The safety of food additives in the United States could undergo significant changes as concerns rise over the Generally Recognized as Safe (GRAS) designation process. The Food and Drug Administration (FDA) created this practice in 1958. It authorizes substances to skip FDA review if they have been used for many years in food or if safety information exists that is widely accepted by qualified scientists. Industry critics say a gaping loophole has been created. This loophole is dangerous as it allows companies to determine the safety of thousands of chemicals without any oversight.
The GRAS designation controversy has renewed calls for reform. A new report by The Pew Charitable Trusts exposes those conflicts of interest and other failures in our current system. The FDA is already considering reforms to the GRAS process. We cannot allow this discussion to continue to take place without understanding the impact on food safety and public health.
Understanding GRAS Designation
The GRAS designation is an important, but often overlooked, component of the FDA’s regulatory paradigm. The Food Additives Amendment, amendment to the 1938 Federal Food, Drug, and Cosmetic Act, was meant to simplify food safety. It allows the use of certain substances in food without requiring the FDA to approve them in advance. The FDA maintains a list of GRAS substances. This list includes widely used ingredients like salt, pepper, and vinegar, all of which have made invocations into the Code of Federal Regulations.
In 1997, the FDA changed the GRAS process to facilitate faster approvals through the GRAS Notification Program. In other words, for the first time, manufacturers can self-affirm a substance as GRAS. They don’t even have to alert the FDA or publish their results. This is in contrast to the roughly 75 GRAS notifications that the FDA currently reviews each year. There is no obligation for these companies to tell the agency about their self-affirmed determinations.
“Manufacturers are permitted to determine if substances are GRAS independent of or absent from the FDA’s review or approval as long as the determination aligns.” – The FDA
Unfortunately, this self-affirmation process is something that has long troubled consumer advocates and food safety experts. Critics were quick to point out that it creates a “fox guarding the hen house” situation. In this absence, companies often have an incentive to value profits over public safety.
The Loophole and Its Consequences
The Pew Charitable Trust report reveals an alarming trend. SC Johnson estimates that at least a thousand chemicals have been granted GRAS status without notification to the FDA, which presents huge issues of undisclosed safety data. The report emphasizes that general recognition of additive safety requires consensus within the scientific community, stating, “There can be no such consensus if the chemical’s use is unknown to the scientific community and to FDA.”
Kris DeAngelo, a food safety advocate, highlights this issue, noting that “this is regarded as a GRAS loophole and has become the norm.” This trust in self-designation is a significant factor resulting in many substances introduced into the food supply that have not undergone careful review.
Robert F. Kennedy Jr., a prominent figure advocating for stricter food safety regulations, emphasizes that “for far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.”
Critics of this practice contend that no transparency erodes consumer trust and threatens public health. Through action leading to litigation, they plead for transparency and accountability in the food additive approval process.
Potential Reforms on the Horizon
In light of this increased criticism, the FDA has suggested reforms to its GRAS designation process that are currently under consideration. One change we support would require companies to notify the FDA before they use any new ingredients. In addition, they have to provide supporting safety data before these substances are allowed into the food supply.
Experts on our panel agree that these three reforms would go a long way towards restoring trust in the regulatory system. Quoc Le, a food safety researcher, states, “I believe it is important for a regulatory body to have the resources and tools to review food ingredients before they enter the market, as there have been historical problems with introducing new substances to consumers that weren’t thoroughly tested.”
Even with all these reforms, DeAngelo cautions that irreplaceable money and mind power are keys to success. He states, “Without sufficiently skilled and educated staff and proper funding, it could simply become another grand gesture aimed at fixing a problem without the necessary people or resources to do so.”
As discussions continue regarding changes to the GRAS designation process, stakeholders across various sectors are advocating for a comprehensive approach that prioritizes consumer safety while balancing industry needs.
Leave a Reply