FDA NDI Guidance Considered Imminent at CRN; Sharfstein Speaks

FDA principal deputy commissioner Joshua Sharfstein, MD, answered audience questions about new dietary ingredient (NDI) draft guidance today at the Council for Responsible Nutrition’s (Washington, DC) annual conference in Austin, TX. Currently, Sharfstein is keeping details about any draft guidance FDA may have established confidential. However, many at the conference seem to believe that FDA will release guidance in the near future.

Questions addressed to the deputy commissioner included how any lists of “grandfathered” ingredients suggested by industry would fare in FDA guidance. Sharfstein refrained from getting into specifics but did stress several times that the agency would consider the guidance, when released, to be a starting point and that it would be seeking industry feedback. “Anything we do is going to be a draft…we will very much be listening to what people are saying,” he said.

Attendees were also concerned how any final NDI regulation could spark wider changes to the Dietary Supplement Health and Education Act of 1994 (DSHEA). Sharfstein reassured attendees that the agency would not be seeking to alter the greater scope of DSHEA. “I think we’re looking for a nice, narrowly crafted solution,” he stated.

He also fielded a question on how FDA would be prepared to handle a potential “flood” of submitted NDIs once regulations are established. He answered only, “We definitely realize that it will be a challenge.”

Sharfstein also touched on the progress of FDA’s current Good Manufacturing Practices (GMP) inspections, which as of this summer pertain to dietary supplement manufacturers of all sizes.

Sharfstein said that one-third of the inspections FDA has conducted so far have found “serious problems.” Problems include no ingredient identity testing (with companies instead relying on an ingredient’s Certificate of Analysis for validation); failure to have manufacturing, recordkeeping, and quality-control plans established; and a lack of end-product testing.

Sharfstein wasn’t able to disclose how many GMP inspections FDA has conducted so far this year, citing that fiscal numbers are still coming in. However, he confirmed that FDA had planned to conduct 250 inspections this year and said that the agency plans to double this number in 2011.

*Editor’s Note:
    Talk about NDIs at the CRN conference is high. Many are sure that FDA guidance exists in some form and that FDA will release the guidance in the very near future, but most talk is speculative at this point. The best industry can do at this point is to try to anticipate what guidance will entail. The consensus is that preparing for what may come ahead of time may help industry to respond more quickly and comprehensively once guidance is made public.