The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says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.
The new dietary ingredient (NDI) draft guidance, as it stands, will not help achieve the objective of full and efficient implementation and enforcement of DSHEA, says the United Natural Products Alliance (UNPA), as it adds its voice to calls for FDA to...
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Food and Food and Drug Administration (FDA) signed by more than 12,000 Americans, calling on the FDA to withdraw its draft guidance...
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all available “legal remedies” should the Food and Drug Administration (FDA) fail to ditch or substantially revise its draft guidance on new dietary ingredients (NDIs).
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.
The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).
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 panel to clarify its contents, according to the American Botanical...
There will be differences in emphasis in comments submitted to the FDA on its draft guidance on new dietary ingredients (NDIs), but the overall message from the supplements industry is clear - and consistent - says the Council for Responsible Nutrition...
While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...
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Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).
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 and the upcoming deadline for NDI comment submissions, say leading...
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 are ignored, said FDA’s Dr Daniel Fabricant.
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 Administration (FDA).
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”, says the chief executive of BI Nutraceuticals.
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 (NDI) draft guidance have prompted an unprecedented...
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.
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 association is proposed.
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 Programs tells NutraIngredients-USA.
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.
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 argued.
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’.
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 the New Dietary Ingredient (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.
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’.
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 ‘insufficient’.
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 consistent with the legislation he co-authored, his office...
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 to finished products, not ingredients, one industry leader...
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 draft guidance on new dietary ingredients (NDIs).
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.
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 ingredients) or even withdraw it altogether, according to food law attorney Jonathan...
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 without devastating the dietary supplements industry, trade associations...
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 attorney.
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 back into its soups. But with good reason, according...
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 is “trying to dismantle” the legislation it is supposed to be clarifying.
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 fresh safety analysis eminently reasonable if extraction...
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.
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 ingredients (NDIs) during a spirited conference call with stakeholders...
Big interview: Daniel Fabricant, Food and Drug Administration (FDA)
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 surprised by it, according to the man in charge of the FDA’s dietary supplements...
While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they cannot pretend they didn’t see it coming, Herbalife’s Vasilios...
While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade, this is actually quite unlikely,...
The amount of safety data the FDA now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified DSHEA and establishes a process “ominously like the one for new food additives”, the Council...
If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.
Preliminary analysis of draft guidance on new dietary ingredients used in supplements appears to confirm many of the trade's worst fears, according to food law experts.
The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.
The safety of probiotics should be evaluated at the species and not the strain level when considering possible New Dietary Ingredients notifications, according to a new position paper by three leading probiotic groups.
Fears are mounting that the Food and Drug Administration’s (FDA’s) long-awaited guidance on new dietary ingredients (NDIs) could prove a “game changer” for the industry, and not in a good way.
