ODSP names new acting director

The FDA office responsible for overseeing the $55 billion-a-year industry for dietary supplements has a new acting director: Greg Noonan.

Noonan previously served as acting deputy director of the Office of Dietary Supplement Programs (ODSP) and also has worked as acting director of ODSP’s Division of Research and Evaluation.

Noonan’s appointment was effective as of this week.

Cara Welch has returned to her post as deputy director of ODSP “after providing stability and continuity of leadership during this time of transition,” an FDA spokesperson said.

Welch had led ODSP as acting director since March after Steven Tave—ODSP’s permanent director for several years—moved into a new job at FDA.

Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), expressed his gratitude to Welch and congratulated Noonan on his new position.

“CHPA thanks Dr. Welch for stepping into the role of acting director of ODSP over the last several months,” he said in a statement. “CHPA applauds her leadership and tireless work supporting the dietary supplements category and we look forward to continuing our work together as she serves in her permanent role as deputy director.”

Melville described Noonan’s background and experience with ODSP and the Center for Food Safety and Applied Nutrition (CFSAN) as “an asset to the category,” and he said it “can drive our momentum forward as we look to modernize dietary supplement regulation.”

“With Dr. Noonan and Dr. Welch, FDA has strong leaders to guide the development of a modernized regulatory structure that will protect public health and reinforce the credibility of the dietary supplement category,” he added. “We look forward to our work together.”

The American Herbal Products Association (AHPA) issued a brief statement in response to Noonan’s appointment as acting director.

“AHPA has always had a good working relationship with FDA’s ODSP, and we will move forward with an expectation that good and open communications with that office will continue now,” a spokesperson for AHPA said.

Awaiting permanency 

CFSAN is planning to recruit for a permanent ODSP director, according to the FDA spokesperson.

Tave became the first permanent director for FDA’s dietary supplement oversight team since the April 2014 departure of Dan Fabricant, who became executive director and CEO of the Natural Products Association (NPA).

The FDA hiring process can be a long one in Fabricant’s personal experience. He said it took him about 10 months to land the job as FDA’s director of the Division of Dietary Supplement Programs after he first submitted his resume.

That FDA has named a new acting director of ODSP doesn’t mean Welch is out of the running for the permanent job, some industry leaders suggested.

“It’s clear it hasn’t happened yet,” Fabricant said. When Tave left ODSP, “they were caught somewhat flat-footed and didn’t have the advertisement in place, the spec in place, everything else,” he said.

Before Tave was named permanent director of ODSP in December 2016, several FDA officials rotated as acting director of the dietary supplement office.

Robert Durkin, a former ODSP official who practices law with Arnall Golden Gregory LLP, said FDA has certain rules regarding how long a person can occupy a detail, and they change based on the individual’s permanent status and the position they are assigned to.

In a follow-up email after this article was first published, an FDA spokesperson explained some of the circumstances leading up to Noonan's appointment as acting director of ODSP.

"A detail opportunity was announced FDA-wide to give other interested candidates an opportunity to perform in this position," the spokesperson said. "This is consistent with typical hiring practices and merit systems principles providing that there should be fair and open competition in connection with permanent selections and had nothing to do with Dr. Welch’s performance. It is possible that other candidates may be selected to serve in the position interim ODSP director in the future as well."

The FDA spokesperson added, "Our plan is to recruit for a permanent ODSP director starting in a few weeks."

Current issues 

The heads of some industry trade associations said they would prefer FDA name a permanent director sooner rather than later.

ODSP has no permanent director at a time when FDA is requesting new dietary supplement authorities from Congress, including a requirement that dietary supplement products be listed with the agency.

“There’s all this push for new legislation and all these new authorities,” Fabricant said. “Meanwhile, there’s no permanent director. That’s just weird to me.”

Certain FDA proposals, including the request for mandatory product listing, may represent the thinking of FDA’s broader institution rather than a specific individual leading ODSP. Several ODSP officials, as well as FDA Acting Commissioner Janet Woodcock, M.D., have discussed mandatory product listing, observed Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“A mandatory product listing—this is something that is agencywide,” Mister said in an interview. “I don’t think you’d find somebody in that position [at ODSP] who is not advocating for mandatory product listing.”

It’s nonetheless important that ODSP name a permanent director who understands the dietary supplement market and can make important decisions regarding the commodity, some industry sources said.

“You’re much less likely to see major new initiatives announced as long as you have acting directors,” Mister said.

He referenced as examples the awaited publication of revised NDI (new dietary ingredient) guidance, or a crackdown on an ingredient called phenibut that FDA says is illegal in supplements and was the subject of recently published research.

“Any of those kind of bold, broad initiatives become less likely when you don’t have a fully appointed director,” Mister said.

Trade association heads also expressed doubt FDA would resolve the spat between the agency and industry over the sale of a popular ingredient in supplements, while the permanent director job remains vacant.

FDA last year proclaimed in warning letters that NAC (N-acetyl-L-cysteine) could not be sold in supplements because it was first approved as a drug. FDA’s conclusions have drawn criticism from industry representatives who said the ingredient has been marketed in supplements for over a quarter century.

“It’s going to be hard to get the agency to issue a decision on things like NAC when you’re playing musical chairs with the directorship,” Mister remarked. “Those are the kind of issues where the industry needs resolution. It is probably not the top priority at the agency, but we need them to address it.”

Fabricant also mentioned the importance of ODSP resolving the NAC issue.

“There should be somebody in that chair willing or clear enough to go, ‘OK, do we really have a public health problem with NAC?’” he said.

FDA officials, some of whom “don’t like the commodity, frankly speaking,” appear to wield “more influence over how the commodity is regulated than” the ODSP official charged with regulating supplements, Fabricant added.