Implementing safety and efficacy regulations

In view of the enormity of the task of evaluating the safety and efficacy of all these products, the Federal Food and Drug Administration turned for help to the Division of Medical Sciences of the National Academy of Sciences—National Research Council. They proceeded to organize a drug efficacy study that began work in 1962. After a long series of preliminary investigations that lasted until 1969, seventeen panels, each of which con- cerned itself with a different therapeutic class of drugs, were formed in 1972 to examine over-the-counter (OTC) drugs. This is the category in which most herbs and herb products were found.

The panels did not utilize all sources of information because some, such as patient testimonials, anecdotal experiences of physicians, and mar- ket success of the product, were considered unreliable. Instead, they relied primarily on in vitro tests (studies not conducted in patients or whole animals) and on various kinds of clinical or patient trials. The panels

Appendix: The herbal regulatory system 225 themselves did not conduct these studies but, rather, evaluated informa-

tion supplied to them by organizations interested in marketing the drugs. It was obviously impossible to examine the approximately one-third of a million drug products in the OTC category, so evaluations were lim- ited to the active ingredients in them. Because of the paucity of information resulting from in vitro tests or clinical trials with herbs, the panels were asked to evaluate a relatively small number of such drugs for specific indications. In addition, most of them had apparently been grandfathered under both the 1938 and 1962 acts and were considered immune from the effective requirements implemented at the later date.

FDA’s herbal regulatory initiative

Nevertheless, the FDA undertook the regulation of herbs by what can only

be termed an extremely innovative application of administrative law. The agency simply declared that any of the grandfathered drugs would be considered misbranded and subject to confiscation if any claims of efficacy were made for them that were not in accordance with the findings of one of the seventeen OTC drug evaluation panels. Thus, it became pos- sible to sell the products only if no claims or statements regarding their value in the prevention or treatment of disease were made on the label. The word label was very broadly defined to include not only the words on the package but also those on any accompanying literature, such as a package insert. In this way, herbs were effectively prevented from being marketed as drugs.

Results of the FDA study of OTC drugs were released to the public in the spring of 1990. 4 Although some of the herbs, including cascara bark and senna leaf, were found to be effective as laxatives and initially placed in category I, some 258 nonprescription drug ingredients, many of them herbs, were not so judged. Of these, 142 were categorized as unsafe or ineffective (category II), and there was insufficient evidence to evaluate the effectiveness of the other 116. These were placed in category III. Again, the panels made these judgments on the basis of evidence submitted to them by the industry.

Implementing safety and efficacy regulations