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NDI draft guidance

NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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

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...

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