Natural Products Insider

NOV-DEC 2018

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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62 INSIDER November/December 2018 Before a supplement can hit the market, it must be tested according to FDA regulations. This makes sense; before consumers put anything into their bodies, they want to be confi dent the products they are using are safe, made with high-quality ingredients and do what they claim to do without unexpected side effects. But the process of testing these products to verify they meet those qualifi cations is complex. To ensure supplements align with the above-mentioned criteria, brands—and the manufacturers they team with to create them—often use contract labs (i.e., outside testing companies) to certify products are fully and validly tested. This INSIDER Q&A with industry experts shines a light on how these companies navigate their complex relationships and obligations to each other to ensure all products hitting the market are safe and effective. INSIDER: What's the biggest issue facing contract labs that affects the credibility of fi nished health and nutrition products? Tammy Blakemore, general manager, SORA Labs: The unknown. Contract labs generally don't know the ingredient interactions for the products they are testing and often, neither does the label owner or manufacturer. Quality-control (QC)-based contract labs are expected to have fast turnaround times at competitive prices, but with the industry moving so fast and growing so quickly, marketing often outpaces science. Understanding the interactions between all the ingredients in a fi nished product is not being given the necessary time or resources. When the industry is doing things accurately, there is ample time during formulation to test the products and determine the matrix effect with each ingredient. Once the product is blended and ready to ship, it's too late to make adjustments and it can be a scramble to determine why results are out of specifi cation. Elan Sudberg, CEO, Alkemist Labs: The issue starts with the fact that most fi nished products are not getting tested by contract labs to confi rm label claims. The second issue is that some clients are taken aback when they realize the cost to test fi nished products. There are no test methods for unique fi nished products unless and until someone commissions their development. While some companies work hard to make this investment, many fi nished products are not tested. There are plenty of testing points along the way, beginning with starting ingredients. What matters more than anything else is the fi nal product; rarely is it actually tested to be sure it meets the label claim. Tara Couch, Ph.D., senior consultant, EAS Consulting Group: The challenge for the contracting laboratory is that it is rarely provided material or product matrix information, any mitigating circumstances pertaining to the sample, or even specifi cations that are necessary to ensure that appropriate, scientifi cally valid test methodologies are used. Some of this lack of sharing is intentional due to proprietary concerns; unfortunately, it is far more common that the manufacturer does not have the scientifi c knowledge and is relying on the contract laboratory to have that understanding in a vacuum. INSIDER: How can fi nished-product brands ensure their contract labs are using fi t-for-purpose assays, given technological advancements and FDA's requirement of "scientifi cally valid?" Couch: A "scientifi cally valid" test method is described in the Preamble to 21 CFR 111—Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—as a method that is accurate, precise, specifi c, consistently does what it is intended to do (often referred to as rugged), and based on scientifi c data or published results. The demonstration that a newly developed methodology, modifi ed compendial test method or adopted compendial test method meets these criteria is a basic tenant of Good Laboratory Practices (GLPs) and GMPs prior to the use of any test and is referred to as a method validation or verifi cation, as appropriate. A brand owner can ensure its contracting laboratory uses only validated or verifi ed test methods by requesting documentation of pertinent test-method validations and verifi cations, and qualifying that lab through a Contract Laboratory Qualifi cation program. Such a program should include an extensive qualifi cation questionnaire to evaluate all the laboratory control processes, including method validation/verifi cation. It should also include an onsite audit of the facility to determine whether the systems indicated on paper are actually adhered to in practice and follow up periodic challenge testing of the results obtained from the laboratory. John Atwater, Ph.D., senior director, verifi cation programs; and Edward P. Wyszumiala, director of customer engagement, United States Pharmacopeia (USP): It is benefi cial for a product brand owner to ensure that its contract laboratory is following all applicable GMP requirements. This requires a close and transparent working relationship with the contract lab. The product brand owner should not treat the contract lab as a "black box," expecting to obtain reliable results by just sending in samples and requesting testing for a particular assay. It is the responsibility of both the product brand owner and its contract laboratory to ensure that properly validated and/or verifi ed test methods are used for testing a particular substance in a product. Of course, the product brand owner should work with a reputable testing laboratory. When possible, the product brand owner should use an offi cially recognized test method (e.g., USP, AOAC) and verify that the validated test method is suitable for use for the product. Sudberg: A fi nished-product brand can ensure its contract labs are using fi t-for- Contract Labs INSIDER Q&A: Contract Lab Best Practices

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