Pear in Mind: A Blog in the Public Interest

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:


  • Prohibiting newly synthesized, novel, or cnoarcigenic substances from qualifying as GRAS substances
  • Requiring pre-market notification and submission of adequate safety data for substances eligible for GRAS
  • Requiring pre-market notification and submission of adequate safety data for substances eligible for GRAS
  • Requiring GRAS notifications and determinations to be available for public comment
  • Directing the FDA to systematically reassess current GRAS substances that do not meet the new requirements

This bill is an important step in providing the FDA with the information needed to keep dangerous chemicals out of our foods.

Help support CSPI’s efforts and tell your member of Congress to support the Toxic Free Food Act.