Sorting Out the Confusion

Sorting Out the Confusion
The importance of third-party dietary supplement certification

by Kathy Pompliano

According to the Dietary Supplement Barometer Survey, nearlysix in 10 American adults (59 percent) report taking dietary supplements on aregular basis. And a recent article by dietitian Sharon Palmer in FoodProduct Design estimated there are more than 29,000 dietary supplementsalready on the market and 1,000 new supplements added each yearall of whichcreate a bewildering array of choices for consumers.

If a consumer cannot tell the difference between twosupplements when making a purchasing decision, how can a supplement manufacturerdifferentiate its quality product? One route is subscribing to the notion ofthird-party product certificationverification that a product is manufacturedaccording to high quality standards and tested to ensure label content claimsand absence of microbiologic, aflatoxin and heavy metal contamination.

Only manufacturers whose products pass vigorous testing andGMP (good manufacturing practice) facility audits are awarded the use ofcertification marks. This provides manufacturers a way to demonstrate qualityand differentiate their products for consumers. To further examine the aspectsof quality that the dietary supplement industry can control, it is important todetermine how to seek and how to convey quality at all points of the supplychain. Typically, manufacturers of both ingredients and finished supplementproducts can ensure quality internally by adhering to a strict set of qualitycontrol procedures, thorough testing for ingredient purity and contaminants,incorporating comprehensive monitoring schedules, using analyticalchemistry-based laboratory analyses and ensuring compliance with GMPs.Manufacturers who adhere to all of these criteria will be far more likely toproduce a consistent, quality product than manufacturers who either do notconsistently maintain these high standards, or choose not to test or monitortheir processes at all.

Understanding the Process

The third-party certification process includes a confidentialreview of product formulations and labels by expert scientists andtoxicologists, and it establishes appropriate testing to determine the qualityof a product or of each raw material in a product. Products are tested to verifythey meet validated quality standards, including meeting label claims foringredient identity and quantity, and not to contain any undeclared ingredientsor unacceptable levels of contaminants.

A variety of chemical analyses can be used to determine aproducts composition. Chromatographic fingerprinting and thin-layerchromatography (TLC) are two popular techniques in testing raw materials andfinished products. Laboratories are able to verify manufacturers quantitativeclaims on products with quantitative analytical techniques such as high-pressureliquid chromatography (HPLC), gas chromatography (GC), liquidchromatography/mass spectroscopy (LC/MS) and polymerase chain reaction (PCR)methods. The procedures used for these processes are recognized bypublic health and regulatory officials, and defined by organizations such as theAOAC, the Institute for Nutraceutical Advancement (INA), U.S. Pharmacopeia (USP)and the American Herbal Pharmacopoeia (AHP).

Laboratory analyses not only help to ensure the validity of amanufacturers claims for the content of an herbal product, but also revealplant materials that may be adulterating the product. Many case reports ofherbal toxicity have been traced to such adulterants rather than to themedicinal herb itself in an herbal product.

Because many dietary supplement ingredients are grown in thesoil or derived from the earth by mining, as in the case of various minerals,they are naturally exposed to pesticides and heavy metals and, in some cases, tomicrobes. Manufacturers must ensure that if any of these potential contaminantsare present, the levels are so low as to pose no measurable threat to theconsumers health. Laboratories are able to test for such contaminants at thecomponent or product level.

While the Food and Drug Administrations (FDA) proposeddietary supplement GMPs will likely be modified in the coming months, theproposed rule provided the industry with a glimpse of the level of testing andmonitoring FDA may deem necessary. There are currently several sets of GMPs usedby industry, including food or pharmaceutical GMPs, NSFs and the NationalNutritional Foods Associations (NNFA) GMPs. While this disparity willdisappear when FDAs final rule is announced, manufacturers can get a headstart on GMP compliance by looking to an independent body such as NSFInternational to ensure their facility meets the current criteria. The jointcommittee responsible for maintaining NSF American National Standard forDietary Supplements: NSF/ANSI 173 plans to adopt FDA GMPs into the standardonce they become a final rule.

To verify that manufacturers comply with GMPs, on-site plantsystem audits are frequently conducted to prevent adulteration and to ensure thecorrect usage of raw materials, processes and finished products. Initial auditsinvolve inspections of manufacturing facilities by experienced field auditors toverify quality-control procedures, staff training, cleanliness, equipmentmaintenance, record keeping, and procedures for receipt and registration of rawmaterials.

GMP compliance is a major component of any good qualitymanagement system. Taking a proactive approach to comply with the proposed GMPguidelines, even when it isnt time to do so, speaks highly of anymanufacturer and its willingness to produce quality products. According to a recent INSIDER article by attorney TonyYoung, If you want to do business with any of the large players in theindustry, it is almost always a requirement that you comply fully with theproposed GMP guidelines that are based on best industry practices to providesafe and effective products.

Ongoing Monitoring

Simply conducting a one-time test or inspection of a facilitydoes not ensure the product continues to meet high quality criteria on anongoing basis. Periodic monitoring is a critical component of third-partycertification, which requires annual auditing and the bi-annual reevaluation ofcertified products to ensure continued compliance. Manufacturers that have received certification are required toinform the certifying body of any changes to or reformulations of theircertified products. This process ensures there are no negative toxicologicalimplications of proposed changes.

Manufacturers undertaking this array of testing, monitoringand GMP compliance will likely realize increased product quality andconsistency. With the FDA GMP final rule pending, demonstrating GMPcompliance is now more important than ever to the government, outsideorganizations andmost importantlyto consumers.

Kathy Pompliano, M.S., R.D., is the general manager of NSFInternationals Dietary Supplements and Functional Foods CertificationProgram. NSF International is a public health and safety organization involvedin the development of national standards and third-party certification programs.Pompliano is a registered dietitian with bachelors and masters degrees infood science and nutrition. She is currently enrolled in the International FoodLaws and Regulations Program at Michigan State University.