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NDI draft guidance
The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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.
Dispatches from SupplySide West
NDI draft guidance release is ‘curious timing’: BI chief
The timing of the release of the new dietary ingredient (NDI) draft guidance is “curious” given pressing economic/resource issues and “far more serious issues that FDA should be looking at”,...
News in brief
NDI guidance prompts unprecedented level of grassroots activism, claims ANH-USA
Attempts by health advocacy group the Alliance for Natural Health USA (ANH-USA) to drum up ‘grassroots’ support for its campaign against the Food and Drug Administration's (FDA’s) New Dietary Ingredient...
Readership split on need for new trade association
NutraIngredients-USA’s readership is torn over the issue of whether the dietary supplements industry needs a new trade association, according to results of a recent poll.
AHPA: Work with existing trade associations, a new one isn’t needed
Dietary supplement companies should work with the existing trade associations to properly address the NDI draft guidance, says the American Herbal Products Association (AHPA), as a new dietary supplement trade...
FDA’s Fabricant: ‘Unreasonable risk’ has nothing to do with efficacy
The issue of ‘unreasonable risk’ in the NDI draft guidance is not about efficacy, despite what some industry personalities have said, the director of the FDA’s Office of Dietary Supplement...
Jarrow Rogovin proposes new supplement trade association: There's no need, say existing associations
The dietary supplements industry may have a new trade association, as Jarrow Rogovin, founder and president of Jarrow Formulas, proposes the creation of the DSMMA.
Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'
The Food and Drug Administration (FDA) is “willfully and grossly misinterpreting the law” by making new dietary ingredient (NDI) submissions product-specific rather than ingredient-specific, advocacy group Citizens for Health has...
FDA has ‘grossly underestimated’ NDI notification process, CRN tells OMB
The Council for Responsible Nutrition (CRN) has told the Office of Management and Budget (OMB) that FDA has ‘grossly underestimated the NDI notification process’ burden’.
Jarrow Formulas challenges FDA on NDIs with 128-item Freedom of Information request
California-based Jarrow Formulas has submitted a 128-item Freedom of Information Request to the US FDA with questions it deems ‘vital’ to any comments it seeks to file in response to...
FDA grants comment period extension for NDI draft guidance
The US Food & Drug Administration (FDA) has granted a 60-day extension to the comment period for the New Dietary Ingredient (NDI) draft guidance, NutraIngredients-USA.com can reveal.
Trade associations: 45-day NDI draft guidance extension request ‘reasonable’
The request from the main trade associations to extend the period for comments on the NDI draft guidance is ‘reasonable’ and the result of ‘carefully weighing the matter at hand’.
Jarrow Formulas calls for 1 year NDI draft comment extension
California’s Jarrow Formulas has called for an extension of the comment period on the FDA’s NDI draft guidance to one year, claiming that the current 90 day comment window is...
DSHEA co-author is ‘alarmed’ by NDI guidance
The chief architect of the 1994 Dietary Supplement Health and Education Act (DSHEA) does not believe the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) is...
AHPA: FDA will be 'laughed out of court' if it sticks to its guns on supplement-specific NDI notifications
The FDA will be “laughed out of court” if it tries to defend enforcement action against supplement manufacturers based on the argument that new dietary ingredient (NDI) notifications should apply...
Hatch NDI guidance meeting: File comments for now, then explore legal avenues …
A range of options – “judicial, administrative and Congressional” – is being explored by the dietary supplements industry should the FDA prove unwilling to make substantial changes to its controversial...
Ullman: NDI guidance creates ‘new dietary supplement’ notification process
The New Dietary Ingredient (NDI) draft guidance represents ‘rulemaking by guidance’ and should immediately be ‘withdrawn and revised’, says New York-based law firm Ullman, Shapiro & Ullman, LLP.
Emord on NDI guidance: Politics has prevailed over science and common sense
If sufficient pressure is exerted on key members of Congress, it is not beyond the realms of possibility that the FDA might suspend its draft guidance on NDIs (new dietary...
Supplements trade: NDI guidance can be salvaged, but give us more time
If stakeholders are granted more time to respond to the FDA’s draft guidance on new dietary ingredients (NDIs), it should be possible to reach a compromise that will satisfy regulators...
‘No logic’ to FDA view on product-specific NDI notifications, says lawyer
There is “no logic” to the FDA’s insistence that NDI (new dietary ingredient) notifications are applicable only to the specific manufacturer that submits them, according to one leading food law...
NDI guidance poll verdict: It’s catastrophic ...
A seemingly innocuous draft guidance document outlining the FDA's views on new dietary ingredient (NDI) notifications has provoked almost as much hysteria as Campbell Soup's move to put some salt...
Lawyer on NDI guidance: FDA is trying to ‘dismantle’ DSHEA
The argument that the FDA has overstepped its legal remit in its draft guidance on new dietary ingredients (NDIs) is gaining ground, with one food law expert claiming the FDA...
Toxicologist: FDA’s NDI guidance is entirely reasonable
Many dietary ingredients used in supplements today bear little resemblance to ingredients that were assumed to be ‘grandfathered in’ post the 1994 Dietary Supplements Health and Education Act, making a...
ABC on NDI guidance: ‘We find this problematic’
The American Botanical Council (ABC) has weighed into the debate over the Food and Drug Administration’s (FDA’s) draft guidance document on new dietary ingredient (NDI) notifications.
Lawyer: FDA line on grandfathered ingredients was not made clear
A leading food law expert and the Food and Drug Administration’s (FDA’s) dietary supplements chief agreed to disagree over several key aspects of the FDA’s draft guidance on new dietary...
Big interview: Daniel Fabricant, Food and Drug Administration (FDA)
FDA on NDI guidance: This is ‘not a doomsday scenario’ for supplements trade
The trade can rail against the Food and Drug Administration's new dietary ingredient (NDI) guidance as much as it likes, but it cannot honestly pretend to be shocked or even...
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