FDA Proposes Requiring Notice of Generally Recognized as Safe Certifications

As federal officials promised, the FDA this week published a Notice of Proposed Rule Making that would require companies to notify the agency of new ingredients the companies claim fall under the Generally Recognized as Safe (GRAS) regulation.

Currently, submission of GRAS notices to the FDA is voluntary, and many manufacturers self-determine the GRAS status of substances without notifying the agency. Under the proposed changes, however, companies would be legally obligated to notify the FDA before marketing any food or feed substance with a GRAS designation.

The concept of food additives being "generally recognized as safe" assumes that an ingredient has been determined by recognized experts – hired by the petitioning company – to be safe for use in foods or beverages. Some GRAS substances include sugar, salt and citric acid – although new ingredients are being developed all the time.

The FDA itself made GRAS determinations until the volume got so large in the 1980s that the agency allowed outside scientific authorities to certify ingredients as safe. The FDA can question the validity of a GRAS substance or withdraw the safety designation, but only if it’s aware of the ingredient.

While the agency still does not want to entirely take over the job of GRAS certifications, that loophole of not notifying the agency of a self-affirmed GRAS substance has become an issue with Health & Human Services Secretary Robert Kennedy.

Experts have noted some legal problems with the agency changing statutory rules, especially without Congressional approval.

Once the proposed rule is officially published in the Federal Register (expected next month) there will be a public (and industry) comment period.