On December 7, 1999, the U.S. FDA reclassified the status of acupuncture needles from class III (investigative devices subject to investigative device exemptions...) to class II (special controls). "The classification regulation (21 CFR 880.5580) for solid, stainless steel, acupuncture needles requires that these class II devices must comply with special controls for single use labeling, prescription labeling, biocompatibility, and sterility." Since that time, acupuncture needles have been available to "qualified practitioners" without prescription through distributors throughout the United States. The FDA allows individual states to regulate the sale and distribution of medical devices as they see fit. However, the FDA gives no specific direction regarding the distribution of acupuncture needles.
In February 2015, the California State Board of Pharmacy (CA B of P) started to enforce their interpretation of Business and Professions Code Sections 4160 and 4161. They have taken the unique position that all companies distributing acupuncture needles in their state must possess a California pharmacy license, even if the distributor is not located in California.
No other state besides California has so far chosen to specifically regulate the sale and distribution of acupuncture needles. Agents of the CA B of P visited offices of companies that supplied acupuncture needles and compelled them to stop all of their needle sales in California until they received a Board-issued pharmacy license. They required immediate Cease and Desist of distribution, shipping, mailing and/or delivering dangerous drugs and devices, into California until the Board-issued license was received, without due process and without notice.
The application is appropriate for interstate pharmaceutical companies, but not for small suppliers of acupuncture needles. The process takes six months or longer from start to finish and requires companies to:
Because of the arduousness of the application process, many of the FDA registered Chinese herbal supplement suppliers have stopped offering acupuncture needles to their LAc customers. If the goal of the interpretation of Business and Professions Code Sections 4160 and 4161 is to limit the number and scope of suppliers of acupuncture needles to California licensed acupuncturists and increase the costs to these health care providers and the public, they have succeeded.
It would be appropriate for the CA B of P, if they continue to license companies that distribute acupuncture needles, to design a process appropriate for these kinds of business that have no intention to distribute Pharmaceutical products. Does any attempt by the Board to regulate the sale of acupuncture supplies into California by out-of-state suppliers violate the Interstate Commerce Clause of the U.S. Constitution?
Unfortunately, there have been advertisements sent to LAc's in California that give the impression that the CA B of P is hunting for them, with imagery of an officer taking someone away in handcuffs. While we are not attorneys and are not able to give legal advice, this was an obvious self-serving opinion of one California wholesaler and not, we believe, the intent of the CA B of P.
Questions to persons interested in the future profession of acupuncture and Oriental medicine:
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When the body is going through a stressful event, the sympathetic system is activated. This activation will help the body with a life-threatening situation. If this state is activated for prolonged periods of time, it starts to consume energy. These traumatic events that generate stressors in the autonomic nervous system (ANS) will eventually become internalized.
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One of the things that makes acupuncture so difficult to measure is that the medicine actually does contain some esoteric aspects. There have been numerous studies that demonstrate the neurochemical reasoning behind why acupuncture points stimulate the autonomic nervous system to enact change However, not all the benefits of TCM can easily be measured by randomized, controlled trials. But does that make them fundamentally and definitively untrue?
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