Search results for: bht

  • On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).
  • FDA released two documents to guide the post-market assessment program. The document “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” describes how FDA  will “identify food chemicals for review, prioritize identified food chemicals for assessment, structure scientific assessments, and communicate risk management plans.” The document describes “chemicals in food” to include “any substance found in or added to food, including nutrients, food additives, contaminants, and natural ingredients.”
  • The document “Post-Market Assessment Prioritization Tool” is intended to help “identify priority food chemicals for full scientific assessment by focusing on potential risk to public health.” The document covers decisional criteria, including toxicity, change in exposure, use or presence in food for susceptible subpopulations, and new scientific information and potential impact.
  • BHT and ADA have been common targets in recent state legislation, as well as listed priorities in FDA’s post-market review agendas, as we have previously blogged. BHT is used to prevent spoilage of fats and oils, and ADA is used as a whitening agent in cereal flour and as a dough conditioner in breadmaking.
  • Keller and Heckman will continue to monitor FDA’s post-market assessment activities.
  • The Wisconsin State Assembly introduced Wisconsin Assembly Bill 550 (AB 550) on October 15, 2025. The bill proposes a mandate that manufacturers of packaged food products intended for human consumption must include prominent warning labels if the product contains any of the fifty-one ingredients listed in the bill.
  • Ingredients that would require a warning label include certain artificial colors, sweeteners, preservatives, and other additives, including the FD&C certified colors, titanium dioxide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), acesulfame potassium, and more. Foods containing these ingredients would be required to bear the label “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.”
  • The bill follows similar laws that were recently enacted in Texas and Louisiana, as we previously blogged. Unlike the Texas law, there is no preemption provision in AB 550.
  • Keller and Heckman will continue to monitor this and other bills related to food labeling.
  • On August 19, FDA announced updates to its List of Select Chemicals in the Food Supply Under FDA Review. The list is part of FDA’s plan to conduct post-market reviews of chemicals in food. Note that the excel spreadsheet on the list includes additional information that is not available on the main page such as the date the review was initiated. (see “Export Excel” button on linked page)
  • The new chemicals officially added to the list are:
    • The antioxidants butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT)
    • Azodicarbonamide (ADA), approved as a bleaching agent in cereal flour and as a dough conditioner in bread baking
    • Synthetic color additives FD&C Blue No.1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6.
    • Opiate alkaloids on poppy seeds. Earlier this year, FDA requested information on agricultural, production, and supply chain practices which may contribute to the presence of these opiate alkaloids.
  • FDA’s announcement also notes that (1) it will seek data on BHA, BHT, and ADA to facilitate its post-market assessments, (2) it has separated lead as an impurity in food contact substances from lead as an environmental contaminant, and (3) that it is taking steps to expedite its review of chemicals included in previous updates, including phthalates, propylparaben, and titanium dioxide.
  • On June 30, 2025, FDA’s Human Foods Program published its proposed 2025 guidance agenda, including the Agency’s priority topics for new or revised guidance documents, as we previously blogged.  As a recent article discusses, the agenda’s publication comes amid heightened scrutiny on food ingredients, particularly petroleum-based synthetic dyes and transparency concerns. Regardless, the agenda is “a strong signal to industry stakeholders of the FDA’s strategy.” Overall, the topics presented in the agenda reflect public and political pressure for FDA to modernize food and beverage industry oversight.
  • Industry response to the agenda, as well as other recent FDA regulatory proposals, has been mixed. Some stakeholders welcome the Agency’s “proactive stance on chemical safety,” especially in light of years of concern about processes for substances that are generally recognized as safe (GRAS). Meanwhile, others are concerned that “the weight of focus given to synthetic dyes and post-market chemical assessments . . . could divert resources from more urgent issues like food insecurity and nutrition labeling.” Following FDA’s recent effort to phase out certain food colors, some companies have moved to reformulate their products, while others are “questioning the science behind the decision.”
