HHS Plans to Regulate Food Additives – But How?

By Abigail Palotas, Staff Writer

Photo Courtesy of Pixabay.com

The second Trump administration, through newly approved Secretary of the Department of Health and Human Services Robert F. Kennedy Jr., plans to crack down on food additives.[1] But what food additives are at issue, why are they in our food in the first place, and how exactly could Secretary Kennedy get them out?

The Food and Drug Administration (FDA) protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.[2] The FDA also ensures the safety and security of our nation’s food supply, including dietary supplements, bottled water, food additives, and infant formulas.[3]

Ingredients are added to foods to serve a variety of functions, such as maintaining or improving safety, freshness, nutritional value, taste, and texture.[4] Generally, all ingredients must be declared on food labels.[5] The FDA evaluates and regulates ingredients added to food to ensure they are safe for consumers.[6] For food additives, privately held data and information about the use of the substance is sent by the additive’s sponsor to the FDA, which then evaluates that data and information to determine whether it establishes that the substance is safe under the conditions of its intended use.[7] Thus, for a food additive, the FDA determines the safety of the ingredient.[8]

However, there is a loophole: the FDA’s “generally recognized as safe” (GRAS) notification process. This process was initially intended to “grandfather in” foods with a long history of safe use, but it now faces criticism as a broken regulation system that relies on self-policing from food manufacturers to determine the safety of ingredients.[9] The GRAS standard requires scientific evidence demonstrating that the safety of food additives and ingredients meets FDA standards.[10] Specifically, to be classified as GRAS, applicants must show that there is reasonable scientific certainty that an ingredient or additive poses no harm to consumers.[11] The FDA maintains GRAS notification submission procedures which require notifiers to provide information about the chemical, toxicological, or microbiological identity and properties of the substance, as well as reasons for concluding the substance is GRAS for the intended use and discussion of any information inconsistent with a GRAS determination.[12] This system essentially allows the determination that an ingredient is GRAS to be made by qualified experts outside of the FDA.[13]

Some of the additives that Secretary Kennedy has already targeted or will likely target in the future include Red Dye 40 (Allura Red), Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow), Titanium Dioxide, Brominated Vegetable Oil, and Potassium Bromate.[14]

Red Dye 40 is a synthetic coloring agent found in candies, snacks, and beverages.[15] Some specific products containing Red Dye 40 include Froot Loops, Lucky Charms, and Skittles.[16] Red Dye 40 is widely used in the U.S., but the European Union requires warning labels on products containing it, citing potential effects on children’s behavior and attention.[17] Some studies have also associated Red Dye 40 with hyperactivity and migraines.[18]

Yellow dyes, specifically Yellow No. 5 and No. 6, are found in cereals, candies, and processed foods, such as Cheez Itz (Yellow No. 6), Skittles, and Lucky Charms (both contain Yellow No. 5).[19] Norway and Finland have banned these dyes, citing potential allergic reactions and behavioral challenges in children.[20] Like with Red Dye 40, the European Union mandates a warning label for foods containing these yellow dyes.[21]

Titanium Dioxide is a whitening agent used in candies, baked goods, and other processed foods, including many ice creams.[22] In 2021, the European Food Safety Authority deemed it unsafe for human consumption, citing potential risks of genetic material damage.[23]

Brominated vegetable oil is used in sodas and sports drinks to stabilize ingredients and prevent separation.[24]Research has raised concerns about its effects on thyroid function and potential toxicity.[25] Brominated vegetable oil has been banned in several countries but remains common in U.S. citrus-flavored beverages, such as Mountain Dew.[26]

Potassium bromate is a baking additive used to strengthen dough and improve texture.[27] It has been classified as a possible carcinogen due to links with kidney cancer.[28] Countries like Canada and those in the European Union have banned its use, but in the U.S., potassium bromate continues to appear in numerous baked goods.[29]

