Over the last several years, the U.S. Food and Drug Administration (FDA) has called out hundreds of adulterated dietary supplements for containing drugs such as sildenafil (Viagra) for sexual enhancement or sibutramine for weight loss. But this is not the only quality problem facing the supplement industry. Through its audits of supplement manufacturers, the FDA has pinpointed another kind of adulteration that is pervading industry: companies not meeting supplement Good Manufacturing Practices (GMPs).
According to FDA's Brad Williams, 25 percent of the dietary supplements manufacturers inspected by the agency in 2010 had significant GMP deficiencies. These deficiencies occurred in small, medium and large companies, said Williams, who is the consumer safety officer for the FDA's Division of Dietary Supplement Programs.
Problems with GMP compliance can lead to a product being labeled as adulterated. According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement will be named adulterated "if it has been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations." The Final Rule on GMPs was issued in 2007; and since then, GMP audits have increased each year. FDA has completed 66 GMP inspections so far in fiscal 2011 and 84 total inspections in 2010.
The problems being identified by FDA are many. Recent GMP audits reveal companies' failure to:
- Perform required identity testing on incoming dietary ingredients
- Set appropriate specifications for components and dietary supplements
- Adopt written procedures as required in the rule
- Prepare and follow Master Manufacturing Records and/or Batch Production Records for manufacture of dietary supplements
- Provide quality personnel to conduct required material reviews and make disposition decisions
Companies that do not comply with GMPs could meet serious action from FDA beginning with a warning letter. A company typically must respond within 15 days to FDA by outlining a resolution to the violation. If the resolution is not recognized as sufficient, product seizure or an injunction could prevent companies from continuing to produce until the violations have been corrected.
"FDA takes compliance with the dietary supplement GMPs seriously and expects the industry to do the same," cautioned Williams.
If it was not written down, it did not happen
Despite high numbers of GMP violations, it's clear FDA wants what's best for industry. "We want to encourage firms to look at an FDA inspection as an opportunity for direct feedback on their practices and a dialogue with FDA," said Williams.
Some companies have seen this coming and are prepared. Last year, contract manufacturers told Functional Ingredients that GMP compliance is the most important criteria to look for in a contract manufacturer—and that audits are occurring regularly.
"We've definitely seen the majority of our customers become more aware of and demand compliance with the current GMPs," said Steve Holtby, president and CEO of Soft Gel Technologies, a contract manufacturer in Los Angeles, California. "In fact, some of our customers require us to undergo periodic internal and third-party audits to confirm GMP compliance."
In a recent conference presentation, Williams said industry is way ahead of the FDA in terms of leveraging these third-party GMP audits. Two credible programs to consider are the NSF Good Manufacturing Practices (GMP) Registration and the Natural Products Association GMP Certification Program.
Above all, be sure to adopt FDA's written procedures, because when it comes to GMPs, if it isn't documented, it didn't happen. "It's an amazing amount of documentation that we have to do," said Beth Lambert, CEO of Herbalist & Alchemist.
"It's also important to remember that GMPs are the minimum standard a manufacturer must meet in order to ensure its product is not adulterated," said Williams. "Hopefully a manufacturer is looking at ways to continually improve the safety and quality of their product, utilizing appropriate preventive control measures."
FDA encourages all members of the supplement industry to familiarize themselves with the final rule, including the guidance contained in the Small Entity Compliance Guide published in December 2010. Email FDA's GMP question center at dds@fda.hhs.gov or call 240-402-1696. Additional guidance, compliance and regulatory information on dietary supplements can be found on FDA's website.
