FDA on Herbal Medicine

Herbal practitioners should be aware that the FDA has been actively working to establish regulations for the distribution and use of herbs and herbal products in this country. They issued their "Final Rule" on June 22, 2007, establishing cGMP (Current Good Manufacturing Practice) guidelines for dietary supplements. The stated intention of this regulation is to assure the quality and safety of supplements and herbal medicines.

Organizations such as the AAAOM (American Association of Acupuncture and Oriental Medicine) and AHPA (American Herbal Products Association) support that goal to ensure that herbs and herbal products do not contain contaminants, are accurately tested and labeled, and have adequate quality controls. They have also voiced their concerns that the regulations do not unreasonably restrict qualified AOM practitioners from offering herbal medicine to their patients. To this end, over the past four years, these organizations and others have engaged in a great deal of discussion, submitting comments and recommendations to the FDA to make sure that the particular training and use of herbs within the AOM profession was fully understood.

Much of the resulting document from the FDA consists of requirements for the manufacturing of herbal products, such as the packaging, labeling, and storing of dietary supplements, as well as quality control procedures, design and construction of manufacturing plants, product testing, evaluation and record keeping.

How the Regulations Affect AOM Practitioners

The following is a brief synopsis of the main points of the Final Rule that more specifically affect AOM practitioners who use Chinese herbs in their private practices:

• Practitioners that resell prepared herbal products (pre-packaged or patent formulas) to their individual patients will not be affected by these regulations (as long as they hold or store these products in their office or retail establishment, not in a warehouse or storage facility, or sell directly from a warehouse).
• Practitioners who maintain an herbal pharmacy and prepare individualized formulas are engaging in "manufacturing", as defined by the FDA, and are subject to the regulations stated in the Final Rule. The FDA states in the preamble to the Rule that it may enforce its ruling in favor of "herbalists, acupuncturists, naturopaths and related health care providers" under certain circumstances and that a "one-on-one consultation by a practitioner adequately trained in their profession may not necessitate the same type of controls as we are establishing in this final rule for manufacturing activities on a larger scale”. They went on to state: "We believe that it would be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis, to determine whether to apply the requirements of the final rule to such persons".
• The AAAOM states: " The FDA is retaining its right to enforce the requirements, while also saying it will consider not enforcing the requirements against these practitioners. While we would prefer that qualified practitioners were fully exempt in these situations, we understand that without any clear guidance distinguishing small from large scale manufacturers, it would be difficult to grant such an exemption."
• The Final Rule states: "Many products that are manufactured by practitioners would not necessarily be considered to be dietary supplements (e.g. certain products used by Traditional Asian medicine practitioners)” and so are not subject to the Final Rule regulations. It is unclear what is meant by this and which herbal products are considered to be "dietary supplements". The AAAOM is working to clarify this statement.

Do We Need To Be Concerned?

John Scott, of Golden Flower Chinese Herbs and a working member of the AAAOM Executive Herbal Medicine Committee, encourages: "In order to genuinely make Chinese herbal medicine more readily available to ourselves as AOM practitioners and to the public, it is advisable to create a separate regulatory category from drugs, food, cosmetics, and supplements. In the European countries, the EU has created a legal designation for herbal products called Traditional Medicine that is separate from the pharmaceutical category. If adopted here, this would be a great step in creating recognition for Chinese herbal medicine as an accepted healing modality. Until we complete this process of creating a level of Chinese herbal products specifically to be used by practitioners, we will be subject to all of the rules of the supplement category. We believe that as practitioners of an herbal medicine that has a documented 2,000+ years of efficacy, we must differentiate ourselves from the products that are available over the counter in health food stores and on the internet. Creating a Traditional Medicine category for Chinese herbs is a way to do this."

The Final Rule takes effect June 2010 for those who have less than 20 employees, and at that time will be applicable to all practitioners and educational institutions. We strongly encourage practitioners who use herbs in their practices to stay informed and involved in this process in order to advocate for the reasonable regulation of our profession. The AAAOM is our national organization working to ensure fair and positive legal status for our profession. Their website is www.aaaom.org. Please consider supporting this work with your membership.

Link to the Final Rule can be viewed at:

http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
Enter docket number "96N-0417" in the search field.

You may also visit the FDA website at www.fda.gov.