Broken GRAS

At least 1,000 ingredients in food products on our grocery store shelves have never been checked for safety by the Food and Drug Administration (FDA). The reason for this lies in the misuse of a little-known legal designation called GRAS—or Generally Recognized as Safe.

What is GRAS and what does it do?

GRAS is a designation created by Congress in 1958 for a small number of commonly used food ingredients which would not need pre-market safety approval by the FDA. These familiar substances, such as oils, vinegar, baking soda and common spices, were found to be safe due to their long history of widespread use.

Unfortunately, the universe of substances designated as GRAS has grown far beyond what Congress originally intended. Today, almost all new food substances that enter the U.S. market are designated as GRAS.

Current law requires manufacturers to demonstrate that a new food ingredient meets the FDA’s safety standard of “reasonable certainty of no harm” before it can be released on the market. However, the FDA interprets the law in a way that allows companies to independently—and often secretly—determine the safety of new substances.

The GRAS designation process is full of conflicts of interest

A substance is eligible for GRAS status if it is widely recognized by experts as safe to use in food. But companies often handpick their own “experts” to help them classify a substance as GRAS, relying on their own employees or hired consultants. Given their financial ties to the company, these reviewers are hardly independent.

The use of hand-picked experts results in a GRAS process plagued with bias and conflicts of interest. To make matters worse, companies are not even required to notify the FDA when they deem an ingredient as GRAS before taking it to market.

The current GRAS system puts Americans’ health at risk

The current GRAS designation process allows companies to avoid FDA review, with real-life impacts on Americans’ health. Harmful substances that have been falsely declared GRAS, such as tara flour, have caused illness and even death.

The voluntary GRAS notification system leaves the FDA largely in the dark about the chemicals in our food, making it ineffective at protecting our health. Records show manufacturers have notified the FDA of fewer than half of the chemicals that they market as GRAS. Even if a company notifies the FDA of a GRAS determination and the agency later questions whether it meets regulations, the company can withdraw its review request and still market the product as GRAS.

We need to reform GRAS

A comprehensive fix to GRAS will require legislation from Congress. In the meantime, the FDA has options to ensure a more rigorous GRAS determination process that better protects Americans’ health.

Actions the FDA can take right away

• Use its existing authority to remove GRAS designations from ingredients it deems unsafe and take them off the market. The FDA can also notify manufacturers, importers, distributors and retailers that the substance is no longer GRAS.
• Enforce the requirement that companies base GRAS designations on publicly available data. Although this won’t curtail companies’ ability to self-declare substances as GRAS, it will require those who do to be transparent in citing their evidence.
• Enforce the requirement that GRAS safety assessments consider vital health information such as a substance’s dietary sources, potential cancer risks and the cumulative health effects of similar substances.
• Prevent companies from withdrawing GRAS notices by notifying them when they fail to comply with GRAS criteria and requiring them to revise and resubmit their data for review.