GRAS: How the Loophole Swallowed the Law
When President Eisenhower signed the Food Additives Amendment of 1958, he established a regulatory program intended to restore public confidence that chemicals added to foods are safe. In the intervening 56 years, the basic structure of the law has changed little. However, the regulatory programs the U.S. Food and Drug Administration (FDA) established to implement the law have fallen behind over time as the agency strived to keep up with the explosion in the number and variety of chemicals in food, and to manage its huge workload with limited resources.
The 1958 law exempted from the formal, extended FDA approval process common food ingredients like vinegar and vegetable oil that are "generally recognized as safe" (GRAS). It may have appeared reasonable at the time, but that exemption has been stretched into a loophole that has swallowed the law. The exemption allows manufacturers to make safety determinations that the uses of their newest chemicals in food are safe without notifying the FDA. The agency's attempts to limit these undisclosed GRAS determinations by asking industry to voluntarily inform the FDA about their chemicals are insufficient to ensure the safety of our food in a global marketplace with a complex food supply. Furthermore, no other developed country in the world has a system like GRAS to provide oversight of food ingredients.
Why Did Companies Forgo the FDA Notification Review Process?
Because of the apparent frequency with which companies make GRAS safety determinations without telling FDA, NRDC undertook a study to better understand companies' rationale for not participating in FDA's voluntary notification program. First, we built a list of companies and the chemicals they made. Then we reviewed public records, the company websites, and trade journals to identify chemicals that appear to be marketed in the U.S. pursuant to an undisclosed GRAS determination, i.e. without notification to the FDA.
All told, we were able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations. This is likely the tip of the iceberg -- we previously published in an industry journal an estimate that there have been 1,000 such undisclosed GRAS determinations. For each chemical we identified in this study, we did not find evidence that FDA had cleared them.
FDA Reviews of Notices Revealed Troubling Risks
In addition, using the Freedom of Information Act (FOIA), we obtained from the FDA copies of communications between the agency and companies who voluntarily sought agency review of their GRAS determinations. We found that this glimpse into the review process shows that often the agency has had serious concerns about the safety of certain chemicals, and that companies sometimes make safety decisions with little understanding of the law or the science. As discussed later, companies found their chemicals safe for use in food despite potentially serious allergic reactions, interactions with common drugs, or proposed uses much greater than company-established safe doses.
On those occasions when the FDA is asked to review a GRAS determination, the agency rejects or triggers withdrawal of about one in five notices. Moreover, the public has even less information about the many substances with GRAS determinations that are never submitted to the agency in the first place -- and which may pose a much greater danger. It is often virtually impossible for the public to find out about the safety -- or in many cases even the existence -- of these chemicals in our food.
The System is Broken
NRDC believes that "Generally Recognized as Secret" rather than "Generally Recognized as Safe" is a better name for the GRAS loophole. A chemical cannot be "generally recognized as safe" if its identity, chemical composition, and safety determination are not publicly disclosed. If the FDA does not know the identity of these chemicals and does not have documentation showing that they are safe to use in food, it cannot do its job.
In an increasingly global marketplace where many additives and foods are imported into the United States, this loophole presents an unsettling situation that undermines public confidence in the safety of food and calls into question whether the FDA is performing its duty to protect public health.
The problem is rooted in a law adopted in 1958 when Eisenhower was president and Elvis was drafted. It is time for the FDA and Congress to fix the problems. In the meantime, consumers need to demand that their grocery stores and their favorite brands sell only those food products with ingredients that the FDA has found to be safe.