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HerbalGram Article Details Procedures for Choosing a Contract Analytical Lab for Dietary Ingredients
Date:9/16/2013

dentity, authenticity, and lack of adulteration of all botanical materials that are known to be adulterated is an important part of maintaining proper Good Manufacturing Practices, as required by federal law," said Mark Blumenthal, founder and executive director of ABC, and editor-in-chief of HerbalGram. "ABC is grateful to the authors for their article, which can help herbal manufacturers and others understand the key issues in choosing analytical services from contract laboratories."

Included in the HerbalGram article is a table of seven basic tips for selecting a contract laboratory. Of particular concern is the possibility of contracting with an illegitimate "dry lab," which provides fabricated yet plausible testing results without actually analyzing the supplied material. The term became part of public parlance after a Dateline NBC exposé of the practice aired in 2012.(2)

The federal government does not have specific regulations for contract laboratories used by the dietary supplement industry. Manufacturers might find labs with third-party accreditations and documented standard operating procedures to be suitable for their needs. Importantly, manufacturers also must ensure that contract labs meet all relevant requirements of dietary supplement cGMPs in order to pass FDA inspection. Although the legal context is somewhat vague, labs should be able to provide evidence that their testing methodologies are "appropriate and scientifically valid" and "appropriate for their intended use."

Finally, the authors discuss some of the main areas of consideration when evaluating testing reports and also provide a number of warning signs of potential dry labs. As a contract lab is considered essentially an extension of the manufacturer, companies must be commit
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SOURCE American Botanical Council
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