Over the 15 years that Alkemists Labs has been in business in Southern California, a lot has changed. Good Manufacturing Processes (GMPs) have been implemented for the dietary supplement industry; Certificates of Analysis (C of As) have been widely discredited as being reliable without further testing of ingredients; and the FDA has issued numerous 483 warning
Some years ago Alkemists’ Elan Sudbergthe CEO title from his father, who now serves as Chief Science Officer. Today the company’s main business is testing botanicals and vitamins. It has also begun to test cosmetics, and is rapidly developing an R&D department. We asked Elan about some of the changes he’s seen, and some of the challenges that the evolving environment has meant for the industry and for his company.
Fi:What is the biggest problem you are helping clients with today?
ES:Mostly it is general GMP identity testing. This is hard for a lot of other labs because they just don’t have the methodology down. Most people now know that you can’t just trust C of As. For instance, you may test green tea for the amount of caffeine it contains, but the second you begin mixing it with something else, that method is no longer considered valid for that particular product.
Fi:Is adulteration still an issue in the botanicals industry?
ES:Yes, but nowadays it is also about quality. Back in the day, hoodia was a prime example of an adulterated product with companies making all sorts of claims. But today, as then, you get what you pay for. Take, for instance, the extract for gingko. We used to have to dilute gingko in order to test it properly. Today, it has reversed. Gingko extract is extremely diluted, and we even have to concentrate it in order for it to show up in our tests. It may be 75 percent filler depending on the price point they want to hit. We’ve had to change our to meet this reality. There are a lot of dilution issues today, especially in berry products.
Fi:What is “dry labbing?”
ES:This is what’s laughingly known in the industry as “using a typewriter to test.” In other words, there is no real testing going on at all, simply the creation of reports with some results without ever having done the tests. Frontline did a piece on this. The standard that everyone should be following today is the old Reagan line: “Trust but verify.” Simply accepting a C of A without verifying with testing opens a company up to huge liability for some unknown ingredient or effect that ingredient may have on someone ingesting it.
Fi: So what should a company do to protect itself?
ES: My advice would be to build a relationship with the lab, and to audit them. Make sure you understand the data the lab is giving you, that they understand their own data, and that the testing is optimized for the particular product in question. One test is not enough. You must retest whenever a product is mixed or altered in any way. And if you have an ingredient on the label but you have a problem.
Remember, it’s your assets that are on the line. I often tell people that the small amount of money spent to fly to where the city where their lab is, book the hotel room, and to audit the lab is pennies compared to what they face if they have to go through a recall or lawsuit. You should be shown full data at the lab, full disclosure of methodology, copies of the lab notebook and their tests.
Fi: Sounds like you’re full of good advice.
ES: We provide a lot education for our customers, teaching them why they need these critical tests in order to keep themselves out of the sights of the FDA. We’re proud of our work, and one day we’d love to see our name touted on the labels of products we’ve tested.