GRAS Labeling Criteria

Center for Food Safety and Applied Nutrition

GRAS is listed on some products.  It means, “Generally Recognized as Safe”.  Per U.S. Food and Drug, Association (FDA) there is a department called, the Center for Food Safety and Applied Nutrition, (CFSAN). It is responsible for food safety information, food ingredients, and their packaging.  GRAS labeling falls under the Food Drug and Cosmetic Act.  Any substance added to food is considered a food additive, that is subject to premarket review and approval by the FDA”.  The GRAS label is exclusively for monitoring the nine most life-threatening ingredients that are on the allergen list.  Because it does not monitor the other 160 non-life-threatening under this label It would still be wise to glance at the ingredients just in case your allergy is not considered a high-risk concern of theirs.  In other words, don’t assume GRAS is safe for everyone.  The FDA updates its GRAS notices monthly.

FDA Food Additive Analysis

For food additives, the FDA determines the safety of the ingredients.  Before 1958, their determination was made through lifetime experience with the additive.  In other words, is this a commonly used additive by a large number of consumers?  To be a product labeled with GRAS

It is important to know that the determination of the safety of the ingredients is subject to the premarket approval and determination of who has reviewed the scientific data and information.

GRAS History of Improvement

In the 1960s, former President Richard M Nixon directed the FDA to re-examine the safety of food substances that were generally recognized as safe. (GRAS) The result of this study made GRAS products safer due to new GRAS regulations ensuring substance use was safe.

The GRAS Notification Program, “Generally Recognized as Safe”

In 1997, the FDA concluded it didn’t have the resources to devote to the GRAS affirmation process.   Concluding that the GRAS program may become a notification process.  It now provides a voluntary means by which a person or company can inform the FDA of the determination and use of a substance along with specific criteria.

Procedure for Submitting a GRAS Notification

A company or person no longer needs to petition the FDA to ensure and affirm the use of a substance is within the GRAS criteria of being recognized as safe.  Instead, the FDA encourages the company or individual to thoroughly review the GRAS notification submission procedures before they’re to send a notification to the FDA’s Office of Food Additive Safety Agency.

  • They must include a “GRAS exemption clai

    The GRAS Exemption Claim

    m”, that provides a detailed description of the ingredient or substance they want to use and the conditions in which they will use them.

  • The information submitted needs to inform about the identity and properties of the substance and a list of reasons it meets the GRAS criteria of being safe.
  • They must further explain whether the substance is chemical, toxicological, or microbiological.
  • The notifier should include any information that is not consistent with the GRAS criteria with its conditions of use in the products.
  • If the substance is intended for use in a meat product the FDA will need to confer with the U.S. Department of Agriculture before its final authorization to use the GRAS label. The process can take the FDA 30 days for a final decision.

 

GRAS Safety and You

You are responsible for making sure when choosing a GRAS-labeled product that it meets your standards of safety.  You must do your due diligence and ensure the preservatives, stabilizers, and emulsifiers used in the product you are buying for consumption are safe.  To do this, you must not only read the label but pull up the substance on your phone and ask the questions.

  • Is this substance derived from eggs [list allergen]?
  • How is this substance made?
  • What are the ingredients of this substance?
  • Are the ingredients natural or man-made?
  • Are there any harmful side effects?

It is important for you or your loved one with an allergy to know they can eat something that won’t be of harm.  Do your homework!  Don’t rely on the manufacturer and their nice friendly labels to keep you safe or give you a good feeling.

 

 

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