The concept of “Generally Recognized as Safe” (GRAS) originated in the United States with the passage of the Food Additives Amendment of 1958. This amendment was a significant milestone in food regulation, as it required manufacturers to prove the safety of new food additives before they could be marketed. However, lawmakers and regulators recognized that many substances had been used safely in food for generations and did not require the same level of scrutiny as new, synthetic additives.
To address this, the Food Additives Amendment included a provision that exempted substances “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of their intended use” from the formal approval process. This is what we now know as the GRAS designation.
This means that a compound on the GRAS list is considered safe to use in food and beverages. As for levels of use, there is guidance documentation by the Flavour Extract Manufacturers Association (FEMA), and those numbers for each compound are what was the typical usage levels back in the 1950s when they did the survey.
Early Implementation
Initially, the U.S. Food and Drug Administration (FDA) maintained a list of substances that were considered GRAS based on a long history of safe use or on the results of scientific research. However, the list was not exhaustive, and many substances used in food did not have a formal GRAS status.
The GRAS Affirmation Process
In the 1970s, the FDA initiated the GRAS Affirmation Process, a voluntary program where manufacturers could submit scientific data for review to affirm the GRAS status of a substance. However, this process was slow and resource-intensive, leading to a backlog of unreviewed substances.
The Modern GRAS Notification Program
To streamline the process, the FDA introduced the GRAS Notification Program in 1997. Under this program, companies can voluntarily notify the FDA of their determination that a substance is GRAS. The FDA reviews the submission and, if it does not question the GRAS status, issues a “no questions” letter. This program is more efficient than the affirmation process and has helped to clear the backlog of substances awaiting review.
Role of Expert Panels
Throughout the history of the GRAS program, expert panels have played a crucial role in evaluating the safety of substances. These panels, often organized by industry groups like the Flavor and Extract Manufacturers Association (FEMA), review scientific data and make independent determinations about the safety of substances for their intended use.
Evolution and Criticism
The GRAS program has evolved over the years and has been the subject of some criticism, particularly around the issue of self-affirmation, where companies can determine GRAS status without FDA review. Critics argue that this can create conflicts of interest, although proponents note that self-affirmed GRAS determinations must still be based on sound scientific evidence and are subject to FDA oversight.
In summary, the GRAS program originated as a practical solution to regulate substances with a long history of safe use in food and has evolved over the years to adapt to scientific advances and regulatory challenges. It remains a cornerstone of food safety regulation in the United States.