Dermatol Ther. 2003 Jun; 16(2): 77-84.

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

Cohen MH.

Director of Legal Programs, Division for Research and Education in Complementary and Integrative Medical Therapies, and Department of Medicine, Harvard Medical School, Boston, Massachusetts.

The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is defined as unskillful practice which fails to conform to a standard of care in the profession and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Ultimately research will or will not establish a specific CAM therapy as an important part of the standard of care for the condition in question. Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation.