don’t leave us in limbo on NDI guidance
While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry...
Jarrow Formulas FOIA request on NDIs: ‘In sum, FDA has told us to drop dead’
Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago...
Proposed 2007 grandfathered date change: Limited chance of success and distraction from NDI comment deadline?
A proposed change to the date defining ‘grandfathered’ dietary ingredients to 2007 shows the industry there are options to the NDI issue, but it should not distract attention from FDA...
FDA on warning letters: ‘We are going to do more than just hand out paper’
The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters...
Herbalife: Six steps to improve functionality of NDI guidance
The functionality of the New Dietary Ingredient (NDI) guidance can be improved in only six steps, says direct selling giant Herbalife in its comments to the US Food and Drug...
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