Third-party certification programs for dietary supplements, recently launched and competing for marketplace dominance, have the industry buzzing with questions such as: What prompted the programs? Who sponsors them? How do they compare? How will they shake out in the future?
The Natural Foods Merchandiser interviewed representatives from certifying organizations and industry trade groups for some answers.
Certification programs have surfaced to fill the gap left by the Food and Drug Administration's tardiness in creating Good Manufacturing Practices, as required by the 1994 Dietary Supplement Health and Education Act. The agency proposed the GMPs but is far from making them final.
"With the current regulatory status," said Susan Winckler, spokeswoman for the American Pharmaceutical Association, "questions have been raised as to whether the dietary supplements contain what they are supposed to ... are contaminated ... disintegrate the way they are supposed to."
Forouz Ertl, a U.S. Pharmacopeia vice president, said, "I have worked in the dietary supplements industry for 13 years and have seen the loss of confidence in quality and label accuracy in the minds of consumers in the last few years. Even core consumers for dietary supplements became very confused about which products they can trust."
Sponsors of third-party certification for dietary supplements are Rockville, Md.-based USP, NSF International (originally the National Sanitary Foundation) of Ann Arbor, Mich., and the National Natural Foods Association, all nonprofit organizations, plus ConsumerLab.com, of White Plains, N.Y., which operates for profit. All except ConsumerLab.com have GMP requirements, and they take FDA's proposals into account.
USP is the oldest of these organizations and has the longest track record in dietary supplements. From its birth in 1820, it has established standards for natural medicines such as chamomile, ginger and valerian, as well as prescription and over-the-counter medicines and health care technologies. Covering identity, strength, quality (e.g., disintegration of the tablet or capsule) and purity, USP specifications are created in consultation with experts in industry, medicine, academia and science and are published in the United States Pharmacopeia and National Formulary, which are official national compendia recognized in the Food, Drug and Cosmetics Act and in DSHEA.
The USP dietary supplements certification program, after a pilot run beginning in February 2001, went national in October. The USP process starts with GMP inspections and company record audits. In addition, randomly chosen product samples are analyzed to confirm that they contain what the label declares and do not contain heavy metals, pesticides or pathogenic organisms beyond acceptable limits. Products to be tested are named by the company, and those that pass bear the USP certification seal. Finally, postmarketing surveillance assures products remain in conformity.
NSF International has been in the certification business since 1944, when it began with food equipment products. It now provides testing and auditing services for more than 130,000 products in 82 countries. Less than a year ago, at the request of the industry, NSF began to confer with company- and trade-group representatives, plus other experts, on how to design a dietary supplements certification program, said Kathleen Pompliano, manager of new business development. The result, much like USP's program, pertains to products named by a company and features plant inspections, GMP standards, records audits, analyses to verify label contents and the absence of contaminants, and postmarketing checks. NSF so far has announced certification for five Nutrilite products.
In November, NSF formed a strategic partnership with the NNFA, which in 1999 had initiated a GMP certification program based on inspections of plants and plant records, but that excluded finished-product testing. Under the alliance, the partners retain their independent stand-alone programs, but NSF adopts NNFA's GMP standards and NNFA relies on NSF for product testing, explained NNFA Director of Communications Tracy A. Taylor.
ConsumerLab.com does not go into the manufacturing plant nor does it review company records. ConsumerLab.com President Tod Cooperman, M.D., said, "Though GMPs are useful, they do not guarantee a good product." His company's focus is on the finished product. Competing items of many makers are purchased in stores and evaluated to see whether the contents meet label claims, whether there are contaminants, and how they degrade or dissolve. ConsumerLab.com decides which products to test, and results (except names of failures) are posted on its Web site. After publication of a review, any manufacturer can ask to have its comparable product looked at, and if it passes, it will be added to the Web site list. (Samples of this product also are bought at retail.)
ConsumerLab.com offers a seal to companies willing to enter a licensing agreement on how to use it. These licensing agreements are one source of income. Another is technical reports revealing, among other things, names of products that have passed and failed, although failed products of a manufacturer participating in the program are not revealed.
"We have evaluated the top 20 types of dietary supplements sold in the United States, which represents more than 85 percent of U.S. dietary supplements sales [since 1999]," Cooperman said. The latest review covered 20 brands of fish oil supplements, for which no mercury contamination was reported, but six of which had inadequate amounts of the essential fatty acid DHA.
Is one dietary supplements certification program best? No one will say.
At the Washington, D.C.-based Council for Responsible Nutrition, whose members have worked with USP and NSF to create their programs, Vice President John Cardellina said, if a member company were "only interested in having the finished products checked, I might tell them ConsumerLab may be time- and cost-effective. But if they are thinking ahead to compliance with GMP practices and checking their products more broadly, [let] USP and NSF do the analyses."
Similarly, the Silver Spring, Md.-based American Herbal Products Association and Consumer Healthcare Products Association of Washington, D.C., have worked with USP and NSF on their programs, and neither association endorses one over the other. AHPA Vice President of Scientific and Technical Affairs, Joseph Betz, Ph.D., said USP is well recognized among pharmacists and physicians and has expert committees on certain supplements, but is new to certification. In contrast, NSF has certification experience, but is new to dietary supplements. "It depends on the needs of each company," he said. "It's not a one size fits all approach."
Will different certification programs and a variety of seals end up adding to consumer confusion? Almost everyone interviewed foresaw that possibility, especially as the sponsoring organizations gear up publicity and public relations campaigns.
Looking ahead, will one become dominant? It's been suggested USP, because of its experience setting dietary supplements standards, may have a leg up. CRN's Cardellina notes that the USP and NSF procedures are evolving, and each may go in a different direction as they are fine-tuned.
Goody L. Solomon is executive editor of Food Nutrition Health News Service in Washington, D.C.
Natural Foods Merchandiser volume XXIII/number 1/p. 13