June/July 2025 Issue

Food for Thought: Food Additive Controversies
By Toby Amidor, MS, RD, CDN, FAND
Today’s Dietitian
Vol. 27 No. 6 P. 12

Parsing Myth From Truth

Food additives are a hot topic at every level in the food industry. According to the International Food Information Council’s 2024 Food & Health Survey, 30% of Americans feel that food additives are a top food safety issue.1 A 2023 study also found that 60% of foods purchased by Americans contain food additives, a 10% increase since 2001.2 This article discusses some popular food additives, examines how their safety is determined by toxicologists in the United States and other countries, and shares recommendations for practitioners.

The Controversy
Social media influencers like Food Babe, alongside some politicians and consumer advocacy groups, have broad antichemical beliefs and advocate for the removal of many food additives from the food supply. Nongovernmental organization activists have also submitted formal petitions to the FDA and several states to ban certain additives. However, James R. Coughlin, MS, PhD, CFS, president of Coughlin & Associates and consultant in food, nutritional, and chemical toxicology and safety, explains that “These organizations claim, using uncertain science, that these chemicals cause cancer or various neurobehavioral effects, but they haven’t actually been shown to cause these endpoints in humans.” These negative claims are often based on studies demonstrating associations without causation, particularly for endpoints such as ADHD, connected weakly with the synthetic colors. Here we’ll take a closer look at four food additives that have come under scrutiny.

Sodium Benzoate
The FDA permits sodium or potassium benzoate to be added to beverages to inhibit the growth of bacteria, yeasts, and molds. Studies have found that benzene, a known carcinogen, can form at very low levels in some beverages that contain both benzoate salts and ascorbic acid (vitamin C) or erythorbic acid (also known as d-ascorbic acid) due to exposure to heat and light.3 A review conducted by the Center for Food Safety and Applied Nutrition of almost 200 samples of soft drinks and other beverages that tested for benzene from 2005 to 2007 found that a small number of products sampled contained more than 5 ppb of benzene.4 Since then, manufacturers have reformulated products so that benzene levels are less than 1.5 ppb. As such, “the FDA has concluded that the levels of benzene found in beverages to date do not pose a safety concern for consumers because of the almost negligible concentrations of benzene,” Coughlin says.

Propylparaben
Propylparaben is one of a class of related parabens used as an antimicrobial and antifungal preservative.5 Various parabens have been widely and safely used for many decades as preservatives in foods, cosmetics, toiletries, and pharmaceuticals due to their relatively low toxicity profile and a long history of safe use.6 “While it’s synthetically made for industry, it’s also a natural compound found in plants and insects, including cereals, fruit, vegetables, and spices,” Coughlin says. In plants, it’s thought to act as a common natural defense against bacterial and fungal infections.

Propylparaben is allowed by the FDA to be used at a maximum level of 0.1% in foods7 and is also approved in Canada.8 In 1994, the European Union (EU) approved propylparaben for use in food, while later revoking approval because of a rat study showing reproductive effects.9 The EU believed there was “unlikely to be any immediate or long-term health danger from propylparaben in the diet at the current use level”9; however, they recommended removing propylparaben out of an abundance of caution. According to Coughlin, “Many studies have demonstrated that the parabens class of chemicals, including propylparaben, is nonteratogenic, nonmutagenic, and noncarcinogenic, and that evidence for toxicity in humans hasn’t been established.”

Some studies suggest that propylparaben can harm the endocrine system, reproductive health, and have other potentially long-term health issues.10 “Some testing of the parabens class has revealed that individual paraben compounds have weakly estrogenic activity in some in vitro screening tests, but compared to estrogen as a control during in vivo studies, the parabens, including propylparaben, are many orders of magnitude less active than endogenous estrogen,” Coughlin explains. “The speculative concern about the adverse effects of propylparaben is based on the potential hazard, but not on a true calculated risk to humans.”

On September 11, 2023, the California Senate passed AB 418, which banned four substances, including propylparaben.11 According to Coughlin, “The California ban was clearly pressed strongly by advocacy groups approaching the California Legislature about the potential hazard of propylparaben related to endocrine-disruption and reproductive effects, while no human risk has actually been demonstrated. There’s no evidence that the Legislature requested a scientific evaluation by any of the health agencies within the government.”

