Cara Welch, PhD, a senior advisor in FDA’s Office of Dietary Supplement Programs, gave her assessment at a meeting in Boulder, CO on Tuesday. The meeting, titled the Rocky Mountain Dietary Supplement Forum, was put on by the consulting firm FDA Compliance Group. Welch cautioned that she did not have the full tally for total number of inspections conducted, the warning letters issued and observations made during the agency’s fiscal 2017, as it had just concluded. But in responding to a direct question on how the industry is doing on GMPs, Welch gave the overall impression that the compliance needle has not moved much in past year.
Big firms lead the way
So how does that look on a granular level? Welch confirmed what many have long suspected, that being that the largest firms in the dietary supplement industry are now indistinguishable from the best pharmaceutical manufacturers in terms of the day-to-day quality and precision of their operations.
“We know that the largest firms had zero OAIs (Official Action Indicated) on inspections,” Welch said.
The consensus within the industry is that warning letters that are posted on FDA’s website are often issued to firms that no one has heard of prior to the communication. Could one make the assumption, then, that most of the products on the market emanate from large firms, those that are in full GMP compliance? Welch said she wasn’t willing to make that leap.
“We don’t know how many of these smaller firms are out there. What we do know is that smaller firms can still put out a lot of product,” Welch said.
Continuing cluelessness still a problem
Another issue is that with the low barrier of entry to the industry (which is an aspect of the situation that Welch did not touch on as such), new firms can crop up and start producing while seeming to have little knowledge of what they’ve gotten themselves into. An example would be a recent warning letter issued to a smaller firm through FDA’s Denver office, which ticked off so many boxes of things the company was not in compliance on, it might have been easier to just print out the GMP rule with the notation: You haven’t been doing any of this.
Welch said that kind of ingnorance on the bottom end of the industry continues to be troublesome. It’s one of the contnuing features of the GMP compliance picture that she said makes her hesitant to say that things are getting better.
“Our inspectors are still walking into firms that are not even aware they are regulated by FDA,” Welch said.
Not your friend, but maybe your partner
The meeting in Boulder, which included employees of the Denver office as well as Welch, is one of the few industry events where FDA officials and industry stakeholders can meet in open forum in a non confrontational environment. Welch and the boots-on-the-ground inspectors emphasized that the agency’s primary objective is to protect consumer safety and enforce the law. So, while FDA can’t act as a company’s ‘friend,’ it can function as a partner in acheiving a higher lever of compliance, Welch said.
“Those firms that choose to invest in compliance, FDA is always willing to work with those kind of companies. But we do always have some firms that simply choose not to comply,” she said.