Legal and Regulatory Resources in Complementary, Alternative, & Integrative Medicine

In addition to Articles by Michael and Books by Michael, this section offers articles and books by others on complementary, alternative, and integrative medicine law, regulation, ethics and policy.

Also listed are helpful websites on these matters. At some point I'd like to annotate all these resources and tell why I think they're important; feel free to send me comments or other resources as well and I can add these to the annotations.

Articles
Astin JA. Why patients use alternative medicine: results of a national study. JAMA 1998; 279:1548-53.

Executive Summary, Final Report, White House Commission on Complementary and Alternative Medicine Policy (2002).

Eisenberg DM. Advising patients who seek alternative medical therapies. Ann Intern Med. 1997;127:61-69.

Hathcock J. Dietary supplements: how they are used and regulated. Journal of Nutrition. 131(3s):1114S-7S, 2001 Mar.

Kaptchuk TJ. Varieties of Healing 1: Medical Pluralism in the United States. 135 Ann. Int. Med. 189 (2001).

Kaptchuk TJ. Varieties of Healing 2: A Taxonomy of Unconventional Healing Practices, 135 Ann. Int. Med. 196(2001).

Kolton EA. Physician Sale of Dietary Supplements (Washington, D.C.: Emord & Associates).

Marcus DM & Grollman AP, Botanical Medicines--The Need for New Regulations. 347:25 N.Engl.J.Med. 2073 (2002).

McNamara SH. Regulation of dietary supplements. New England Journal of Medicine. 343(17):1270, 2000 Oct 26.

Pelletier KR, Astin JA, Haskell WL. Current trends in the integration and reimbursement of complementary and alternative medicine by managed care organizations (MCOs) and insurance providers: 1998 update and cohort analysis. Am J Health Promot 1999; 14(2):125-33.

Pelletier KR, Marie A, Krasner M, Haskell WL. Current trends in the integration and reimbursement of complementary and alternative medicine by managed care, insurance carriers, and hospital providers. Am J Health Promot 1997; 12:112-123.

Studdert DM, Eisenberg DM, Miller FH, Curto DA, Kaptchuk TJ, Brennan TA, Medical malpractice implications of alternative medicine [see comments], 280 JAMA 1610 (1998).

Young AL. Bass IS. The Dietary Supplement Health and Education Act. Food & Drug Law Journal. 50(2):285-92, 1995.

Articles by Alan Dumoff, JD
My colleague and friend Alan Dumoff has written quite a number of articles beautifully explaining a number of specific legal issues in CAM:

Dumoff A. A Legal Audit for Integrative Practice: Recognizing and Working with Legal Issues--Parts I and II. Alternative & Complementary Therapies (April 2004 and June 2004).

Dumoff, A. ACM: An International Perspective. Alternative/Complementary Therapies 2003; 9(1):45-48

Dumoff, A. Minimizing Malpractice Risk (A Review). Integrative Medicine Consult 2002;4(8):88-89.

Dumoff, A. Coding System for Alternative and Complementary Therapies: It's Not as Easy as ABC. Alternative/Complementary Therapies 2002;8(4):246-252

Dumoff, A. New Codes for CAM: HHS Review Could Make Them A Reality. Alternative Therapies in Health and Medicine 2002; 8(4):32-36.

Dumoff, A. The Federation of State Medical Boards' New Guidelines for ACM Practice: Improvements and Concerns. Alternative/Complementary Therapies 2002;8(5):303-309

Dumoff, A. New FSMB CAM Guidelines: Significant Steps in the Right Direction. The Integrative medicine Consult 4(9):97, 102-103.

Dumoff, A. Protecting ACM Physicians from Undeserved Discipline: Legislative Efforts in Maryland. Alternative/Complementary Therapies 2002;8-2:120-126

Dumoff, A. A Collision Between Principles and Law: A Case Study in Why Integration is So [Damn] Difficult. Alternative/Complementary Therapies 2002;8:(1):8-9

Dumoff, A. Is It Merck or is it Pharmanex? The Regulatory Tale of Lovastatin and Cholestin. Alternative/Complementary Therapies 2001;7(5):310-314

Dumoff, A. Legal Aspects of Integrative Medicine: A Brief Look at LifeWorks Wellness Center. Alternative/Complementary Therapies 2001;7(4):244-245

Dumoff, A. Creating the New Medicine: Harmonizing Diverse Viewpoints. Alternative/Complementary Therapies 2001;7(3):174-179

Dumoff, A. Balancing Experience Versus Paradigm: Moving Toward the New Medicine. Alternative/Complementary Therapies 2001;7(2):112-116

