HHS Moves to Close Food Safety Loophole—But Is It Enough?

In a significant move toward tightening food safety regulations, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has directed the FDA to explore rulemaking that would eliminate the self-affirmed GRAS (Generally Recognized as Safe) pathway—a long-standing loophole allowing companies to introduce new food ingredients without notifying the FDA or the public.

If enacted, this policy shift would force companies to publicly disclose their ingredients and provide supporting safety data before they enter the U.S. food supply. Kennedy, citing concerns over unregulated chemicals and unknown safety risks, framed the move as part of his broader initiative to “Make America Healthy Again.”

“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,” Kennedy stated. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track and ultimately, Make America Healthy Again.”

The FDA’s current voluntary GRAS Notification Program has reviewed over 1,000 food safety notices and evaluates an average of 75 per year. However, under existing rules, companies are not required to report new substances deemed “generally recognized as safe,” effectively allowing them to self-regulate. This has led to a murky and largely unaccountable system where unknown substances can quietly enter the market—some of which may pose health risks to consumers.

What This Move Could Mean for Food Safety

This new regulation could have wide-reaching implications for food manufacturers and ingredient suppliers if implemented. By closing the self-affirmation loophole, companies will no longer be able to introduce new chemicals, preservatives, or flavoring agents without FDA oversight. This could:

The Critical Questions No One Is Answering

While the FDA’s push for greater transparency appears to be a win for consumer safety, the plan raises major questions about enforcement, corporate influence, and unintended consequences:

• How will the FDA handle the backlog of previously self-affirmed ingredients?

Over the years, hundreds—if not thousands—of ingredients have entered the market under the self-affirmed pathway. Will the FDA retroactively review these substances, or will they be grandfathered in without scrutiny?

• Does the FDA even have the resources to handle this increased workload?

The FDA’s food division has been criticized for being underfunded and overburdened. Will additional staffing and funding be allocated to support this new level of oversight? Or will the process become a bureaucratic gridlock, leading to longer delays in approving even safe ingredients?

• What about industry pushback?

Food industry lobbyists will likely fight these changes, arguing that additional FDA oversight will increase costs, slow down innovation, and create an unnecessary regulatory burden. How much power will corporate interests have to water down the final rule?

• What about “GRAS loopholes” in imported foods?

Even if domestic companies are forced to comply, foreign food manufacturers exporting to the U.S. could still bypass this requirement. What steps will be taken to prevent unregulated ingredients from entering through global supply chains?

• Will Congress actually pass supporting legislation?

Kennedy’s plan includes exploring congressional support to close the GRAS loophole permanently. However, past attempts at food safety reform have been blocked by political gridlock. Without bipartisan cooperation, will this just become another regulatory fight that goes nowhere?

A Necessary Step, But Far From a Complete Solution

The FDA’s move to eliminate self-affirmed GRAS status is long overdue and a crucial first step in protecting American consumers from unknown food additives. However, unless it is backed by strong enforcement, additional FDA resources, and airtight legislation, the food industry could find new ways to circumvent the system.

With powerful corporate interests poised to challenge these changes, the real question is: Will this initiative lead to genuine food safety reform, or will it simply become another regulatory battle where consumers are left in the dark?