by Trey Catanzaro*
If you ask most Americans what food additives they may “generally recognize as safe,” it is highly unlikely that they would answer “propyl paraben” or “beta hydroxy acid.” Rather, they may say vinegar, olive oil, or black pepper. In fact, when asked about what “generally recognized as safe” means, a national poll found that 77 percent of respondents thought that standard meant the FDA has evaluated the product and determined it to be safe. However, under current FDA regulations, a company may self-determine whether its product is “generally recognized as safe” under FDA guidelines, and then bring it to market without even notifying the FDA as to its existence. In other words, there are currently thousands of chemicals in everyday food that the FDA has no clue even exist. As succinctly stated by the former Deputy Commissioner for Food at the FDA, “[w]e simply do not have the information to vouch for the safety of many of these chemicals.”
Most chemical additives enter the American food supply due to an exception in FDA pre-market review for ingredients that are generally recognized as safe (GRAS). In legislation drafted in 1958 to address the rising issue of additives in food, Congress specifically exempted certain ingredients which were “generally recognized . . . to be safe under the conditions of [their] intended use” from the definition of additives. Therefore, anything determined to be GRAS would not be subject to pre-market review and approval by the FDA. At the time of passing the amendment, the reasoning for the GRAS exemption was so that ingredients that had long been used in foods without apparent harmful effects, such as salt, sugar and other familiar substances, would not have to undergo extensive testing to be used in food products. However, the GRAS exemption continued to expand, eventually permitting companies to self-determine whether their ingredient was GRAS, and giving them the choice of whether or not to notify the FDA of their GRAS determination.
Under the present iteration of the rule, companies’ GRAS determinations are filled with a litany of conflicts of interest. Rather than relying on peer-reviewed data, companies often convene panels of experts to make a GRAS determination. These panels are frequently made up of the same small group of individuals who have made a career out of GRAS panel participation. To put this in perspective, a comprehensive study looked at convened GRAS determination panels from the year 2015 to 2020, and, out of the 732 panel positions available, there were a mere 7 individuals who filled 339 (46%) of these positions. Their determinations of safety are often never sent to the FDA for review. Further, even if a GRAS determination is sent to the FDA for notification, which is not required, and valid concerns are raised about the safety of the product, this does not always preclude the product from coming to market. Companies have the ability to voluntarily withdraw their petitions should they foresee unfavorable results from the FDA’s review. Therefore, after receiving health concerns from the FDA based on its review of a GRAS notification, the company may then withdraw its notification and continue to market the product. The FDA will then issue a letter of withdrawal without acknowledging the safety concerns raised during the review.
As a result, nearly 73% of food in American grocery stores is considered ultra-processed, and its increased consumption has helped contribute to the 678,000 diet related deaths in America every year. The death toll from the American diet is now higher every year than the death toll of Americans in every war in American history—combined. Beyond the immense number of deaths resulting from the American diet, an estimated 50 billion dollars is spent annually in healthcare costs resulting from diet related illnesses.
Reform efforts must be directed towards closing the GRAS loophole. First the FDA should eliminate the voluntary notification system currently in use for GRAS ingredients and institute a mandatory petition for FDA review. Doing so would not only give the FDA an understanding of every chemical entering our food system, but also allow the American public to review the safety data and provide comments where there are concerns.
Next, FDA review must take into account public health goals, and it must include a guiding principle of precaution. A product’s safety cannot be determined in a vacuum, rather, it must be determined to be safe in the context of America’s health goals. For instance, high levels of added sugar in a product are not a problem in a vacuum, but, with an understanding of America’s high added sugar intake, these levels are clearly a health concern. Furthermore, there must be a precautionary principle that leans towards exclusion to ensure the safety of novel additives. Whenever there is scientific uncertainty regarding a products safety, the FDA must favor being precautious. The precautionary principle has been adopted by many countries, and is even enshrined in the EU General Food Law. Therefore, any additive which is allowed in the food supply must be done with precaution.
Removing harmful ingredients from food has received bipartisan support, with Democratic Congress members introducing the Toxic Free Food Act to help reform certain aspects of the GRAS approval method, and messaging from the incoming Trump administration regarding the desire to remove harmful chemicals from food. However, the approaches to improve the safety of food additives vary greatly, and the solutions outlined here require significant investment of resources to support the FDA, rather than a cheaper de-regulatory approach. To fund these measures, Congress may implement user fees, which are already in use for pharmaceutical review, and can impose taxes on ultra-processed foods. Regardless of whether such methods can fully defray the costs of a heightened GRAS review, increased investment into nutrition has been shown to reduce healthcare costs across the globe, and delivers long-term savings over time. Therefore, while full reform of the system is challenging and costly, it is worth the benefit.
In conclusion, major reform is needed to rectify the crisis that American health and nutrition is facing, and the GRAS approval method represents a major impediment to positive progress. By reforming this loophole, the US will be taking a positive step towards improving the health of its citizens.
*Trey Catanzaro is an attorney with an interest in food law and policy. He graduated from The Ohio State Moritz College of Law in 2022, and is currently living in Nashville, TN with his partner and two dogs.
On Food Law 