Senate confirms Robert Califf as commissioner of FDA

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The Senate has confirmed Robert Califf, MD as commissioner of the U.S. Food and Drug Administration (FDA) by a vote of 50-46. Califf was nominated to the position by President Joe Biden in November of 2021. A cardiologist and researcher, Califf previously served as FDA commissioner during the Obama administration.

Industry trade groups have been largely positive about the nomination, and continue to be now that Califf is confirmed.

“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,” said Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA; Washington, D.C.), in a prepared statement. “The recent pandemic exposed the critical importance of personal healthcare in public health which Dr. Califf recognizes…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.”

The Council of Responsible Nutrition (CRN; Washington, D.C.) also applauded Califf’s confirmation. “Congratulations to Dr. Califf on his confirmation as FDA Commissioner. 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,” said Steve Mister, president and CEO of CRN, in a press release. “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.”

Mister offered a number of action items which CRN urges the new commissioner to prioritize. These include:

1. Increase funding to the Office of Dietary Supplement Programs (ODSP) at FDA
2. Work with Congress to enact legislation to establish mandatory product listing for supplements
3. Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement
4. Issue final guidance on the labeling of probiotics
5. Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law
6. Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements

In a statement, Daniel Fabricant, president and CEO of the Natural Products Association (NPA; Washington, D.C.), acknowledged the agency's hard work over the course of the pandemic, but called out deficiencies which he hopes can be remedied under the leadership of the commissioner “This agency has been on the front lines of the pandemic for over two years, and we salute them for their extraordinary work during this time. Nonetheless, there are still glaring deficiencies in establishing a reasonable regulatory approach for certain products like CBD and NAC that need to be addressed immediately," said Fabricant. "We look forward to working with Dr. Califf and the agency in a productive fashion to ensure consumers continue to enjoy safe and accessible natural products. Americans are turning more and more to natural products to prevent illness and support their immune systems, and we want to work together to ensure that this healthy trend continues,” said Daniel Fabricant, President and CEO of NPA."

Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Sping, MD) emphasized the importance of consumers having access to safe supplements to support their health. "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," said McGuffin. "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."

Updated on 2/16/22 at 9:08 AM EST