RFK Jr.’s New Role Will Likely Change 6 Longstanding FDA Practices, Says National Expert

On Thursday, February 3, Robert F. Kennedy Jr., was officially confirmed as the next leader of the U.S. Department of Health and Human Services (HHS). The HHS oversees several key health agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Medicare, and Medicaid.

The politician, who is commonly referred to as simply RFK, was a controversial pick due to his past comments which were considered to be against public health and vaccination practices, as well as criticized for his understanding of national healthcare payer models and his manner of articulating some of his own medical history. Still, the Senate narrowly voted to approve Kennedy at 52-48.

Former Republican Senate Majority Leader Mitch McConnell was notably the lone Republican to vote against the confirmation, citing his experience as a polio survivor. McConnell released a statement about his “no” vote, stating in part: “I’m a survivor of childhood polio. In my lifetime, I’ve watched vaccines save millions of lives from devastating diseases across America and around the world. I will not condone the re-litigation of proven cures, and neither will millions of Americans who credit their survival and quality of life to scientific miracles … As he takes office, I sincerely hope Mr. Kennedy will choose not to sow further doubt and division but to restore trust in our public health institutions.”

An expert on FDA compliance and regulations weighs in on this subject, and several others, to explain what could change in the near future under RFK’s direction. David Lennarz, President of Registrar Corp, has over 20 years of experience within the FDA compliance industry.

1) A reduction in FDA staff

As a recent fact sheet put out by the White House confirms, the Trump Administration is working to “to shrink the size of the federal workforce and limit hiring to essential positions.” Press reports have suggested staff could be reduced by as much as 50%, which will likely impact the timeliness of reporting violations and new mandates.

2) Reduction in publication of guidance documents

Lennarz states that the lack of guidance “will leave the food and safety industry hanging in limbo.” He says this change could result in few notices about food and other product recalls, among other potential changes.

3) The FDA User Fee program will come under scrutiny

The FDA’s site states that the agency “collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.” Some might say this fee helps the perceived legitimacy of the product, and does in fact help ensure appropriate market oversight.

Lennarz points out the program is a critical revenue stream for FDA funding, but it’s also long been criticized because it’s considered a conflict of interest as “Pay for Play.” “[It] often only benefits the biggest player in the pond,” he says, “pushing out a lot of smaller businesses who can’t afford the fees.”

It’s possible the new HHS leadership will make changes to this practice.

4) Dietary supplements will likely be more strongly regulated

Djavan Rodriguez/Getty Images

We’ve reported that some products, like herbal supplements and some protein powders, aren’t regulated by the FDA. This inherently presents safety and quality control concerns.

Lennarz points out that dietary supplement ingredients—along with the efficacy of them—could all be a part of this potential strong regulation. He says product listings may be required as a result of this.

5) Processed foods will come under intense scrutiny

MillefloreImages/Getty Images

Lennarz predicts more transparent food labels—specifically the ingredients used to produce them—will likely result in the changes of some products all together, as we’ve seen with the recent ban of red dye #3 (which the FDA has had underway for several years). “Robert F. Kennedy is a huge advocate for reducing harmful chemicals from our everyday ‘junk’ foods,” says Lennarz, “and this will likely be a main priority for him during his time as Secretary of Health.”

6) Stricter rules around the use of food additives

Among the possible incoming stricter rules, Lennarz suggests the GRAS (“Generally Recognized as Safe”) process functions could be revamped. Lennarz says, “Of course, there are other likely areas of focus, including vaccine development and approvals, 510k medical device processing, access to raw milk products, etc.” Credentialed clinicians and researchers have expressed concerns.

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