How Prepared is the Supplement Industry for FDA’s Next Phase of GMP Inspections?


On August 25, 2008, exactly 60 days after the U.S. Food and Drug Administration (FDA) began requiring the largest dietary supplement companies to comply with its new Good Manufacturing Practices (GMPs) for supplement makers, the agency sent a recently trained team of inspectors to NBTY’s Florida manufacturing facilities for one of the first GMP audits under the new guidelines. The company’s facilities had not been subjected to an FDA inspection since 2001and prior inspections had fallen under the FDA’s food GMP guidelines, which are less stringent than the new supplement GMPs. The 2001 inspection did not result in the issuance of a 483 letter, which is a form used by investigators to record observations of non-compliance with GMPs. But, the FDA’s 2008 screening of NBTY’s facilities under the new supplement GMPs did produce a 483 letter, along with a 28-page inspection report.

NBTY proved to be well-equipped to handle the wide-ranging inspection. All of the observations made by FDA inspectors in its 483 letter were minor, and NBTY was able to correct the areas of non-compliance almost immediately. The pervasive thought throughout the industry has been that large companies such as NBTY ought to be able to manage the wide scope of inspections more easily than smaller firms due to the extensive quality-control resources available to companies of that size. In addition, large companies typically have long-standing relationships with industry trade associations, which have been proactive in communicating the importance of GMP compliance, and invest in private GMP audits from independent companies such as NSF International.

Given those factors, it’s not surprising that the first wave of approximately 15 inspections of large supplement companies with 500 or more employees went off without any major enforcement actions. “We have been generally pleased with the results of the first inspections under the GMP program for dietary supplement manufacturers,” Brad Williams, member of the Dietary Supplement Division at the Center for Food Safety and Applied Nutrition (CFSAN), told Nutrition Business Journal. Williams cautioned, however, that the next wave of inspections—which will hit once mid-sized companies with more than 20 and fewer than 499 full-time employees become subject to supplement GMPs on June 25, 2009—may prove to be a more accurate gauge of the industry’s ability to comply with the new rules. “As we reach into the smaller, less resource intensive firms, it is possible that more problem areas will be found, and we can adjust our outreach efforts to focus attention on those areas of need,” Williams said.

Bruce Wood, president and CEO of Schiff Nutrition, a supplement manufacturer with just under 500 employees, said his company is looking forward to officially falling under the GMP rules when they go into effect for mid-size supplement companies next week. “We have long supported the adaptation of GMPs and were frustrated by the years of inactivity at FDA,” Wood said. “Now that GMPs are here, we feel very comfortable with our compliance capability and look forward to the inevitable audit that should take place at some point in the next 12 months.”

Despite the FDA’s beefed up resources and public commitment to fully enforcing supplement GMPs, Wood said he believes the agency could be challenged to complete the audits for the many new companies that will fall under the GMP guidelines this year and next year. “This will be a stern test for the FDA,” he said.

NBJ explores the issue of GMP compliance and what to expect from an FDA audit in our U.S. Nutrition Industry Overview issue, which will publish in July and be distributed at the 2009 NBJ Summit, July 22-24. To order your copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com. To register for the NBJ Summit, go to www.nbjsummit.com.

Related NBJ articles:
New Supplement Regulations Most Important for Industry Since Passage of DSHEA

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