Industry needs standardized testing methods
supplement and herbal industries is that there have not been enough
standardized methods for different formulations and products,
according to a contract lab specialist.
Jana Hildreth, an expert panelist at the recent SupplySide West Expo in Las Vegas, is the CEO and technical director of California-based Blaze Science Industries and has 20 years of experience in the science of dietary supplements. Her expertise lies in chromatography and chemical calibration standards.
The US Food & Drug Administration (FDA) does not audit laboratories unless they are testing pharmaceuticals, nor are methods for testing dietary supplements required to be standardized. And this leaves a lot of room for interpretation, according to Hildreth.
This is because the dietary supplement industry is regulated by the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act.
Unlike pharmaceuticals, which must go through a series of pre-market approvals - finished dietary supplements are post-market regulated. Only ingredients not marketed in the United States before October 1994 must be approved by the FDA before being used in consumer products.
According to Hildreth, many nutraceutical companies do in fact do the proper legwork to make sure their ingredients are tested responsibly when they send them to labs.
However, she also said some companies either do not know what to ask contract labs for when submitting ingredients, or they knowingly cut corners to economize or to get the results they want. Such short cuts can then lead to trouble down the road, pointed out Hildreth.
"By educating people as to what are the discrepancies, we can maybe get people to ask their contract labs the right questions," Hildreth said in an interview with NutraIngredients-USA.com.
And Hildreth said she has seen it all when it comes to companies' lack of knowledge as well as companies taking the easier way out to bring a supplement ingredient to market - from cases where supplement makers do not know what questions to ask, to cases where contract labs do not even perform the tests themselves.
"I'll hear about an official method, but companies don't realize it's not for the same ingredient," said Hildreth.
An example of a case where companies would have to use two different testing methods, according to Hildreth, is with a vitamin versus a vitamin premix for fortification. Companies have to assume one test does not fit all ingredients.
"They have to make sure an ingredient is valid within the scope of the matrices of an official method," she said.
Hildreth pointed out that companies should work with reputable labs and get involved with the process.
"Good labs will have procedures and work with you when something fails," she added.
In 2001, the Association of Analytical Communities (AOAC International) joined forces with the National Institute of Health, the Office of Dietary Supplements and FDA to begin identifying methods for testing dietary supplement ingredients. The aim is to develop 20 AOAC official methods for those dietary supplement ingredients deemed most in need of standard analytical methods.
Hildreth said this to be a good first step, but she indicated industry needs fill the remaining gap.
"Industry should get together and create qualifications for standardized methods."
Hildreth was previously the technical director at ChromaDex, a supplier of phytochemical reference standards. She has also come to know the regulatory scene for testing supplements through her work in conjunction with analytical testing and health organizations such as the National Institutes of Health, United States Pharmacopeia and NSF International.
