February 3, 2025

RFK Jr.'s 2 Days in the Spotlight: Food Additives, Vaccines and Clinical Trials

Holland & Knight Alert
Michael J. Werner | Jordan K. Brossi

Highlights

  • Robert F. Kennedy Jr., nominated to be Secretary of the U.S. Department of Health and Human Services (HHS), appeared before the Senate Finance Committee and Health, Education, Labor and Pensions (HELP) Committee last week for his confirmation hearings.
  • Among other topics, Kennedy was asked for his position on policies related to additives in food products, the safety and efficacy of vaccines, and the makeup of clinical trials, all of which he will have an outsized role in shaping if confirmed to lead the HHS.
  • Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Finance Committee will vote on advancing Kennedy's nomination to the Senate floor for consideration on Feb. 4, 2025. The HELP Committee does not vote on the confirmation of the HHS Secretary nominee. As of now, the Finance Committee vote is expected to be close.

Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few primary subjects. Below is an overview of the discussion of these issues, especially those under the jurisdiction of the U.S. Food and Drug Administration (FDA), which became a central focus of the hearings.

Additives in Food Products

Kennedy shared additional information about his vision for implementing the Trump Administration's Make America Healthy Again (MAHA) agenda, including "better deploying" the National Institutes of Health (NIH) and FDA to research the relationship between chronic disease and food additives, including scrutinizing red, blue and yellow food dyes and other ingredients to bring U.S. food ingredient standards on par with European nations. Kennedy also proposed potentially revisiting the FDA's "generally recognized as safe" (GRAS) standard, criticizing it as one that "looks at any new chemical [as] innocent until proven guilty." By doing so, he signaled a potential shift in regulation to require food ingredients to meet a higher burden of proof before they can be authorized for use.

Safety and Efficacy of Vaccines

In his prepared testimony, Kennedy addressed criticism of his positions on vaccines, saying he isn't anti-vaccine, but "pro-safety."  However, he didn't elaborate on the implications of that view, especially given his previous statements and actions regarding vaccines, despite committee members repeatedly asking him to clarify his views. In response to questions about Kennedy's previous work for groups who oppose vaccine requirements, Kennedy tried to assure senators that he would not "do anything" to discourage or prevent individuals from accessing vaccines to prevent measles and other diseases. However, he refused to acknowledge scientific studies that show no definitive link between childhood vaccines and autism. He also remained vague on his support for the HPV vaccine.

Kennedy's responses left several senators, including HELP Committee Chair Bill Cassidy (R-La.) seemingly dissatisfied. Cassidy, a key Republican senator, stated he was "struggling" with Kennedy's nomination. Other senators expressed concerns about potential conflicts of interest due to Kennedy's financial stake in lawsuits challenging the safety of vaccines.

FDA Draft Guidance on Clinical Trial Diversity

Kennedy did not commit to finalizing FDA guidance requiring sponsors to submit information to the FDA regarding how they will incorporate different patient populations into clinical trials for drugs and medical devices. This requirement was signed into law as part of the 2023 omnibus spending package. Pages on the FDA's website regarding the draft guidance issued in June 2024 were taken down following the Trump Administration's order to freeze all pending regulatory items. With the administration's focus on eliminating initiatives related to diversity, equity and inclusion (DEI), it is increasingly unlikely this guidance will be finalized.

Impact

Expect the Senate Finance Committee's Feb. 4 vote to be close.

If Kennedy is confirmed, it remains unclear what policies he would prioritize as HHS Secretary. Many of the views he expressed at the hearing fall under the FDA's jurisdiction. Therefore, it will be important to hear the views of Dr. Marty Makary, the nominee for FDA Commissioner, to assess how many of the administration's priorities will ultimately be implemented. The Senate HELP Committee is expected to take up the nomination of Dr. Makary to be FDA Commissioner within the next few weeks.

For more information or questions, please contact the authors.

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