Welch, who is acting director of the Division of Dietary Supplement Programs at FDA’s Center for Food, Safety and Nutrition, spoke at a session of the Oxford International Conference on the Science of Botanicals, taking place this week at the University of Mississippi. Industry stakeholders, some of whom seemed to be expecting the agency to take a position that Schneiderman’s avowed effort to set up a herbal supplement regulatory regime in New York state was usurping authority that more properly rests with FDA, were both surprised and dismayed.
“We know there is a GMP problem out in the industry. So in that respect we are very interested in every aspect of cleaning up the industry, whether it is from industry self-regulation, whether that is from the states themselves or whether that is from FDA,” Welch told the meeting attendees.
Welch emphasized that FDA was not and is not privy to the NY AG’s actions.
“We are not part of the NY AG investigation. They didn't tell us. They did tell the press, obviously. But the GMP standards are minimal standards. Anything over and above that industry might want to set up, or the states might want to undertake, if it strengthens the industry we are all for that,” she said.
GMP compliance picture not improving
To underscore her view, Welch presented some update information about the state of the dietary supplement industry’s GMP compliance. It’s not a pretty picture, she said. Compliance figures took a hit when the smallest firms began to be inspected in 2010 and 2011, something that was to be expected. But those figures have remained stuck in an unacceptable range, Welch said, with only about a third of GMP inspections resulting in no actionable observations on the part of the inspectors.
“Unfortunately these figures have not moved at all. Firms aren’t testing the raw materials when they come into their facility, they have no control procedures written down for controlling the product as it makes its way through the facility, and they don’t know what kind of product they are making if they have no specifications. That’s concerning to us and it should be concerning to industry as well,” Welch said.
One of the key questions about Schneiderman’s attack on the industry has been whether it is based on a falsehood. The DNA barcode testing that Schneiderman used has been widely criticized by experts both within and outside of industry. Welch hedged her bets a bit on that one, saying that any of the ancillary efforts to improve the industry to which she alluded must have a scientifically defensible basis.
“It is important that the testing methods used be scientifically valid. We don’t specify what the testing methodology ought to be, and that goes for industry as well,” she said.