Verifying the authenticity and quality of raw materials and finished products requires supplement manufacturers to be highly diligent in compliance with dietary supplement current Good Manufacturing Practices (cGMPs), but seven basic tips can help companies in their selection of contract laboratories, according to a new review in the American Botanical Council’s Herbalgram.
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. Numerous contract labs exist in the marketplace for dietary supplement companies, and the selecting a lab that meets their particular needs and specializes in the appropriate methods is a vital first step.
Of particular concern is the possibility of contracting with an illegitimate “dry lab,” a practice whereby research or analysis is claimed to be done, but in reality the conclusions are guessed at or copied from other sources without actually doing any analysis.
“Determining the proper identity, 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.”
The HerbalGram article was authored by Paula Brown, PhD, director of the British Columbia Institute of Technology’s Natural Health and Food Products Research Group; Joseph Betz, PhD, director of the Analytical Methods and Reference Materials program at the National Institutes of Health’s Office of Dietary Supplements; and Frank Jaksch, co-founder and CEO of ChromaDex Corporation.
Speaking with NutraIngredients-USA at the SupplySide West show in Las Vegas last year, Jaksch said that the dry labbing issue, exposed in a report on Dateline NBC in March 2012, was ‘mushrooming’ and ‘metamorphosing’,
“We’re not seeing the same blatant dry labbing that was exposed in the Dateline piece,” Jaksch told us.
“The labs that were participating in this have metamorphosed into what I would call selective dry labs, meaning that they are not necessarily as blatant a practice as the lab that was exposed, they are now doing some dry labbing and a little bit of testing and trying to make it difficult for a company to pin it on them.”
The federal government does not have specific regulations for contract laboratories used by the dietary supplement industry. Manufacturers 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.”
The Herbalgram article lists the seven basic tips for selecting a contract laboratory as:
- Qualify the contract labs before sending any samples or trusting the results
- Qualify more than one analytical lab
- Define the relationship with the third party analytical labs by signing a contract or agreement
- Visit, audit, and inspect the contract labs
- Do not provide the exact results to the lab when sending samples,
- Send ‘challenge samples’ could be beneficial in the context of a long-term relationship
- Use reference materials to evaluate lab proficiency
To read the important and extensive Herbalgram article, please click here.
2013, Issue 99, Pages 52-59
“How to Qualify an Analytical Laboratory for Analysis of Herbal Dietary Ingredients and Avoid Using a “Dry Lab”: A review of issues related to using a contract analytical laboratory by industry, academia, and regulatory agencies”
Authors: P.N. Brown, J.M. Betz, F.L. Jaksch, Jr.