By: Melissa Navarro
What do potassium bromate, propylparaben, and butylated hydroxyanisole have in common? All three are linked to cancer and banned in the European Union yet remain legal in the United States. In the U.S., these food additives can be found in bread, cream cheese, potato chips, cured meats, chewing gum, and countless other common food products.
In February, Florida, Arizona, and Utah, each introduced legislation that would ban certain food additives in their states, most of which have already been banned in other countries. In 2023, California became the first state to ban four food additives that were allowed by the FDA, despite their link to cancer and other diseases. The law’s enactment highlighted an ongoing FDA regulatory gap that allows an unknowable number of unreviewed chemicals into the American food supply.
In 1938, the Federal Food, Drug, and Cosmetic Act (FDCA) was signed into law, creating the Food and Drug Administration (“FDA”) which promised to “protect the public health by ensuring that foods are safe.” Under the FDCA, any substance that becomes a component of food or affects the characteristic of a food is considered a food additive. Originally, all food additives were subject to review and approval by the FDA prior to being placed on the market. However, in 1958, Congress amended the FDCA to create an exception for the regulation of certain food additives. Under the amendment, food additives must be reviewed by the FDA, unlessthe substance is “generally recognized as safe” (“GRAS”). In other words, a food additive may entirely circumvent FDA review and regulation if it is classified as GRAS.
In the initial decades following the creation of the GRAS classification, the FDA regulated and monitored the list of substances that fell under GRAS. Then in 1997, the FDA established a voluntary notice program where food industry members could choose to either submit a notice of GRAS to the FDA or make a self-determination that a substance is GRAS. Manufacturers can self-determine that an additive is GRAS by conducting a safety review themselves, even depending on the opinions of their own employees. If a manufacturer submits a notice to the FDA, the product cannot be placed on the market until the FDA accepts the notification. If a manufacturer chooses to make an independent conclusion that a substance is GRAS, the product can immediately be placed on the market. Because of the GRAS exception, the food industry can decide for itself whether its additives qualify as GRAS or not and therefore, whether they should disclose the ingredient’s use and safety to the FDA. One study estimated that by 2011, over 1000 unreviewed substances had been added to the food supply in the United States.
Additionally, because GRAS additives are unreviewed, so is the amount of the additive used in the product. For example, caffeine’s GRAS status has come under scrutiny in recent years because beverage manufacturers have added dangerous and unregulated amounts of caffeine to beverages, leading to increased caffeine-related hospitalizations.
In 2017, the Center for Food Safety sued the Secretary of Health and Human Services arguing the FDA’s GRAS rule unlawfully delegated the FDA’s authority and duty to regulate food to members of the industry. The New York district court upheld the GRAS notification program, agreeing with the government’s argument that the FDA still has the power to act if it does not agree with a manufacturer’s GRAS determination. Despite the court’s contention that the GRAS notification program does not impede on the FDA’s enforcement powers, actual enforcement has proven long and difficult. For example, in 2013, the FDA announced it sought to revoke the GRAS status of partially hydrogenated oils, but the rule did not go into effect for another five years. This means that, in practice, once a chemical is found to be unsafe for human consumption, it may continue to be placed on the market for years.
In contrast, the European Union (“EU”) takes a largely different approach to food safety regulation. Instead of specifying only what cannot be put into food, the EU runs a positive list of legal food additives. The EU’s regulatory system more closely resembles the original 1938 FDCA and gives a glimpse into what our food supply could look like without the GRAS exception.
In the EU, food safety across member nations is regulated by the European Commission (the “Commission”). Under Regulation EC 1333/2008, all food additives must be authorized by the Commission. While the regulation sets out certain exceptions to the definition of food additive, the exceptions refer to specific substances and do not provide a GRAS-type exception. When the Commission approves a food additive, it is added to a database along with conditions for its use. If a manufacturer seeks to use a food additive that is not already in the database, it must file an application with the Commission. The Commission then conducts a safety assessment, determines whether there is a technological need, and considers if the use of the additive will mislead consumers. If the Commission approves it, the database will be updated. If a producer becomes aware of any information that may affect the safety assessment of an additive, they are required to inform the Commission.
Japan’s Food Sanitation Act, Australia and New Zealand’s FSANZ, and China’s newly revised GB 2760-2024 similarly provide a positive list of legal food additives and require food manufacturers to apply for approval to use any food additives not on the list. No other developed country in the world uses a GRAS type of loophole.
While the GRAS exception has been repeatedly criticized and challenged in the almost thirty years since its implementation, newly appointed Secretary of Health and Human Services, Robert F. Kennedy Jr., brought attention to GRAS in his confirmation hearing. There, Kennedy described the loophole as one that “looks at any new chemical as innocent until proven guilty,” and promised to target it if appointed. This stance against GRAS reflects an ideological shift for a Republican administration. In 1994, a historic mid-term election flipped control of Congress from Democrats to Republicans for the first time in forty years. At the time, deregulation played a major theme in the party’s primary objectives, including the deregulation of the FDA. After facing criticism from pro-deregulators for his restrictions on the tobacco and pharmaceutical industries, FDA Commissioner David Kessler stepped down in February 1997. Two months later, the GRAS voluntary notice program was implemented.
Now, even current FDA regulators agree with Kennedy’s stance that GRAS requires reform. Yet several states decided not to wait, introducing their own legislation to ban certain food additives. The combined populations of every state that has introduced or successfully passed legislation banning additives equal nearly one-third of the U.S.’s total population. If successful, the legislation is likely to have a large impact on major food distributors and challenge the authority of the FDA.
However, one of the largest obstacles to removing GRAS remains. The strong presence and success of lobbying in the U.S. has consistently blocked efforts to abolish the GRAS exception. In 2013, the Natural Resources Defense Council began advocating for a reform of GRAS and was immediately met with pushback from large lobbying firms and food industry trade groups. One group called The Flavor and Extract Manufacturers Association, whose members include Dr Pepper, Nestle, and PepsiCo, told Politico that “it stands prepared to defend FDA’s current approach.” Last year, food and beverage companies spent over $29,000,000 on lobbying, with some of the top spenders including Coca-Cola, McDonalds, and Mars.
As political scrutiny of GRAS intensifies, pressure is building on the FDA to reform the loophole. Whether through state legislation or federal reform, the U.S. food regulatory system may finally begin to shift toward greater accountability.