  • Congress is also increasing pressure on FDA to tighten food chemical oversight. Two recent bills aim to reform the GRAS process:
    • The Ensuring Safe and Toxic-Free Foods Act, introduced by Sens. Edward Markey and Cory Booker, would require FDA review and public comment on all GRAS determinations, as well as require FDA to reassess the safety of at least 10 substances or substance classes every three years.
    • In addition, the Food Chemical Reassessment Act, introduced by Reps. Jan Schakowsky and Rosa DeLauro, would also require reassessment of at least 10 substances every three years, starting with Tert-butylhydroquinone, titanium dioxide, red dye 40, yellow dye 5, blue dyes 1 and 2, green dye 3, perchlorate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), trichloroethylene, methylene chloride, benzene, ethylene chloride, propyl gallate, sodium nitrite, and sodium benzoate.
  • Keller and Heckman will continue to monitor developments related to the regulation of food ingredients and additives.

  • Yesterday, the Make America Healthy Again (MAHA) Commission, released its “Make Our Children Healthy Again” report outlining its priorities for improving the health of American children. President Trump requested the report in a February executive order establishing the MAHA Commission.  The report targets “ultra-processed foods” (UPFs), exposure to environmental chemicals (microplastics, pesticides), a decline in physical activity, and “overmedicalization” as some of the main drivers of an increase in childhood chronic diseases such as obesity and cancer. The MAHA Commission is set to issue further policy recommendations in August.
  • The report loosely defined UPFs as those that are high in added sugars, refined grains, unhealthy fats (such as seed oils), and sodium while low in fiber and essential nutrients. The report also identifies certain food additives, including food colorings (such as Red 40), titanium dioxide, propylparaben, butylated hydroxytoluene (BHT), and artificial sweeteners (such as aspartame, sucralose, saccharin).
  • The report also criticizes the Dietary Guidelines for Americans (DGA) for not specifically addressing UPFs in its dietary recommendations and “remaining largely agnostic to how foods are produced or processed.” The report is also critical of the DGA and nutrition research at large claiming they are being improperly influenced by the food industry, citing an analysis that found $60 billion in industry funding for nutrition research, without acknowledging the significant cuts to research funding undertaken by the administration in the last several months. (Pages 30-32)
  • The report goes on to criticize other government programs. It claims that children who are Supplemental Nutrition Assistance Program (SNAP) participants consume more unhealthy food and beverages than income-eligible non-participants, leading to worse health outcomes. The report further claims that the National School Lunch Program (NSLP) fails to limit UPF consumption and allows food companies to make minor ingredient adjustments to qualify their products for the Smart Snack program. (Pages 32-34)
  • Cumulative chemical exposure, increased use of technology, and overtreatment/overdiagnosis of common illnesses are all claimed to be drivers of chronic disease. The report calls for studies on the effect of cumulative exposure to chemicals including PFAS, phthalates, bisphenols, microplastics, fluoride, electromagnetic radiation, and crop protection tools (e.g., pesticides, herbicides, and insecticides).  (Pages 43-44)
  • The report made a single reference to GRAS Oversight reform, recommending that independent studies are funded to evaluate “the health impact of self-affirmed GRAS food ingredients.” (Page 72)
  • On May 15, 2025, FDA announced a three-part agenda “to increase transparency and ensure the safety of chemicals in our food.” This step follows from the Agency’s post-market activities last fall, where FDA published a discussion paper and held a public meeting to outline its plan for developing a robust post-market review process for chemicals in food and to seek input from stakeholders. It is unclear from the announcement to what extent the comments submitted to FDA in January 2025 have been considered, following FDA’s public meeting on the development of a post-market assessment program.
  • Regarding its current proposal, FDA’s initiative will include the following elements: (1) a modernized, evidence-based prioritization scheme for reviewing existing chemicals; (2) a final, systematic post-market review process shaped by stakeholder input; and (3) an updated list of chemicals under review. FDA will continue to share information about the status of this work on its public website as part the Agency’s push for greater transparency.
