Washington, D.C.—The Senate voted to confirm Dr. Robert Califf as the next FDA commissioner,the New York Times reports,despite opposition from some Democrats over his ties to the pharmaceutical industry.

The vote was 50-46. Six Republicans voted for Dr. Califf, and five Democrats voted against.

TheTimesstated that Democrats are concerned about Dr. Califf’s stance on opioids: In 2016 and 2017, under Dr. Califf’s leadership, FDA approved five new opioids, in spite of the fact that the opioid epidemic had already killed thousands. On the Republican side, anti-abortion advocates are upset that during Dr. Califf’s prior tenure, FDA eased access to medication abortion pills.

UPDATE:The Council for Responsible Nutrition (CRN) has issued a press release applauding the nomination. Steve Mister, CRN President and CEO, stated the following:

“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.

“Dr. Califf’s confirmation comes at a pivotal time for this industry," Mister continued. "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:
  1. 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
  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
“CRN has enjoyed a strong working relationship with FDA for nearly 50 years, and we look forward to continuing under Dr. Califf’s leadership," Mister concluded. "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.”

UPDATE:The Natural Products Association has released a statement congratulating Dr. Califf. “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," said Daniel Fabricant, Ph.D., President and CEO of NPA. "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. 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."

UPDATE:The American Herbal Products Association (AHPA) looks forward to working with Dr. Califf, according to a statement from AHPA President Michael McGuffin, who said:
"AHPA 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."

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