Regulating Botanicals As Traditional Medicinal Products
New international trend may provide chance for further growth in the U.S.
By Joerg Gruenwald
The stagnation of the American market of botanical/herbal products has many causes—negative press, insufficient backup from physicians and pharmacists, partially inconsistent quality and missing education of the consumers.
In contrast to most international markets, herbals are regulated as dietary supplements in the U.S. compared to different regulatory systems internationally, giving botanical products some form of a drug status. Table 1 compares the market in Germany and the U.S., indicating that the U.S. market has further growth potential, but requires a number of changes over time.
In between these extremes—the full drug status in Germany and the dietary supplement or food-like status in the U.S.—there are several international approaches for harmonization of herbal products in a lower drug category based on their traditional use. In Europe a recent draft of the European Commission proposes to introduce a Directive of Traditional Medicinal Products, which shall become the basis for national regulations and registrations in the European member states. This draft requires the botanical to have been marketed for a period of at least 30 years and that the registered product should include the same ingredient, should be used for the same reason in equivalent dosage and with the same route of administration. Such a registration requires pharmaceutical data regarding the quality, but not safety or efficacy.
Much discussion will be needed before this Directive will become law. Open questions include whether tradition in one member state is sufficient for all of Europe or only for a national registration, whether 30 years are really required or if 10 years would be enough and where the borderline is between traditional herbal medicinal products and those with well-established use, which are usually also based on bibliographic data.
In Europe in the long run we expect to see four or five categories of how botanical products can be regulated. Table 2 indicates those groups and the potential claims that can be made.