Drug Regulation

Today in the United States, herbal products can be marketed only as food supplements. An herb manufacturer or distributor can make no specific health claims without FDA approval.

Two features of European drug regulation make that market more hospitable to natural remedies. First, it costs less and takes less time in Europe to approve medicines as safe and effective. This is especially true of substances that have a long use history and can be approved under the "doctrine of reasonable certainty." European guidelines for the assessment of herbal remedies follow up on WHO’s Guidelines for the Assessment of Herbal Medicines, which state that a substance’s historical use is a valid way to document safety and efficacy in the absence of scientific evidence to the contrary.

France, where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. Germany considers whole herbal products one active ingredient; this makes it simpler to define and approve the product. The German Federal Health Office regulates products such as ginkgo and milk thistle extracts so that potency and manufacturing processes are standardized. England generally follows the rule of prior use; that is, years of use with apparent positive effects and no evidence of detrimental side effects constitute enough evidence---in lieu of other scientific data---that the product is safe.

In Japan, China, and India, patent herbal remedies composed of dried and powdered whole herbs or herb extracts, often in tablet form, are the rule. Traditional herbals are the backbone of China’s medicine. Japan’s traditional medicine, kampo, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese folklore. Herbal medicines are the staple of medical treatment in many developing countries and are used for many types of ailments.

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