Steven Tave to leave FDA's ODSP, Dr Cara Welch to be acting director

By Stephen Daniells

- Last updated on GMT

© bankrx / Getty Images
© bankrx / Getty Images

Related tags Fda Dietary supplements dietary supplement regulations Office of Dietary Supplement Programs

Dr Cara Welch will step in as the acting director of the Office of Dietary Supplement Programs (ODSP) at the FDA from March 15, as Steven Tave accepts a new role as director of the Office of Strategic Planning and Operational Policy.

Tave led ODSP since March 2016, shortly after the office was created (it was previously the Division of Dietary Supplement Programs).

In an internal FDA email shared with NutraIngredients-USA, the Agency commended Tave’s work with the office.

“As ODSP’s first permanent director, Steve has done a remarkable job leading the new office to create a mission-driven strategy while increasing the office’s size and funding,” ​stated the email. “The office has taken a number of actions to protect consumers from dangerous dietary ingredients, poorly manufactured products, and unfounded claims.   Steve initiated a robust dialogue with the industry and other stakeholders and championed the most significant effort to modernize the regulatory framework for dietary supplements in more than 25 years.” 

Dr Welch joined FDA in 2014 and is currently ODSP’s deputy director. Previously, Dr Welch was a senior advisor in ODSP and recently served as a special assistant in the Office of Policy, Legislation and International Affairs in the Office of the Commissioner. 

Industry response

Dietary supplement stakeholders weighed in on the news, with Michael McGuffin, President of the American Herbal Products Association, telling us: “Steve Tave has served quite effectively over the past several years in his leadership position at FDA’s ODSP and directed the Office with a degree of openness and transparency that has encouraged engagement. Mr. Tave has consistently communicated his interest in understanding industry perspectives, even as he made clear his commitment to enforcement of FDA’s regulations as they apply to dietary supplements.

“AHPA looks forward to continuing to engage with ODSP under Cara Welch’s able direction in the interim. We have worked with Dr. Welch for many years and greatly respect her depth of knowledge on the regulation of supplements. We expect from our prior experience with her that the same atmosphere of openness instilled under Mr. Tave’s management will endure.”

Dr Daniel Fabricant, president and CEO of the Natural Products Association (NPA), told NutraIngredients-USA that he hopes the FDA’s dietary supplements program will have a robust enforcement plan. “That’s the critical thing,” ​he said. “We need FDA to be engaged and involved with the industry.”

When asked to comment on Tave’s tenure as ODSP director, Fabricant said that there was a “different focus than we had seen prior. I don’t know that there was much focus on enforcement. There was a lot more discussion on policy. What’s lasting from all of that, I don’t know.”

The FDA has said the selection process for a new ODSP director will begin in the near future. Dr Fabricant led the FDA’s DS program while it was still a division, and he noted that his hiring process was about five months, showing that a permanent director could be several months away.

Steve Mister, president & CEO, for the Council for Responsible Nutrition (CRN), said his association was saddened to hear that Steven Tave is leaving his position as director of ODSP, but congratulated Tave on his new position in the Office of Regulatory Affairs at FDA.

“CRN is privileged to have had the opportunity to work closely with Mr. Tave over the last five years on initiatives to help strengthen the dietary supplement marketplace,” ​said Mister.

“We have valued his candor and transparency, and his willingness to consider industry perspectives when the agency made decisions affecting us. During Mr. Tave’s tenure, he presided over the elevation of ODSP from a Division to an Office, allowing for increased funding to monitor, inspect and enforce the growing dietary supplement marketplace. We commend Mr. Tave for his continued commitment to protect public health and wish him great success in his new role.

“CRN is delighted that Dr. Cara Welch will step into the role of acting director of ODSP starting March 15. We have also had the opportunity to work closely with Dr. Welch over the years and witness her commitment to strengthen the current regulatory framework for dietary supplements. We look forward to working with her on a number of critical industry initiatives in the future.”

Loren Israelsen, president of the United Natural Products Alliance (UNPA), wished Tave well in his new role at FDA, "and would note that we enjoyed a cordial and open door relationship with him and his staff during his tenure at ODSP.  He made a point of getting out into the industry to speak and engage personally

"I invited him to tour a number of facilities in Utah, he readily accepted and walked the factory floors, booties and all, to learn first hand the workings of our industry.  

"In his new role at the Office of Regulatory Affairs, I expect we will continue to be in contact with him."

George Paraskevakos, Executive Director of the International Probiotics Association, told us that IPA is sad to see Tave leave the ODSP because, "he did a great job in opening dialogue and embracing exchange with the dietary supplement industry but also paid particular attention to probiotics as he realized we are a unique dietary supplement and ingredient. We wish him all the best in his new challenge.

"IPA and myself are looking forward to continuing that stewardship with Dr Cara Welch, which I am sure we’ll be able to build on. Cara also has the openness of exchanging with industry but also listening and understanding about probiotics. We also wish Cara all the best in her new challenge of making a difference at ODSP,"​ added Paraskevakos.

Scott Melville, President and CEO of the Consumer Healthcare Products Association (CHPA), stated: “The FDA’s Office of Dietary Supplement Programs (ODSP) made important progress to improve the regulation of dietary supplements, including enhanced enforcement, under the leadership of outgoing director, Steven Tave.  We applaud Mr. Tave’s collaborative and constructive efforts with the regulated industry and look forward to working with newly appointed Acting Director Cara Welch.  CHPA is committed to industry-agency collaboration that will support and enhance consumer access to safe and beneficial dietary supplements."

CHPA's VP for scientific affairs & dietary supplements, John Troup, PhD, added: “Dr. Welch has an established record at FDA on supplement issues, and we applaud her appointment as Acting Director of ODSP. As she assumes this leadership role, CHPA looks forward to working together with ODSP to ensure consumers have access to the highest quality dietary supplements with the scientific underpinnings to engender credibility and trust.”

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