Overview
Systems of rules and guidelines comprise the legal framework enforced by institutions to regulate economics, politics, and many other aspects of modern society. While all legal systems deal with comparable basic issues, each respective country recognizes, classifies, and interprets its legal components and topics differently. Typically, the purpose of a law is to restrict and control harm to others by serving as a social mediator among the parties involved. Thus, focusing on public protection, which includes patient and health consumer safety, governments regulate affairs in the public health arena and in the care provided by health professionals.
Consumers appropriately want to have confidence in their health professionals, whether those professionals are practicing conventional Western medicine or complementary alternative medicine (CAM). When people need care, they entrust themselves to doctors, nurses, and a whole range of other trained health care professionals, including CAM practitioners. People want to know that their trust is appropriately placed and that they will not be mistreated or harmed. The preservation of trust is the foundation for the care provided. Through regulation and oversight, a framework of guidelines, rules, and controls are built into the system to maintain patient safety and efficacy of treatments, products, therapies, and practices.
CAM is a $34 billion annual industry, according the 2007 National Health Survey conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics. Most of this spending for therapies, products, office visits, classes, and relaxation techniques is not covered by health insurance in the United States. The safety and efficacy of these products and therapies are not the only pressing issues that require regulatory attention.
Despite CAM’s popularity, strong debates surround its practice because of the unclear nature of some of its therapies and because of the broad array of claims different practitioners make. Some of the ingredients and claims of natural products and practices contribute to greater controversy because of the lack of formal quality standards and clinical trials, which are normally expected by the scientific community.
Although CAM use has been rising around the world through the years, the evolution of CAM regulation has been ineffective, failing to keep up with the expansion of its use, demands, and needs. Generally, existing CAM regulatory models have either been absent or been inadequate. CAM advocates defend consumer freedom and their right to have access to healing alternatives compatible with their own values, beliefs, and philosophies toward health and life. However, government regulators are still trying to find a regulatory balance to protect consumers from negative outcomes, adulteration, or misbranding of products or therapies. At the same time, regulators are trying to avoid limiting access to holistic, nonbiomedical therapies.
Federal Legal Authority
The U.S. Food and Drug Administration (FDA) issued the “Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration” (2006) in response to the increased use of CAM practices and products in the United States. This document also addresses rising public confusion about whether certain therapies or products used are subject to regulation.
“The Guidance” has two main regulatory points. First, a CAM product might be subject to regulation as a drug, a biological or cosmetic device, or a food (including food additives and dietary supplements) under the Federal Food, Drug and Cosmetic (FFDC) Act or the Public Health Service (PHS) Act. These statutory classifications cover several CAM products.
Second, neither FFDC nor PHS relieves CAM products from regulation. As the FDA receives its laws from the U.S. Congress, it has legal authority based on the legal tools Congress has given the agency. In deciding law-science issues, FDA efforts are based on sound scientific rationale related to ensuring safe therapies and products for consumers, while balancing access to the highest reasonable standard of health.
The FFDC is a federal law enacted by Congress that establishes the legal framework for how the FDA works. The FFDC is found in the United States Code (starting at 21 U.S.C. 301). The FDA develops regulations based on the laws under which it operates. The agency, guided by the Administrative Procedure Act (a federal law), follows procedures to issue its regulations. FDA regulations are also federal laws, although they are not part of the FFDC. FDA regulations are found in Title 21 of the Code of Federal Regulations. The agency adheres to procedures in its “Good Guidance Practice.” Guidelines, however, are not legally binding.
Some CAM advocates oppose any legal intervention in their affairs, considering guidances and regulations to be governmental restrictions. Regulation critics state that the FDA’s criteria for experimental evaluation methods are orthodox and that it obstructs CAM practioners attempting to bring valuable and effective treatments to the public. CAM advocates argue that their contributions and breakthroughs are often unjustly dismissed, unnoted, or stifled. CAM providers acknowledge that health fraud does occur, and they agree that it should be appropriately addressed and curtailed. However, they also argue that restrictive regulations should not spread to valid CAM health practices and products.
Standards and Science-Based Regulation
Conventional biomedical drugs obtain FDA market approval only after clinical trials establish their efficacy. Safety testing is another legal requirement. Biopharmaceutical manufacturing standards are strictly regulated to guarantee a given medicine has uniform and standard quantity, identity, purity, and strength of an active ingredient in its formulation, and that it is not contaminated or adulterated. Because alternative health products are not governed by the same quality-control standards as non-CAM products, one might see inconsistencies among doses. As result, CAM products are susceptible to contamination, adulteration, misbranding, and fraud.
