Former US FDA Commissioner Robert Califf admitted in the interview show that the biggest challenge during his tenure was not from the FDA itself. Still, from the “dysfunctional Congress”, such as vapes, marijuana and other products that do not fully meet the standards of traditional drugs or medical devices, are in urgent need of an independent regulatory system, but the split position of Congress makes it impossible to advance.
Key points:
1. Former U.S. Food and Drug Administration (FDA) Commissioner Robert Califf has pointed to congressional “dysfunction” as the biggest challenge facing the FDA.
2. He believes that the United States has failed to establish an effective regulatory system to deal with controversial public health products such as vapes and marijuana and that the divided Congress is a key reason.
3. Regarding vapes, California supports an Australian-style pharmacy model but acknowledges that the U.S. concept of individual freedom has prevented similar policies from being implemented.
4. He suggested that his successor, Marty Makary, needed to focus on an internal team of professionals and rely on evidence to set policy.
Former FDA chief: dysfunctional Congress is the biggest obstacle to regulating products like vapes
According to MedPage Today, Dr. Robert Califf, former commissioner of the Food and Drug Administration (FDA), admitted on the talk show that the biggest challenge during his tenure did not come from the FDA itself, but from a “dysfunctional Congress.”
“Working in federal agencies is extremely dependent on Congress reaching agreement, but they simply can’t communicate with each other.” “This has complicated or stalled a lot of problems that could have been solved,” Califf said. For example, he said, products such as vapes and marijuana that do not fully meet the standards of traditional drugs or medical devices urgently need an independent regulatory system, but the divided stance of Congress has prevented it from moving forward.
On the issue of vapes, Califf agrees that they can be used as a harm reduction tool under certain conditions, but he points out that American society’s emphasis on individual freedom makes strong regulation difficult to implement.
- “If I were king. I would adopt a system similar to Australia’s – having to go to a pharmacy to buy a vape product as part of nicotine addiction treatment.” But in the United States, if you want to vape when you’re 22 years old, it’s your freedom.”
He further pointed out that current U.S. law only requires manufacturers to pass FDA approval, and does not restrict the intent of use by adults. He stressed that children should be protected, but that respect for the freedom of adults posed a regulatory dilemma.
Referring to the new FDA Commissioner, Dr. Marty Makary, Califf offered three suggestions:
- Get to know the internal team: The FDA has many professionals, and understanding their experience and advice is critical.
- Respect the evidence: Policy must be based on good data, especially in controversial areas.
- Be aware of the limitations: With more than 20% of the FDA’s staff already laid off when the new commissioner takes office, and with frequent political interference, the work ahead will be extremely difficult.
Califf concluded by emphasizing that the public should recognize that the FDA is not a “team owner,” but a “referee.” “Congress makes the rules, and we can only enforce them within the framework.” He called on society to rethink the role and empowerment of the FDA, especially in light of growing cross-cutting issues such as food, nutrition, and new addictive products.
Califf served two terms as commissioner of the Food and Drug Administration (FDA). He first served in the role from 2016 to 2017 and again from 2022 to 2025.
