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FDA dietary supplement office taps third acting director

FDA buildings 2020

It’s been nearly a year since FDA announced Steven Tave was leaving his post as director of the Office of Dietary Supplement Programs (ODSP).

Tave joined FDA’s Office of Regulatory Affairs as principal advisor in March 2021.

Since that time, an office responsible for overseeing a $55-billion-a-year supplements industry has been without a permanent director. ODSP recently named its third acting director, Sharon Lindan Mayl, a veteran FDA official who began her new job on Dec. 19th.

Mayl has been with FDA for more than 27 years and previously served as senior advisor for policy in the Office of Food Policy and Response in the Office of the Commissioner.

“Sharon has a wide range of experience on regulatory, legislative and policy issues,” Lindsay Haake, an FDA spokeswoman, said. “She served in leadership roles in implementing the Food Safety Modernization Act [FSMA] and the New Era of Smarter Food Safety initiative. She currently serves as co-lead for the Cannabis Product Committee to identify, manage and resolve novel and complex policy issues relating to the marketing and sale of cannabis products.”

With Tave’s departure from ODSP, Cara Welch—a veteran regulator in the dietary supplements industry—was named as acting director. Then she was replaced in September by Greg Noonan, who previously served as acting deputy director of ODSP.

Dan Fabricant, president and CEO of the Natural Products Association (NPA), worked with Mayl on some dietary supplement issues when he led FDA’s Division of Dietary Supplement Programs several years ago.

Photo courtesy of FDA Sharon Lindan Mayl

Sharon Lindan Mayl

“She’s very smart, very wise about the ways of the agency,” he said in an interview.

But given her breadth of experience at FDA, he doesn’t expect her to be the agency’s selection to permanently lead ODSP.

FDA acting directors typically maintain their posts for short stints until a position is filled permanently. According to a handbook from the U.S. Office of Personnel Management, agencies have authority to send employees to another detail in 120-day increments to fill a temporary need.

Asked about FDA’s status in naming a permanent director of ODSP, Haake responded her agency “is continuing its search for the position and is working expeditiously” to make its permanent section.

FDA also is without a permanent commissioner. President Joe Biden in November nominated Robert Califf, M.D., who previously led FDA from February 2016 to January 2017.

On Monday, by a vote of 13 to 8, the U.S. Senate Committee on Health, Education, Labor & Pensions advanced Califf's nomination to serve as commissioner of FDA. He cannot assume the role unless confirmed by the full Senate.

“Having any confirmed commissioner … is almost always preferable to not having a confirmed commissioner because there are so many things on the FDA’s plate, and a number of them involve dietary supplements,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), during a Jan. 11 “Washington Watercooler” series hosted by SupplySide Network 365. “And we always see the agency is less willing and more reluctant to take those kinds of bold initiatives to put out big rulemakings.”

(Editorial disclaimer: Informa Markets, the publisher of Natural Products Insider, owns SupplySide Network 365, an industry hub for health and nutrition professionals).

Mister cited, for example, promised guidance on new dietary ingredient notifications (NDINs). FDA has yet to publish final guidance more than five years after issuing a second draft document in October 2016.

It’s also important to industry that ODSP name a permanent director—preferably sooner than later.

ODSP needs “a new direction leadership-wise,” Fabricant said. “Someone in the chair has to ultimately see the reality that 70%-plus of the country uses the commodity every day.”

But the longer the position remains unfilled, the longer key dietary supplement issues, such as CBD and NDIN enforcement, linger, Fabricant added.

“There are lots of … middle-range issues that would never get to the commissioner’s office but need to be decided by the director of ODSP,” Mister said, “and as long as you have this musical chairs of people coming in and out of that seat, you don’t have somebody who has the … long-term commitment to make the kinds of decisions we need to have made.”

Mister said he is hopeful FDA will soon tap someone to permanently lead ODSP.

“It’s kind of like what they talk about in the financial markets. The worst thing is uncertainty and the unknown,” responded Jon Benninger, vice president and market leader of SupplySide, who moderates the CRN Washington Watercooler series with Mister about key regulatory issues in the nation’s capital.

Benninger acknowledged the industry may not find favorable all action by a permanent director at ODSP, “but right now, it feels like a lot of things are just kind of in a holding pattern at this point.”

Mister added supplement companies may be somewhat reticent to discuss an issue with ODSP at this time.

“Do I want to go in and talk to an acting director who may not even be there two months from now?” he asked. “That’s a lot of effort to set up these meetings, gather all of your data and go in and talk to somebody who’s out of a job in a month or two.”

 

 

 

 

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