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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68 INSIDER November/December 2018 The stuff that sinks businesses—like product recalls, warning letters and class-action suits—are most often related to insuffi cient product testing. Using the wrong method, or not testing at all, has taken steam out of many in the food and supplement industry. Let's admit it: There are a lot of problems with testing. It costs time and money, which exponentially increase when a product fails the test. Ignorance is bliss, until it causes a crisis. Focusing on supply chain preventive controls under the Food Safety Modernization Act (FSMA) is great, but the devil is in the details. A brand can visit its suppliers all it wants, but if it is not reviewing and ensuring the validity of results for the substances that pose a risk to a product, it hasn't covered all the bases. For the average consumer products fi rm, it's not just about pathogens and allergens, but also about substantiating label and marketing claims. The past decade has shown that testing-validity issues are central in many expensive actions related to product and ingredient identity, as well as "natural" and nutrient content claims for food. Paper certifi cations like organic and non- genetically modifi ed organism (GMO) are slowly adopting testing, too. Contract labs are like any other supplier and should be verifi ed with the same level of rigor. Contract labs who are for-profi t have a business to run. Their ability to obtain a correct answer depends on the employment of numerous incremental controls that help to ensure the probability of their correctness. Most, if not all, of these controls cost money or time. Method verifi cation and validation, running duplicate samples versus single runs, performing calibration curves weekly or monthly instead of daily, and using certifi ed reference materials are all steps that impact both the profi tability of a lab and the reliability of results—except in opposite ways. So, while many responsible labs are doing their best to achieve accurate results, remember that every for-profi t contract lab is working to strike the balance of profi tability and reliability on a daily basis. Certifi cations come second. Methods, references and processes should be evaluated fi rst. Certifi cations are great, but don't often cover the method a brand needs to use. Beyond certifi cations like ISO 17025, verifying the lab fi rst requires transparency on the methods and processes that affect its reliability of results. Some of the top questions include: 1 Is the method compendial (i.e., peer-reviewed and approved by experts) or otherwise validated? FDA, AOAC or USP are common compendial-source methods listed on specifi cation. (Compendial methods should have a unique method number or reference a particular document.) If the lab has validated a method, what were some of the key elements of the validation? Has the method been validated in multiple independent labs? 2 Does the method fi t the matrix or type of a sample? A method validated for an herb may not also be valid for an extract of that herb. Validity to a particular matrix is an issue that's often overlooked. Ask the lab if it foresees any issues with interference from the composition of the sample, because it may not be considering this issue before testing the sample. 3 How long has the lab been running the method, and how many samples are tested weekly with the method? Expertise in testing is often method-specifi c, and profi ciency comes through repetition. Consider it a red fl ag if a lab says it only uses this method occasionally. It's typically expensive and time consuming to perform all the necessary instrument calibration and verifi cation for just one or two samples, so this is where shortcuts may be taken. 4 What calibrations and quality control (QC) procedures are employed? How are circumstances that compromise reliability of results—like incomplete extraction or signal suppression in chromatography— addressed through ongoing calibration of the instrument? Examples may include running an instrument blank every few samples to determine no carryover, a daily calibration curve with freshly made reference standards, and weekly or monthly control samples. 5 What are the reference materials? Information like source, purity and method of verifi cation should be the "standard" for reference material certifi cates of analysis (CoAs) but are sometimes not. Also, the purity of a reference standard may have been determined at date of manufacture, Selecting a Contract Lab to Ensure Valid Lab Results by Blake Ebersole Contract Labs Contract Labs at SupplySide West Learn more about selecting a contract lab from Blake Ebersole during the "Effectively Partnering with a Contract Laboratory" Workshop on Wednesday, Nov. 7 at 1:30 p.m. at SupplySide West in Las Vegas. Scan Here The past decade has shown that testing-validity issues are central in many expensive actions related to product and ingredient identity, as well as "natural" and nutrient content claims for food.

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