Jarrow wants sit-down with FDA

Jarrow wants sit-down with FDA

Jarrow founder asks FDA officials to meet with key supplement companies, including the probiotic segment, to discuss FDA-industry relations and the next iteration of the NDI Guidance.

In late April, Jarrow L. Rogovin, founder and president of Jarrow Formulas Inc., wrote to William Correll, acting director of FDA's Division of Dietary Supplement Programs, and Dr. Corey Hilmas, then chief of the agency’s Dietary Supplement Regulation Implementation Branch but who since departed to the Natural Products Association. Mr. Rogovin requested that FDA officials meet with key dietary supplement companies, including the probiotic segment, in the near future to discuss FDA-industry relations as well as the next iteration of the NDI Guidance.

In his April 29, 2014, letter, Mr. Rogovin complimented the agency on the recent appointment of Mr. Correll. "I am glad to see the FDA has selected an experienced professional agency official with more than two decades of service," he said. "Along with many dietary supplement industry stakeholders, I look forward to working with Mr. Correll, and I remain hopeful that an open and productive relationship between Industry and the FDA can develop.”

Mr. Rogovin has been a vocal critic of the FDA's hiring of Dr. Daniel Fabricant, the former director of Dietary Supplement Programs, away from the NPA. Rogovin says that the FDA should learn from that experience that it is inappropriate and a conflict of interest to hire its executive personnel out of the ranks of trade association executives. “Yet Dr. Hilmas’ recent move from FDA to NPA, and Cara Welch’s move in reverse, earlier this year, appear to continue this very disturbing trend,” Mr. Rogovin said.

The letter to Acting Director Correll also urged the FDA to respond fully to Jarrow Formulas’ two pending Freedom of Information Act (FOIA) Requests:  a 2011 Request seeking the basis for the Agency’s radical new NDI notification requirements; and a 2014 Request demanding FDA substantiation for unsupported statistics and pronouncements disparaging the industry, made by Daniel Fabricant, Ph.D., throughout his FDA tenure—comments often made with no attempt whatsoever to distinguish the unscrupulous purveyors of both tainted foreign goods, or of drugs and steroids disguised as supplements, from the vast majority of highly reputable dietary supplements firms and their products. With reckless disregard for the truth, skewed statistics were quoted and often magnified by the mainstream press after they had been fed misleading information by the agency. Mr. Rogovin believes that prompt response to the two outstanding document requests will serve the best interests of FDA and industry.

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