FDA GRAS Status: The Final Ruling

 

origins: fda gras status

To better understand the recent FDA GRAS Status final ruling, it is crucial to provide the historical context from which is born. In 1958, in response to growing public and industry concern, the FDA modified the Federal Food, Drug, and Cosmetic Act to include the Food Additives Amendment.  Additives were now defined as any substance intentionally added to food and required pre-market approval by the FDA- all except those generally recognized as safe (GRAS list-Section121.1019(d)).

With a greater spotlight placed on the ingredients in our food, President Nixon directed the FDA to more thoroughly investigate those substances designated as GRAS- one of the first FDA GRAS status rulings. Starting in 1970, the FDA began the intensive review process, though it must be noted since previously approval of GRAS items had not been required, the FDA did not have a completed record of all products that should be re-evaluated.

Because of these limitations, the FDA developed the GRAS Affirmation Petition process in 1972. With this new standard, the FDA had a clearer set of established procedures to assert the GRAS Status of a given product.

 Greater accountability and transparency was still needed. Building on the advances of the GRAS Affirmation Petition, the FDA enacted the GRAS Notification in 1997. The notification process went as follows: Company submits notification of GRAS product, FDA determines if sufficient evidence has been provided to support this claim, and then a final decision was sent to the company.

gras-substances-infographic

Illustrates types of gras substances submitted

Above image illustrates the types of substances submitted for FDA GRAS Status.

Current State of GRAS Regulation

Since the last update in 1997, the FDA opened a forum for continued conversation about the next steps to take in the evolution of GRAS Status regulation. A combination of consumer concern as well as  feedback from both the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) during the pilot programs, helped to shape the the most recent FDA  GRAS Status final ruling

The definition of a GRAS substance is NOT changing; however, the process in which an individual would submit a food substance for review by the FDA is and additional information is required during GRAS notice filing.

Although filing a GRAS notice is voluntary, GRAS substances must still be recognized, among qualified experts, to be safe under the conditions of their intended use. The final rule further clarifies the regulations for when a food is GRAS.

Not only does the final rule clarify requirements for scientific procedures, it also gives specifics on how to file a GRAS notice. Though submission for review is voluntary, once a company begins the process, the FDA has established mandatory information that must be supplied. Unlike earlier iterations, where both the submission and information provided were voluntary.  

Once the FDA has received all required information, under the final GRAS rule update, they will have 180 days to inform the company of their decision. The new rule also stipulates that FDA has the right to extend this review period by 90 days if deemed necessary.

FDA Notification Letters

Along with the revision to the GRAS review process, changes will also be seen in the types of notification letters companies receive:

 FDA GRAS Status Notification Infographic

FDA GRAS Status Final Ruling

October 17th, 2016 is slated as the official start date for the new GRAS mandates. With this date fast approaching, it is easy to understand why some companies would try to push their affirmation petition through as quickly as possible.

Before doing so, manufacturers should keep in mind that any pending items will more than likely have to submit a GRAS notice and request the FDA to incorporate the GRAS affirmation petition previously submitted.  You may even need to supply more information, now required by the final rule.

FDA-GRAS-Documentation

With the launch date for the new GRAS ruling looming, many questions still remain about its potential efficacy. Key factors to consider in the final analysis will include the decision maintain voluntary participation, the effect on large vs. small companies to handle increased documentation mandates, and whether any of this will lead to increases in GRAS submissions.

Ultimately, each endeavor to revise the GRAS Rule is meant to ensure the highest levels of safety and best manufacturing practices are being maintained.