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Another category that requires a special focus: “It’s very important to note that test methods for finished product formulas containing multiple ingredients do not exist until they are developed for that specific blend of components,” says Sudberg. “Here’show it works: a manufacturer brings a formula to their favorite testing lab and requests test methods be developed for that finished product. The lab then does that work, which the manufacturer pays for, after which test methods do exist for that specific finished product. Not all brands have this done, probably to save money, but they need to as FDA has started to ask about this step during regular audits. It’s also the right thing to do to ensure the finished product is what the label says it is. And it’s smart for retailers to ask their sales reps if a brand follows that process as part of the progression in deciding what products to stock.”Related: Alkemist Labs, REJIMUS Partner to Offer Comprehensive GMP Compliance Solutions
At Alkemist Labs, which specialized in botanical identity testing with expanded capabilities in phytochemical potency analysis, Sudberg says: “Our Certificate of Analysis is transparent and comprehensive, including everything you need to reproduce the analysis, and defend the results to auditors. We can also provide an easier to read, consumer-friendly version should you choose to give your customers access to test results. We're family-owned and sticklers for transparency. Alkemist Labs' mission is to bring transparency to all areas of natural products industry testing, including education tools designed to demystify testing and help companies obtain accurate results to support regulatory compliance and illustrate their quality commitment to consumers.”To that end, Alkemist’s latest transparency initiative, Next Generation Transparency, is focused on encouraging manufacturers to reveal details about their testing program. “Suppliers and manufacturers spend a lot of marketing dollars telling their story, and they also spend a lot of money on product testing to assure identity and strength, but don’t share that beyond FDA inspectors and internal QC staff,” Sudberg says. “We believe that consumers would be very interested in that information too, so we’ve developed a template for a consumer-friendly Certificate of Analysis suitable for disclosing because it explains what it says. We’re hoping this will become the next standard ‘best practice’ in the industry.”
Botanical testing is also available from NSF. Miller explains, “NSF International has recently advanced the state of laboratory certification with the finalization of our new protocol for verification of botanical ingredients (P485-1 Plant Material Verified) and we are proud to say that we can offer the NSF mark on raw materials being sold in the industry. This protocol protects and improves public health by using a robust testing battery that looks for commonly-found adulterants as well as toxic contaminants in a sample.”