Cracking down on food additives would dramatically broaden the FDA’s workload because the agency would have to screen new notifications as well as look back at previously greenlighted chemicals.[30] FDA officials have long called for Congress to increase funding for oversight of food additives.[31] One way Congress could do this would be by attaching fees to GRAS notification applications submitted by food manufacturers, similar to the “user fees” programs for medical products.[32] However, Secretary Kennedy has been critical of user fees, and this idea has also failed to gain support from Congress.[33] Kennedy’s team acknowledges that food additive issues may need to be resolved through legislation, but they are also open to enacting change solely through the executive branch, for instance, by asking President Trump to “declare a national emergency, but not for infectious disease, but for chronic disease”.[34]  Another option is that Kennedy could work within existing regulatory frameworks to improve America’s food systems by altering US Dietary Guidelines, which set nutritional standards for industry and federal government programs, including school lunches and military meals.[35]

While several public health experts stand behind Kennedy’s goal to tackle ultra-processed foods and foods containing additives and dyes, it is important to note that public health experts also warn of potential harm from some of Kennedy’s other initiatives, such as removing regulations regarding raw milk consumption and removing fluoride from water.[36] Drinking raw milk that has not been pasteurized – a process that helps kill bacteria – can make people sick or even kill them.[37] And fluoride, in the low levels found in water, has been proven to improve dental health.[38] Experts also find Kennedy’s long-term opposition towards vaccines and his interest in pausing research on infectious diseases concerning.[39]

All in all, our nation’s system for food safety and regulation is complex, but Kennedy, whether through legislation, the executive branch, or other existing administrative channels, has the opportunity to make an enormous impact by altering the American diet to reduce consumption of ultra-processed foods, additives, and dyes.[40]


[1] https://www.cbsnews.com/news/rfk-jr-weighing-fda-crackdown-on-food-additives-under-trump/.

[2] https://www.fda.gov/about-fda/what-we-do.

[3] https://www.fda.gov/about-fda/what-we-do; https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate.

[4] https://www.fda.gov/food/food-ingredients-packaging/food-additives-and-gras-ingredients-information-consumers.

[5] Ibid.

[6] Ibid.

[7] https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works

[8] Ibid.

[9] https://www.cbsnews.com/news/rfk-jr-weighing-fda-crackdown-on-food-additives-under-trump/.

[10] https://www.fda.gov/food/food-ingredients-packaging/food-additives-and-gras-ingredients-information-consumers.

[11] Ibid.

[12] https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works.

[13] Ibid.

[14] https://www.msn.com/en-us/health/other/18-grocery-items-that-may-be-banned-under-rfk-jr-s-health-initiatives/ss-AA1vvpa7#image=3

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] https://www.msn.com/en-us/health/other/18-grocery-items-that-may-be-banned-under-rfk-jr-s-health-initiatives/ss-AA1vvpa7#image=4

[20] Ibid.

[21] Ibid.

[22] https://www.msn.com/en-us/health/other/18-grocery-items-that-may-be-banned-under-rfk-jr-s-health-initiatives/ss-AA1vvpa7#image=5

[23] Ibid.

[24] https://www.msn.com/en-us/health/other/18-grocery-items-that-may-be-banned-under-rfk-jr-s-health-initiatives/ss-AA1vvpa7#image=6

[25] Ibid.

[26] Ibid.

[27] https://www.msn.com/en-us/health/other/18-grocery-items-that-may-be-banned-under-rfk-jr-s-health-initiatives/ss-AA1vvpa7#image=7

[28] Ibid.

[29] Ibid.

[30] https://www.cbsnews.com/news/rfk-jr-weighing-fda-crackdown-on-food-additives-under-trump/

[31] Ibid.

[32] Ibid.

[33] Ibid.

[34] Ibid.

[35] https://www.bbc.com/news/articles/cze391y17z7o

[36] Ibid.

[37] Ibid.

[38] Ibid.

[39] https://www.nbcnews.com/health/health-news/kennedys-confirmation-will-breed-harm-good-public-health-experts-say-rcna192124

[40] https://www.bbc.com/news/articles/cze391y17z7o; https://www.cbsnews.com/news/rfk-jr-weighing-fda-crackdown-on-food-additives-under-trump/