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NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy.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

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...

NDIs, GRAS & GMOs: CFSAN outlines priorities for 2013-14

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,...

Synthetic versions of natural ingredients with NDI notifications crop up in marketplace

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...

Does an NDI notification open door for me-too ingredients? Answer: It depends

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...

Members of Congress ‘concerned’ about speed of progress on NDI draft guidance

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...

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,...