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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, nearly six in 10 American adults (59 percent) report taking dietary supplements on a regular basis. And a recent article by dietitian Sharon Palmer in Food Product Design estimated there are more than 29,000 dietary supplements already on the market and 1,000 new supplements added each yearall of which create a bewildering array of choices for consumers.

If a consumer cannot tell the difference between two supplements when making a purchasing decision, how can a supplement manufacturer differentiate its quality product? One route is subscribing to the notion of third-party product certificationverification that a product is manufactured according to high quality standards and tested to ensure label content claims and absence of microbiologic, aflatoxin and heavy metal contamination.

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

Understanding the Process

The third-party certification process includes a confidential review of product formulations and labels by expert scientists and toxicologists, and it establishes appropriate testing to determine the quality of a product or of each raw material in a product. Products are tested to verify they meet validated quality standards, including meeting label claims for ingredient identity and quantity, and not to contain any undeclared ingredients or unacceptable levels of contaminants.

A variety of chemical analyses can be used to determine a products composition. Chromatographic fingerprinting and thin-layer chromatography (TLC) are two popular techniques in testing raw materials and finished products. Laboratories are able to verify manufacturers quantitative claims on products with quantitative analytical techniques such as high-pressure liquid chromatography (HPLC), gas chromatography (GC), liquid chromatography/mass spectroscopy (LC/MS) and polymerase chain reaction (PCR) methods. The procedures used for these processes are recognized by public health and regulatory officials, and defined by organizations such as the AOAC, 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 a manufacturers claims for the content of an herbal product, but also reveal plant materials that may be adulterating the product. Many case reports of herbal toxicity have been traced to such adulterants rather than to the medicinal herb itself in an herbal product.

Because many dietary supplement ingredients are grown in the soil 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, to microbes. Manufacturers must ensure that if any of these potential contaminants are present, the levels are so low as to pose no measurable threat to the consumers health. Laboratories are able to test for such contaminants at the component or product level.

While the Food and Drug Administrations (FDA) proposed dietary supplement GMPs will likely be modified in the coming months, the proposed rule provided the industry with a glimpse of the level of testing and monitoring FDA may deem necessary. There are currently several sets of GMPs used by industry, including food or pharmaceutical GMPs, NSFs and the National Nutritional Foods Associations (NNFA) GMPs. While this disparity will disappear when FDAs final rule is announced, manufacturers can get a head start on GMP compliance by looking to an independent body such as NSF International to ensure their facility meets the current criteria. The joint committee responsible for maintaining NSF American National Standard for Dietary Supplements: NSF/ANSI 173 plans to adopt FDA GMPs into the standard once they become a final rule.

To verify that manufacturers comply with GMPs, on-site plant system audits are frequently conducted to prevent adulteration and to ensure the correct usage of raw materials, processes and finished products. Initial audits involve inspections of manufacturing facilities by experienced field auditors to verify quality-control procedures, staff training, cleanliness, equipment maintenance, record keeping, and procedures for receipt and registration of raw materials.

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

Ongoing Monitoring

Simply conducting a one-time test or inspection of a facility does not ensure the product continues to meet high quality criteria on an ongoing basis. Periodic monitoring is a critical component of third-party certification, which requires annual auditing and the bi-annual reevaluation of certified products to ensure continued compliance. Manufacturers that have received certification are required to inform the certifying body of any changes to or reformulations of their certified products. This process ensures there are no negative toxicological implications of proposed changes.

Manufacturers undertaking this array of testing, monitoring and GMP compliance will likely realize increased product quality and consistency. With the FDA GMP final rule pending, demonstrating GMP compliance is now more important than ever to the government, outside organizations andmost importantlyto consumers.

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

TAGS: Regulatory
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