Dr Califf led the Agency from February 2016 to the end of the Obama Administration after a year as the agency’s deputy commissioner for medical products and tobacco, according to FDA’s website. He was succeeded as commissioner by Dr Scott Gottlieb, MD.
Dr Califf received his MD at Duke University Medical School and served as a professor of cardiology at the school. He founded and directed the Duke Clinical Research Institute at the school, which at the time he was first nominated to lead FDA had a budget of more than $320 million.
Several Republican Senators voted to confirm Dr Califf, including Sens. Blunt, Burr, Collins, Murkowski, Romney, and Toomey, while several Democrats and Independents voted against, including Sens. Blumenthal, Hassan, Markey, Manchin, and Sanders. Not voting were Sens. Capito, Graham, and Lujan.
Welcome
Trade organizations active in the dietary supplement reacted positively to the news with a few caveats.
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said the nomination comes as a critical juncture.
“We look forward to engaging him for a speedy resolution on NAC, CBD and ensuring the agency is using all the current tools at their disposal versus wasting the American taxpayers time on asking for new authorities with no benefit to public health,” said Dr Fabricant.
“Dr. Califf has previously stated that the agency has ample authority to regulate the dietary supplement marketplace, we look forward to working with him in that regard. We understand he even used NAC in his medical practice.”
Loren Israelsen, president of the United Natural Products Alliance, commented: "We congratulate Dr. Califf on his confirmation as FDA Commissioner after a lengthy process in closely divided Senate. Dr. Califf certainly has the experience at FDA to allow him to hit the ground running as Commissioner. And having a permanent commissioner in place at FDA should help the agency move forward on a number of important issues, including those related to dietary supplements.
"UNPA has a strong working relationship with FDA officials and we look forward to continuing that with Dr. Callif. We look forward to meeting with Dr. Califf and making him aware of our priorities and the important role supplements play for millions of Americans."
Six points
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), congratulated Dr. Califf on his confirmation.
“CRN supports his confirmation, and we look forward to working with Dr. Califf and other FDA leaders to keep strengthening the dietary supplement and functional food industry and protecting consumers’ ability to access safe and beneficial products. We’ll do this together by ensuring products continue to meet all regulatory requirements.
“Dr. Califf’s confirmation comes at a pivotal time for this industry. Consumers are more proactive than ever about their health—four out of five Americans use a dietary supplement, according to CRN’s latest consumer survey. This industry needs a robust and responsive FDA that enforces the law, addresses safety concerns, and provides incentives for continued innovation and high-quality manufacturing. As Dr. Califf begins planning his agenda, we urge him to prioritize the following action items:
- Increase funding to the Office of Dietary Supplement Programs (ODSP) at FDA, recognizing this Office must keep pace with the rapidly growing industry it oversees
- Work with Congress to enact legislation to establish mandatory product listing for supplements
- Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement
- Issue final guidance on the labeling of probiotics
- Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law
- Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements
“CRN has enjoyed a strong working relationship with FDA for nearly 50 years, and we look forward to continuing under Dr. Califf’s leadership. Together, we can work toward the shared goal of growing an innovative and safe dietary supplement marketplace that protects consumers, while keeping at bay unnecessary regulatory burdens for the industry.”
AHPA: Califf brings his significant experience and credentials
American Herbal Products Association (AHPA) President Michael McGuffin said that his organization looks forward to working with Dr. Califf as "he brings his significant experience and credentials to once again lead the U.S. Food and Drug Administration.
"We know that the Commissioner does not work in isolation, and we will continue to work with—and foster the strong relationships we have developed with—key FDA personnel with whom the Agency’s institutional memory for dietary supplements resides.
"As Dr. Califf sets policy priorities at the Agency moving forward, we hope he will appreciate that Americans have continuously used dietary supplement for a half a century or more. Any decisions made on how best to regulate these remarkably safe and health-promoting products must reflect consumer demand for a broad range of safe dietary supplements to support individual healthcare choices. To do so, any amendments proposed to current dietary supplement laws and rules must preserve the essential balance—between consumer access to safe dietary supplements and sufficient regulatory authority for FDA—as established by the Congress when it passed the Dietary Supplement Health and Education Act almost 30 years ago.
"AHPA expects the longstanding critics of dietary supplements to attempt to push the ‘unregulated’ or ‘under-regulated’ myth and demand that the new Commissioner take steps that would create unnecessary barriers to this safe product category for consumers and unnecessary burdens on the industry that provides them. We stand ready to encourage Dr. Califf to guard against these misperceptions and to support the millions of Americans who safely use these products daily.”
Modernization of the regulatory framework for dietary supplements
Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), said: “Dr. Califf is a highly respected clinician and researcher with an outstanding record of public service, including previously serving as FDA commissioner. CHPA applauds the confirmation of Dr. Califf as FDA Commissioner once again, an experienced choice to lead the Agency at such an important time for public health.
“The recent pandemic exposed the critical importance of personal healthcare in public health which Dr. Califf recognizes. Safe, beneficial, affordable, and accessible self-care products including OTC medicines like pain relievers, dietary supplements like immune support products, and consumer medical devices like face masks and at-home test kits are essential for diagnosis, prevention, care, and overall wellness of Americans.
“We look forward to continuing to work with Dr. Califf on shared priorities, including OTC Monograph reform implementation, modernization of the regulatory framework for dietary supplements, and expansion of conditions for safe use of nonprescription medicines to enable innovations including Rx-to-OTC switch.”