FDA’s Role in Food Chemical Safety

Amanda Scott

Associate Editor

Loyola University Chicago School of Law, JD 2024

The U.S. Food and Drug Administration (FDA) protects people from exposure to adverse chemicals in food through the implementation of rigorous regulations. The FDA can do so through the close evaluation of the use of chemicals as food ingredients and the substances that come into contact with food, as well as the broad monitoring of the food supply for chemical contaminants.  This can include the food packaging process, storage process, and other handling measures.

Chemicals present

 There are many chemicals found in the food we eat every day. Certain chemicals serve a useful purpose for food or packaging. They may be used during food production and in the packaging for the preservation of quality, for the supplementation of nutritional value, the improvement of texture and appearance, the extension of shelf life, or the protection of food from dangerous pathogens. There are many other chemicals present in food and packaging. A common example is environmental contaminants. These are present due to the soil, water, or air present where the food is located at any point in the production process. These environmental contaminants can result in arsenic, lead, cadmium, and mercury in some foods commonly eaten by infants and young children. Reducing this exposure is among the FDA’s highest priorities.

The impact of chemical contaminants in food can manifest in two different ways. First, there are acute episodes associated with a single exposure to a contaminated food. An example of this is gastrointestinal illness caused by food poisoning. Exposure to contaminated food can also cause chronic illness due to repeated long-term exposure. This can be as serious as liver cancer due to chronic exposure to mycotoxins. The effects of chemical contaminants need to be better mitigated to ensure disease prevention. This is where the FDA can assist.

Steps taken by the FDA

 A large role is played by the FDA in the implementation of regulations, guidance documents, and regulatory programs. If the FDA finds a chemical or substance that does not meet the appropriate standard, steps are enacted to ensure the protection of public health. This includes the revocation of authorizations or approvals for certain uses, the implementation of phase-out agreements, recalls, and the issuance of alerts to inform consumers.

The FDA is involved in food manufacturing from its very early phases including in the pre-market review process. For example, food additives are highly controlled by the FDA at this stage. For food and color additives to enter the market, they must first be authorized. The authorization process includes the requirement of the submission of information to the FDA that demonstrates how the use of the additives is complicit with the safety standard in place. The FDA also extends its regulations in this sector to an environmental level. It requires the submission to also entail an environmental assessment that ensures the use of the additive does not negatively implicate the environment.

There are also several activities that the FDA is heavily involved in during the post-market stage. These regulations are intended to continue to monitor the food supply for chemical contaminants on an ongoing basis. It monitors the food supply through the testing of both domestic and imported foods. It is also intended to continue to ensure the chemicals used as food ingredients and substances that contact the food are safe on an ongoing basis. The FDA improves its regulations on an ongoing basis through the constant review of new scientific information on the authorized uses of ingredients and food contact substances. Even if a substance was previously authorized, the FDA reviews petitions and notifications that are submitted by the industry and other stakeholders. It also proactively reassesses chemicals when warranted. These reassessments that are initiated by the FDA are done on a case-by-case basis.

Closer to Zero initiative

The work done by the FDA has resulted in material progress toward reducing childhood exposure to food contaminants. The FDA’s Closer to Zero initiative has built on this progress as well. The agency is focusing on reducing the exposure to lead,  arsenic cadmium, and mercury. The development of new testing methods to measure lower levels of contaminants in food is among the steps that have been taken in this initiative. It has also established action levels, increased compliance, and enforcement activities, and monitored levels over time to determine potential adjustments to proposed action levels. All of this is essentially the implementation of stricter and more attuned regulations on food contaminants, with the prioritization of foods commonly eaten by babies and young children. The FDA chose to focus on foods commonly eaten by babies and children because young people are more vulnerable to the negative effects of the contaminants.

So far, the FDA has made significant progress in the reduction of children’s exposure to lead and arsenic. The actions taken are expected to result in a twenty-four to twenty-seven percent reduction in exposure to lead among children and babies. This work started in the 1970s  with the reduction of lead in cans. From 1980 to 2016, lead levels have decreased ninety-seven percent. Inorganic arsenic levels have also shown a steep decrease in infant rice cereal. From 2012 to 2018 it has been reduced by twenty-nine percent. These patterns are predicted to continue and improve even further with the steps taken with the Closer to Zero initiative.

Going forward

 Going forward, I think the FDA needs to continue to strictly regulate the market and instead of reassessing on a case-by-case basis, reassessing in every instance. There are many measures and initiatives in place to improve food chemical safety, however, there is still more that can be done.