Contamination ControlFood TypeRegulatoryChemicalIngredientsFDA

Restrictions on Human and Animal Food Additives: Will FDA Join in the Action?

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Food manufacturers continue to face an evolving and expanding patchwork of state-specific restrictions on food additives.

On October 7, 2023, California became the first state to enact a law prohibiting the use of brominated vegetable oil (BVO), potassium bromate, propylparaben, and red dye No. 3 as food additives. Effective January 1, 2027, the California Food Safety Act¹ bans the manufacturing, selling, delivering, distributing, holding, or offering for sale of food or beverage products intended for human consumption that contain these substances.

Some states have proposed copycat legislation that mirror California's new food additive restrictions, including Illinois (SB2637),² Missouri (HB 2474),³ and Washington (HB1921).⁴

Other states have pending legislation that would restrict the use of additional additives in food and beverage products intended for human consumption:

New York proposed legislation (A06424-A and S06055-B)^5,6 that would prohibit the use of BVO, potassium bromate, propylparaben, red dye No. 3, azodicarbonamide, butylated hydroxyanisole (BHA), and titanium dioxide.
Pennsylvania introduced two bills (HB2116 and HB2117)^7,8 that would collectively prohibit the use of red dye No. 3, red dye No. 40, yellow dye No. 5, yellow dye No. 6, blue dye No. 1, blue dye No. 2, potassium bromate, BVO, and BHA.

California's recently passed California School Food Safety Act⁹ would restrict the use of various color additives (i.e., blue dye No. 1, blue dye No. 2, green dye No. 3, red dye No. 40, titanium dioxide, yellow dye No. 5, and yellow dye No. 6) in food and beverage products sold or offered by public K-12 schools in the state, effective December 31, 2027.

FDA Response to State Action

As this groundswell of activity at the state level builds, the U.S. Food and Drug Administration (FDA) has announced it is reconsidering the safety of certain additives used in food and beverage products intended for human consumption.

FDA revoked the regulatory authorization for the use of BVO in food and beverages products on safety grounds, effective August 2, 2024. Companies will have one year from the effective date (i.e., until August 2, 2025) to phase out the use of BVO.

FDA also indicated¹⁰ that it is currently reassessing the chemical safety of some additional food additives that have been targeted at the state level to determine whether regulatory action is warranted based on new safety data, including:

Red dye No. 3
Titanium dioxide
Potassium bromate
Propylparaben.

The Look Ahead: Will FDA Begin to Take a More Active Role?

As part of a broader strategy to address potentially unsafe food additives, FDA has recently proposed new approaches for its post-market assessment of substances present in human food and pre-market review of animal food ingredients—a signal that the agency is inclined to take a more active role in this space moving forward than in years past.

Post-market Assessment of Substances in Human Food

FDA announced¹¹ it will hold a public meeting on September 25, 2024, on the "Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food," which it intends to establish under the new Human Foods Program. FDA also published a discussion paper¹² outlining its proposed approach for identifying and targeting substances that are currently in the food supply for post-market review. It would involve a multicriteria decision analysis method that primarily focuses on the risks to public health, including:

The toxicity of the substance
Any changes in exposure to the substance that have occurred
The substance's presence in food for vulnerable subpopulations (e.g., infants)
Newly available information, data, or science that may significantly impact the conclusions from the prior assessment of the substance.

Other factors may also be considered, including "interest and/or attention to this chemical by other organizations or the public."

This proposed approach to identifying and targeting substances for post-market assessment suggests that actions at the state level (including state-specific restrictions on food additives) could impact what substances are designated for post-market assessment by FDA.

Proposed Approach to Review of Animal Food Ingredients

FDA announced¹³ that it will not renew the memorandum of understand (MOU) that has been in place for nearly two decades with the Association of Animal Feed Control Officials, and subsequent actions suggest that it will begin to take a more active role in reviewing the ingredients used in animal food (e.g., pet food).

FDA released a draft guidance¹⁴ proposing an interim process for the agency's pre-market review of animal food ingredients once the MOU expires, and explained that it intends to reevaluate the existing pathways available to developers for the review of animal food ingredients. FDA accepted comments from industry stakeholders on the draft guidance through September 9, 2024. The period for comments on the existing pathways available to developers for the review of animal food ingredients ends on December 9, 2024.