  • FDA’s updated list of substances in the food supply undergoing review includes butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA). All three of these substances have been targeted by Vani Hari, aka the Food Babe, indicating what appears to be an increase in her influence of the Make America Healthy Again (MAHA) agenda. The Agency also stated it will take steps to expedite substances currently under review, including titanium dioxide, for which FDA had determined in 2024 does not present a safety concern when used as a color additive for foods, phthalates, and propylparaben.
  • FDA’s announcement was concurrent with a presentation by Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) at the Food and Drug Law Institute’s (FDLI’s) Annual Meeting in Washington, DC, where Hartman reassured the audience that, although a substance may undergo post-market review, this does not mean it is destined to be deemed unsafe. The OFCSDSI Director also relayed during his presentation that FDA is actively working on a rulemaking regarding self-GRAS determinations, a directive from HHS Secretary Kennedy on March 10, 2025. In this regard, Hartman shared that FDA is considering whether new chemicals should be allowed to continue to operate under a voluntary system or require mandatory GRAS Notice submissions, and which regulatory approaches should be used to address the lack of visibility on past self-GRAS positions.
  • Keller and Heckman is continuing to monitor these and other FDA developments. 

  • On April 5, 2025, Texas Attorney General Ken Paxton announced an investigation of W.K. Kellogg Co. (Kellogg) for potential violation of Texas consumer protection laws, alleging that Kellogg’s marketing of its cereals as “healthy” is deceptive marketing because they include artificial food dyes and butylated hydroxytoluene (BHT).
  • As we previously reported, the Texas Senate recently passed SB 25, which if passed into law would require food labels to warn Texas consumers if a food product contains ingredients banned in other countries.  The bill is now under review with the Texas House Committee on Public Health.  AG Paxton’s announcement signals the Texas government’s continued focus on food additives and “healthy” claims by food manufacturers.
  • AG Paxton alleges that Kellogg’s “healthy” claim is deceptive because the artificial dyes “have been linked to hyperactivity, obesity, autoimmune disease, endocrine-related health problems, and cancer in those who consume them.”  However, not all food scientists agree with this link to health issues, and many of the food dyes and additives are currently approved for use by the U.S. Food and Drug Administration (FDA).
  • Keller and Heckman will continue to monitor this investigation and relay any developments.
  • On March 18, 2025, Louisiana introduced Senate Bill 14, a bill that would require products containing artificial dyes, chemical additives, and other ingredients to include a warning label on the product where the substances are banned or not authorized in other countries.  The bill lists 51 different ingredients that would require the warning, including several synthetic dyes, synthetic or artificial vanillin, propylparaben, potassium bromate, melatonin, bleached flour, and others.  Any food items containing any of the listed ingredients would be required to bear the following warning label, “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.” 
  • Additionally, SB 14 would prohibit public schools and non-public schools receiving state funds from serving ultra-processed foods.  The bill defines ultra-processed food as any food or beverage that contains the following: Blue dye 1, Blue dye 2, Green dye 3, Red dye 3, Red dye 40, Yellow dye 5, Yellow dye 6, azodicarbonamide, Butylated hydroxyanisole (BHA), Butylated hydroxytoluene (BHT), Potassium bromate, propylparaben, and titanium dioxide.
  • Some additional provisions of the bill would also require any food service establishment that cooks or prepares food using seed oil to display a disclaimer on the menu or other clearly visible location, prohibit soft drinks from SNAP eligibility, and require physicians and physician assistants to complete continuing education on nutrition and metabolic health.
  • This bill mirrors Texas SB 25, as we’ve previously blogged about, which would also require warning labels on packaged food products containing artificial colors, chemicals, or food additives that do not have a regulatory clearance in other countries.
  • LA SB 14 is the latest in a host of newly proposed bills this legislative cycle targeting synthetic dyes and various other food additives, which, if adopted, will create a divided and complicated regulatory scheme across the country.
