The 1958 Food Additives Amendment to the Food, Drug, and Cosmetic Act states that “any substance intentionally added to food is a food additive and is subject to pre-market approval by the Food and Drug Administration (FDA) unless the use of the substance is generally recognized as safe (GRAS).” In order for a substance to make it onto the GRAS list, it must be “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of [their] intended use.” There are over 700 items on the list to date.
But while the law ostensibly requires evidence of scientific consensus to determine that a substance is GRAS, there is little oversight to make sure that consensus exists. All a food company has to do in order to use any given additive is self-affirm that it has found the substance to be safe. The companies aren’t even required to notify the FDA about their findings.
As the new JAMA analysis shows, even when they choose to inform the agency, those notifications are made by people with a “vested interest” in the industry whose products they are evaluating. About 22 percent of the 451 additive safety notices that were submitted to the FDA between 1997 and 2012 were drafted by an employee of the food additive manufacturer itself. An additional 13 percent were written by consultants that work with firms hired by the food industry. The remainder of the notifications were written by panels of food safety experts — but every single one of those panels’ members were hand-picked either by the food industry or consultants working for the food industry.
Additives that can’t preemptively be considered GRAS, such as food coloring and preservatives, are subject to higher standards of scrutiny. Food companies must submit relevant data about possible harmful effects, chemical composition, and any investigations surrounding the additive’s safety to the FDA. But the FDA-issued guidelines regarding the proper level and method of testing for these products aren’t legally binding for food corporations.
So if a substance — GRAS or otherwise — is eventually found to be harmful, the FDA has to wait until there is clear evidence of its harmfulness before it can pull its approval, work to revoke its GRAS notification, initiate a recall, or institute reforms such as limiting how much of the substance may be put into food. Even these steps may be met with fierce resistance from the corporate food lobby, which stymied labeling requirements for deadly trans fats for a decade and continues to fight proposed limitations on salt content.
These lapses in oversight — and the evidence indicating that the food industry is in essence self-regulated — led the JAMA researchers to call for major reforms. The authors write that the FDA should bar people with ties to the food industry from submitting GRAS or additive safety notifications, move from a voluntary system of GRAS notifications to one that requires companies to inform the FDA whenever they determine a substance to be GRAS, have corporations report conflicts of interest when it comes to assessing an item’s food safety, and release all relevant information to the public.