by Mark Blumenthal and Daron Watts

On March 7, 2003, the U.S. Food and Drug Administration (FDA) issued its long-awaited proposed current good manufacturing practices (cGMP) regulation for herbs and other dietary supplements. The proposed regulation is posted on the FDA website at <http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.pdf>. The 547-page document was published in the Federal Register on March 13, 2003.¹

Industry groups unanimously greeted the publication of the GMPs with a sense of relief, although many leaders reserved final evaluation until they could wade through the massive document and receive comments from member companies (see Industry Repsonse below).

Upon publication of the proposed regulation, the FDA issued a press release that quoted U.S. Health and Human Services Secretary Tommy G. Thompson as saying, "Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels. Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products theyre paying for."

FDA Commissioner Mark B. McClellan, M.D., Ph.D., also was quoted, "This proposed regulation is another major step in our efforts to help Americans take more control over their own health. Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting. This proposed regulation would require that dietary supplements provide accurate information on the type and amount of ingredients they contain and that dietary supplements are produced using safe methods. Consumers should have access to dietary supplements that are accurately labeled and are free from contaminants."²

FDAs press release also contains a statement that experienced industry observers consider misleading, perhaps untruthful, "The proposed rule would, for the first time, establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled accurately to reflect the active ingredients and other ingredients in the product." In reality, because dietary supplements are legally classified as food, they have been governed by federal GMP regulations for conventional foods since the passage of the Dietary Supplement Health and Education of 1994 (DSHEA).

The press covering FDAs publication of the proposed regulation spun the action negatively toward the industry, often suggesting that the agency was finally stepping in to regulate an "unregulated industry." This was due, in part, to the negative press that has plagued herbs in the past few years, some of it deservedly warranted based on egregious examples of inadequate quality control, adulteration or substitution of herbs, and, in some cases even the presence of prescription drugs in certain products sold as dietary supplements.^3,4

Some of the medias referencing of examples of adulterated and misbranded products came directly from FDAs own press release.² FDA included examples of tests of supplements that showed that products failed to meet levels of ingredients stated on labels. These examples included isoflavones on some soy bean (Glycine max (L.) Merr., Fabaceae) and red clover (Trifolium pratense L., Fabaceae) products.

The expressed views of FDA and the media are symbolic of public frustration with the manufacturing practices of some in this industry and the opportunity this proposed regulation brings for the industry to regain public confidence.

Statutory and Regulatory History

DSHEA limits regulation.