GRAS Notifications: The Final Ruling by the FDA (10 years in the making)

October 24, 2016 By


As of August 17 2016, the FDA issued a final ruling on Substances “Generally Recognized as Safe” (GRAS). The original ruling about GRAS Substances was proposed in 1997 with a further reopening of the comment period in 2010 where updated input was permitted. The Final Ruling brings forward a commitment to timelines of when a response from FDA is required, the properties of the information supporting a GRAS Notification, and the nature of the GRAS Notification (originally an affirmation petition process) remaining voluntary. The final ruling became effective October 17, 2016.

One of the most commented aspects of GRAS Notification received by the FDA concerned the long time elapsed before a GRAS decision was made. The original proposed ruling in 1997 stated that a final response would be provided to the notifier within 90 days of the GRAS Notification. In practice, the average elapsed time was between 7-8 years. In consequence, the FDA has committed that they will respond with their evaluation of the GRAS Notification within 180 days of the original filing. However, on an as-needed basis, the FDA reserves the right to extend the 180 day timeframe by 90 days (which they will inform the notifier during the original 180 day review period), making the longest total review period be 270 days. While not a swift review time, it is significantly faster than the review times actually occurring from previous years.

In terms of the properties of the information that is provided in a GRAS Notification, the FDA emphasizes the importance of the information being available to the public. The GRAS Notification should not contain information that is trade secret or confidential commercial information. As well, the conclusion of GRAS status must be based on scientific procedure and accepted scientific facts. Tying both together, the scientific information provided to satisfy GRAS criteria must allow the FDA to conclude the substance is not harmful under the conditions of intended use without access to “corroborative” information.

Though the Final Ruling provides specific description of the mandatory information required in the new GRAS Notification procedure (ex. 7 sections, with rationales required to explain omission if section not included), the GRAS Notification procedure still remains a voluntary process. Many voices from the industry indicate the need for the process to be mandatory to ensure the safety of food ingredients, though the FDA has acknowledged that they do not have the authority to require GRAS determination at this time.

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