The proposal to use Master Files for IP protection and to expedite the notification process is attracting attention within FDA, as the agency considers comments submitted in response to its controversial NDI draft guidance.
Sales of 7-Keto have exploded following a mention on the Dr Oz show in February, with brand owner Humanetics Corp “on track to post triple digit gains this year” for the fat-burning ingredient, should current sales trends continue.
Select members of the highly influential House Energy & Commerce Committee have written to FDA calling for a 'significant reworking' of the controversial new dietary ingredient (NDI) draft guidance.
Jarrow Formulas has submitted a formal appeal to the Food & Drug Administration objecting to its “incomplete response” to a Freedom of Information Act (FOIA) request about its controversial draft guidance on New Dietary Ingredients (NDIs).
Food and Drug Administration (FDA) officials were “engaged” and “receptive” during a meeting with the Council for Responsible Nutrition (CRN) this week about its controversial draft guidance on new dietary ingredients (NDIs), says the CRN.
A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.
It might have been roundly slammed by the trade as draconian and unworkable, but according to one academic, the Food and Drug Administration’s (FDA’s) controversial draft guidance on new dietary ingredients (NDIs) does not go far enough.
Exclusive interview: Paul Gilner, chief executive, Life Extension
While cynics might raise an eyebrow at the Life Extension Foundation’s ambitious mission statement (“to conquer the aging process within the next decade”), bosses at its supplement arm have every reason to feel optimistic, CEO Paul Gilner tells Elaine...
An increase in GRAS (generally recognized as safe) determinations for an ingredient, and particularly self-affirmed GRAS, suggests that industry is looking at the alternatives to NDI notifications, but what are the consequences?
Momentum behind ChromaDex’s branded antioxidant pTeroPure is continuing to build with growing interest from food manufacturers and new listings for the pTeroPure-based supplement line BluScience at Walgreens.
The United Natural Products Alliance (UNPA) says it agrees with the AHPA that supplement makers should not label the stimulant DMAA (1,3-Dimethylamylamine) as geranium oil or as any part of the geranium plant.
Trade in sports products containing the controversial stimulant DMAA (methylhexaneamine/1,3-dimethylamylamine) is illegal in the European Union, and should be brought to an immediate halt by EU and member state authorities, according to the Council for...
Staff for Senators Harkin and Hatch are still waiting for a response from the Food and Drug Administration (FDA) following calls from the Senators for FDA to withdraw its NDI draft guidance and for January meetings to discuss concerns.
USPLabs has insisted that the DMAA (1,3-Dimethylamylamine) in its Jack3d and OxyELITE Pro supplements is from geranium in the wake of continued speculation over the source and regulatory status of the popular stimulant.
The dietary supplements industry is doing better than many consumer brand industries, despite issues such as NDIs, says the new president of NOW Foods.
Jarrow Rogovin, never a man to mince his words, says it is high time the IPA and other trade groups stepped up to the plate to defend a sector that has been under regulatory siege on both sides of the Atlantic for several years.
The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.
Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.
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 draft guidance on new dietary ingredients (NDIs), says the American...
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 aisles? And are gummies the solution to ‘pill fatigue’?
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 challenged again this week.
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 we head into 2012, but it is not the only thing causing sleepless nights.
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 attorney.
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 has argued.
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.
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”, according to the International Probiotics Association (IPA).
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 States Pharmacopeia (USP).
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 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’.
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