Roger A. Clemens

It seems almost yesterday that hide-and-seek was an innocent childhood game. Within the pharmaceutical, food, and dietary supplement industries, however, seeking to uncover the hidden is serious business, critical for consumers’ health and essential for regulatory compliance.

The seriousness is evidenced in warning letters, safety alerts, and product recalls. No manufacturer desires to have a message like the following associated with its product: “Safety is a concern for users of these products. The Food and Drug Administration and the manufacturer both advise consumers to discontinue their use immediately.”

One of the more recent recalls focused on a dietary supplement that contained undeclared prescription drug ingredients. The presence of these drugs was detected through an accredited state-operated laboratory using validated analytical procedures with calibrated instruments and technically competent analysts. Since the December 1999 approval of ISO 17025—which outlines minimum standards for laboratory operations and quality practices—numerous laboratories have achieved accreditation.

In addition to accrediting laboratories, there is an active movement to certify dietary supplements, which would not be possible without the establishment of validated analytical methods and standardized reference materials. In August 2000, the U.S. Dept. of Health and Human Services issued a draft guidance document which outlined approaches to analytical procedures, reference standards, methods validation, and statistical analysis. Two years earlier, HHS had provided a guidance document calling for national uniformity for nonprescription, over-the-counter drugs. Dietary supplements are not considered drugs, but the principles of certification and uniformity of active and inactive ingredients are applicable and critical if the industry is to regain credibility among consumers and regulatory agencies.

The health-conscious, self-care consumer seeks the guarantee of product quality from the nearly $20-billion dietary supplement business. The 1994 Dietary Supplement and Education Act was a significant but small step toward guaranteeing quality of these products. It is noteworthy that infant formula is the only food that requires FDA registration of product and notification of adverse events. We may be approaching the time where such registration and adverse event reporting will be expanded to include dietary supplements. At this time, it is “buyer beware” when it comes to truthful product labeling and good manufacturing practices for dietary supplements, especially those containing herbal and botanical components.

Label truthfulness is only possible through thorough analytical analysis. The development and validation of appropriate analytical methods involve a significant investment by the industry in terms of time, treasure, and talent. Thus, several dietary supplement certifying programs have emerged. The United States Pharmacopoeia developed a Dietary Supplement Verification Program (DSVP), and Pharmavite, a leading dietary supplement manufacturer, was the first to participate in this program. Its products should display the USP DSVP mark on its approved Nature Made supplements by the end of this year.

The National Sanitation Foundation, founded in 1944 and originally focusing on certifying food equipment, subsequently became NSF International, which developed standards and certification for a diversity of food products, including dietary supplements. NSF assembled a scientific group from academia, government agencies, and manufacturers to develop certification standards for dietary supplements. In partnership with the National Nutritional Foods Association, NSF developed a comprehensive program in 2001 that focused on accuracy of product claims, potency, contamination from heavy metals, pesticides, bacteria, and suspected plant toxins. NSF maintains its own ISO 17025–certified analytical laboratory. Like USP, NSF may award its logo to certified products.

These organizations’ laboratories have been thoroughly audited and certified. They incorporated the rigorous ISO 17025 standards and those outlined by the American Association for Laboratory Accreditation, which promotes competent testing through quality laboratories in a variety of areas, including food and dietary supplement analysis.

Dietary supplements are complex nutrient and non-nutrient delivery systems. Consumers assume that the purity, accuracy, and quality are not compromised. Yet, without established and enforced good manufacturing practices and the implementation of validated analytical methodology in certified laboratories, the expected quality attributes are but a game of hide-and-seek.

Contributing Editor
Director, Analytical Research Laboratory
USC School of Pharmacy, Los Angeles