Dietary Supplement Quality: A Complex Situation

By Mark Blumenthal, Founder & Executive Director, American Botanical Council; Editor, HerbalGram and Jana Hildreth, CEO and Technical Director, Blaze Science Industries LLC

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With all the recent negative press surrounding the quality of dietary supplements, it is no wonder that consumers are confused on how to select a product amidst the vast sea of brand names, formulations, and price tags claiming to deliver the same health benefit. As the founder and executive director of a nonprofit devoted to medicinal herb education and the CEO of a company involved in the testing of dietary supplements, respectively, it is not uncommon for consumers to ask us: "What herbs and brands of supplements do you take or recommend?"

Unfortunately, even with our expertise, neither one of us can come up with a simple answer to this extremely loaded question. Telling people to use "trusted brands" is often of little or no help when trying to assist them in identifying reliable and high-quality supplements.

 

The Good News: FDA Issues Good Manufacturing Practices

In 2007, the US Food and Drug Administration (FDA) finally published its long-awaited Current Good Manufacturing Practices (cGMPs) for dietary supplements. These cGMPs essentially provide supplement manufacturers with the rule book that they must all follow as of June 2010.

The new cGMPs are a welcome development. Their publication has been hailed by responsible members of the herbal and supplement community as an important milestone to help ensure that consumers have access to high quality products.

Some members of the herbal and supplement community, however, believe that the cGMPs do not go far enough in ensuring the quality of raw ingredients (especially herbs) and finished products. They believe that more visible evidence of quality control compliance is needed. (A review of the FDA's cGMPs on dietary supplements is available here.)

Third-Party Verification Programs

Well before the FDA issued its cGMPs for dietary supplements, there were concerns surrounding the quality of dietary supplements. As a result, several third-party organizations have emerged over the past 10 years offering certification and verification programs to supplement ingredient and product manufacturers. These programs fall in to 2 main categories: (1) facility certification, wherein the third party inspects and approves the company's factory, and (2) product/ingredient verification, in which the third party verifies the product's label through testing of the material inside the package. Once a company has been approved by such a group, they are given permission to use the group's "mark" or "seal" on its product in hope of increasing consumer confidence in the brand. The 4 main groups currently offering this kind of a third-party certification are: ConsumberLab.com, the Natural Products Association, NSF International, and the United States Pharmacopeia. An overview of these programs is available in an article in the American Botanical Council's peer-reviewed journal HerbalGram, available here.