  • Keller and Heckman will continue to monitor developments related to state legislative efforts to prohibit food additives.
  • Since the start of February, at least four states have introduced or advanced proposals to ban various food chemicals and address concerns over the use of ultra-processed foods (UPFs).  New food chemical bans have surfaced in recent days in Florida, Arizona, and Utah, while lawmakers in Illinois advanced a food chemicals ban that has long raised concerns for industry stakeholders.
  • The Illinois chemicals ban (SB 93) would prohibit brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3, effective in 2028.
  • Florida has been one of the latest states to introduce a food chemical ban.  If passed, the bill (SB 560) would prohibit food companies from manufacturing, selling or distributing food that contains nine food chemicals, including potassium bromate, propylparaben, Blue No. 1, Yellow No. 5, benzidine, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).
  • In Arizona, Republican Sen. Leo Biasiucci said he was inspired by the MAHA movement to introduce HB 2164, which would ban any food that contains eleven chemicals: potassium bromate, propylparaben, titanium dioxide, brominated vegetable oil, Yellow No. 5 and 6, Blue No. 1 and 2, Green No. 3, and Red No. 3 and 40.  The bill would also ban UPFs in school meals – however, the definition for UPFs included in this bill categorizes these as foods that contain any of the eleven chemicals set to be banned by the proposal.  This definition differs significantly from other approaches, by focusing more on specific additives, rather than the degree of processing.
  • Utah has followed a similar approach to Arizona with HB 402.  If passed, this bill would ban certain ultra-processed foods from being served at schools.  UPFs are defined here as foods containing one or more of the following ingredients: brominated vegetable oil, potassium bromate, propylparaben, titanium dioxide, Blue No.1 and 2, Green No. 3, Red No. 3 and 40, and Yellow No. 5 and 6.
  • On May 27, Senator Edward J. Markey (D-Mass.), alongside Senators Richard Blumenthal (D-Conn.) and Elizabeth Warren (D-Mass)., introduced the Ensuring Safe and Toxic-Free Foods Act, which is described as “comprehensive legislation that ensures the Department of Health and Human Services (HHS) fulfills its responsibility to promote the health and well-being of American families by directing the Food and Drug Administration (FDA) to strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which exempts companies from seeking pre-market approval for food chemicals.” A summary of the legislation is available here.
  • The legislation would prohibit manufacturers from independently designating substances as GRAS (or manufacturing or selling food containing those substances) without supplying notice and supporting information to the Secretary of HHS. Substances that are carcinogenic or that have evidence of reproductive or developmental toxicity would be prohibited from receiving a GRAS designation. Further, the legislation would require that a GRAS Notice and all supporting information be publicly available online and subject to a 90-day review period.
  • The legislation would also direct the Secretary to create an Office of Food Chemical Safety Reassessment within FDA’s CFSAN. The new office would be responsible for reassessing the safety of existing food additives, food contact substances, color additives, and substances that had already received GRAS status. The office would be required to reassess at least 10 substances (or class of substances) once every three years. As included in the bill, the first 10 substances to be reviewed would be:
    • Perfluoroalkyl substances and polyfluoroalkyl substances
    • Ortho-phthalates
    • The class of bisphenols
    • Titanium dioxide
    • Potassium bromate
    • Perchlorate
    • Butylated hydroxyanisole (BHA)
    • Butylated hydroxytoluene (BHT)
    • Brominated vegetable oil (BVO)
    • Propyl paraben
  • With regard to the legislation, Senator Markey has said “The FDA too often falls short on their responsibility to promote food safety, highlighted recently by the baby formula crisis where FDA’s deputy commissioner for food policy did not learn about the whistleblower complaint for four months. It is long past time we revise existing food safety measures and close the loophole allowing manufacturers to self-regulate what new substances can enter our food supply.”
  • Keller and Heckman will continue to monitor the progress of the Act and provide any updates.