FDA's GMPs for Dietary Supplements

President McGee Responds to the Membership

Dear AAAOM Members and Colleagues:

On May 4, 2007, the AAAOM sent you an Action Alert stating our position on the Food and Drug Administration’s (FDA) proposed regulations on Good Manufacturing Practices (GMPs) for dietary supplements. This proposed rule establishes the minimum GMPs necessary to ensure that dietary supplements are not adulterated or misbranded, and requires manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary supplements and ingredients.

Many of you have contacted us with concerns and questions about our position, including some state Acupuncture associations seeking to advise their members. We understand everyone’s confusion, because there has been a lot of conflicting, and in some cases, alarming statements being made on the internet about how these regulations may affect herbal practitioners. I would like to address your concerns and provide further details on this matter.

These proposed regulations apply to manufacturers and distributors. They are not targeted toward individual AOM practitioners, who are not typically engaged in manufacturing. When finalized, some of the provisions in these proposed rules will apply to a practitioner if he or she is manufacturing a prescription for a patient out-of-state or for another practitioner’s patient, or is manufacturing a prescription not intended for a specific patient. If a practitioner is making an out of state purchase, their supplier will need to comply with the GMPs.

When these proposed regulations first came out in 2003, the Acupuncture and Oriental Medicine Alliance (AOM Alliance) and the American Association for Oriental Medicine (AAOM) sent comments to the FDA. In the four years since then, there have been many discussions with the FDA and others on these proposed GMPs. We expect that the final regulations will be issued soon. Until then, any new requirements in the proposed regulations are not in effect. There are likely to be significant changes to the new regulations when they are issued and we will review these carefully once they are made public.

Dietary supplements are a multibillion dollar industry, of which only a very small percentage includes herbs, and only a small segment of the herbal market is served by TCM practitioners. The majority of our herb suppliers are from Japan, China and Taiwan, and most of these companies currently apply pharmaceutical-grade GMPs for TCM products. As a result, the FDA's proposed GMP guidelines on dietary supplements should not impose additional cost to these suppliers who are already in compliance with pharmaceutical GMPs. However, suppliers currently using lower quality ingredients and standards are likely to be affected.

The AAAOM had always supported standards and will continue to do so. As we stated in our previous letter, our goal is to develop policies that respect the need for public safety assurances, while limiting excessive regulatory burden to individual practitioners and suppliers of traditional Chinese medicinal herbs. Appropriate GMP standards can help to improve public confidence in using custom Chinese herb prescriptions.

The AAAOM has a very active Herbal Medicine Committee led by Christine Chang, DAOM, LAc, DiplOM, and includes both practitioners and suppliers*. They, along with other AAAOM Directors, have reviewed the proposed GMPs, which consists of over 200 pages of regulations. We will continue to monitor these and other regulations that may affect our membership, and if there are changes that you should be aware of, we will inform you immediately. We will also continue to work with the FDA and other regulatory agencies to ensure that the rights of appropriately trained practitioners to prescribe herbal medicines, and the rights of consumers to utilize herbal medicines that are safe and effective, is never compromised.

Sincerely,

Leslie McGee, RN, LAc, DiplAc/CH
President, American Association of Acupuncture and Oriental Medicine

*The Herbal Medicine Committee includes Christine Chang, Claudette Baker, Gene Bruno, John Chen, Bill Egloff, Dave Molony, and John Scott

__Dietary Supplements Good Manufacturing Practices (GMPs):
http://www.cfsan.fda.gov/~lrd/fr030313.html

A form for your feedback:
http://www.aaaomonline.org/interactive.asp?ID=11