11.01.13
The peer-reviewed, quarterly journal HerbalGram, of the non-profit American Botanical Council (ABC), Austin, TX, has published a report that examined how companies navigate the FDA dietary supplement rules and regulations for current Good Manufacturing Practices (cGMPs). Further, the article offered advice as to how manufacturers should go about selecting a contract analytical laboratory, as well as how to avoid fraudulent “dry labs.”
The process of navigating cGMPs requires supplement manufacturers to be highly diligent in compliance, especially in the case of selecting contract analytical laboratories to verify the authenticity and quality of raw materials and finished products. Since many herb and other dietary supplement manufacturers do not have—and are not required to have—analytical laboratories on site, they must outsource required analyses of raw materials to third-party laboratories. These contract labs provide an extensive range of testing services.
Included in the HerbalGram article was 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.
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 discussed 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 committed to qualifying, auditing and inspecting contract labs to ensure the highest quality products for their customers, the authors concluded.
The process of navigating cGMPs requires supplement manufacturers to be highly diligent in compliance, especially in the case of selecting contract analytical laboratories to verify the authenticity and quality of raw materials and finished products. Since many herb and other dietary supplement manufacturers do not have—and are not required to have—analytical laboratories on site, they must outsource required analyses of raw materials to third-party laboratories. These contract labs provide an extensive range of testing services.
Included in the HerbalGram article was 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.
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 discussed 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 committed to qualifying, auditing and inspecting contract labs to ensure the highest quality products for their customers, the authors concluded.