What Will It Take to Get More GMP Compliance?

July 11, 2012

CRN's Mister Responds to Senators Durbin and Blumenthal: Compliance Requires Both a “Carrot and a Stick”

Improving industry compliance with dietary supplement GMPs will depend both on responsible action by supplements companies as well as enforcement by FDA, said Steve Mister, president and CEO of dietary supplement trade association the Council for Responsible Nutrition (CRN; Washington, DC). Mister spoke to Nutritional Outlook about a letter he and CRN sent today to Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT), in response to a July 6 letter the senators themselves sent to several industry trade associations expressing concern over GMP compliance. The senators’ letter was sparked in part by a June 30 Chicago Tribune article which stated that over the last four years, FDA has found GMP violations in half of the nearly 450 facilities the agency inspected, and that one in four companies inspected ended up receiving a FDA warning letter.

In their letter, the senators wrote, “We are deeply concerned about the pervasiveness of poor manufacturing standards that expose consumers to potentially serious health risks due to dietary supplements containing ingredients in amounts greater or less than those listed on the label, unintended or undisclosed ingredients, and contamination by bacteria or lead. The good manufacturing standards have been final since 2007, and many of the practices that have been cited as failing to comply are basic, common sense safety practices that should not require regulatory guidance in the first place….To ensure consumer safety, we are eager to hear of the industry’s plans for improving the successful adoption of cGMPs by companies that manufacture, package, label, and distribute dietary supplements marketed in the United States.”

 

More Inspections, More Violations?

FDA has aimed to steadily increase the number of GMP inspections it performs each year, as stated by FDA officials. This increase in the number of inspections performed also parallels the increase in the number of GMP violations uncovered. And, with the regulation’s phase-in period complete as of 2010,  all dietary supplement firms-big, medium, and small-are now subject to the rule, broadening the pool of firms subject to inspection.

“What we saw in 2011, and now again this year, is a huge uptick in the number of inspections, which we think is a good sign,” Mister said. “It means that FDA is now enforcing the law.”

He continued, “In the first year [of the phase-in period, which started by inspecting large firms and then moved to smaller firms], there were very few companies that had over 500 employees so not a lot of companies got inspected in that first year…It wasn’t until 2010 that the whole industry was really under the law. And I think it was at that point that we saw this big uptick in inspections because [FDA said], ‘Okay, everybody’s covered; it’s time to really enforce.’”

Also, Mister reminded that many companies are undergoing GMP inspections for the very first time and that there may understandably be a learning curve. “For many of these companies, this is the first time they’ve had an inspector show up on their doorstep with regard to CFR Part 111. And as I said, it’s unfortunate that we don’t have 100% compliance but we shouldn’t be surprised that on that first go-around that there are companies who are learning as they’re being inspected.”

 

“It’s Still Disturbing…”

Still, Mister said, the number of violations FDA says it has found is concerning. “No one likes to see one in four companies inspected have a warning letter. That’s disturbing,” he said.

In his letter to Senators Durbin and Blumenthal, however, Mister also took care to point out that many times industry members have voluntarily acted to correct GMP violations, eliminating further regulatory action, and also that FDA has purposely concentrated its inspections largely on what are considered high-risk areas where violators are likely to be found. “So the firms [FDA] selects for inspections are not a random sampling of the entire supplement industry, nor are they representative of the many firms in full compliance with the GMP requirements,” he wrote.

 

Going Forward

Continuing to improve GMP performance not only requires company compliance but also FDA’s enforcement of violators, Mister said.

“I think that the way you coerce compliance is through a combination of a carrot and a stick,” he said. “[CRN] is certainly doing our part on the carrot. We’re doing lots of education, we’re doing programs where we involve FDA, and we’ve had any number of FDA officials involved in our programs. So we’re doing what we can to give companies the opportunity to learn."

He continued, “The other part of this is the enforcement side. And unfortunately, some companies will only learn if they see the example of somebody else getting in trouble. And so these enforcement actions, as unfortunate as they are, are necessary, too, because for some companies, they need to know that there’s a consequence to putting your head in the sand…We believe in GMPs. We believe they’re good for consumers, we believe they’re good for industry, and [FDA] should enforce them when they find companies that are not compliant.”

Mister also commented on a suggestion some in the industry have made, that perhaps industry members should focus more heavily on GMP compliance over other “hot button” FDA issues that have commanded recent industry attention, such as the agency’s new dietary ingredient (NDI) draft guidance:

“I think there’s enough intellectual capacity in this industry that we can focus on both at the same time. But I do agree that people need to focus on GMPs because those are areas where the rules are very clear. With the NDIs, we’re arguing about what the rules should be, but with the GMP requirement, it’s relatively clear what your obligations are. And so companies should be redoubling their efforts to make sure they’re compliant.”

He also added that, moving forward, the Food Safety Modernization Act will help FDA oversee the dietary supplements industry. “The Food Safety Modernization Act has gone into effect, and one of the things that will be implemented over the next year is the requirement for registration every two years for supplement facilities. This will make it even more transparent for FDA to find and identify supplement facilities because we’ll have to register those facilities every two years, and we’ll also now have to identify them as dietary supplement facilities as opposed to just indicating that they’re food facilities, which is what they were required to do under The Bioterrorism Act of 2002. So that will make it harder for companies to hide from FDA, which is again a good thing, and it will make it easier for FDA inspectors to find you.”

“People should be taking this seriously," he concluded. “This should be a wake-up call.”

Read more on what FDA officials have recently reported about GMP compliance issues.