Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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72 INSIDER September/October 2017 A company is developing a new supplement—one that has a valid claim substantiation and that market analysis shows customers want. The company is aware of industry's history of problems with the quality and safety of dietary supplements and warning letters by FDA. The supplier of the needed ingredients comes with the best price. These ingredients are GRAS (generally recognized as safe), and the company knows the regulatory status of every ingredient in the new product. Finally, the supplier provided the Certifi cates of Analysis (CoAs) of these ingredients. Therefore, everything is in place. Not necessarily! GMP (good manufacturing practice) compliance in the supply chain is crucial for the assurance that ingredients in products are not contaminated and are safe for human consumption. Though safe, these ingredients may have limited potency. The provenance of some ingredients might not be clear. In addition, the CoA can be fraudulent or a duplicate of previously used CoAs. Therefore, some "suppliers" may produce ingredients with questionable quality. Indeed, FDA requires identity testing; however, these tests are not standardized and can be developed, modifi ed or chosen by manufacturers. The only valid information and certifi cation that ingredients are of the declared quality will be obtained with independent contract laboratory testing. Since FDA does not regulate standards and methods for the identifi cation of ingredients, reliable manufacturers may use voluntary testing in independent contract labs. Ingredient quality in dietary supplements can be evaluated in several ways. Testing methods have been published by the American Herbal Pharmacopeia (AHP), U.S. Pharmacopeia (USP) and AOAC International. The proper determination of the concentration of ingredients is crucial for the quality. This can be used to confi rm the potency of clearly defi ned dietary ingredients, including amino acids, vitamins and minerals. However, the analyses of herbs, botanicals and extracts are more complicated since these are not clearly specifi ed as in the previously mentioned dietary ingredients. Suppliers and manufacturers usually refer to the percentage of one compound or a group of structurally related natural compounds in botanical and food extracts. For example, they may reference the percentage of curcumin and curcuminoids in turmeric extracts or the percentage of epigallocatechin-3-gallate (EGCG), catechins or polyphenols in green tea extracts. These pieces of information, obtained by chemical methods and compared to standards, are required for a proper dietary supplement label. However, since these natural compounds are only portions of the whole extract, it is impossible to clearly characterize the "real" potency/effi cacy (biological/ functional activity) of the whole extract. Indeed, the production of botanical supplements is based on strong laboratory research and clinical trials. However, these trials are performed with the pure compound or an extract that was previously validated for biological activity. Because of the global supply of ingredients, the amount of active ingredients depends on the origin, cultivation conditions and extraction methods. Chemical analyses can determine the percentage of major ingredients in the extract. However, these extracts may contain other compounds not identifi ed in the chemical analyses, which can affect the effi cacy of the pure compound. The biological effi cacy of dietary supplements containing botanical or food extracts can be analyzed by cell-based laboratory methods. DSTest Laboratories analyzed several supplements marketed for antioxidant and anti-infl ammatory benefi ts. Some of the supplements demonstrated strong activity, whereas others did not show any effects for which the products were marketed. Although the declared amount of ingredients on the label may be correct, the promised benefi t is missing. Consumers have turned to the internet, including social media, to search for high-quality (effi cacious) products. Although some online reviews of supplements present published scientifi c data, the major focus is usually on customer satisfaction (easy ordering, delivery, etc.), not tested effi cacy of reviewed supplements. Third-party contract labs can evaluate the potency and effi cacy of dietary ingredients. This validated and certifi ed info will increase the marketing value of ingredients and fi nished supplements. The higher level of transparency will distinguish between the top-quality products and the other "untested supplements," resulting in customers buying verifi ed supplements they can trust. Daniel Sliva, Ph.D., is the acting chief scientifi c offi cer and founder of DSTest Laboratories LLC ( He has more than 25 years of experience in academic research in the fi elds of nutrition, biochemistry and molecular biology at the Karolinska Institute, Sweden, and the Indiana University School of Medicine. He is currently developing new methods and functional assays for the evaluation of effi cacy of natural ingredients, as well as herbal and botanical extracts. Contract Labs Help Supplement Brands Follow GMPs by Daniel Sliva, Ph.D. Contract Labs Learn more about using contract labs from Daniel Sliva during the "Selecting and Testing Your Contract Laboratory" Workshop on Tuesday, Sept. 26 at 9 a.m. at SupplySide West in Las Vegas. The session is underwritten by Alcami, Analytical Resource Laboratories, Eurofi ns, Micro Quality Labs and MIDI Labs. Scan Here Selecting and Testing Your Contract Laboratory at SupplySide West

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