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Senate Confirms Robert Califf as FDA Commission, Associations Respond

Colorcon
 
Kaneka

On Feb.15, the U.S. Senate confirmed Dr. Robert Califf to lead the U.S. Food and Drug Administration (FDA) for a second time
in a 50-46 vote.

Non-GMO Project

In response to the confirmation, the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the Consumer Healthcare Products Association (CHPA) released the following statements:

“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, 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.”

CRN’s President and CEO, Steve Mister stated: “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. 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 (NDIs), along with an official list of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) 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. 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.”

“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,” said CHPA Scott Melville, president and CEO.

“The recent pandemic exposed the critical importance of personal health care in public health which Dr. Califf recognizes,” Melville added. “Safe, beneficial, affordable, and accessible self-care products including OTC (over-the-counter) 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.”

For more information, visit www.fda.gov, www.npanational.org, www.crnusa.org or https://chpa.org.

Kaneka
 
Colorcon