Regulatory Issues in Complementary and Alternative Medicine (cam)
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Regulatory Issues in CAM
Current regulations for the use of Complementary and Alternative Medicine [CAM] within the United States vary from state to state. The Federal Government regulates dietary supplements through the U.S. Food and Drug Administration [FDA] and provides some oversight concerning use and safety of CAM (National Center for Complementary and Alternative Medicine [NCCAM], 2011). Traditional Chinese Medicine, Biofeedback, Aroma Therapy, the Alexander Technique, and Magnetic Therapy are forms of CAM that fall under NCCAM. Potential deficits and adverse outcomes that may occur within the current system include insufficient research as defined by the FDA. Proposals currently under consideration state that the FDA needs to regulate CAM modalities in the same manner as they do for traditional medication. This new program would improve consumer protection by making CAM meet the same rigorous standards as traditional medicine. Obstacles to this new plan for consumers may include an increased difficultly and expense in obtaining CAM products.
Traditional Chinese Medicine
Traditional Chinese Medicine [TCM] dates back 3,000 years. According to Britannica online “Chinese healers seek to restore a dynamic balance between two complementary forces, yin (passive) and yang (active), which pervade the human body as they do the universe as a whole” (NA, 2011, p. 1). Traditional medicine and Fontaine focuses on the breathing part of yin and yang because “oxygen is toxic to viruses, bacteria, yeasts, and parasites in the body and cancer cells find it more difficult to survive in an oxygen-rich environment” (Fontaine, 2005, p. 38). Another example of traditional medicine using TCM is anesthetics. A young surgeon Hua Tuo who helped soldiers during the wars is believed to have discovered anesthetics, his preparation of hemp and wine, alleviated pain in his patients (NA, 2011, Britannica Online p. 4).
Preventive treatment is the basis of TCM because as Britannica Online says actions such “persons who begin to dig a well after they have become thirsty” is pointless (NA, 2011, Britannica Online p. 3). Included in TCM is acupuncture, herbal remedies, qi (life force, or energy), and numerous other remedies and procedures. In a 1578 publication by Li Shizhen naming 1,892 drugs and 11,000 formal prescriptions shows how massive TCM is (NA, 2011, Britannica Online p. 1).
Biofeedback is a “therapeutic tool which provides physiological information in order to help individuals improve self-regulation skills” (Anderson, 2010, 6). Under the FDA, Biofeedback equipment falls under the Class II medical device regulation. “Class II devices are those for which special controls are considered necessary by the FDA for assuring safety and effectiveness and where there are existing methods for providing such assurances” (Sherman, 1994, para. 2). Selling biofeedback equipment without FDA premarket notification/approval is in direct violation of laws. Selling unapproved equipment to unlicensed health care providers is also a violation of law.
Biofeedback equipment under the FDA is “grandfathered” in as devices to promote relaxation. Once the FDA approves equipment and makes no specific conditions of claims for equipment such as the ability to cure anxiety, the manufacturer has avoided process governed in treating specific conditions. Biofeedback equipment is used for the treatment of many disorders. One way to regulate the process is to revise the “grandfather” equipment clause and require specifically of what use the devices will be treating. This will assist with improving the monitoring of equipment for safe consumer use. Some manufacturers go through the processes that others will still avoid, even though it reduces the legal risk of the company and protects the safety of the public and providers who use the equipment.
In general, there are no regulations or oversight, which exist in the United States for aromatherapy (National Association for Holistic Aromatherapy [NAHA], 2011). If no presentations or scientific evaluations with direct claims of medical benefits are advertised, the product will not warrant aromatherapy regulation (NAHA, 2011). The practices of aromatherapy performed are normally in conjunction with other complementary and alternative medicines that require a license or regulation (NAHA, 2011). For example, applying essential oils to the body with intent to help or fulfill a medical claim would require a massage license (NAHA, 2011). In certain instances, the composition of aromatherapy products can fall under the FDA prevue with limited regulation (FDA, 2011).
No requirements or regulations are put in place if the product intends to beautify (is for cosmetic purposes) (FDA, 2011). On the other hand, if the intent is to cure or treat a disease regulations and testing may be a requirement before marketing (FDA, 2011). Many loopholes in the current oversight would allow marketing of certain aromatherapies as cosmetics. This in turn can cause a problem if an individual decides to self-medicate or if a license professional misuses the product. Currently, the oversight applied is sufficient until there is more research. Aromatherapy is a very noninvasive form of therapy but topical applications are an area of concern. However, licensed professionals can undertake various courses to obtain certification in the field (NAHA, 2011).