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Generally Recognized as Safe (GRAS) Consulting

Before a substance can be added to a food item in the United States, it must first obtain a generally recognized as safe status.

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KNOWLEDGEABLE

Navigating the FDA on behalf of clients since 2002

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EXPERTISE

Our team consists of 50+ members including toxicologists, engineers, and medical doctors
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RESULTS

Our team boasts a 100% success rate

There are 2 paths available when obtaining a GRAS status

  1. FDA-Notified GRAS – where you petition the FDA to review your ingredient and provide a GRAS status by way of a “No Questions/Objections Letter”
  2. Self-Affirmed GRAS – where you self-affirm that your product is Generally Recognized As Safe based on the conclusion of a scientific expert panel

 

In either case, the applicant must demonstrate that the substance will not cause harm under the conditions of its intended use. This includes the provision of scientific evidence supporting the safety of the substance.

Services for Self-Affirmed and FDA-Notified GRAS

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  • Feasibility Review and Classification: Ingredients can be classified as an Old Dietary Ingredient, a New Dietary Ingredient, a Food Additive, or be Generally Recognized as Safe. We will help you determine which path is right for your ingredient
  • Data Gathering & Literature Searches: This involves searching and gathering all available data, both proprietary, and within the scientific literature
  • Gap Analysis: This involves reviewing all available data and providing a report outlining gaps needed in order to prepare a complete GRAS dossier
  • Coordinating the conduct of toxicological studies when required
  • Research for scientific evidence demonstrating that the substance is safe under the conditions of its intended use
  • Prepare and file FDA GRAS Notifications and liaison with FDA and USDA
  • Source independent experts and mediate expert panel reports on GRAS conclusions
  • Prepare Self-Affirmed GRAS dossiers

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