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NDI draft guidance

NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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.

Durbin, Blumenthal urge FDA to take action against BMPEA

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...

UNPA moves to ban sale of BMPEA as uncertainty swirls around Acacia rigidula's status

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...

Guest article

Recent enforcement trends: state attorneys general target the dietary supplements industry

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...

Cohen releases study that finds form of amphetamine in weight loss, sports products

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...

Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA

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. ...

High NDI failure rate putting more emphasis on GRAS status for new ingredients

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...

Warning letter cites NDI status of magnesium ingredient but doesn't raise safety concern

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...

Guest article

20 Years of DSHEA: Focusing on the Future

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...

Insights from SupplySide West

McGuffin: DSHEA was about preserving right to direct one's own self care

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...

Insights from SupplySide West

Israelsen: DSHEA created world's most vibrant supplement marketplace

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,...

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

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...

Particulars of GRAS process leave it open to criticism, expert says

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...

Jury's out whether recent data shows improvement in NDI picture

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...

Nascent 100% confident in the quality and safety of its PQQ, despite FDA safety concerns

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...

Long strange trip: The evolution of botanicals since the inception of DSHEA

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...

Natural astaxanthin group’s questioning of synthetic astaxanthin quality met with strong DSM defense

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...

Fabricant leaves FDA, replaces Shaw as head of NPA

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...

Consulting firm Ingredient Identity expands capabilities with new divisions

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...

Prochnow: GMPs, NDIs and liquid supplements among prominent regulatory concerns for 2014

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...

2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes

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...

2013’s top regulatory, policy & enforcement news

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...

Dispatches from SupplySide West 2013

Hiring an attorney early is cheaper than hiring one late, expert says

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...

Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

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.

Dispatches from SupplySide West 2013

FDA’s Dr Fabricant: GMP violations are staying the same, and that’s a concern

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...

Reaction to CFSAN's priorities for 2013-14

UNPA: Does CFSAN’s plan for GMO labeling guidance signal a change of thinking at FDA?

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...