Toxicologists Weigh In: Serious Consequences for Food Additive Bans

Toxicologists Weigh In: Serious Consequences for Food Additive Bans

As more states consider bans on FDA-approved food additives, two toxicologists shared their thoughts on the consequences of these bills for the Institute of Food Technologists. This article gets right to the core of the issue, saying that "these allegations…stem from a fundamental misunderstanding of the science of toxicology, the linchpin of food additive safety, and the meticulous regulatory oversight by the U.S. Food and Drug Administration (FDA)."

As Dr. Coughlin and Dr. Llewellyn say: "The goal of all stakeholders involved in the U.S. food supply needs to be the safety of consumers and decisions made based on the weight of the scientific evidence." We are in support of science-based evaluation of food additives - and we follow and will continue to follow regulatory guidance from the authorities in this space - but challenges to FDA's authority create a state-by-state patchwork of inconsistent state requirements that increase food costs, create confusion around food safety, and erode consumer confidence in our food supply.

Read more in the IFT piece from Dr. James R. Coughlin and Dr. Craig Llewellyn:

The California Food Safety Act, signed into law in October 2023, states that four food additives-brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3-will, starting January 1, 2027, no longer be allowed to be sold or produced in the state. The ripple effect reaches other states; bills mirroring California's have emerged in Illinois, New York, and Washington. In addition, a bill focused on high fructose corn syrup was introduced in Indiana, while Illinois is requesting further research into the antioxidants butylated hydroxyanisole and butylated hydroxytoluene.

A pattern emerges from this legislative frenzy-a collective lack of awareness of the robust umbrella of U.S. regulations that ensure the safety and abundance of our food supply. Numerous reports have included reference to the potential banning of the food additives in other countries, insinuating that the U.S. lags in safeguarding consumers. These allegations, however, stem from a fundamental misunderstanding of the science of toxicology, the linchpin of food additive safety, and the meticulous regulatory oversight by the U.S. Food and Drug Administration (FDA).

It's crucial to grasp that the FDA does not outlaw additives solely based on identity or perceived hazards. Instead, it meticulously regulates their usage levels in alignment with the Federal Food, Drug, and Cosmetic Act (FFDCA), employing the "reasonable certainty of no harm" standard. A core tenet of toxicology-that the effect is dependent on the amount of exposure and the actual use of an ingredient-underscores that any substance can be harmful in excessive amounts. In addition, the science must be brought to bear to address conclusions that additives shown to be toxic or carcinogenic in animal studies (at exposures vastly higher than human dietary intakes) do not necessarily represent relevant risks to humans that require banning any food additive. Unlike other countries that can use a precautionary principle approach, which can have provisions that can allow a requirement for absolute certainty for scientific questions, the FFDCA acknowledges the impossibility of ensuring complete harmlessness associated with the use of a substance in foods.

From a toxicological perspective, human safety concerns associated with three of the food additives, potassium bromate, propylparaben, and Red Dye No. 3, have been addressed by the FDA. For potassium bromate when used as an additive in baking, the FDA and industry worked together to reduce use levels that have been determined to contribute minimal exposures of dietary bromide.

For propylparaben, animal studies raised concerns about the potential for developmental and reproductive effects as well as endocrine-disrupting effects. In humans, it is readily metabolized and rapidly excreted in the urine. Without bioaccumulation, the uses of propylparaben in foods do not present a concern for human safety.

One study in rats on Red Dye No. 3 induced male rat thyroid tumors at the highest dose tested. Additional research demonstrated that Red Dye No. 3 is not genotoxic and operated via a secondary mechanism of carcinogenesis that does not occur in humans. The findings observed in rats are not relevant to humans and do not impact the safe use of Red Dye No. 3.

The fourth food additive subject to the California legislation, brominated vegetable oil, was abandoned by major beverage brands over 10 years ago. Recent research conducted by FDA indicated that the approved use in beverages may contribute exposure to dietary bromide at levels that cannot currently be demonstrated to be safe, resulting in the FDA acting to remove the currently approved use.

The current haphazard state-by-state approach undermines the FDA's jurisdiction and sound scientific evaluations and decisions, jeopardizing the interstate commerce that ensures a diverse and safe food market. The likely consequences? A dwindling array of choices for consumers and logistical nightmares for manufacturers.

This trajectory will likely not stop with the present additives on trial. If states have questions or concerns on the safety of food ingredients, they should consult with federal experts and work together to bring science to the forefront of dialogue on the safety of food ingredients. The goal of all stakeholders involved in the U.S. food supply needs to be the safety of consumers and decisions made based on the weight of the scientific evidence.