One of the most persistent myths promulgated by the media and other parties is that the herb and dietary supplement industries are not regulated. While people can argue whether federal and state regulatory agencies adequately or uniformly enforce all existing laws and regulations, an objective view of the situation leads only to the conclusion that the industry is indeed regulated. Consider the many authorities for the regulation of herbs and other dietary supplements and their ingredients—from Good Manufacturing Practices to limits on products’ claims, and much, much more.

In 2000, Bill Soller, then senior vice president of science and technology at the Consumer Healthcare Products Association—the trade association representing the over-the-counter drug industry, including some companies that make dietary supplements—wrote an article for HerbalGram 49 on the “Myth of the Unregulated Industry.” Curiously, 12 years later, many media outlets, legislators, healthcare professionals, et al., continue to mindlessly parrot the inaccurate mantra that the industry is “unregulated.” Dr. Soller, now executive director of the Center for Consumer Self Care at the School of Pharmacy at the University of California - San Francisco (UCSF), has teamed up with a leading supplement industry attorney and herb industry veteran, Holly J. Bayne, as well as UCSF pharmacy graduate student Christopher Shaheen to provide extensive and compelling evidence confirming that herbs and dietary supplements are sold in a highly regulated market. This article has been carefully peer reviewed by 7 experienced legal experts in the area of food and drug law.

More on the regulatory front this issue: We provide a comprehensive overview of how various trade organizations in the dietary supplement industry in the United States—as well as nonprofits and others—have responded to the US Food and Drug Administration’s (FDA) highly controversial draft guidance document on New Dietary Ingredients. In ABC’s comments to FDA, we proposed the official recognition of a list of so-called Old Dietary Ingredients (ODIs) to help reduce confusion in this area and the creation of a committee of herb industry and appropriate science experts to revise the existing consolidated ODI list so that it can be granted official status.

In the past few years I have given about a dozen lectures about herb adulteration during which I discussed what I thought was a bygone occurrence: the adulteration of skullcap (aka “scullcap”) with germander—only to learn this summer that a new analysis of commercial “skullcap” products shows that some still contain the potentially hepatotoxic germander. We invited Steven Foster, an expert on this subject, to write a review of the situation. It was he who wrote a short, one-column news item published in the Fall 1985 issue of HerbalGram warning the industry of this problem. Unfortunately, it still persists. His article is another installment in the ABC-AHP-NCNPR Botanical Adulterants Program (the first being Steven’s feature, “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs,” which appeared in our last issue).

And, speaking of herb identification and quality control, in this issue we also present a brief article reviewing the educational resources available to distinguish between Chinese star anise and its occasional adulterant, Japanese star anise, which has been documented as causing adverse neurological events such as seizures.

In our Research Review section, we summarize numerous recent clinical trials of note, including one sponsored by the food conglomerate Unilever, which reported that a hoodia extract did not produce clinically positive benefits for weight loss and also revealed some potential safety concerns, thereby dashing the company’s plans to develop a functional food with this formerly “hot” (in the market sense) African herb.