Oftentimes, people claim that food additive regulations are more stringent in Europe compared with the United States. Coughlin explains how this belief is not accurate. Europe uses a hazard-driven precautionary principle, while the US regulatory system for foods and food additives is based on modern risk assessment principles, where animal-derived toxicity results are evaluated based upon the true relevance to humans, including the realistically lower daily intake levels of food additives compared with the massive doses fed in animal toxicity and carcinogenicity studies. As such, Coughlin says, “It’s a gross mischaracterization to call the system used by the US FDA a ‘looser’ system compared with that used in the EU and some other countries.” When California banned propylparaben, they did so by using the precautionary principle, as is done in the EU, where the decision to ban is based on the potential hazard instead of actual human risk.

Red Dye No. 3
On January 15, 2025, the FDA banned the use of Red No. 3 in food and ingested drugs12 in response to a color additive petition filed by over 20 consumer advocacy groups.13 The consumer groups claimed the ban should be based on the 1958 Delaney Clause, which states that any food additive that appears to be carcinogenic in animals or humans must be removed from the market.14

However, Toronto-based dietitian Abby Langer, RD, owner of Abby Langer Nutrition, says, “This might sound fine to the layperson, but the clause does not take into account the quality of the studies used to determine safety of an additive, nor does it take into account the dosage or whether the research on the additive was done on humans or animals.” Langer explains that Delaney removes additives from the shelves even if there’s only a correlation (no causation required) with cancer in massive doses that humans would never approach, or if all the research except for one weak study points to the additive being safe. Even as early as 1992, the clause was called out as being obsolete.14 According to Coughlin, the “FDA made the merely legal decision that they were forced to invoke the Delaney Clause of the FDCA, even though I and many other scientists believe it is unsupported based on modern toxicologic principles.”

It’s important to remember that synthetic additives (like those made of petroleum) slated to be replaced by natural colorants come with concerns as well. Coughlin explains that much less is known about their toxicology and safety since they are produced as extracts of plants and insects. Some are allergenic; they are sensitive to heat, light, and acidic conditions, making them less stable than the synthetic colors. Larger quantities are also needed to achieve the desired coloring effects.

Titanium Dioxide
The FDA allows for the safe use of titanium dioxide as a color additive in foods according to particular specifications and conditions, including that the quantity does not exceed 1% by weight of the food.15 In 2023, the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives reevaluated the safety and concluded that total daily intake of the substance does not represent a hazard to health.15

In 2023, the color additive petition filed by consumer advocacy groups asked to ban titanium dioxide, and it’s currently under review by the FDA. The petition argued that the European Food Safety Authority’s 2021 Opinion couldn’t rule out potential genotoxicity based on tests on titanium dioxide nanomaterials.15 However, the FDA and other international regulatory bodies in the United Kingdom, Canada, Australia, and New Zealand point out that some of the genotoxicity tests considered in the European Food Safety Authority assessment included test materials not representative of the color additive, and some tests used administration routes not relevant to human dietary exposure.15 “The EU has banned the use of titanium dioxide based on the potential hazard,” Coughlin says.

When it comes to titanium dioxide, it “has never been shown to be carcinogenic in animals or humans, and many recent published studies on its genotoxicity, including for various nanoparticles, have firmly concluded that titanium dioxide is not genotoxic in a wide battery of appropriate test protocols,” Coughlin explains and goes on to agree with the non-EU evaluations that titanium dioxide is safe for use in foods at current levels of approval and that any consideration of its banning is scientifically unjustified.

Recommendations for Practitioners
Many consumers have become increasingly concerned about the safety of food additives due to raised voices in and around the industry calling for a ban on certain additives in food. Dietetic professionals must do their due diligence and educate themselves on the science and history of food additives so they can decipher facts from misinformation.

