Daniel Fabricant, Ph.D., addressed the Ingredient Marketplace crowd in early June with a presentation entitled, “There and Back Again.” Reflecting upon his time as the director of the U.S. Food and Drug Administration’s (FDA) division of dietary supplements, Fabricant, now executive director and CEO of the Natural Products Association (NPA), offered insight into FDA’s current thinking on dietary supplements and what could be on the agency’s radar for the future.
“There are still challenges to health and wellness,” he stated, noting that the agency responds to political pressure. Fabricant showed the audience a list of several Congressman. “How many of those people know us?” he asked. Fabricant said that the natural products industry ranked far behind other industries in political fundraising at 50th on the list and suggested that is something that should be addressed.
Fabricant noted several issues FDA is deeply interested in, including good manufacturing practices (GMPs), tainted products, new dietary ingredients (NDIs) and adverse event reports. On GMPs, he said some field offices are more active than others, resulting in a greater likelihood that plants in some areas get visited more.
Fabricant spent a fair amount of time on NDIs, suggesting that FDA’s NDI Guidance might be ready this year. He called failing to file an NDI a critical issue. “If you don’t file an NDI, then there’s a problem,” he stated. Fabricant advised industry that the agency is looking into “look alike” NDIs, which is something companies should closely consider.
He also made the point that companies that review their case prior to submitting an NDI have a great chance of getting a favorable response. “Just two companies got a ‘good day’ letter without talking to the agency before,” he stated.
Published in WholeFoods Magazine, July 2014