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Volume 20, Issue 6
How dietary supplement testing changed over two decades
By Elan Sudberg, CEO, Alkemist Labs
Looking back at the last 20 years, I feel like the dietary supplement industry has matured from an unruly child with neglectful parents and a “Why follow the rules if no one else does?” attitude to a mostly mature young adult, still finding its way but on the right path with as much hope as opportunity for improvement. We’ve also seen advances in technology impact the world of dietary supplement testing-sometimes not for the better.
Back in 1998, Alkemist Labs had a handful of clients who were big companies trying to do things right-although what that meant was not yet very well defined. Good Manufacturing Practices (cGMPs) were specified under the Dietary Supplement Health and Education Act of 1994 (DSHEA), but it would be a ridiculous number of years later until the FDA outlined just what those cGMPs were in the agency’s eyes. During those gray years, cGMPs came up as fuel for prosecution only when there was a serious event. Although there weren’t a lot of them yet, companies who either had big enough liability or who were owned by other companies in better regulated industries relied on our services to limit their liability. Alkemist survived those years, but had some memorable times. With gas tanks nearly empty, we limped into the bank to make anemic deposits and robbed Peter to pay Paul, and then paid Peter back with a loan from Paul. It was a long, dry, dusty road ahead for the next 10 years, with a few ups and many downs. We do not miss those times at all.
When FDA finally spelled out its cGMPs regulations, the industry realized that complying with the cGMPs was the right thing to do-or, at least, the smart thing to do. Fortunately, Alkemist Labs had become known as being a very proficient testing lab, and companies serious about botanical identity came calling.
This year, thanks to continuous improvement in industry compliance with cGMPs, Alkemist Labs is celebrating its 20th year in business and growing faster than ever. Things are great and are getting even better. The industry has more players, more complicated formulas, and more adherence to federal regulations. We see more companies committed to doing things right, investing in reference standards, working through discrepancies to get real answers, and focusing on more than just getting a cheap price when sourcing ingredients.
Still, we have work to do. There are those who still abuse the vaguely written cGMPs, which state that a scientifically valid method must be used to test the identity of all incoming raw ingredients. These companies do the least amount of quality control possible.
Shiny balls will also come and go. Technologically speaking, DNA testing has been a disruptive, shiny ball that some have tried to apply before it was fit for purpose; as a result, those who overstate the accuracy and applications for DNA testing have created a brouhaha of biblical proportions. While DNA testing will eventually be fit for some purposes, the “oldie but goodie,” tried-and-true technique of HPTLC (high-performance thin-layer chromatography) is still the most trustworthy and accurate method available for testing plant identity.
Happy Anniversary, Nutritional Outlook! I look forward to the journey as both our companies head towards our 30s.
Elan Sudberg is CEO of Alkemist Labs (Costa Mesa, CA), a passionatwely committed contract testing laboratory specializing in plant authentication, botanical ingredient identification, and quantitative analytical services to the food and beverage, nutraceutical, and cosmeceutical industries.