In the early 1900s, as Americans moved from making their own food to buying manufactured goods, manufacturers were largely unregulated. Food and drug companies did not have requirements about safety or labeling ingredients. (For example, Mrs. Winslow’s soothing syrup was marketed toward children but contained dangerous amounts of alcohol and morphine.)
The government created the Food and Drug Administration (FDA) to ensure that food and medication are safe. However, a recent paper published in the American Journal of Public Health notes that the FDA has a legal loophole that allows manufacturers to keep creating and adding unsafe ingredients to food.
The paper’s authors note that the FDA currently differentiates between chemical substances that are food additives or fall within the “generally recognized as safe” (GRAS) category, which require little to no FDA oversight.
In 1958, Congress passed the Food Additives Amendment, which requires that the FDA evaluate food additives for safety. The amendment also included a carveout for food additives that are categorized as GRAS, which do not have to go through a regulatory process so long as scientific experts agree the substance is safe. This was initially meant for commonly used additives such as salt and pepper.
In 1997, this was loosened so that manufacturers could decide for themselves whether or not a food additive fell in the GRAS category and then notify the FDA. This leaves companies with the choice of going through the cumbersome FDA approval process or conducting their own internal review to determine if the food additive is safe. Companies that opt for the second can then sell foods with the new additive without notifying or getting oversight from the FDA.
To self-regulate or not to self-regulate?
Unsurprisingly, many companies opt for self-regulation. Between 1990 and 2010, an estimated 1,000 manufacturer decisions around ingredient safety were not reported to the FDA. One study of voluntary GRAS notices sent to the FDA found that 100% of the safety decisions were made by people who had a conflict of interest, such as employees of the company or consultants paid by the company. However, the FDA has rarely revoked GRAS status, in part because it lacks resources and a system for reviewing GRAS food additives when they are on the market.
“There are now hundreds, if not thousands, of substances added to our foods for which the true safety data are unknown to independent scientists, the government, and the public,” said study senior author Dariush Mozaffarian, director of the Food is Medicine Institute and professor at the Friedman School of Nutrition Science and Policy at Tufts University.
A spokesperson from the FDA commented in an email: “The food industry is responsible for ensuring the safety of the ingredients they use in foods before they go to market. The safety of food additives must be supported by science that demonstrates their use meets the FDA’s safety standards. The same safety standards and required evidence (quantity and quality of information that would support the safety of a food additive) applies to uses of ingredients that are considered generally recognized as safe (GRAS). All uses of ingredients considered GRAS, food additives, color additives and food contact substances must meet the same safety standard – reasonable certainty of no harm.”
The paper’s authors had several recommendation. First, that the FDA require companies publicly notify it of new food additives. Next, that the FDA create a review process for food additives already on the market. In addition, they recommended Congress provide additional funding to the FDA, so it has the resources to carry out a more rigorous review process.