The FDA office responsible for overseeing the $ 55 billion a year dietary supplement industry has a new acting director: Greg Noonan.
Noonan previously served as the Acting Deputy Director of the Office of Dietary Supplement Programs (ODSP) and also worked as the Acting Director of the Research and Evaluation Division of the ODSP.
Noonan’s appointment is effective this week.
Cara Welch has returned to her post as deputy director of the ODSP “after ensuring stability and continuity of leadership during this period of transition,” said an FDA spokesperson.
Welch had headed the ODSP as an interim director since March after Steven Tave, ODSP’s permanent director for several years, moved into a new position at the FDA.
Scott Melville, President and CEO of the Consumer Healthcare Products Association (CHPA), expressed his gratitude to Welch and congratulated Noonan on his new role.
“APHC thanks Dr. Welch for taking on the role of Acting Director of ODSP over the past few months,” he said in a statement. “APHC applauds her leadership and tireless work in support of the dietary supplement category and we look forward to continuing our work together as she fulfills her continuing 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 further our momentum as we move forward. seek to modernize the regulation of food supplements ”.
“Together with Dr Noonan and Dr Welch, the FDA has strong leaders to guide the development of a modernized regulatory structure that will protect public health and strengthen the credibility of the dietary supplement category,” he added. “We are looking forward to working together. “
The American Herbal Products Association (AHPA) issued a brief statement in response to Noonan’s appointment as interim director.
“The AHPA has always had a good working relationship with the FDA ODSP, and we are moving forward with the hope that good and open communications with this office will continue now,” a spokesperson said. word of the AHPA.
Waiting for permanence
CFSAN is considering hiring a permanent ODSP director, according to the FDA spokesperson.
Tave became the first permanent director of the FDA’s dietary supplement oversight team since the departure in April 2014 of Dan Manufacturer, who became Executive Director and CEO of the Natural Products Association (NPA).
The FDA hiring process can be a lengthy person’s personal experience. He said it took him about 10 months to land the post of director of the FDA’s dietary supplement programs division after submitting his resume for the first time.
Just because the FDA has appointed a new acting director of the ODSP does not mean Welch is not in contention for the permanent position, some industry executives have suggested.
“It is clear that this has not happened yet,” said Manufacturer. When Tave left ODSP, “they were caught off guard and didn’t have the advertising in place, the specs in place, everything else,” he said.
Before Tave was appointed permanent director of the ODSP in December 2016, several FDA officials served as acting director of the dietary supplements office.
Robert Durkin, a former ODSP official who practices law with Arnall Golden Gregory LLP, said the FDA has certain rules about how long a person can occupy a detail, and they change based on the individual’s permanent status. and the position to which he is assigned.
In a follow-up email after this article was first published, an FDA spokesperson explained some of the circumstances that led to Noonan’s appointment as the acting director of the ODSP.
“A detailed opportunity has been announced across the FDA to give other interested candidates the opportunity to fill this position,” said the spokesperson. “This is in line with typical hiring practices and the principles of merit systems that there should be fair and open competition in permanent selections and has nothing to do with Dr. Welch’s performance. It is possible that other candidates will be selected to serve in the position of Acting Director of ODSP in the future as well.
The FDA spokesperson added, “Our plan is to recruit a permanent director of ODSP in a few weeks.”
The heads of some industry trade associations have said they would prefer the FDA to appoint a permanent director as soon as possible.
The ODSP does not have a permanent director as the FDA asks Congress for new dietary supplement authorities, including the requirement that dietary supplement products be listed with the agency.
“There’s all this pressure for new legislation and all of these new authorities,” Manufacturer said. “Until then, there is no permanent director. It’s just weird to me.
Some of the FDA’s proposals, including the mandatory product listing request, may represent the thinking of the larger FDA institution rather than that of a specific individual leading ODSP. Several ODSP officials, as well as Acting FDA Commissioner Janet Woodcock, MD, discussed mandatory product listing, observed Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN ).
“A mandatory product list is something that concerns the whole agency,” Mister said in an interview. “I don’t think you find anyone in this position [at ODSP] which does not recommend the compulsory registration of products.
It is nonetheless important that the ODSP appoints a permanent director who understands the dietary supplement market and can make important decisions about the product, some industry sources said.
“You’re much less likely to see major new initiatives announced as long as you have interim directors,” Mister said.
He cited as examples the expected release of revised NDI (New Dietary Ingredient) guidelines, or a crackdown on an ingredient called phenibut which the FDA says is illegal in supplements and was the subject of recently published research. .
“All of these bold and broad initiatives become less likely when you don’t have a fully appointed director,” Mister said.
The heads of trade associations have also expressed doubt that the FDA will resolve the dispute between the agency and the industry over the sale of a popular ingredient in supplements, while the post of permanent director remains vacant.
Last year, the FDA proclaimed in warning letters that NAC (N-acetyl-L-cysteine) cannot be sold as a supplement because it was first approved as a drug. The FDA’s findings drew criticism from industry representatives who said the ingredient had been marketed in supplements for more than a quarter of a century.
“It’s going to be difficult to get the agency to make a decision on things like the NAC when you’re playing musical chairs with the direction,” Mister noted. “These are the kinds of problems the industry needs to solve. It’s probably not the agency’s top priority, but we need them to fix it. “
Manufacturer also mentioned the importance of ODSP solving the NAC problem.
“There should be someone on that chair willing or clear enough to say, ‘OK, do we really have a public health problem with NAC?’ “, did he declare.
FDA officials, some of whom “don’t like the product, frankly,” seem to have “more influence over how the product is regulated than” the ODSP official responsible for regulating supplements, added. Maker.