Comments on the Development of an Enhanced Systematic Process for the Food and Drug Administration’s Post-Market Assessment of Chemicals in Food

The Food and Drug Administration (FDA) is proposing a new system for assessing the safety of chemicals after they are on the market.

The Harvard Law School Food Law and Policy Clinic (FLPC) submitted comments on the FDA’s proposal, acknowledging it as a step in the right direction but arguing that the changes proposed are not significant enough.

Key Concerns and Recommendations:

We highlighted several key concerns with the current system and offered the following recommendations:

• Continuous Monitoring: The FDA should establish a continuous monitoring system to regularly assess the safety of all chemicals currently on the market. This could involve a system similar to the Environmental Protection Agency’s (EPA) TSCA chemical evaluation process, a rolling review process, or an advisory committee to identify chemicals needing priority review.
• Strengthening GRAS Oversight: We recommend that the FDA require companies to notify the agency when they place a “Generally Recognized As Safe” (GRAS) substance on the market. Such notification is currently not required by FDA, but such a requirement would allow the FDA to better track chemicals and ensure they are safe over time and in the quantity they appear in the diet.
• Addressing Chronic Health Effects: The FDA should explicitly consider the long-term and chronic health effects of chemicals, beyond just acute risks, in its safety assessments.

We agree with the FDA that the current system for ensuring the safety of chemicals in food is inadequate. We urge the FDA to strengthen its post-market safety assessment system by implementing the recommendations outlined in their comments.

Read our full comments.