Editorial: Will the Market Competition Urge GMP Compliance?

It’s always a pleasure when FDA provides its GMP regulatory compliance updates. I’ve heard Brad Williams, manager of FDA’s Division of Dietary Supplement Programs, speak several times at industry events and, most recently, at October’s SupplySide West show in Las Vegas. Hearing firsthand from FDA how our industry is doing in terms of GMP compliance provides a good idea of where we are-and how far we have to go.

What does the current picture look like? Not pretty, apparently. According to Williams, 2010’s GMP violation rate was nearly 25%. With FDA inspections starting with large firms and more recently moving to smaller firms, “We expected noncompliance to grow as the size of the firm decreased, but we find that too many firms don’t understand [what they should be doing], regardless of their business model,” he said. That includes dietary supplement manufacturers, own-label distributors, and contract manufacturers, he said.

With all the recent attention on FDA’s New Dietary Ingredients (NDI) draft guidance and how it could affect industry, we should nevertheless be devoting as much attention to the current state of GMPs, said Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). McGuffin and attorney Anthony Young of Kleinfeld, Kaplan and Becker LLP hosted a joint presentation at SupplySide West about how the number of GMP warning letters issued by FDA has been trending upwards.

“I can tell you that in my last conversation with an FDA representative, he said it’s interesting that there’s this big focus on NDIs when the focus should be on GMPs,” McGuffin said. “FDA already thinks that this is a problem area, and I think they’re surprised at the level of noncompliance.”

In other words, while it’s absolutely crucial for industry members to continue monitoring and commenting on the NDI draft guidance, as it is the launching pad for regulations that could affect industry’s very core, it’s necessary to pay attention to the regulations that already exist, the GMPs.

Under the Federal Food, Drug, and Cosmetic Act, all GMP violations are considered adulterations, McGuffin pointed out. Given that, it’s surprising to see the number of noncompliant companies on the market today, as evidenced by an increasing number of FDA warning letters. According to AHPA’s database that tracks industry warning letters, there has been a consistent rise. (Compared to 18 letters sent in 2009, and 42 between January to July 2010, there were 142 letters sent between August 2010 and May 2011.)

While FDA has so far only issued warning letters and has not yet used its new mandatory recall power, Williams said, “Who knows what might come next?”

So what will cause dietary supplement companies to comply? It could come down to good ol’ capitalism. “This [GMP compliance] is what it meant when we said we are a regulated industry,” said Young. “If you’re a contract manufacturer that has not spent the money to ensure you’re in compliance, I would assume that you’re trying to figure out what your next business is going to be. Because you’re not going to survive. No own-label company should be doing business with a company that is not in compliance with the GMPs.”

“If a contract manufacturer goes through an inspection that has multiple observations on a 483 [warning letter], that’s a matter of public record,” McGuffin added. “A contract manufacturer might be able to explain [problems found during inspections] to its customers upon a first inspection, but after a reinspection by FDA, if there are still observations, your customers are going to look for a contract manufacturer with experience in excellent FDA inspections.”

“I think that to some degree, market factors will have much more of an impact than any kind of regulatory shift,” he concluded.

Jennifer Kwok Grebow
Editor-in-Chief