What Should Industry Be Doing Now?

Companies should start preparing for increased oversight of food additives in products intended for human and animal consumption. Stakeholders should consider:

Evaluating the formulation of existing food and beverage products in light of federal and state restrictions on food additives that have been proposed or enacted
Determining potential actions (e.g., modifying supply chain agreements) that may be needed to respond to these new federal and state restrictions on food additives
Considering the ingredients used, the packaging materials used, and the potential contaminants against the backdrop of the proposed and enacted state legislation, as well as the potential for federal action in this space, when developing new products

Staying apprised of developments on food additive restrictions as the regulatory landscape continues to evolve.

References

California Secretary of State. California Food Safety Act. Assembly Bill No. 418. October 7, 2023. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB418.
Illinois General Assembly. "SB2637: Prohibited Food Additives." https://www.ilga.gov/legislation/BillStatus.asp?DocNum=2637&GAID=17&DocTypeID=SB&SessionID=112&GA=103.
Missouri General Assembly. "HB2474: Prohibits the Manufacture of Sale of Certain Food Additives." https://legiscan.com/MO/text/HB2474/id/2889585.
Washington State Legislature. "HB1921." https://app.leg.wa.gov/billsummary?BillNumber=1921&Year=2023&Initiative=false.
New York State Assembly. "Bill No. A06424A." https://nyassembly.gov/leg/?term=2023&bn=A06424.
New York State Assembly. "Bill No. S06055B." https://nyassembly.gov/leg/?term=2023&bn=S06055.
Pennsylvania General Assembly. "HB2116." https://www.legis.state.pa.us/cfdocs/billInfo/billInfo.cfm?sYear=2023&sInd=0&body=H&type=B&bn=2116.
Pennsylvania General Assembly. "HB2117." https://www.legis.state.pa.us/cfdocs/billInfo/billInfo.cfm?sYear=2023&sInd=0&body=H&type=B&bn=2117.
California General Assembly. "AB2316." https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB2316.
U.S. Food and Drug Administration (FDA). "List of Select Chemicals in the Food Supply Under FDA Review." Current as of March 4, 2024. https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review.
FDA. "Public Meeting on the Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food." September 25, 2024. https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food.
FDA. "Discussion Paper: Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food." August 2024. https://www.fda.gov/media/180942/download.
FDA. "FDA Letter to Stakeholders: Acknowledgment of Expiring FDA-AAFCO MOU." August 2, 2024. https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou.
FDA. "DRAFT: CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)." August 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic.

KEYWORDS: additives legislation

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Samuel D. Jockel, J.D. is a Partner at Alston & Bird LLP in Washington D.C.He focuses his practice on regulatory, policy, and litigation matters involving industries regulated by FDA, USDA, TTB, FTC, and relatedstate regulatory agencies. From ingredient suppliers to manufacturers todistributors to retailers, Sam's approach to counseling clients leverages his time as a trial attorney in the USDA'sOffice of the General Counsel and as an Oak Ridge Institute for Science and Education Fellow at the FDA. Sam counsels clients across multiple product categories through enforcement actions and potential crises, including in response to import detentions, inspectional findings, recalls, warning letters, and civil and criminal investigations and actions. Sam also has substantial experience on USDA regulatory issues, including on bioengineered food disclosure, the Perishable Agricultural Commodities Act (PACA), and organic labeling (AMS); meat, poultry, and egg products regulatory matters (FSIS); the import of animal and plant products, and animal welfare (APHIS); and SNAP compliance and nutrition programs (FNS).

Ashley Yull, J.D. is a Senior Associate at Alston & Bird LLP in Washington D.C. She counsels clients in industries regulated by FDA, USDA, and FTC. Ashley concentrates her practice on helping clients navigate complex compliance and enforcement related issues involving food, beverages, dietary supplements, drugs, medical devices, and cosmetics. Ashley also provides regulatory support in food and beverage litigation.Before joining the firm, Ashley advised clients on the regulation of food contact materials in multiple jurisdictions at another international law firm. Ashley earned her J.D. from the American University Washington College of Law,where she served as a senior staff member on theAmerican University Journal of Gender, Social Policy, andthe Law,and as the Executive Editor of theHealth Law & Policy Brief. She was also a student attorney in the Glushko-Samuelson Intellectual Property Law Clinic.