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FDAs Supplement Division Still Without Permanent Leader

Article-FDAs Supplement Division Still Without Permanent Leader

<p>Dan Levy is the agency&#8217;s third acting supplement chief since Daniel Fabricant resigned earlier this year to join the Natural Products Association as its CEO.</p>

WASHINGTON—FDA is continuing to rotate officials for short assignments to head up its dietary supplement division several months after the agency’s permanent chief resigned to join a trade association. 

Dan Levy, a 19-year veteran of FDA, is presently the acting director of the agency’s division of dietary supplement programs. He assumed the position last month to replace Charlotte Christin, said Siobhan DeLancey, a spokeswoman for FDA. Christin served on the job for approximately four months.

A senior microbiologist in the Office of Food Additive Safety, Levy is a familiar face to the supplement industry. He previously held a number of positions in the division of dietary supplement programs, including as supervisor of the New Dietary Ingredient Review team, DeLancey said.

Levy is not expected to make a long-term impact on the supplement division. Interim supplement chiefs have been rotating on assignment every few months.

DeLancey had no comment on a timeline to hire a permanent supplement chief. The supplement division has named three temporary leaders since Daniel Fabricant left the agency in April to join the Natural Products Association (NPA) as its executive director and CEO. William Correll stepped into Fabricant’s role for just a few months before Christin took over.

Duffy MacKay, senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), cited the importance of “stable leadership at FDA.

“It does impact us in the sense of continuity. We have a few big issues out there that we would like to see continue moving in the right direction," MacKay said in a phone interview. “It’s better for us to not have the position rotating, but I understand they need to take their time to find the right person for the job."

Susan Mayne, an epidemiology professor at the Yale School of Public Health, may prove to be instrumental in moving someone into the head supplement slot next year. Effective January 2015, she will become the director of the Center for Food Safety and Applied Nutrition (CFSAN). Michael Landa is retiring after leading the center for more than four years.

As the leader of CFSAN, it is expected that Mayne would oversee, or at least provide her input, into key appointments, including the hiring of a supplement chief and a head at the Office of Nutrition Labeling and Dietary Supplements, which hasn’t had a permanent director in about two years.

Meantime, it is expected that any acting supplement chief at FDA “will continue to work hand in hand with the industry," Fabricant said. “The industry and agency have a common goal and that is to make sure consumers have access to safe products."

Still, the revolving door at FDA’s supplement division can be frustrating to the industry. MacKay cited challenges scheduling an industry meeting with FDA to discuss certain issues such as technical matters related to current good manufacturing practices (cGMPs). The industry and FDA gathered for a similar meeting a few years ago that proved to be fruitful.

“We have been trying to have a second one and it’s been really difficult with all the changing leadership," MacKay said.

The industry also is concerned that the absence of permanent leadership makes it difficult to have meaningful dialogue on hot-button issues, such as new guidance on new dietary ingredients (NDIs) that FDA has yet to release.

“We want to continue the progress along the lines of full implementation of DSHEA (Dietary Supplement Health and Education Act of 1994) and we’re concerned the lack of strong leadership is slowing us down," MacKay said.

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