For almost 70 years, food and beverage firms have been able to classify new ingredients as safe without having to inform the Food and Drug Administration (FDA). A new proposal could change this by requiring companies to notify the FDA when introducing a new substance for human or animal consumption.
Understanding GRAS
Currently, companies use a self-certification process classifying ingredients as “generally recognized as safe” (GRAS). This process has drawn criticism from food safety experts, noting a gap in information. The proposed rule addresses this by mandating notification though companies can still sell without waiting for FDA’s safety determination.
The Historical Context
Congress established the GRAS exemption in 1958, originally intended for common ingredients like salt and vinegar. Over time, companies expanded this exemption to cover far more ingredients than Congress originally intended. A 2025 analysis by the Environmental Working Group found that 99% of new food chemicals since 1958 entered the market via GRAS rather than formal approval.
The Need for Change
Instances like the 2022 outbreak linked to tara flour and Daily Harvest crumbles showcase the challenges arising from the current process. The FDA reclassified tara flour as unapproved after determining it didn’t meet GRAS standards. Experts argue that mandatory reporting could preempt issues like these.
The Proposed Changes
The proposal aims to make the FDA’s GRAS notification program mandatory. Companies would need to notify the FDA of their reasoning behind a substance’s safety. While the rule stops short of enforcing a full review, it would provide the FDA with more consistent data, assisting in post-market safety evaluations.
Industry and Expert Opinions
Critics often refer to the GRAS exemption as a “loophole.” Patricia Zettler from Ohio State University argues the exemption aligns with Congressional design, though it may have grown beyond original intentions. The proposal would require companies to register their already self-determined GRAS substances within a year, without the need for safety data.
Resources and Enforcement Concerns
Marion Nestle from New York University questions whether the FDA has the capability to review all notifications, especially with resource constraints. The proposal lacks details on enforcement mechanisms for non-compliance, adding to skepticism about its efficacy.
What Remains Unchanged
Companies won’t need to wait for FDA review before marketing a GRAS substance. This differentiates GRAS from the formal food additive process, which requires detailed scientific evaluation before marketing.
Impacts on Food Safety
The proposed GRAS changes fall under the broader “Make America Healthy Again” agenda, prioritizing additive and chemical scrutiny in food. These changes focus on transparency rather than addressing microbe-related food safety like cyclospora or salmonella outbreaks.
Future Steps and Implementation
The proposal invites public comment until early December, and modifies the process based on feedback. The rule might not be finalized before 2027. Stakeholders are likely to contest the FDA’s enforcement capabilities and staffing.
According to critics, a transparent database and independent FDA review would enhance the process. If implemented, the proposal could give the FDA better insights into the food supply’s ingredient content, offering a more reliable safety framework.