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NDI draft guidance
The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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.
Nutrition 21 gets NDI for arginine silicate ingredient
The US Food and Drug Administration has accepted Nutrition 21’s inositol-stabilized arginine silicate (Nitrosigine) as a New Dietary Ingredient (NDI).
CRN submits comments to FDA on ‘chemically altered’ definition for NDIs
The Council for Responsible Nutrition (CRN) has submitted comments to the FDA via international law firm Steptoe & Johnson, LLP, to address when an ingredient is chemically altered such that...
Trade associations urge FDA to issue revised draft guidance on NDI ingredient identity
The five associations representing the dietary supplement industry have asked the Food and Drug Administration (FDA) to issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus...
Sen. Martin Heinrich: 'The model that DSHEA created is working well'
Sen. Martin Heinrich, D-NM, one of the dietary supplement industry’s new champions on Capitol Hill, spoke with NutraIngredients-USA to offer his views on the industry and the challenges it faces...
AHPA expands staff with program development position
To go with an expanding membership, the American Herbal Products Association has expanded its staff with the addition of Jane Wilson in the newly created role of director of program...
With Harkin's departure, industry needs to step up outreach, observers say
The ancient Israelites had Moses and Aaron. The dietary supplements industry has Senators Tom Harkin and Orrin Hatch, but not for long—Harkin has announced that he will retire at the...
GRAS status will boost benfotiamine, XSTO says
Benfotiamine, a form of thiamine or vitamin B1, has been on the market for decades. So what makes BenfoPure, a branded form of the ingredient now represented by XSTO Solutions,...
2012’s regulations in pictures: GMPs, NDIs, and energy drinks
As 2012 comes to a close, NutraIngredients-USA looks back on an action packed year. In the second of our series of galleries capturing the year’s main events, we take a...
2012’s predictions: How did we do?
In January, NutraIngredients-USA raised its head above the parapet and made some predictions for 2012. As the year draws to a close, we look back on what did and didn’t...
Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’
Strong enforcement from FDA on cGMPs (current good manufacturing practices) will continue, says FDA’s Dr Daniel Fabricant, but given that many GMP basics are still not being met and the...
FDA: Inflammation and diabetes raising red flags for tainted products
Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of...
NPA uses history to back NDI views on synthetic botanicals, chemical alteration
The Natural Products Association has filed an addendum to its comments on the NDI draft guidance, focusing on the legislative history of DSHEA.
Will the FDA revise its stance on synthetic botanical constituents? It’s not looking promising…
Firms hoping the FDA might change its unpopular stance on synthetic copies of botanical constituents as it rewrites its draft guidance on new dietary ingredients (NDIs) could be disappointed.
June in pictures: The ORAC debate, stem cell nutrition and Olympic dreams
USPLabs hit back at DMAA critics, USDA quietly removed its online ORAC database and the FDA unveiled plans to re-issue a draft of its much-maligned draft guidance - all in...
IPA hails ‘huge move forward’ in NDI draft guidance revision
The International Probiotics Association (IPA) has hailed the announcement that FDA is revisiting its controversial new dietary ingredient (NDI) draft guidance, but has warned that more work is required.
NPA boss: Every industry has bad apples, but they must not ruin the batch
He might not have worked in the natural products industry, but John Spitaleri Shaw is also acutely aware that “highly technical, inside baseball talk” does not make for a winning...
Breaking news
Who says the FDA doesn't listen? Industry welcomes plan to issue revised draft NDI guidance
The FDA might have spent the past year vigorously defending its much-maligned draft guidance on new dietary ingredients (NDIs), but it appears it has been listening to industry concerns as well....
Jarrow calls for Congressional hearings to address NDI guidance woes
Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress...
California judge allows DMAA class action v Nutrex Research to proceed
A class action lawsuit filed against Nutrex Research over the safety and regulatory status of supplements containing DMAA (1,3-Dimethylamylamine) has been given the green light to proceed by a judge...
Natural Products Association names John Shaw as its new CEO
Washington DC insider and former administration official John Spitaleri Shaw has been named as the new chief executive and executive director of the Natural Products Association (NPA).
USPLabs sues retailer for defamation over 'false and disparaging' comments about Jack3d, DMAA
USPLabs has taken legal action against a Max Muscle franchisee in Reno, Nevada, accusing owner Philip Tracy of making "false and disparaging" comments about its Jack3d supplement, and its core...
Comment
Safety & efficacy – The industry’s mission statement in two small words
Company mottos and mission statements are marvelous – they talk about lofty goals, commitments to people and the environment, and leaving the planet a better place than how they found...
Dendrobium-containing Craze pre-workout supplement hit with CA class action
Tipped by many as the heir apparent to DMAA supplements in the pre-workout category, the dietary supplement Craze is the latest to be hit with a class action in the...
DMAA latest: FDA considers next steps; GNC remains defiant; Nutrex says FDA is 'demonstrably wrong'
All 10 recipients of FDA warning letters on DMAA have now written back, although only one - Nutrex Research - has so far revealed what it said (notably that the...
Dispatches from AHPA's Botanical Congress
FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue
The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product...
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