Finding and Recommendation 6
Little Hover Commission 2004
Regulation of Acupuncture: A Complementary Therapy Framework
Finding 6:
The California Acupuncture Board has missed significant opportunities to protect the public, particularly in the areas of consumer information and herb-related safety.
Many of the specific issues that the Governor and the Legislature asked the Commission to review have festered because the Acupuncture Board too frequently acted as a venue for promoting rather than regulating the profession. As a result, the board has missed opportunities to protect the public by providing accurate and complete information about the therapies that licensees can provide. The board also has not adequately incorporated emerging scientific evidence into board policies, regulations and public communications.
One critical example is the board's presentation of the scientific evidence regarding the efficacy of acupuncture. The National Institutes of Health found that acupuncture needle therapy is effective for "postoperative and chemotherapy nausea and vomiting and postoperative dental pain." However, the Acupuncture Board's Web site, fact sheet and consumer brochure implies efficacy for a broader range of ailments. Moreover, those materials do not provide cautionary information to consumers about the limits of what may be expected from traditional Oriental medicine, the need to coordinate with MDs, or how to go about selecting a qualified practitioner.
Also, the NIH in 1997 recommended shifting to the use of single-use needles by acupuncturists instead of following the older practice of sterilizing equipment between uses. This is in part due to the evolution of AIDS and antibiotic-resistant bacteria that can be life-threatening. FDA requires that acupuncture needles be labeled as single use only. However, in California, regulators have not required exclusive use of single-use needles and the law has not been updated to incorporate this fundamental public safety measure.
Much greater attention also needs to be placed on the portion of the scope of practice related to prescribing herbs. These substances are not regulated for purity, potency or effectiveness by the federal Food and Drug Administration nor California authorities. This issue extends beyond the purview of California regulators, and beyond the regulation of this profession. However, since California includes herbs in the scope of practice for acupuncturists, regulators are obligated to take the actions that are within their purview to protect the public.
Herb-drug interactions pose an increasing risk to the public that was not present when ancient herbal practices were developed. Further, in California, herbs from around the globe are used, posing further risk of herb combinations that were unknown in ancient Asian practice, but can result from the intermingling of healing practices.
Recommendation 6:
The Governor and the Legislature, through the Sunset Review Process or other mechanisms, should ensure that the California Acupuncture Board becomes a strong advocate for consumers. Among the steps that should be taken:
- The board needs to develop a patient safety strategy. This strategy should ensure that federal recommendations for improving patient safety -for instance, the exclusive use of single-use needles are quickly adopted in policies, examinations and written materials such as the consumer brochure. The California regulator could be required to submit, as a regular part of their sunset review, or annual report, what their compliance is with federal recommendations along with new research findings from the NIH. The board should study malpractice trends and publish the results. California regulators also should bolster efforts to work with individual practitioners and clinics to ensure ongoing compliance with evolving consumer protection laws.
- Develop consumer protections for herb products. California should empanel legal and scientific experts to explore herb-drug interactions, herb purity and potency, accurate labeling, and reporting of adverse effects. The panel should identify regulatory and other policy steps the State could take to protect consumers.
- Restructure the regulator to benefit consumers. If policy-makers believe a board is desirable, the majority of the members should not have an economic interest in acupuncture. They should include consumers as well as experts in infection control and research methodology. And the regulator should develop standing advisory panels that are more representative of the various cultures throughout the world that are integrating traditional Oriental medicine into health care and regulatory schemes.