Key Event Summary
Representative Rosa DeLauro introduced a new bill that would significantly modify the Generally Recognized as Safe (GRAS) process that many food products currently undergo. This proposed change, if passed, would impact the amount of chemicals allowed in food products by allowing consumer and the public to object to them.
The proposed Toxic Free Food Act will require manufacturers to notify the Secretary of Health and Human Services of their GRAS determinations, and each determination will be made publicly available on the FDA website. The Secretary of HHS and the public will then have a period of at least 3 months to review each GRAS determination and object to them. Furthermore, synthesized or novel substances would be prohibited from using the GRAS approval process, and the bill will create a separate process by which HHS can reassess any substance that has been determined to be GRAS, if the determination did not meet the revised standards set forth in the bill.
Consumer organizations have long complained about the current GRAS process, in which manufacturers independently perform safety reviews to determine that the ingredient or substance is reasonably certain not to be harmful under the conditions of its intended use, based on common scientific knowledge. However, it is up to the manufacturers whether or not to inform FDA of this determination. Consumer advocates have criticized the current GRAS process as lacking transparency and effective oversight, allowing potentially unethical behavior.
Chemicals such as PFAS or orthophthalates have been allowed in new food products under the GRAS process.
Consumer advocacy organizations such as the Center for Food Safety, Breast Cancer Prevention Partners, Environmental Working Group, and other groups are supportive of this proposal, while some industry observers are concerned that the bill will be overly burdensome.
Given the current partisan nature of Congress and priorities being given to other bills, it is not clear whether the proposal will gain traction or support.
If enacted, the Toxic Free Food Act could introduce much more transparency to the GRAS process, long a point of contention among consumer advocates, while introducing an element of pre-market approval and public opinion for the GRAS ingredient.
Reach out to RegASK to identify the potential impacts of regulations on your products and ways to mitigate them. Get in touch with RegASK’s experts.
Contact RegASK for more details Read more