Because there are no global, harmonized CAM regulatory guidelines, world commerce amplifies the problem, as each country may or may not have its own quality standards, levels of regulation, and legal authority to enforce compliance. The FDA believes that all of this puts consumers in an unfair and difficult position: how to properly evaluate the risks and qualities of natural treatments.
CAM proponents assure consumers that their healing therapies are natural, harmless, and effective. From the CAM perspective, regulations personify a dividing model within the healing arts flanked by traditional medicine and unconventional health care. Proponents argue that the law endorses and favors biomedicine. Some CAM promoters state that guidance language is confusing to the consumer and is unconstitutional. They are concerned that regulations are restricting access to natural therapies. Proponents want the FDA to better articulate the equilibrium between consumer protection and consumer freedom.
Regulation of CAM Therapies
The National Center for Complementary and Alternative Medicine (NCCAM) is part of the National Institutes of Health (NIH). The FDA’s CAM guidance expanded on the CAM categories of NCCAM for its development and issuance. The five major regulated categories are whole medical systems, mind-body medicine, biologically based practices, manipulative and body-based practices, and energy medicine. The intended use of a product plays a vital role in the way it is regulated. Therefore, when a product satisfies the statutory definition of a drug, device, food, or biological product, it will face regulation under FFDC or PHS, or both.
Manufacturers of natural goods as well as holistic practitioners cannot promote their products or services as cures or treatments. They are allowed only to claim that the products or practices may promote a specific outcome. They also must include on the product’s label or on a practitioner’s advertisement an FDA disclaimer. Likewise, there is no assurance that natural goods are consistently formulated to guarantee strength, amount, and purity of the active ingredient in each dose. When using health therapies, choosing a suitable manufacturer is vital to confirm safety, intended use, and end result.
Future Challenges and Goals
CAM regulation affects a number of constituents, including health care providers trying to reduce the legal risks of integrating CAM into their biomedical practices; FDA officials and judges, attorneys, and legislators; credentialing and licensing agencies and organizations that standardize CAM-practice qualifications; consumers and patients hoping to access available wellness options; and insurers, clinics, and hospitals striving to integrate CAM therapies in health plans. As the FDA’s guidance is relatively young, these constituent groups are reshaping the developing legal authority for the coexistence of the safe and effective exercise of integrated health care. The FDA pursues a scientific regulatory model.
For CAM proponents, an ideal future includes forward-thinking regulation that sustains a broad, nonbiomedical, holistic, and neutral move that embraces wellness alternatives. The type of regulation needed will help integrate biomedicine and CAM so that consumers will be protected from fraudulent and dangerous therapies.
Bibliography
Astin, J. A. “Why Patients Use Alternative Medicine.” Journal of the American Medical Association 279 (1998): 1548-1553. Provides survey results of a study assessing what prompts consumers to use alternative medicine.
Briggs, J. P., and R. L. Nahin. “Cost of Complementary and Alternative Medicine and Frequency of Visits to CAM Practitioners.” Atlanta: Centers for Disease Control and Prevention, 2007. Results from the National Health Survey of 2007 regarding CAM-related spending in the United States.
Cohen, M. H., and K. J. Kemper. “Complementary Therapies in Pediatrics: A Legal Perspective.” Pediatrics 115, no. 3 (2005): 774-780. Examines the legal considerations of CAM therapies for pediatric patients.
Eisenberg, D. M., et al. “Credentialing Complementary and Alternative Medical Providers.” Annals of Internal Medicine 137, no. 12 (2002): 965-973. A review discussing the status and mechanisms of licensing and the establishment of standards of practice to protect patients.
Fontanarosa, P. B., and G. D. Lundberg. “Alternative Medicine Meets Science.” Journal of the American Medical Association 280 (1998): 1618-1619. An editorial that promotes scientific evidence-based methods for determining quality medicines and therapies.
Hutt, Peter B., Richard A. Merrill, and Lewis A. Grossman. Food and Drug Law: Cases and Materials. 3d ed. New York: Foundation Press, 2007. A brief account of the FDA’s administrative law. Deals with governmental attempts to protect public health and individual welfare in the development and marketing of essential products.
National Center for Complementary and Alternative Medicine. “Statistics on CAM Costs: 2007 National Health Interview Survey.” Available at http://nccam.nih.gov/news/camstats/costs. Provides statistics on CAM costs in the United States from the 2007 National Health Survey.
U.S. Food and Drug Administration. “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” Rockville, Md.: Author, December, 2006. The first FDA guidance on CAM in the United States.
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