Cutting the GRAS

For decades, the Generally Recognized as Safe (GRAS) loophole has allowed companies to self-certify newly synthesized chemicals as safe to consume. Manufacturers often secretly introduce these substances into our foods without ever notifying the Food and Drug Administration. Unfortunately, the FDA sanctions this “secret” GRAS loophole by expressly not requiring GRAS notifications.

This means the agency, the public, and watchdogs like the Center for Science in the Public Interest lack the data needed to assess the safety of chemicals in our foods. Experts estimate that there are about 1,000 GRAS substances where safety determinations were made by food companies without notifying the FDA. 

Essentially, we must trust that food companies will conduct unbiased safety determinations before adding these new GRAS substances to our food.

We believe that this role should not be in the hands of the companies that already have a financial investment and interest in using these chemicals.

Instead, the FDA should be the unbiased regulator that stops unsafe chemicals from entering the market. Currently, the law requires the FDA to fulfill that role. However, both industry and the FDA have relied on the GRAS loophole to circumvent the law and their responsibilities to public safety.

In 2014, Former Deputy FDA Commissioner for Foods Michael Taylor commented on FDA’s failure to regulate food chemicals, saying: “We simply do not have the information to vouch for the safety of many of these chemicals.”

Our solution: Start Closing the GRAS Loophole. CSPI helped introduce and is lobbying for Rep. Rosa DeLauro’s Toxic Free Food Act (H.R. 3699). This act closes the loophole for new food substances and provides the FDA with more robust safety data. Major provisions of this act include: