Why Do You Need a Contract Laboratory?Why Do You Need a Contract Laboratory?
Your company is developing a new supplement, one that market analysis shows customers want, and your research and development (R&D) director is coming with the valid claim substantiation.
September 5, 2017
Your company is developing a new supplement, one that market analysis shows customers want, and your research and development (R&D) director is coming with the valid claim substantiation. You are aware of the several problems with the quality and safety of dietary supplements and warning letters by FDA. You found the supplier of needed ingredients with the best price. These ingredients are Generally Recognized as Safe (GRAS) and you know the regulatory status of every ingredient in your new product. Finally, you have the Certificate of Analysis (CoA) of these ingredients from the supplier. Therefore, everything is in place. Not necessarily!
GMP (good manufacturing practice) compliance in the supplier chain is crucial for the assurance that the ingredients in the 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, modified or chosen by manufacturers. Therefore, the same product from two different manufacturers may or may not contain the declared amount of active ingredients. In addition, the individual brand from one manufacturer may not be the same. In the worst-case scenario, some manufacturers do not require high-quality ingredients, since their products are marketed only online.
The only valid information and certification 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 identification of ingredients, reliable manufacturers may use voluntary testing in independent contract laboratories.
There are several possibilities to evaluate the quality of ingredients in dietary supplements. Testing methods have been published by the American Herbal Pharmacopeia (AHP), U.S. Pharmacopeia (USP) and Association of Official Analytical Chemists (AOAC International). The proper determination of the concentration of ingredients is crucial for the quality. This can be used as confirmation of potency of the clearly defined dietary ingredients, including amino acids, vitamins and minerals.
However, the analyses of herbs, botanicals and extracts are more complicated since these are not clearly specified as in the above mentioned dietary ingredients. Suppliers and manufacturers are usually referring to the percentage of one compound or a group of structurally related natural compounds in botanical and food extracts. For example, they may be referencing 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/efficacy (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 identified in the chemical analyses, which can decrease or eliminate the efficacy of the pure compound.
The biological efficacy of dietary supplements containing botanical or food extracts can be analyzed by using cell-based laboratory methods. DSTest Laboratories analyzed several supplements, which are marketed for their antioxidant and anti-inflammatory health effects. Some of these supplements demonstrated strong activity, whereas others did not show any effects for which these supplements are marketed. Although the declared amount of ingredients on the supplement label may be correct, the promised function or the health effect is missing.
The easy access to social media and the instant connection to the internet results in the increase of educated customers who are interested in high-quality (efficient) products. Although some online reviews of supplements present published scientific data, the major focus is usually on customer satisfaction (easy ordering, delivery) but not the real tested efficacy of reviewed supplements. Nevertheless, the new generation of educated customers will soon demand supplements that have promised functions.
In summary, third-party contract laboratories can independently evaluate the potency (chemical composition) of defined dietary ingredients, and the efficacy (biological/functional activity of herbal and botanical extracts). This validated and certified information will increase the marketing value of ingredients and the final dietary supplements. The higher level of transparency will distinguish between the top-quality products and the other “untested supplements", resulting in customers buying verified supplements they can trust.
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 Workshop is underwritten by Alcami, ARL, Eurofins, Micro Quality Labs and Midi Labs.
Daniel Sliva, Ph.D., is the acting chief scientific officer and founder of DSTest Laboratories LLC. (dstest-lab.com) He has more than 25 years of experience in academic research in the fields 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 efficacy of natural ingredients, as well as herbal and botanical extracts.
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