Silver Spring, MD—Robert M. Califf has been confirmed as the new commissioner of the U.S. Food and Drug Administration (FDA).
Califf is no stranger to the agency. For the past year, he had been FDA’s Deputy Commissioner for Medical Products and Tobacco. Before coming to FDA, Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He was also the director of the Duke Translational Medicine Institute, the founding director of the Duke Clinical Research Institute and led numerous pharmaceutical clinical trials.
His appointment has some individuals questioning whether his connections to the pharmaceutical industry are too strong. For instance, while at Duke, he received research funding from numerous drug companies, served as a consultant for some and had other involvement with them.
Several industry groups like the Natural Products Association (NPA) have reached out to Califf and the agency to schedule meetings to learn how Califf plans to enforce laws and regulations related to the supplement industry. In a letter to Califf, Daniel Fabricant, Ph.D., NPA’s CEO and executive director, also expressed concerns regarding some of Califf’s past comments “suggesting that the same standard in which pharmaceutical drugs are tested be applied to supplements. We would ask that you please clarify these comments, as such a drastic change in regulatory practice would not only significantly increase the cost it takes to produce, manufacture and sell supplements, but also limit consumers’ access to millions of supplements that are taken safely each and everyday.”
Meanwhile, an official statement from the United Natural Products Alliance (UNPA) indicated the group is happy with recent FDA initiatives to take action against supplement companies that break the law. UNPA state, “We have also been encouraged by recent FDA statements in support of the positive steps taken by companies and industry to provide Americans high quality products while ensuring consumer safety. UNPA’s ongoing series of supplement quality summits, including the just completed Raw Materials & Supply Chain Summit, are just the most recent examples of industry’s commitment to exactly those principles.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), stated that based on statements made during his confirmation heart, “we feel confident that Dr. Califf will be fully committed to enforcing the laws and regulations for our industry that help protect consumers.”
CRN, like UNPA, hopes the new commissioner will continue to action against illegal activity by unscrupulous companies and individuals.
Published on WholeFoods Magazine Online 2/26/2016
