11.16.21
After 10 months in which the U.S. Food and Drug Administration was led by interim commissioner Janet Woodcock, President Joe Biden recently nominated Dr. Robert Califf to be the new FDA commissioner, pending approval from the U.S. Senate.
Califf, a cardiologist and clinical researcher from Duke University who worked closely as a paid consultant with several large pharmaceutical companies, previously served as FDA Commissioner under the Obama Administration from February 2016 until he stepped down from the position in January 2017, and as Deputy Commissioner for Medical Products and Tobacco during 2015.
Familiar with the overall role he took during the Obama era, several trade associations representing the dietary supplements industry commented on Biden’s nomination optimistically.
Looking Ahead
“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,” CRN president and CEO Steve Mister said. Mister went on to list six action items that the trade association intends to make regulatory priorities while Califf is at the helm of the agency.
Firstly, CRN seeks increased funding to the Office of Dietary Supplement Programs (ODSP) at FDA, commensurate with the pace at which the industry is growing. CRN also hopes that the organization and Califf could enact mandatory product listing legislation for dietary supplements. The organization also hopes to see the establishment of a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement. With regulatory uncertainty surrounding probiotics, the organization also hopes the agency could achieve a legal/regulatory definition for these ingredients, as a means to better establish guidance on best practices in labeling, stability testing, and storage recommendations.
CRN also seeks “final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are ‘grandfathered’ under the 1994 law.” In essence, most within the nutrition space believe it was the intent of Congress that new dietary ingredients which previously did not appear in foods should be subject to thorough safety approvals via the agency’s NDI process. At this time, however, many companies eschew the NDI submission process in favor of achieving self-affirmed GRAS (Generally Recognized as Safe) status for their ingredients – a less intensive, expensive, and time consuming route. Lastly, Mister said that he hopes the FDA will prioritize enforcing existing dietary supplement legislation more proactively.
“For nearly 50 years, CRN has enjoyed a strong working relationship with FDA, which we look forward to continuing under Dr. Califf’s leadership. 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.”
Scott Melville, president and CEO of the Consumer Healthcare Products Association, lauded Biden’s pick as an excellent choice based on Califf’s track record with consumer healthcare technologies.
“CHPA applauds President Biden’s choice for the next permanent FDA Commissioner,” Melville said. “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.
“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 medical devices. OTC medicines, dietary supplements, and consumer medical devices are accessible and affordable healthcare 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 healthcare products.”
In response to Califf’s nomination, Daniel Fabricant, PhD, president and CEO of the Natural Products Association noted the challenges embedded in the position that lay in the years ahead.
“NPA welcomes the return of a Senate confirmed commissioner to lead the Food and Drug Administration,” Fabricant said. “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 [the Dietary Supplement Health and Education Act of 1994], regulating the rapidly expanding CBD industry, and addressing the issue of adulterated ingredients through the NDI process.”
Califf, a cardiologist and clinical researcher from Duke University who worked closely as a paid consultant with several large pharmaceutical companies, previously served as FDA Commissioner under the Obama Administration from February 2016 until he stepped down from the position in January 2017, and as Deputy Commissioner for Medical Products and Tobacco during 2015.
Familiar with the overall role he took during the Obama era, several trade associations representing the dietary supplements industry commented on Biden’s nomination optimistically.
Looking Ahead
“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,” CRN president and CEO Steve Mister said. Mister went on to list six action items that the trade association intends to make regulatory priorities while Califf is at the helm of the agency.
Firstly, CRN seeks increased funding to the Office of Dietary Supplement Programs (ODSP) at FDA, commensurate with the pace at which the industry is growing. CRN also hopes that the organization and Califf could enact mandatory product listing legislation for dietary supplements. The organization also hopes to see the establishment of a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement. With regulatory uncertainty surrounding probiotics, the organization also hopes the agency could achieve a legal/regulatory definition for these ingredients, as a means to better establish guidance on best practices in labeling, stability testing, and storage recommendations.
CRN also seeks “final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are ‘grandfathered’ under the 1994 law.” In essence, most within the nutrition space believe it was the intent of Congress that new dietary ingredients which previously did not appear in foods should be subject to thorough safety approvals via the agency’s NDI process. At this time, however, many companies eschew the NDI submission process in favor of achieving self-affirmed GRAS (Generally Recognized as Safe) status for their ingredients – a less intensive, expensive, and time consuming route. Lastly, Mister said that he hopes the FDA will prioritize enforcing existing dietary supplement legislation more proactively.
“For nearly 50 years, CRN has enjoyed a strong working relationship with FDA, which we look forward to continuing under Dr. Califf’s leadership. 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.”
Scott Melville, president and CEO of the Consumer Healthcare Products Association, lauded Biden’s pick as an excellent choice based on Califf’s track record with consumer healthcare technologies.
“CHPA applauds President Biden’s choice for the next permanent FDA Commissioner,” Melville said. “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.
“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 medical devices. OTC medicines, dietary supplements, and consumer medical devices are accessible and affordable healthcare 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 healthcare products.”
In response to Califf’s nomination, Daniel Fabricant, PhD, president and CEO of the Natural Products Association noted the challenges embedded in the position that lay in the years ahead.
“NPA welcomes the return of a Senate confirmed commissioner to lead the Food and Drug Administration,” Fabricant said. “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 [the Dietary Supplement Health and Education Act of 1994], regulating the rapidly expanding CBD industry, and addressing the issue of adulterated ingredients through the NDI process.”
