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.

It is important to note, however, that in order to participate in these programs, companies are required to pay a fee for the service. Consumers should therefore be cautioned against forming any inappropriate conclusions about companies that choose not to pay the fee and participate in such programs. Although the presence of a seal from a third-party verification program may indicate that a consumer can usually rely on the company and/or its products to meet certain base-line quality standards, the absence of such a seal does not suggest the opposite, because the companies must now follow the new cGMPs. Some companies, whether they are small, medium, or large, choose not to participate in third-party programs either because they do not want to incur the extra costs or because the company believes that their own internal quality control procedures are sufficient.

Economically Motivated Adulteration

As with all profit-driven businesses, one of the biggest problems responsible members of the dietary supplement industry face is the presence of fraudulent ingredients in the marketplace. The drive for companies to increase profits by demanding lower prices from their suppliers has led to an unfortunate outcome--a big incentive for substitution or addition of cheaper ingredients. The Melamine Pet Food Recall back in 2007, although not related to the dietary supplement industry, is a perfect example of this kind of adulteration and also illustrates the serious consequences it can have. The addition of melamine into protein ingredients for animal foods was not intended to harm animals. The material was chosen based on its ability to fool the existing test method for protein and thus create a false impression that the material was of high quality by artificially boosting the perceived protein levels of the ingredient.

Another, even more serious type of adulteration has been the addition of prescription drugs to products being touted as "all natural herbal blends."  This type of adulteration is intended to boost sales by offering a product that works as well as a prescription drug while pretending to be a safer, all natural alternative. Weight loss and performance-enhancement supplements are 2 types of products that have been found to contain undeclared prescription drugs. This practice is clearly fraudulent and illegal, and even though cases like this receive significant attention in the media, they do not represent the majority of dietary supplement products that are produced by responsible manufacturers who follow government rules and industry self-regulatory guidelines.

Conclusion

The issuance of the cGMPs, along with the third-party certification/verification programs and industry organization-promulgated self-regulatory trade practices, are signs that the reliable elements of the supplement industry are addressing issues surrounding product quality. It is up to consumers to educate themselves on the facts and issues surrounding herbal and other dietary supplements. Consumers use dietary supplements to help enhance their nutritional alternatives as well as for self-medication. And self-medication requires self-education.

For more information on herbal supplement safety:

US Pharmacopeia

National Library Medicine

National Institutes of Health National Center for Complementary and Alternative Medicine