The Food and Drug Administration (FDA) is responsible for the safety of the U.S. food supply, but a new study shows that the agency is not getting involved when it comes to the safety of many of the additives already in our food.
Self-regulation of food additives
Under current regulations, the FDA allows the food industry to self-regulate thousands of additives. Companies decide for themselves which ingredients are classified as “generally recognized as safe” (GRAS) and whether to disclose their use and safety data to the FDA.
This self-regulation has resulted in many new substances entering the food supply without government control.
“Neither the FDA nor the public are aware of how many of these ingredients – most commonly found in ultra-processed foods – are present in our food supply,” said Jennifer Pomeranz, associate professor at the NYU School of Global Public Health and lead author of the study.
A legal loophole
Since 1958, the FDA has been responsible for evaluating the safety of new chemicals and substances added to food. However, food safety laws distinguish between “food additives,” which require FDA review, and GRAS ingredients, which are exempt.
Originally, GRAS status was intended for well-known substances such as vinegar, but since 1997 the FDA has allowed companies to determine for themselves whether new substances are GRAS, often without notifying the FDA or sharing safety data.
The study’s lead author, Dariush Mozaffarian, director of the Food is Medicine Institute at Tufts University, said FDA policy gives the food industry the ability to “self-GRAS” review new substances it wants to add to foods without notifying the FDA or the public.
“Hundreds, if not thousands, of substances are added to our food today, the actual safety data of which is not known to independent scientists, the government or the public.”
More resources needed to review food additives
The study shows that the FDA lacks the resources and formal strategies to review existing food additives and GRAS substances. Even when new research indicates potential dangers, the FDA rarely intervenes.
In March, the FDA announced it would review 21 chemicals, including potassium bromate, a substance added to baked goods and beverages that has been linked to cancer. Potassium bromate is banned in several countries, and states such as California have also considered banning it.
“This is a glaring example of the FDA’s regulatory gap,” Pomeranz said. “We’re seeing states starting to take action to close the regulatory gap created by FDA’s inaction on substances that are increasingly associated with harmful substances.”
Minimal control of food additives
The study also points out that FDA’s oversight of GRAS ingredients is minimal. The agency rarely revokes GRAS status and does not consistently review the safety of ingredients that are safe in small amounts but can be harmful in larger amounts, such as caffeine.
“In 1977, the FDA approved caffeine as a GRAS substance for use in sodas at a low level: 0.02 percent,” Pomeranz said. “Today, however, caffeine is added to energy drinks at much higher levels, leading to caffeine-related hospitalizations and even deaths.”
Emily Broad Leib is co-author of the study and director of the Center for Health Law and Policy Innovation at Harvard Law School.
Ensuring a safe food supply
Leib argued that the sheer number of GRAS substances and food additives on the market – combined with the lack of knowledge about the existence of self-GRAS ingredients, inadequate resources, and documented time delays even with well-supported measures – makes trust in post-market authority flawed and unreliable when it comes to ensuring a safe food supply.
The researchers recommend that the FDA and Congress take several steps to improve oversight. For example, they could require companies to notify the FDA of the use of GRAS ingredients and share safety data before adding those ingredients to foods. They also suggest establishing a process to re-evaluate the safety of existing GRAS ingredients and food additives.
“Both the FDA and Congress can do more to enable the FDA to fulfill its mission of ensuring a safe food supply,” Pomeranz concluded.
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