With his nomination to be secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy Jr. has expressed a bold vision to reform the U.S. Food and Drug Administration (FDA). Known as an outsider, Kennedy will be empowered by President Donald Trump to address the inefficiencies and systemic problems that have plagued the agency for years.
There are several areas in need of reform that Secretary-designate Kennedy should focus on, but a few key issues should be addressed early on.
One of Kennedy’s primary reform targets should be the FDA’s “Generally Recognized as Safe” (GRAS) system for food additives. Critics have long decried the GRAS process as a regulatory loophole that allows companies to self-certify the safety of chemicals added to food, often without FDA oversight. This has led to the approval of additives despite concerns regarding their safety, even those banned in other countries.
One Kennedy advisory, Calley Means, provided a preview of how Kennedy may approach the GRAS process, calling it a “completely rigged system” that allows “companies to put chemicals in our food that have hundreds of studies proving their harm is unacceptable.”
Narrowing the GRAS loophole would reverse years of self-policing by the food industry and prioritize public health over corporate convenience.
Kennedy’s reform agenda should also extend to the FDA’s Center for Tobacco Products (CTP), which has faced criticism for its stagnated review process for smoke-free alternatives. Since 2009, the FDA has authorized fewer than 50 of the 26 million applications submitted for review. This backlog has stifled innovation and inadvertently fueled the rise of illegal and unregulated vaping products.
As a former smoker and current user of smoke-free nicotine products, Kennedy also understands the risks associated with traditional cigarettes and the importance of providing adults with better alternatives.
By prioritizing the authorization and regulation of nicotine pouches, e-cigarettes and heated tobacco products (HTPs), Kennedy could pave the way for a better, healthier and more informed future for those affected by smoking.
To specifically cut down on the backlog of products at the FDA, Kennedy will have to address the agency’s Premarket Tobacco Product Application (PMTA) process to ensure it meets the 180-day, congressionally mandated review timeline.
I hope that Robert F. Kennedy’s Jr.’s nomination marks a turning point for the FDA. His reform agenda, which he says will emphasize public health, transparency and accountability, could reshape the agency’s role in ensuring the safety and efficacy of food and tobacco products—if done properly.
As a maverick, Kennedy can swiftly Make America Healthy Again by tackling bureaucratic ineptitude and prioritizing innovation.