A new California bill could change how food ingredients get FDA green light

Given California’s size, which made up about 14% of the national GDP ($3.9 million) in 2023, changes to its food regulations often have national implications, as manufacturers may reformulate products or adjust supply chains rather than produce state-specific versions.
Given California’s size, which made up about 14% of the national GDP ($3.9 million) in 2023, changes to its food regulations often have national implications, as manufacturers may reformulate products or adjust supply chains rather than produce state-specific versions. (Image: Getty/Spondylolithesis)

In the absence of swift federal action, California is proposing to ban food additives it deems unsafe or poorly tested

California is once again moving to tighten oversight of food chemicals, setting up another potential state-level shift beyond FDA.

Introduced Feb. 17, Assembly Bill 2034 would overhaul how certain food ingredients are disclosed and reviewed in the state, with a particular focus on the federal self-affirmed Generally Recognized As Safe (GRAS) pathway. The bill was introduced by Assemblymember Dawn Addis and sponsored by the Center for Science in the Public Interest (CSPI).

CSPI argues that federal oversight has failed to sufficiently protect consumers from unsafe or poorly tested food chemicals.

How could food additive testing change?

At its core, AB 2034 targets substances introduced after 1958 that have not undergone FDA pre-market review.

Under an exemption in the 1958 Food Additives Amendment, companies can self-determine if ingredients are GRAS and add them to products without notifying FDA. However, many companies voluntarily submit GRAS notifications to FDA for review even though it is not required. Those that do and which receive a ‘no questions’ letter from the agency may find manufacturers more willing to use their ingredient because they have more assurance that FDA does not have any questions about it safety. A third more arduous path is a formal food additive petition with full FDA review and approval.

AB 2034 would mandate companies using unapproved food additives or a “no questions” letter to submit detailed safety notices to the California Department of Public Health (CDPH). CDPH would compile those notices into a publicly accessible database available to regulators, researchers and consumers.

Beginning July 1, 2027, any intended use of a food substance not subject to an FDA regulation or no-question letter would require submission of a notice to the state containing the same level of detail as a GRAS notice, according to the bill. If deemed appropriate by CDPH, it would issue a license to the manufacturer. New substances introduced after July 1, 2027 would also be subject to public comment.

The bill mandates CDPH to review at least 10 food substances every three years and to prohibit the use of any considered unsafe or poorly tested. In conducting reviews, CDPH would consider factors including cumulative exposure, carcinogenicity and whether a substance is listed under California’s Proposition 65. The bill authorizes CDPH to establish user fees to fund the program.

Additionally, the legislation would require manufacturers of packaged food products sold in California that do not individually list each ingredient, including those ingredients that make up proprietary blends, to disclose to CDPH the full list of ingredients. These ingredients may be identified by a common name, Chemical Abstract Service (CAS) number and Flavor Extracts and Manufacturers Association (FEMA )number.

Companies must specify whether these ingredients are a natural flavor, artificial flavor, artificial color or spice as defined in federal regulations, according to the bill.

Supporters: Closing a ‘loophole’

CSPI says the bill would close what it describes as a loophole in the federal system that allows companies to self-certify ingredients as safe without FDA review. The organization says the bill is necessary given the agency’s “longstanding failure” to adequately monitor unsafe or poorly tested chemicals in food.

The bill also aligns with broader federal scrutiny of self-affirmed GRAS. HHS Secretary Robert F Kennedy Jr has publicly called for exploring the elimination of the self-affirmed GRAS pathway. Separately, FDA has moved ahead with proposals to amend GRAS regulations and has been determining whether changes to the notification framework are valid. Currently, federal ruling timelines remain uncertain.

Industry concerns and federal preemption

Industry response so far has been limited but targeted. The trade group Flavor and Extract Manufacturers Association (FEMA) said the bill presents significant conflicts with existing federal law and regulations governing the use and labeling of food ingredients, including flavors.

Some regulatory experts warn that patchwork food safety legislation is ultimately harmful for the industry and consumers. Former FDA Deputy Commissioner Frank Yiannas wrote in a LinkedIn post:

“In a country built on interstate commerce, our food system does not stop at state lines. If a food ingredient is proven to be unsafe based on sound science, then it should be banned nationwide through formal federal rulemaking. That ensures transparency, consistency, and fairness. It also protects consumers in every state equally.”

He added: “The American system was designed with checks and balances for a reason. Federal agencies are accountable to Congress. Rules are subject to public comment. Courts can review agency actions.When it comes to food safety in a national economy, we should trust the process designed to protect all Americans equally – not create 50 different versions of it."

A coalition of food manufacturers and trade groups operating as Americans for Ingredient Transparency argued that a patchwork of state-level ingredient rules would drive up food costs. Citing a study by the Policy Navigation Group, the coalition said similar state nutrition laws in West Virginia, Louisiana and Texas could increase grocery prices by 12% for the average American household. The group is advocating for uniform federal standards rather than state-by-state protocols.

Other adjacent trade associations, including those representing flavor suppliers and color manufacturers, did not respond to requests for comment by the time of publication.

Part of a broader California trend

AB 2034 builds on a series of California food policy moves that have already gone beyond federal requirements. In 2023, the state passed the California Food Safety Act removing four additives, including red dye No. 4, from foods sold in the state. Lawmakers have also targeted ultra-processed foods in school meals, positioning California as a testing ground for policies that could ripple nationally.

Given California’s size, which made up about 14% of the national GDP ($3.9 million) in 2023, changes to its food regulations often have national implications, as manufacturers may reformulate products or adjust supply chains rather than produce state-specific versions.