In September 2023, the California Senate and Assembly passed assembly bill (AB) 418, also known as the California Food Safety Act, which banned the use of brominated vegetable oil, potassium bromate, propylparaben, and FD&C red no. 3 (California Legislature 2023). Originally, the bill also included a provision to ban titanium dioxide. However, the assembly members who authored the bill later amended AB-418 to remove a ban on titanium dioxide, possibly due to a lack of scientific evidence showing adverse human health effects at use levels seen in the food industry. California governor Gavin Newsom signed the bill into law on October 7th, 2023, and the ban will go into effect in California in 2027.

It is worth noting that global regulatory bodies and the literature have not yet reached a consensus on the health hazards posed by low oral doses of titanium dioxide, such as those used in food products in California. In the U.S., the FDA’s color additive status list, which is segmented by product such as food and medical devices, allows for cases in which titanium dioxide may be used as a color additive (U.S. Food and Drug Administration (FDA) 2023). Titanium dioxide is used in various ocular products, notably contact lenses and cosmetics (U.S. Food and Drug Administration (FDA) 2021). The European Commission banned titanium dioxide in food in 2022, with a justification of reducing potential genotoxicity (European Food Safety Authority (EFSA) 2022). Those concerns have not been echoed by the FDA. Titanium dioxide nanoparticles, which are receiving increased attention from the toxicological community, are not used in food products (Dreno et al. 2019; Younes et al. 2019).

Red dye no. 3, in the U.S. also known as erythrosine, is currently used as an additive in ingested drugs and foods (Rosol and Gröne 2016; U.S. Food and Drug Administration (FDA) 2023). However, FD&C red no. 3 has been restricted from use in orally ingested drugs and cosmetics per FDA’s color additive status list (U.S. Food and Drug Administration (FDA) 2021). In contrast, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) revised their acceptable daily intake (ADI) of FD&C red no. 3 on numerous occasions since the late 1990’s to the current ADI, which is 0-0.1mg/kg bw (Joint FAO/WHO Expert Committee on Food Additives (JECFA) 2018). 

In the United States, potassium bromate is permitted as a direct food additive in certain products, including grain products such as malted barley and wheat flour (U.S. Food and Drug Administration (FDA) 2023). It is typically detected in baked goods such as breads, cookies, and tortillas given use as a leavening agent (Smith 2023). The FDA’s food additive status list reports use of potassium bromate as allowable at <75 ppm in whole wheat flour and 50 ppm in white and cereal flour. 

Brominated vegetable oil is typically used as an emulsifying agent and listed on the FDA’s food additive status list as a stabilizing agent (U.S. Food and Drug Administration (FDA) 2023). Per the FDA food additive status list, brominated vegetable oil is acceptable at <15 ppm in fruit flavored drinks (U.S. Food and Drug Administration (FDA) 2023). It can also be found as an agent in citrus drinks that allows these beverages to maintain a homogenous flavor profile when including ingredients that may otherwise float to the top (Chuck 2023). 

Propylparaben is a preservative that can be found in cosmetics and foods that contains estrogen-like properties that make it a potentially endocrine disrupting chemical (EDC) (Chuck 2023). According to the FDA’s food additive status list, propylparaben is accepted at <0.1% by weight generally when it is used in jelly and preserves, milk from dairy animals, and mastitis formulations. It is worth highlighting that the FDA currently views propylparaben as generally recognized as safe (GRAS) in foods at <0.1% by weight.

Takeaways

Given the size of the California economic market, promulgation of AB-418 and its ban on four food additives (red no. 3, potassium bromate, brominated vegetable oil, and propylparaben) will affect many food and drug products across the United States. The use of these food additives is widespread and, therefore, removing these food additives will cause several outcomes including 1) recall of foods containing these food additives, 2) food committees at the state and federal level to adjourn on finding appropriate replacements, 3) financial unrest and/or, 4) a removal of certain food products from the market altogether. The discrepancies of food regulations between other states and California should be emphasized as this will play a key factor as the market processes the changes brought forth by California’s regulations. Under any scenario, the nationwide financial costs of this ban, if implemented, would be substantial.

A comprehensive review by Lehto et al. (2017) compared the similarities and differences of regulatory agencies across the U.S. and Europe for food color regulations. They noted that entities seeking to manufacture food products that can be exported from either the U.S. or Europe will have to align their regulations on specific food additives, as there are several additives with regulatory discrepancies between locations (Lehto et al. 2017). Moreover, the authors noted that differing regulations internationally contribute to a more complex set of liabilities for manufacturers. Proper risk assessments of ingredients are critical to understanding potential health risks, or lack thereof, to consumers. 

Table 1. A non-comprehensive example list of food and drug products containing the four food additives to be banned by AB-418 (Drugs.com 2023; Garcia-Toledo 2023; Letenyei 2023; Meyer 2023; Milbrand 2023).

In understanding the need to perform a thorough risk assessment for a diverse array of food additives, proposed regulations concerning aspartame have differs across scientific and governmental bodies. While the FDA suggests that aspartame is safe to ingest, the International Agency for Research on Cancer (IARC) has disagreed. California is slated to be the first U.S. entity to ban FD&C red no. 3, brominated vegetable oil, propylparaben, and potassium bromate. The ability for manufacturers to find a suitable and equitable replacement of these food additives in due time may prove difficult.

