Lawmakers Should Reject RFK Jr.’s Food Safety Plan

Food prices are high—and rising. Americans are right to wonder whether they are at least spending their hard-earned dollars on safe and uncontaminated food. Today, the House Committee on Energy and Commerce Subcommittee on Health will examine that question in a hearing titled, “Healthier America: Legislative Proposals on the Regulation and Oversight of Food.”

While there have been sensible proposals to harness markets and innovation to make food safer, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested introducing new bank-breaking restrictions on food production and sales. In a rule that will likely be proposed this spring, producers would be forced to ditch the current straightforward approach to getting food ingredients approved, and instead embark on a yearslong process with reams of red tape. Lawmakers must work with agencies such as the HHS and FDA to keep food affordable and safe, but only with sensible regulations that embrace market innovations.

Currently, companies selling foods to the public containing new ingredients—or old ingredients used in a new way—can claim that these ingredients are “generally recognized as safe” (GRAS). The FDA will stick with this light-touch approach if the scientific evidence is already “generally available and accepted” (and better yet, previously affirmed by the FDA). And, while companies are strongly encouraged to submit formal GRAS notifications discussing this scientific evidence, companies don’t have to. However, not playing show-and-tell comes with some risks. For instance, the FDA might believe that the product is not in fact GRAS and force the producer to pull their product from the market and undergo a decade-long food additive process.

Everyone wins under this process. Producers don’t have to undergo an onerous food additive approval process, while the FDA is still free to pull products it feels has sketchy safety data. And consumers don’t have to deal with the high costs that too often come with excess regulation.

But this may all change soon. RFK Jr.’s latest bright idea will force manufacturers to submit formal GRAS notifications. This will mean increased paperwork costs and correspondence time with FDA bureaucrats, which will almost certainly be passed along to consumers in the form of higher costs. Meanwhile, the FDA will have the same power as always to investigate foods it suspects are unsafe or adulterated with strange substances.

It’s unclear what consumers are getting in exchange for all this extra bureaucracy. Foodborne illness mostly stems from undercooked meat products and tainted produce, which have long been recognized as “safe” by the FDA and wouldn’t be impacted by GRAS regulations. And, while chronic diseases have been blamed (without much evidence) on ultra-processed foods such as chips, ice cream, and candy, these foods deliver fat and sugar to consumers through long-recognized and accepted ingredients that likely wouldn’t be impacted by this regulation.

Ingredients that do go through the GRAS process often confer some unconventional added benefit for consumers. For example, one promising food safety technology relies on living organisms (called “bacteriophages”) to fight harmful pathogens and can be applied to virtually all food groups. These phages were originally used in World War II to treat soldiers’ many infections, but research in the 1990s concluded that phage cocktails could work wonders when applied to the food supply.

On February 21, 2024, the Taxpayers Protection Alliance Foundation submitted a Freedom of Information Act request to the agency requesting internal discussions and correspondence with outside groups relating to phage product safety. On March 5, the agency responded with a slew of emails between regulators and producers along with (already public) GRAS approval notifications from the FDA. The emails give helpful insight into a sclerotic, dysfunctional regulatory culture surrounding food safety. In a May 29, 2020 email conversation with senior Intralytix employees, FDA staff fellow Dr. Stephanie Hice elaborated why the FDA in conjunction with the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) had qualms about allowing Intralytix to use an already-approved product called SalmoFresh for ground beef.

The problem was not even a safety issue, but rather that “the direct addition of water at any level to ground beef is in conflict with the regulatory standard of identity found in 9 CFR 317.15(a). If the Salmofresh phage is determined to be a processing aid in this product category, the water would need to be descriptively labeled. The submitter’s data did not include data to support a processing aid determination.” Never mind that, as Intralytix pointed out in a July 21, 2020 email to Dr. Hice, SalmoFresh had already been approved as a processing aid for other meat products and SalmoFresh is applied at less than 0.5 percent to ground beef. The amount of “water” added to the ground beef would be essentially zero, but that wasn’t enough for the FDA. The company had to submit additional studies for their already-approved product before the agency would greenlight it for ground beef—which technically requires another GRAS. This regulatory rigidity not only raises costs to consumers and delays food safety efforts but also sends a signal to other innovators that the FDA won’t go easy on biotech.

If GRAS rules tighten, consumers can expect this regulatory nitpicking to become the norm. This would mean not only added costs for consumers, but diminished food safety. Lawmakers should press Secretary Kennedy to rethink this flawed approach and embrace light-touch food safety regulations.