It's now been a month or two since the CGMPs for medium-sized dietary supplement manufacturers were instated.
Some manufacturers had been dreading what full compliance requires. "As we can see from the results of FDA audits conducted in recent months, even some of the larger dietary supplement manufacturers have a lot to do to comply fully with the new GMP regulations. Many of the smaller companies with fewer resources are even less prepared," says Ed Wyszumiala, general manager of NSF International's (Ann Arbor, MI) dietary supplements program, which has registered 137 companies that demonstrate GMP compliance.
He adds, "The overall cost of full compliance is high. Many companies hope that FDA will pass them by until they have time to address all of the deficiencies at their plants."
Besides the costs and headaches of an inspection, there may be another reason that even high-quality facilities hope that FDA inspectors pass them by. Some say that certain aspects of the GMP requirements aren't specific enough, laying grounds for confusion.
Among aspects that may cause confusion is what FDA considers acceptable and scientifically valid tests. "The regulation was purposely written so that a broad interpretation could be made by the manufacturers," says Matt Arveseth, laboratory director for testing company Silliker Inc. (Orem, UT). Together with Silliker's John Williams, he authored this issue's story on product testing. "Many manufacturers have thus interpreted the regulation as they see fit and are now waiting to see whether their interpretation will match up with FDA's."
Thus, says Arveseth, "quality-minded companies are also apprehensive at the thought of an upcoming GMP inspection. Despite their best efforts, they may have interpreted the GMP regulation differently than the incoming inspector. With little history and guidance available, companies are hoping not to be the first on the list for inspections. A company does not want to get a Form 483 from the inspector because of a difference of opinion on how the regulation is interpreted."
Whether or not manufacturers are ready, FDA may soon be knocking on their doors. Although no inspections for mid-sized companies have been reported to date, FDA is preparing to ramp up inspections soon and is aiming to complete 200 of them in the next year. "We will definitely be conducting more GMP inspections during the coming year, since there are many more medium-sized firms than large firms," says an FDA spokesperson. Industry members predict inspections to start picking up in the fall.
Despite the costs of compliance, there are some that welcome the inspections, hoping that the GMPs will help to "weed out" the underperforming competition.
"My company spends millions of dollars a year ensuring that the products we produce are compliant and of the highest quality possible," says George Pontiakos, president and CEO of BI Nutraceuticals (Long Beach, CA). "Very few of our competitors have invested in steam sterilization methodology or can identify irradiated or adulterated components. They don't have botanists and chemists on staff, and they just don't have the infrastructure to comply with the GMPs. So these guys—the ones who continually proffer poor-quality products—aren't going to make it, and I think that's great for the industry."
"There has been a wide range of quality within the supplement industry," agrees Arveseth. "Those that produce quality have done so at an increased cost. Those that have not are able to manufacture and produce at a lower cost. Many are hopeful that the inspections will level the playing field."
For unscrupulous companies, the time for reckoning may be sooner than they expect. Pontiakos says that companies producing substandard product may just be the ones FDA inspects first. "All FDA needs to do is hit the right people, and FDA knows who those people are," he says. "You don't need to blacken the skies over the industry. FDA knows who is not doing the right thing—and so does the industry."
The Council for Responsible Nutrition will express its take on the CGMPs in our September issue.