How Paustenbach & Associates Can Help

Litigation associated with food additives such as titanium oxide and FD&C red no. 3 may increase in the coming years based on publication of AB-418. The only way to ensure that the public and juries reach sound decisions about the four food additives at issue is to conduct a proper health risk assessment evaluating a diversity of toxicological endpoints across differing doses. In the case of titanium dioxide, we believe, based on various approaches to risk assessment, that this chemical would be considered safe for the vast majority of Americans who ingest the consumer products containing this color additive. Scientists at Paustenbach & Associates have over 55 years of experience in conducting many risk assessments of orally ingested chemicals, including diacetyl and potassium sorbate, and many food additives, as well as pesticides (Fries and Paustenbach 1990; Haws et al. 2008; Tvermoes et al. 2013; Monnot et al. 2016; Paustenbach and Moy 2018). 

We have offered testimony in more than 500 depositions and 30+ trials over the years where we presented our risk analyses. In the cases for which we were retained, we applied exposure science and the health risk assessment methodology embraced by the National Academies of Science to characterize the possible risks. Over the years, we have conducted more than 1,000 risk assessments. Please contact Mr. Grayson Abele for more information regarding our capabilities at gabele@paustenbachandassociates.com or 303-598-0998.

References

California Legislature. 2023. AB-418 The California Food Safety Act. September 1, 2023. 

Chuck E. 2023. California Legislature passes first bill in U.S. banning food additives, including red dye No. 3.  NBC News. September 12, 2023. 

Dreno B, Alexis A, Chuberre B, Marinovich M. 2019. Safety of titanium dioxide nanoparticles in cosmetics. Journal of the European Academy of Dermatology and Venereology. 33(Suppl 7): 34-46.

Drugs.com. 2023. FD&C Red No. 3. Drugs.com. https://www.drugs.com/inactive/fd-c-red-no-3-247.html.

European Food Safety Authority (EFSA). 2022. Commission Regulation (EU) 2022/63 of 14 January 2022 Amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as Regards the Food Additive Titanium Dioxide. Official Journal of the European Union. 1-5.

Fries GF, Paustenbach DJ. 1990. Evaluation of potential transmission of 2,3,7,8-tetrachlorodibenzo-p-dioxin-contaminated incinerator emissions to humans via foods. Journal of Toxicology and Environmental Health. 29: 1-43.

Garcia-Toledo A. 2023. Are You Eating Parabens? Food Found to Contain High Levels of Parabens. Three Little Plums. 

Haws LC, Tachovsky JA, Williams ES, Scott LL, Paustenbach DJ, Harris MA. 2008. Assessment of potential human health risks posed by benzene in beverages. Journal of Food Science. 73(4): T33-T41.

Joint FAO/WHO Expert Committee on Food Additives (JECFA). 2018. FD and C Red No. 3. Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), World Health Organization. https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/503.

Lehto S, Buchweitz M, Klimm A, Strassburger R, Bechtold C, Ulberth F. 2017. Comparison of food colour regulations in the EU and the US: a review of current provisions. Food Additives and Contaminants: Part A. 34(3): 335-355.

Letenyei D. 2023. Foods That Contain the Controversial Red Dye No. 3.  Green Matters. September 13, 2023. 

Meyer A. 2023. What Is Potassium Bromate – and Should You Avoid It?  Eating Well. April 24, 2023. 

Milbrand L. 2023. Food Additives to Watch Out For – and Where You’ll Find Them.  Real Simple. May 10, 2023. 

Monnot AD, Tvermoes BE, Gerads R, Gürleyük H, Paustenbach DJ. 2016. Risks associated with arsenic exposure resulting from the consumption of California wines sold in the United States. Food Chemistry. 211: 107-113.

Paustenbach DJ, Moy P. 2018. Chapter 5, Section 5.2: Regulations regarding chemicals and radionuclides in the environment, workplace, consumer products, foods, and pharmaceuticals. In: Greim H, Snyder R. Toxicology and Risk Assessment: A Comprehensive Introduction. Chichester, West Sussex, UK, John Wiley & Sons. 

Rosol TJ, Gröne A. 2016. Endocrine Glands. In: Maxie MG. Jubb, Kennedy, & Palmer’s Pathology of Domestic Animals Volume 3 Sixth Edition, Saunders Ltd.: 269-357.

Smith DG. 2023. Two States Have Proposed Bans on Common Food Additives Linked to Health Concerns.  The New York Times. April 13, 2023. 

Tvermoes BE, Finley BL, Unice KM, Otani JM, Paustenbach DJ, Galbraith DA. 2013. Cobalt whole blood concentrations in healthy adult male volunteers following two-weeks of ingesting a cobalt supplement. Food Chem Toxicol. 53: 432-439.

U.S. Food and Drug Administration (FDA). 2021. Color Additive Status List. U.S. Food and Drug Administration. https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list#:~:text=FD%26C%20Red%20%233%20-%20All%20lakes,and%20ingested%20drugs%20is%20allowed.

U.S. Food and Drug Administration (FDA). 2023. Food Additive Status List. U.S. Food and Drug Administration. https://www.fda.gov/food/food-additives-petitions/food-additive-status-list#ftnT.

Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, et al. 2019. Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution. EFSA Journal. 17(7): 1-23.