Dumoff, A. An Open Letter to the White House Commission of Complementary and Alternative Medicine Policy, Part 1: Suggestions for Federal Policy & Part 2: Suggestions for State Policy. Alternative/Complementary Therapies 2000;6(5):249-257 & 6(6):355-357

Dumoff, A. State Medical Board Prohibition's on Physician Sale of Supplements. Physician Consult 2000;

Dumoff, A. Medical Board Prohibitions Against Physician Supplements Sales. Alternative/Complementary Therapies 2000;6(4):226-236

Dumoff, A. CPT Coding for ACM Services: A Short Course. Alternative/Complementary Therapies 2000;6(3):152-161

Dumoff, A. Defining"Disease:"The Latest Struggle for Turf in Dietary Supplement Regulation. Alternative/Complementary Therapies 2000;6(2):95-104

Dumoff, A. Regulating Professional Relationships: Kickback and Self-Referral Restrictions on Collaborative Practice. Alternative/ Complementary Therapies 2000;6(1):41-46

Dumoff, A. Understanding the Kassebaum-Kennedy Health Care Act: Addressing Legitimate Concerns and Irrational Fears. Alternative/Complementary Therapies 1997;3(4):309-313

Dumoff, A. Legislation versus Self-Regulation in the Somatic Practices Field: Comments from the Editor. Alternative/Complementary Therapies 1997;3(3):220-222

Dumoff, A. Expanding the Office of Alternative Medicine into the Center for Integral Medicine and Creating Access to Medical Treatment; Two Agendas for the 105th Congress. Alternative/ Complementary Therapies, 1997;3(1):59-63

Dumoff, A. Protecting Your Practice: Myth v. Fact. Alternative/Complementary Therapies 1996;2(3):186-191

Dumoff, A. Malpractice Liability of Alternative/Complementary Health Care Providers: A View From the Trenches. Alternative/Complementary Therapies, 1995;(1(4):248-253 & 1(5):333-334

Dumoff, A. Including Alternative Providers in Managed Care--Managing the Malpractice Risk (Part I & II). Medical Interface (May & June, 1995).

Dumoff, A. Private Right of Action, Administrative Law, Stein, et al. (1987).

Alan and I have also written several articles together, including "Advising from a Distance: The Legality of Web-Based Clinical Consultations--Parts I and II" in Alternative & Complementary Therapies (August and October 2004.

I acknowledge Alan for developing a strong practice and knowledge base in the field, as well as fellow attorneys Debra Bass, JD and Tony Martinez, JD, and Georgetown law professor Sherman Cohn, JD and Harvard School of Public Health professor David Studdert, LLB, all of whom have greatly contributed to the field (and to my own understanding) in one form or another.

Books
Callahan D, ed. The role of complementary & alternative Medicine: accommodating pluralism. Washington, D.C.: Georgetown University Press, 2002.

Ernst EE, Pittler MH, Stevinson C, & White A. The desktop guide to complementary and alternative medicine: an evidence-based approach. London: Harcourt Publishers Ltd., 2001; 444 pages.

Faas, N, ed. Integrating complementary medicine into health systems. Gaithersburg, Maryland: Aspen Publishers, Inc., 2001; 763 pages.

Humber JM & Almeder RF, eds.. Alternative medicine and ethics. Atlanta: Humana Press, 1998; 220 pages.

Slater V & Rankin-Box D. The nurses' handbook of complementary therapies. New York: Churchill-Livingstone, 1996.

Statutes

Dietary Supplements Health Education Act, 103 P.L. 417; 108 Stat. 4325; 1994.

Regulatory Material

Federation of State Medical Boards, Guidelines for Complementary and Alternative Therapies in Medical Practice (2002).

Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry

Food and Drug Administration. Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 21 CFR Part 101, 65:4 Fed Reg 1000 (Jan. 6, 2000).

Websites

Websites specifically pertaining to regulation of dietary supplements
American Dietetic Association

Berkeley Wellness Letter

FDA

FDA - Labels

FTC

NIH

NLM

Dietary Supplement Info Bureau

USDA

USDA--Books and Other Resources

USP

Other websites

White House Commission on Complementary and Alternative Medicine Policy

Institute of Medicine, Committee on Use of Complementary and Alternative Medicine by the American Public

Institute for Health Freedom
The Institute for Health Freedom is a nonpartisan, nonprofit Washington-based think tank whose mission is to present the ethical and economic case for strengthening personal health freedom. Through its research, publications, and public policy debates, the Institute provides a forum for exchanging ideas about health freedom. The Institute is run by my friend Sue A. Blevins, a leading advocate and spokesperson for consumers' freedom to choose their health care, and author of Medicare's Midlife Crisis. The Institute also has its own links to legal and regulatory resources. I have incredible respect for Sue and her forward-thinking work at the Institute.

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