Reaction to FDA’s herb regulations

Reaction of the herb industry to the FDA’s stricture on therapeutic labeling of products judged ineffective by the panels took a variety of forms. Some herbs were no longer marketed. Others continued to be sold as before, apparently in the hope that an underfunded and overworked FDA might overlook, at least for a while, some of the infractions. But the most frequent course of action was simply to remove the offending information from the label and to market the product as a food, nutritional supplement, or, in

226 Appendix: The herbal regulatory system some cases, a food additive. Unfortunately, this left little more on the label

than the name of the herb; however, a vast literature (often laced with hyperbole and inaccuracies) was available to the consumer—ostensibly to supply product information but mostly intended to promote sales.

For some time, the FDA has maintained a list of substances “generally recognized as safe”—better known in the trade as the GRAS (generally recognized as safe) list. 5 About 250 herbs appear on this list, primarily based on their culinary use as food—that is, as flavors or spices in the culinary arts and the beverage industry. Some of them, such as ginger and licorice, are also employed for their medicinal action. Obviously, if a plant material is simply labeled “ginger,” it is impossible to know whether it will be used as a flavoring or as a medicine (e.g., to prevent motion sick- ness). In some cases, ginger from the same package possibly would be used both ways.

The FDA formerly maintained two other lists in addition to the GRAS list. These were “herbs of undefined safety” and a list of twenty-seven “unsafe herbs.” Both were flawed by inappropriate inclusions, and both were discarded in 1986 when the FDA updated its Compliance Policy Guidelines on the safety of food additives. The policy then called for herbal safety to be

determined on an ad hoc basis, usually following a consumer complaint. 6 There is now no FDA compilation of unsafe or possibly unsafe herbs, but sometimes examples on these older lists are referred to in the literature.

One action that was never taken by members of the herb industry was to prove their products safe and effective and to market them as drugs. The reason for that was money; the costs involved are extremely high.

A 1990 report by the Center for the Study of Drug Development at Tufts University placed the average cost for developing a new drug at $231 million and the time involved at twelve years. 7 While these figures might well

be double that required for a traditional herbal remedy, the figures of $115 million and six years are still excessive. This is particularly true considering the difficulty of obtaining a patent, as well as the exclusive marketing rights it affords, on a traditional drug that may have been used for centuries, even millennia. Unless a novel chemical entity is involved, the likelihood of patent protection is slim, and the capital investment required will likely never be recovered.

Reaction to FDA’s herb regulations