As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems on the back end is inevitably more expensive, said attorney Ivan Wasserman.
Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.
One year on and 'GMPs' and 'concern' continue to be used together by Dr Daniel Fabricant, Director of the Division of Dietary Supplement Programs at the agency, with many of the compliance issues still basic.
The Center for Food Safety and Applied Nutrition's (CFSAN) priority to publish guidance to help manufacturers with voluntarily GMO labeling could signal a change in thinking at the agency, says the United Natural Products Alliance (UNPA).
The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has outlined its priorities for 2013-14, with a 'surprising' number relevant to supplements, including NDIs, GRAS, and GMOs.
The question whether an NDI notification opens the door for follow on ingredients has yet to be definitively answered. But sources say the question is a lot clearer when the putative follow on ingredient might not even be the same thing.
Let’s assume you’ve done your homework on your new ingredient and have successfully filed a New Dietary Ingredient notification with the Food and Drug Administration. Can a competitor launching a me-too product come along and trade on that status? It’s...
Key members of the United States Congress have voiced concern over the speed of progress of revising the controversial draft guidance for new dietary ingredients (NDIs), and called on FDA to produce a revised draft guidance in a 'timely manner'.
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 it would require a separate NDI notification.
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 on the information to be included to identify...
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, special? The differentiator, said XSTO’s Dan Murray, is in the details.
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 end of his current term next year.
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 look at the regulatory issues that made the headlines.
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 Agency's limited resources, many of the issues seen today may...
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 CFSAN at FDA.
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.
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 “elevator speech” in the corridors of power in Washington DC.
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 to the dangers the “fatally flawed” document presents to the...
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 in California.
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 ingredient DMAA (1,3-Dimethylamylamine).
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 it. But boil it all down and there are only two words that companies...
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 agency's interpretation of the law is “demonstrably wrong”).
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 seizures related to current good manufacturing...
The whole “adventure” over DMAA (1,3-Dimethylamylamine) is “a perfect example of a gaping loophole in the Dietary Supplement Health and Education Act (DSHEA) which needs to closed”, according to one academic.
With the road ahead now appearing closed - or at least decidedly rocky - for pre-workout stimulant DMAA (1,3-Dimethylamylamine), attention is turning to alternatives. But could they be just as controversial?
The law firm responsible for the flurry of class action lawsuits against 10 firms named by the FDA in its DMAA crackdown last week has now targeted four other firms selling products containing the stimulant.
They’ve had the sword of Damocles hanging over their heads for months. So when 10 firms selling DMAA supplements were finally told to put up or shut up by the FDA last week, it looked like the game might finally be up for the controversial stimulant.
In warning letters sent as part of its recent crackdown on DMAA, the FDA says “synthetically produced DMAA is not a dietary ingredient and, therefore, is not eligible to be used as an active ingredient in a dietary supplement”.
UPDATED May 3 - All 10 recipients of FDA warning letters over supplements containing DMAA (1,3-Dimethylamylamine) have now been targeted in a new wave of class action lawsuits in California alleging their products contain DMAA in a synthetic form that...
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.
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.
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.