On Nov. 12, President Biden announced that he will nominate Robert M. Califf, MD for commissioner of the U.S. Food and Drug Administration (FDA).
Califf is an internationally recognized expert in clinical trial research, health disparities, health care quality and cardiovascular medicine. He has nearly four decades of experience as a doctor, researcher, leader and public servant, including previous service as FDA Commissioner from 2016-2017. Currently, Califf is a professor of medicine at the Duke University School of Medicine, where he previously served as vice chancellor and founded the Duke Clinical Research Institute, and also works as head of clinical policy at Verily Life Sciences, a life sciences research organization.
In response, the Natural Products Association (NPA), Consumer Healthcare Products Association (CHPA), and the Council For Responsible Nutrition (CRN)released the following statements:
“NPA welcomes the return of a Senate confirmed commissioner to lead the Food and Drug Administration,” said NPA President and CEO Daniel Fabricant, PhD. “If confirmed, Dr. Califf will be responsible for leading the Agency during one of the most challenging moments in history. We look forward to hearing Dr. Califf’s views on enforcing DSHEA, regulating the rapidly expanding CBD industry, and addressing the issue of adulterated ingredients through the NDI (new dietary ingredient) process.”
“CHPA applauds President Biden’s choice for the next permanent FDA Commissioner. Having previously served at the helm of FDA, Dr. Califf is an excellent choice to lead the agency at such an important time for public health. In addition, his experience and insights on digital health and technology will be critical for helping to shape the future of FDA and the growth of consumer self-care,” stated Scott Melville, CHPA president and CEO.
“Once confirmed, we look forward to continuing to work with the new commissioner on shared priorities to strengthen the safety and accessibility of self-care options. Our mutual focus includes important regulatory modernization efforts like 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, both for drugs and for medical devices.
“OTC medicines, dietary supplements, and consumer medical devices are accessible and affordable health care options. Our industry looks forward to working with Dr. Califf and the FDA staff to further promote public health by increasing access to safe, effective, and beneficial consumer health care products.”
CRN’s President and CEO, Steve Mister said “CRN congratulates Dr. Robert M. Califf for his long-anticipated nomination to FDA Commissioner. We support his confirmation and will look forward to working with Dr. Califf and FDA leadership to strengthen the dietary supplement industry and protect consumers by ensuring products are safe and meet regulatory requirements.
“We urge Dr. Califf to prioritize the following action items in his agenda:
- 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
“For nearly 50 years, CRN has enjoyed a strong working relationship with FDA, which we look forward to continuing under Dr. Califf’s leadership,” Mister continued. “We anticipate working together on the shared goal of growing an innovative and safe dietary supplement marketplace that protects consumers, while avoiding unwarranted regulatory burdens for the industry.”