(The Center Square) – The U.S. Food and Drug administration has proposed a rule that aims to close a long-neglected regulatory food safety loophole, but consumer advocates warn the effort amounts to a “regulatory mirage.”
For nearly 70 years, the FDA has relied on a voluntary disclosure system, where manufacturers are effectively allowed to self-certify their own chemical products as “Generally Recognized as Safe,” or GRAS.
Though companies are required to produce safety studies if the FDA demands it, that rarely happens. As a result, more than a thousand chemical additives are present in the American food supply that have not undergone rigorous safety testing or received FDA approval.
The FDA’s proposal, which is currently open to public comment, requires companies to notify the agency when claiming a new additive ingredient is safe for human or animal consumption.
But breaking that mandate would carry no real consequences, rendering the rule “toothless,” Brian Ronholm, director of food policy at Consumer Reports, told The Center Square.
Though the rule might “give the appearance" of shifting toward a mandatory notification process, Ronholm said, “it really fails to address that fundamental regulatory gap that's long plagued this framework.”
“If a company doesn't notify the FDA, there's really no accountability attached to that. So let's say the company fails to do it – all that does under this proposed rule is to make them a ‘higher risk’ for being audited and subject to a post-market assessment,” Ronholm said. “There's no immediate recourse available that would require the companies to pull the ingredient from the market.”
Crucially, the rule does not apply retroactively to GRAS additives already on the market, including those that are banned in other countries, such as titanium dioxide, potassium bromate, and propyl paraben.
Another section of the FDA’s proposal – which Consumer Reports highlighted in its report entitled “A Regulatory Mirage: Why the Proposed GRAS Rule Fails to Protect Public Health” – allows companies to withhold their products’ health and safety data from the public, including independent researchers.
“The proposed rule introduces a regressive policy regarding data transparency by permitting companies to exempt safety-related information from disclosure under the Freedom of Information Act (FOIA),” write the report’s authors.
“Ensuring the safety of the food supply requires transparent, verifiable scientific evidence; by permitting the concealment of safety data under the guise of proprietary exemption, the FDA risks prioritizing corporate secrecy over the public’s ability to independently verify the safety of substances introduced into the marketplace.”
Despite the flaws in the proposed rule, Ronholm told The Center Square, it’s a sign of progress that national-level conversations about revisiting the GRAS rule are happening at all.
“In the grand scheme of things, there's been a lot of discussions on additives and chemicals and GRAS that hasn't had a deep discussion in more than a decade,” Ronholm said. “So if there is one positive aspect to point to, it's that we're having some decent conversations about this particular issue. It just hasn't yet translated into meaningful action.”