A newly introduced California bill aims to address gaps in federal oversight of food additives and ingredients by giving state health officials the authority to conduct independent safety assessments.

Introduced by Assemblymember Dawn Addis (Democrat–Morro Bay), California Assembly Bill 2034 (AB 2034) is intended to close the Generally Recognized as Safe (GRAS) “loophole,” which allows manufacturers to introduce new ingredients to the food supply without a formal safety review by the U.S. Food and Drug Administration (FDA).

If passed, AB 2034 would:

• Require firms to submit a notice to the California Department of Public Health (CDPH) when intending to use a new food additive or ingredient in their products, which must include the same evidence and information that is required for federal GRAS notifications
• Require CDPH to review the notice submitted by the firm, and if the information is complete, publish the notice in a public database
• Require CDPH to issue or decline a license for new food additives and ingredients, and when assessing the safety of an ingredient, consider factors including, but not limited to, whether the substance is banned or restricted in other jurisdictions due to concerns about adverse health consequences
• Require CDPH to systematically reassess the safety of at least ten substances every three years
• Authorize CDPH to create and update user fees for notices, assessments, and reassessments
• Require the manufacturer of any packaged food product to provide the department with a list of its food products that are sold in the state and identify each ingredient not individually named in the ingredient list (e.g., ingredients must be speficially listed by name instead of using terms like "artificial flavors," "natural flavors," "spices," or "artificial colors”).

The requirements would start going into effect on July 1, 2027, if AB 2034 is passed as-is.

AB 2034 now awaits referral to committee. The legislation is supported by the Center for Science in the Public Interest (CSPI).

What is the GRAS “Loophole?”

Established in 1958 through an amendment to the Federal Food, Drug, and Cosmetic Act, the GRAS process enables food substances to be used without premarket approval by FDA as long as scientific experts determine the substance to be “safe” under the conditions of its intended use. GRAS determinations effectively exempt a food substance from being subjected to the premarket safety review process required for food additives by FDA.

GRAS determinations can be made by experts outside of the government, using literature compiled by food companies. Food companies can choose to voluntarily notify FDA when they have made a GRAS determination about a new substance—or they can begin using the intended ingredient without notifying FDA once they have compiled the scientific evidence required to make their determination.

The GRAS process was originally intended to allow widely used food ingredients, commonly understood to be safe for consumption (e.g., vinegar), to remain on the market without extensive review. However, it is now used by firms to put new ingredients in their products, earning GRAS its reputation as a “loophole” and drawing criticisms for potentially allowing unsafe additives into the food supply.

In recent years, GRAS has increasingly come under public scrutiny, and federal changes to the GRAS process may be forthcoming. An FDA proposed rule that is reportedly intended to tighten GRAS oversight is currently pending White House review.