Nutrasource Blog

Top questions to ask our regulatory and clinical team at Engredea/Expo West

Posted by Jennifer Andrews, M.Sc. on Wed, Mar 02, 2016

Heading to Anaheim next week for Engredea/Natural Products Expo West? Our clinical and regulatory team will be there with bells on, ready to answer all your burning questions!

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Tags: William Rowe, Product Testing, Clinical Research, Regulatory, Concept to Claim, Events, IGEN, GRAS Associates

New Dietary Ingredient (NDI) notifications remain a hot-button issue for dietary supplement industry

Posted by Jennifer Andrews, M.Sc. on Mon, Jan 18, 2016

Manufacturers bringing new substances to the U.S. market must notify the Food and Drug Administration (FDA) 75 days in advance.  The requirement, known as New Dietary Ingredient (NDI) notifications, was well-intentioned at the time it was implemented in 1994 but remains a source of debate and confusion for the dietary supplement industry.

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Tags: Dietary Supplements, Regulatory, Foods, GRAS Associates

5 things you need to know about Generally Recognized as Safe (GRAS) filings for food ingredients

Posted by Jennifer Andrews, M.Sc. on Thu, May 14, 2015

GRAS is an acronym for Generally Recognized as Safe.  GRAS status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act).  Its purpose was to exempt certain food ingredients from the definition of food additive.

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Tags: Regulatory, Foods, GRAS Associates

You asked, we answered: top regulatory, R&D and testing questions we hear on the trade show floor

Posted by Jennifer Andrews, M.Sc. on Mon, Apr 13, 2015

It's no secret that bringing a product to the next level can be a challenge.  There are many hurdles you'll need to overcome, whether your goal is to support a new claim or re-position your product for a new market segment (read about some of these regulatory and R&D challenges here).

In today's post we've rounded up some of the most common questions we hear at industry events like Engredea and Ingredient Marketplace in the hopes that our answers will help you overcome your latest product development challenge.

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Tags: Product Testing, Regulatory, Concept to Claim, IGEN, Diteba, GRAS Associates

The Future of GRAS

Posted by Jennifer Andrews, M.Sc. on Thu, Mar 12, 2015

Authored By: Dr. Robert S. McQuate, Ph.D., and Dr. Richard C. Kraska, Ph.D., DABT of GRAS Associates LLC, a Nutrasource company

April 17th will mark 18 years since The United States Food and Drug Administration (FDA) published its 1997 proposal to modify the operating procedures for Generally Recognized as Safe (GRAS) evaluations. Besides providing a wealth of information on the GRAS concept with detailed guidance on the requisite information to support a valid GRAS determination, FDA’s 1997 publication proposed discontinuing the GRAS petitioning process while instituting voluntary GRAS notification procedures. Interestingly, FDA began implementing the procedures shortly after they were proposed in the Federal Registerdocument, presumably in anticipation that the procedures would be finalized without substantial changes. The proposed GRAS procedures that are operational with FDA today have not been finalized.

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Tags: Regulatory, Foods, GRAS Associates

Safety considerations with FDA’s anticipated NDI guidance document

Posted by Jennifer Andrews, M.Sc. on Tue, Dec 09, 2014

By Robert S. McQuate, PhD, and Richard C. Kraska, PhD, DABT, GRAS Associates LLC, a Nutrasource company - See more at: http://www.nutraceuticalsworld.com/contents/view_experts-opinion/2014-12-09/safety-considerations-with-fdas-anticipated-ndi-guidance-document/#sthash.AWW6dr69.dpuf
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Tags: Dietary Supplements, Regulatory, Foods, GRAS Associates

Nutrasource acquires GRAS Associates LLC

Posted by Jennifer Andrews, M.Sc. on Thu, Sep 11, 2014

Nutrasource is pleased to announce the acquisition of GRAS Associates LLC.  Located in Bend, Oregon, GRAS Associates is a premium supplier of regulatory consulting services for companies seeking a wide range of approvals to bring their products to the marketplace.

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Tags: Corporate News, GRAS Associates