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.

Brazil, Asia Also Offer Potential Models

Another good example of a new regulatory framework is the Brazilian law re­garding the regulation of phytomedicine registrations, which came into effect at the beginning of this year. It defined two types of possible registrations, new phytomedicines and traditional phytomedicines. While new phytomedicines require their own safety and efficacy data in addition to the quality dossier, traditional phytomedicines need only a quality dossier about raw material, standardization, stability, etc., but no pharmacological, clinical or safety studies.

They have to prove safety and efficacy based on published literature, however, and here the Brazilian regulators have created an interesting system, which requires six points from different literature sources to be compiled. Three points are received for Commission E, ESCOP or WHO mono­graphs, two points are earned for the American or British Herbal Pharmacopoeia and others, while the PDR for Herbal Medicines, etc. earns one point and other individual publications earn half a point.

In many Asian countries we have comparable regulations, which take the tradition of use of herbal products into account, with the addition of a good quality dossier, but not requiring full safety and efficacy data on each product.

The question is whether such an approach would also be appropriate for the U.S. to improve the status of botanical products, get better recognition from pharmacists and physicians, be able to make a mild medical claim and guarantee good quality of the products.

All company initiatives to self-regulate the quality of their products are very supportable, but an additional category of traditional medicines for those products that want to make a medical claim might be a new direction to bring further growth into this frustrated market.

NW

Joerg Gruenwald, Ph.D., is president of Phytopharm Consulting, Institute for Phytopharmaceuticals, a consulting company for herbal medicines and dietary supplements, specialized in international alliances, product and partner findings for new product development and regulatory advice worldwide. He is also the author of the PDR for Herbal Medicines. Dr. Gruenwald can be reached at Waldseeweg 6, D-13467 Berlin, Germany; 49-30 4000 8100, Fax.: 49-30 4000 8400; E-mail: jgruenwald@phytopharm.org; Website: www.phytonet.com.