On March 10, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration (FDA) to examine changes to the current system for classifying new food ingredients as safe. This new directive targets the rules governing substances that are classified as Generally Recognized as Safe (GRAS).
The GRAS system, established by Congress in 1958, allows certain substances to bypass FDA review if they are proven to be safe based on a long history of use or available scientific data. Originally, companies had to request FDA approval for GRAS status for specific uses of substances. However, a 1997 rule allowed manufacturers to independently declare substances as GRAS without notifying the FDA.
Kennedy’s order aims to close this loophole, which he believes has allowed potentially unsafe ingredients to enter the food supply without proper oversight. “For far too long, ingredient manufacturers have exploited a loophole, introducing chemicals and new ingredients with unknown safety data,” Kennedy said in a press release.
What Is the GRAS System?
The GRAS designation was introduced as part of the 1958 Food Additives Amendment, which modified the 1938 Federal Food, Drug, and Cosmetic Act. The FDA initially published a list of GRAS substances, which included common ingredients like salt and vinegar. In the late 1960s, safety concerns about cyclamate salts led to their removal from the GRAS list, prompting the FDA to reassess other substances on the list.
In 1997, the FDA updated the GRAS system to make it more efficient, allowing companies to notify the FDA about substances they believed were GRAS without needing formal approval.
The 1997 Rule: A Loophole in the System
Under the 1997 rule, companies can now determine if a substance is GRAS based on expert opinions, bypassing FDA review altogether. While the FDA encourages companies to notify the agency, it is not a requirement.
Critics, like Kris DeAngelo from Michigan State University’s Institute for Food Laws and Regulations, refer to this as a “GRAS loophole.” It allows manufacturers to introduce substances to the market without FDA review, as long as their assessment follows the FDA’s safety guidelines. This self-affirmation process has become widespread in the industry.
Bryan Quoc Le, a food science consultant, explains that the rule was designed to allow companies to move quickly and maintain their competitive edge. However, this approach has raised concerns about the safety of untested ingredients.
The Impact of Self-Affirmation: How Many Substances Are Unreviewed?
A 2013 report by Pew Charitable Trusts estimated that about 1,000 chemicals have been classified as GRAS without notifying the FDA. The agency typically reviews only around 75 such notices each year.
Common GRAS substances include enzymes, natural preservatives, and spices, according to Quoc Le.
Kennedy’s Proposal: More FDA Oversight
Kennedy has directed the FDA to revise its GRAS rules, eliminating the self-affirmation loophole. Under his proposal, companies would be required to notify the FDA before introducing new ingredients into the food supply, along with safety data to back up their claims. This change aims to improve transparency and ensure food safety.
Acting FDA Commissioner Sara Brenner expressed support for this direction, emphasizing the FDA’s commitment to safeguarding the food supply by reviewing ingredients before they reach consumers.
Would Closing the Loophole Improve Food Safety?
Experts agree that eliminating the self-affirmation rule would improve food safety. DeAngelo points out that the current system creates a “fox guarding the hen house” scenario, where manufacturers are in charge of determining their products’ safety.
The Pew Charitable Trusts report found that many GRAS substances have not been tested according to FDA guidelines. Without scientific consensus, it’s difficult to ensure the safety of these ingredients.
Quoc Le emphasizes the growing importance of regulatory oversight, especially as new food ingredients are created using synthetic biology. These ingredients present new risks that need careful evaluation.
However, both DeAngelo and Quoc Le caution that even if the GRAS loophole is closed, the FDA may struggle to keep up with the workload. Recent staff cuts have left the agency under-resourced, which could hinder its ability to properly review all food additives.
Conclusion
Kennedy’s proposal aims to ensure better oversight of food ingredients, ultimately enhancing consumer safety. However, for the plan to be effective, the FDA will need adequate funding and staff. As the food industry continues to evolve, especially with new technologies, a robust regulatory framework will be essential to protect public health.
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