Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms

Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.
Jul 01, 2009

Traditional Chinese Medicine (TCM) is a collection of medical practices grounded in observational theory that originated thousands of years ago and continues to be widely practiced in China, among emerging populations and, increasingly, around the world. TCM is complex, in part because it is derived from physical, philosophical, cosmological, environmental, and cultural elements, as well as aspects of indigenous religion. Practices associated with TCM include acupuncture, massage, dietary therapy, and herbal medicines.

TCM faces regulatory challenges in the US and Europe. Regulatory options are available, and the US Pharmacopeial Convention (USP) and other international standards-setting bodies hope to develop compendial standards for discrete ingredients used historically in TCM. A portion of the USP annual scientific meeting held with the Chinese Pharmacopoeial Commission (ChP) in Tianjin, China, Nov. 6–7, 2008, addressed TCM and the opportunities for various Western compendia to include TCM ingredients in healthcare paradigms. This article focuses on herbal and botanical materia medica, drawing on presentations made at the meeting.

Regulatory options

TCM is espoused by the Chinese government; it is taught within dedicated TCM colleges and universities, practiced by TCM physicians, managed by TCM hospitals, and widely used by the Chinese populace. The singularly defined, authenticated ingredients that make up the complex TCM mixtures compounded by the practitioner for the patient fit into four categories recognized by the US Food and Drug Administration: pharmaceuticals, dietary supplements, foods or food ingredients, and cosmetics.

Options for incorporating TCM into US regulations are defined and, thus, may be viewed as restricted. The first limitation is that the herbal ingredient must be approved or allowed as a singular ingredient. Mixing and compounding can be performed but only with a defined set of approved (i.e., safe, singular) ingredients. The second limitation is how to regulate TCM. If one accepts the TCM assertion that an ingredient is curative or disease- or condition-preventive, then TCM immediately falls under applicable FDA drug regulations.

Although one might contend that FDA regulations are designed for recent allopathic drugs (synthetic chemically purified moieties), it is important to remember that the US has a 200-year history of standardizing drug products. The original USP of 1820 contained mostly botanically based decoctions, extracts, infusions, and tinctures (1). Improved opportunities have arisen for the development of botanical drugs.

In the US and Europe, the development of a drug (purified and/or botanical ingredients) must take place according to the paradigms of allopathic drugs. The prevailing US regulatory model is expensive and time-consuming, requiring many years of studies.

Manufacturers have concerns about patent protection and marketing exclusivity for finished TCM ingredients that undergo drug regulatory submission. Two regulatory alternatives may help resolve these issues: Treat the TCM ingredient as a dietary supplement or treat it as a food ingredient (most likely a functional food).

Food petitions and affirmations

In the US, food ingredients, functional or otherwise, must undergo one of two processes: the FDA-centric food additive petition (FAP) path or the more expedient and more cost-effective Generally Recognized as Safe (GRAS) affirmation path (2, 3). Opting not to submit an FAP would be in most manufacturers' best interests unless FDA or legal counsel requires doing so.

As is the case with drugs, FAP is a process that requires intensive safety testing and time- and money-consuming activities. The GRAS route affords the same level of acceptability for sales by manufacturers, use by end-product formulators, and consumer accessibility. GRAS certification can be based strictly on a vendor's self-affirmation and demonstration of safety. The latter are privately shared between the company or organization making the affirmation and the eventual user of the ingredient. A GRAS notification to FDA is optional and often of value to both selling and buying parties because it suggests that FDA does not disapprove the GRAS conclusion.

TCM's singular botanical ingredients, or, more likely, standardized extracts from singular botanical ingredients, are likely candidates for the GRAS process. Safety is fundamental and is demonstrated by appropriate animal studies linked to likely exposure scenarios and public acceptance, i.e., the general recognition, via peer-reviewed publications of the pivotal safety data. Many innovative companies are diligently developing safety packages for standardized botanical ingredients as they move toward GRAS affirmations and notifications (e.g., baby kiwi [Actinidia arguta], spirulina [Arthrospira platensis]) (4).