With the volume of omega-3 science tripling in 10 years, the world’s leading omega-3 trade group is working with international regulators to have that research reflected in authorised claims – especially in the EU and the US.
The timing of the release of the new dietary ingredient (NDI) draft guidance is “curious” given pressing economic/resource issues and “far more serious issues that FDA should be looking at”, says the chief executive of BI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.
US companies need to get up to speed with European Union health claim changes or face big hits on existing trade or missed opportunities, according to the chief of a leading UK supplements group.
It might be controversial, but the FDA's draft guidance on new dietary ingredients (NDIs) does not mean the end of the dietary supplements trade as we know it, insists Daniel Fabricant in an exclusive interview with NutraIngredients-USA at SupplySide...
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‘grassroots’ support for its campaign against the Food and Drug Administration's (FDA’s) New Dietary Ingredient (NDI) draft guidance have prompted an unprecedented...
The Canadian government has put forward a proposal for energy drinks to be regulated as foods rather than as natural health products, which could see a raft of new labeling and formulation requirements for energy drinks in Canada.
Israeli nutritional lipids giant Enzymotec has weighed into the patent infringement row engulfing the krill oil industry with a statement from its boss declaring rival Neptune’s new US patent for marine phospholipids ‘invalid’ and ‘unenforceable’ and...
The biggest players in krill oil are at war again - this time over a US patent awarded to Neptune Technologies & Bioressources, which its arch rival argues should never have been granted, and Neptune has immediately moved to enforce in the courts.
Dietary supplement companies should work with the existing trade associations to properly address the NDI draft guidance, says the American Herbal Products Association (AHPA), as a new dietary supplement trade association is proposed.
The issue of ‘unreasonable risk’ in the NDI draft guidance is not about efficacy, despite what some industry personalities have said, the director of the FDA’s Office of Dietary Supplement Programs tells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.
Firms making structure/function claims about foods and supplements in the US could face difficult questions when the final list of general function claims permitted in Europe is released and it becomes clear that scores of products sold in the US feature...
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’.
Recommended Daily Allowances (RDA) and upper safe limits for nutrients in food supplements will be on the agenda this week at a congress in Buenos Aires organised by The International Alliance of Dietary/Food Supplement Associations (IADSA).
The US Food and Drug Administration (FDA) has been urged to continue to use its administrative detention authority sparingly under new food safety regulations, according to comments from the American Herbal Products Association (AHPA).
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).
Supplement makers with products containing free phytosterols should not be prevented from making heart health claims if they can prove their formulations are effective, the Council for Responsible Nutrition (CRN) has argued.
Three more firms have followed Cargill’s lead and submitted petitions to the FDA urging it to rethink plans to amend the criteria for making health claims about phytosterols and heart disease or risk causing “irreparable injury”.
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...
The maker of the melatonin-laced ‘relaxation’ brownies at the center of a debate over where a dietary supplement ends and a food begins says it will make “all necessary changes to market and sell the product as a supplement”.
The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...
The attorney representing Shaping Beauty – the recipient of a recent FDA warning letter claiming multiple violations of the Federal Food, Drug and Cosmetic Act – says her client is cooperating fully with the FDA.
It could be several months before a qualified health claims petition about vitamin D is submitted to the Food and Drug Administration (FDA), according to the lawyer coordinating the application.
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.
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 Food and Drug Administration (FDA) is hoping to publish new rules on how daily values on food labels are calculated this year, something that could have broad ramifications for the dietary supplements trade.
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.
Leading dietary supplement trade associations are lining up to help industry understand the Food and Drug Administration’s draft guidance for new dietary ingredients (NDI) and the potential implications.
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...
A proposal to overturn a ban on the use of hemp seeds in food products in Australia could see the use of the staple in food products available in the country.
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 Dietary Supplement Labeling Act is ‘misinformed and misguided’ and the Council for Responsible Nutrition (CRN) will oppose it, its president Steve Mister tells NutraIngredients-USA.
