A concentrate of an old dietary ingredient may need to file a new dietary ingredient notification, according to a new warning letter from the US Food and Drug Administration about bitter orange.
The USPLabs case demonstrates the tools investigators and prosecutors can bring to bear when looking into the dealings of a dietary supplement company, a former prosecutor says.
Dietary supplement trade associations have universally welcomed the Department of Justice’s nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.
Following a recent meeting with high ranking FDA officials, Jarrow Rogovin, President/Founder, Jarrow Formulas, Inc, says that the dietary supplements industry has an historic opportunity to negotiate with the agency.
Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit versus risk” to one of “access with safety.”
The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of the Council for Responsible Nutrition.
Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at the Food and Drug Administration, signaled a change in emphasis at the agency with a willingness to publicly acknowledge the dietary supplement industry’s GMP successes...
The Food and Drug Administration is continuing enforcement actions based on the precepts laid out in the draft guidance on New Dietary Ingredients with a warning letter sent to a company marketing a product that contains the stimulant-like ingredient...
The NY AG affair has “tenderized” the dietary supplements industry in ways that other issues have not, and made it more vulnerable to other legal and regulatory attacks, said Steve Mister, president and CEO of the Council for Responsible Nutrition.
US Senators Dick Durbin and Richard Blumenthal sent a letter yesterday to the Food and Drug Administration asking the agency to take action against products containing the synthetic stimulant ingredient known as BMPEA, products which the pair called both “mislabeled...
The controversy surrounding the low-profile botanical Acacia rigidula and its purported amphetamine-like constituents seems to have caught regulators flat footed and has lead one trade association to ban the sale for its members of formulations featuring...
By By Douglas F. Gansler, Brian P. Kelly and Leslie L. Meredith
Editor’s note: The recent actions of New York Attorney General Eric Schneiderman have changed the enforcement landscape of the dietary supplements industry. This guest article from former Maryland Attorney General Douglas Gansler and his colleagues explore...
Prominent dietary supplement industry critic Dr Pieter Cohen has released a new study that shows that a synthetic stimulant was found in more than half of weight loss and sports performance products tested that listed Acacia rigidula as an ingredient...
The dietary supplement industry received a welcome breath of fresh air in a meeting of industry representatives with Rep. Ted Lieu, the newly elected Democrat in California’s 33rd Congressional District. The meeting was arranged by Jarrow Formulas and...
The high rate of failure in New Dietary Ingredient notifications has led some companies to seek workarounds. Anecdotal evidence gathered by NutraIngredients-USA shows that companies are increasingly leaning on GRAS status as a way to avoid having to enter...
The Food and Drug Administration has issued another warning letter taking a company to task for marketing a product with an ingredient that lacks a New Dietary Ingredient filing. But one observer wonders why more such letters haven’t come from the agency.
By Daniel Fabricant, PhD, CEO and Executive Director, Natural Products Association
While we should certainly take a second to pause and reflect in honor of the 20th anniversary of the passage of the Dietary Supplement Health and Education Act (DSHEA), it’s important to keep in mind that the industry as a beacon of growth must focus...
Michael McGuffin, president of the American Herbal Products Association, has a unique perspective on the 20th anniversary of DSHEA having started in the herbal products industry in 1974, twenty years before the law was passed. The law, as he sees it,...
The dietary supplement business has gone from fighting for its life to enjoying the fruits of an open, dynamic marketplace, and it’s all because of DSHEA, according to Loren Isrealsen, president of the United Natural Products Alliance.
Despite ongoing vacancies in the main office of the Division of Dietary Supplements, companies must continue to build relationships with FDA’s district offices to ensure ongoing GMP compliance, says Dr Daniel Fabricant, CEO of the Natural Products Association.
The GRAS process as it stands in the United States is vulnerable to criticism based on possible conflicts of interest and low-quality safety work, said Claire Kruger, PhD, president of Spherix Consulting, a division of ChromaDex.
Preliminary figures from the American Herbal Products Association show that one in four recent New Dietary Ingredient notifications went through without objections from the Food and Drug Administration. Whether that represents an improvement in the overall...
Nascent Health Sciences has resubmitted a New Dietary Ingredient notification (NDIN) for its PureQQ pyrroloquinoline quinone ingredient following a negative response from the FDA first time around, and the company stands by the safety of its product....
The Dietary Supplements Health and Education Act has given rise to a thriving dietary supplements industry. Botanical ingredients have always been a part of that picture, but the concept of where they fit within that category has shifted over the years...
The Natural Algae Astaxanthin Association (NAXA) has again questioned the quality and regulatory status of DSM’s synthetic astaxanthin ingredient, with new data reportedly showing ‘vastly inferior antioxidant potential’ compared with the natural, algae-derived...
The Natural Products Association (NPA) announced this morning that Daniel Fabricant, PhD, will succeed John Shaw as chief executive officer of the organization effective immediately. Shaw had tendered his resignation several days ago, the organization...
A key new hire has enabled consulting firm Ingredient Identity to signficantly ramp up its capabilities. In line with that development, the company has formed four new divisions to better present the new capabilities to its customers, said Jim Lassiter,...
Attorney Justin Prochnow has made a career of reading the FDA tea leaves for his clients. As the industry enters 2014, he sees a long-term trend of GMP enforcement and nascent guidances on New Dietary Ingredients and liquid dietary supplements as the...
Reading through the warning letter tea leaves, Denver-based attorney Justin Prochnow has come up with some important themes from the Food and Drug Administration. Obligations of brand holders, status of liquid products and the regulatory status of new...
From warning letters to GMO labeling and FSMA, it’s been a busy year for the regulatory people. In this special gallery we review the top regulatory, policy & enforcement headlines from 2013.
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...
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 now.
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 development.
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.
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 come to pass.
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.