When it comes to consumer education, Langer recommends practitioners educate themselves regarding harmful vs nonharmful dosages and how additives are tested in the United States. “There’s a common perception that the FDA is ‘asleep’ when it comes to these things, and it’s absolutely not … the US food system is highly regulated and safe,” Langer says. In addition, Langer recommends that practitioners educate consumers about social media and how to spot fact from fiction where much of the misinformation around food and food additives is being spread.

It’s also imperative that practitioners listen to consumer concerns regarding food additives and build a trusting relationship with clients and patients. Even after explaining the US additive regulations, consumers may still be skeptical. Practitioners can help guide these individuals to better select products free of the food additives they may be concerned about.

— Toby Amidor, MS, RD, CDN, FAND, is founder of Toby Amidor Nutrition (tobyamidornutrition.com) and a Wall Street Journal bestselling author. She’s written 11 cookbooks, including Up Your Veggies: Flexitarian Recipes for the Entire Family, Diabetes Create Your Plate Meal Prep Cookbook: 100 Delicious Plate Method Recipes, and The Family Immunity Cookbook: 101 Easy Recipes to Boost Health. She’s also a nutrition expert for FoodNetwork.com and a contributor to U.S. News and other national outlets.

References
1. International Food Information Council. 2024 IFIC food & health survey. https://foodinsight.org/wp-content/uploads/2024/06/2024-IFIC-Food-Health-Survey.pdf. Published June 20, 2024.

2. Dunford EK, Miles DR, Popkin B. Food additives in ultra-processed packaged foods: an examination of US household grocery store purchases. J Acad Nutr Diet. 2023;123(6):889-901.

3. Nyman PJ, Diachenko GW, Perfetti GA, McNeal TP, Hiatt MH, Morehouse KM. Survey results of benzene in soft drinks and other beverages by headspace gas chromatography/mass spectrometry. J Agric Food Chem. 2008;56(2):571-576.

4. Questions and answers on the occurrence of benzene in soft drinks and other beverages. FDA website. https://www.fda.gov/food/environmental-contaminants-food/questions-and-answers-occurrence-benzene-soft-drinks-and-other-beverages. Updated February 25, 2022.

5. Compound summary: propylparaben. PubChem website. https://pubchem.ncbi.nlm.nih.gov/compound/Propylparaben

6. Golden R, Gandy J, Vollmer G. A review of the endocrine activity of parabens and implications for potential risks to human health. Crit Rev Toxicol. 2005;35(5):435-458.

7. Soni MG, Burdock GA, Taylor SL, Greenberg NA. Safety assessment of propyl paraben: a review of the published literature. Food Chem Toxicol. 2001;39(6):513-532.

8. Health Canada’s proposal to revise permitted uses of the food additives methyl paraben, propyl paraben and their sodium salts in various foods. Government of Canada website. https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/proposal-revise-permitted-food-additives-methyl-paraben-propyl-paraben/document.html. Published November 15, 2019.

9. EFSA advises on the safety of paraben usage in food. European Food Safety Authority website. https://www.efsa.europa.eu/en/news/efsa-advises-safety-paraben-usage-food#:~:text=The%20former%20EC%20Scientific%20Committee,ecosystem%20in%20male%20juvenile%20rats. Published September 24, 2004.

10. Nowak K, Ratajczak–Wrona W, Górska M, Jabłońska E. Parabens and their effects on the endocrine system. Mol Cell Endocrinol. 2018;474:238-251.

11. Office of the Governor. California Government website. https://www.gov.ca.gov/wp-content/uploads/2023/10/AB-418-Signing.pdf. Published October 7, 2023.

12. FD&C Red No. 3. FDA website. https://www.fda.gov/industry/color-additives/fdc-red-no-3#:~:text=added%20to%20food.-,Regulatory%20Information,order%20to%20revoke%20these%20authorizations. Published January 15, 2025.

13. FDA to revoke authorization for the use of red no. 3 in food and ingested drugs. FDA website. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs. Published January 15, 2025.

14. Weisburger JH. The 37 year history of the Delaney Clause. Exp Toxicol Pathol. 1996;48(2-3):183-188.

15. Titanium dioxide as a color additive in foods. FDA website. https://www.fda.gov/industry/color-additives/titanium-dioxide-color-additive-foods. Published March 4, 2024.