March 11, 2022
Cara Welch has been named the permanent director of FDA’s Office of Dietary Supplement Programs (ODSP).
Welch, who has been serving as deputy director of ODSP, is its first permanent director since attorney Steve Tave left the position in March 2021 to join FDA’s Office of Regulatory Affairs. Several FDA officials have been rotating as acting directors since Tave's departure.
Welch will start her new job Monday, March 14, an FDA spokeswoman said.
Welch and her team of around 30 employees are responsible for regulating and policing a commodity that, according to Nutrition Business Journal, yields over $55 billion in annual sales. FDA estimated at least 50,000-80,000 dietary supplement products were on the market in 2019.
“Cara’s education as a scientist, along with her leadership and technical expertise in dietary supplement policy and compliance, make her uniquely qualified to effectively carry out the roles and responsibilities of ODSP director,” Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said Thursday in an email to CFSAN employees.
Cara Welch, Ph.D., is the new permanent director of FDA's Office of Dietary Supplement Programs, effective March 14, 2022. With several years of experience at FDA and previously with the Natural Products Association (NPA), Welch is a very familiar face to industry stakeholders.
In 2014, Welch joined what was then called FDA’s Division of Dietary Supplement Programs, where she reviewed current good manufacturing practices (cGMPs) and labeling cases.
“Over the next two years, she played a prominent role in conceptualizing and laying the groundwork for decisions that ultimately led to the creation and elevation of the Division of Dietary Supplement Programs to the office it is today,” Mayne wrote.
Before joining CFSAN, Welch spent four years at the Natural Products Association (NPA). She has a doctoral degree in medicinal chemistry from Rutgers University and undergraduate and graduate degrees in chemistry.
Reaction from industry
Industry stakeholders who have known Welch for many years congratulated her, including Larisa Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA), who said her organization had a "good working history" with Welch and the ODSP team.
Pavlick and UNPA President Loren Israelsen said they looked forward to working with Welch "and the ODSP staff during the coming year and beyond."
"We look forward to progress on a potential updated guidance on new dietary ingredients, improving industry understanding on requirements for specifications for dietary supplements, GMP [good manufacturing practices] compliance and other important regulatory standards," they added in an email.
Michael McGuffin, president of the American Herbal Products Association (AHPA), also congratulated Welch for being named ODSP’s permanent director.
“The herbal products industry has many interests in common with FDA, and we look forward to continuing to work closely with ODSP now that Dr. Welch is filling this important leadership role,” he said in an email.
Dan Fabricant, president and CEO of NPA, also has known Welch for many years. Fabricant, who previously oversaw FDA’s Division of Dietary Supplement Programs, said he hired her at NPA and FDA.
Fabricant said he was pleased Welch obtained the position she was seeking and that someone is permanently overseeing ODSP at a time of uncertainty regarding such ingredients as hemp-based CBD (cannabidiol) and NAC (N-acetyl-L-cysteine).
“We look forward to more communication with the agency in moving solutions forward on those,” he said in an email.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), pointed out several FDA officials have had stints overseeing ODSP since Tave’s departure. He described the appointment of a permanent director as a positive development.
“It’s so important to get someone in there who will have continuity,” he said in an interview.
Mister said he “could not be more delighted” with Welch’s appointment specifically, noting her experiences working at FDA and in industry at NPA.
“We’ve always really valued the candor from Cara,” he added. “She’ll give you good news. She’ll give you bad news. She will tell you basically where the agency is headed.”
He also expressed hope that with a permanent director in place, industry would get resolution on various issues, including NAC and the publication of a new dietary ingredient (NDI) guidance or guidances.
“Having her in the permanent spot will hasten the agency getting some things done," Mister said.
Duffy MacKay, senior vice president of dietary supplements with the Consumer Healthcare Products Association (CHPA), also congratulated Welch.
"Her experience, knowledge of the issues and previous leadership at ODSP will surely be good for FDA and consumers," he said in a statement.
“CHPA and ODSP are aligned in our mission: to ensure consumers have access to safe, high quality dietary supplements," MacKay added. "We look forward to our continued partnership as we work together to modernize the regulatory framework for dietary supplements. With permanent leadership and a fully staffed ODSP, we anticipate FDA will be able to more proactively regulate the dietary supplements industry.”
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