The FDA draft publication entitled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" has generated outcry and commentary.
But is it worth all the noise?
The Integrator Blog by John Weeks has put together an outstanding packet of information with relevant links.
The FDA's Guidance is, as the FDA writers clearly state, almost entirely doing nothing more than clarifying powers and perspectives that already exist. Seasoned policy and legal analysts and FDA observers believe that the margin for concern represented in almost relate principally to two aspects of the Guidance. One is the phrase "CAM products" which the FDA took from the NIH National Center for Complementary and Alternative Medicine (NCCAM). Some worry that this may come to represent a "new category" that is part of a larger FDA strategy. An FDA co-author denies this. The other is that the document represents an attempt to "reclaim FDA authority" that might have been lost in court cases. Thus far this is speculation. An FDA co-author of the document denies any such motivation. See the Integrator interview here.
The FDA never did and still does not regulate the practice of health care or medicine. More emphatically, and to the point: the FDA does not regulate the off-label uses of drugs, and so, by extension, the medical and treatment-oriented uses of dietary supplements or devices by integrative medicine or natural health practitioners in their practices. Such regulation is a state's responsibility. By further extension, the Guidance will take away neither your holy water or Rosary beads, though the FDA could conceivably bust any religious order which starts stamping unapproved medical claims on these or other religious artifacts.
If the power of the FDA as described in this Guidance document makes you nervous, you had reason to be nervous already. The most prominent, activist "health freedom" groups show concern and active interest but do not support the hysterical claims generated by others. Vigilance remains critical. Crying wolf is detrimental. This energy might have been better spent on other FDA-related issues where action now is important.
Weeks has aptly made the point that the FDA cannot, by law, regulate the practice of medicine, which is left under the Tenth Amendment to the states.
Thanks to the Integrator Blog for links and for quoting this comment I gave:
The guidance reads more like an assertion of potential FDA jurisdiction than an actual guide to industry conduct. And consistent with its history, the FDA is asserting as broad a potential jurisdictional reach as possible.
"Some of this may be motivated by 'homeland security' concerns (see, for example, the discussion of biological products). Some may simply be agency expansionism. Some may simply reflect the paternalistic stance of being too controlling in trying to protect consumers from bad outcomes. And some may simply be an attempt to clarify a confusing regulatory landscape.
"I would encourage the agency to be ever more mindful of the balance between consumer protection (regulate where you can) and consumer freedom (abstain from regulating except to require sufficient disclosure as to facilitate informed consumer choices). And I think it would be healthy for the FDA to actually articulate this balance.
"In drawing the balance more accurately, one place where we still need an injection of creative thinking is the confusing borderland between supplements and drugs. For example, prohibited disease claims mysteriously convert a 'supplement' into a 'drug.' I think it might have been Stephen DeFelice, MD who coined the apt term, 'epistemological chaos.' A substance is what it is regardless of the claim.
"There has to be a more intelligent way to regulate manufacturer labeling, perhaps by tying allowed language to existing clinical data, or simply drilling down more into the notion of what is false and misleading. And, state licensing laws and scope of practice rules can take up the slack in dealing with practitioners who make overbroad claims.
"In general, and particularly in the age of the Internet, the whole regulatory structure needs to give more credit to consumers' ability to make wise choices concerning what goes into their bodies. That stance, as opposed to asserting the long arm of jurisdiction, will help the FDA increase its legitimacy and credibility while providing a negotiated buy-in for manufacturers, practitioners and patients."
Also of note is the Integrator Blog's piece, The FDA's CAM Guidance: Interview with FDA's Co-Author and Senior Scientific Adviser Philip Chao. In it, the FDA's spokesperson says: "This document does not require licensed physicians to dispense. It does not effect who prescribes or dispenses. Nor does it talk about the subject of referral. Nor does it turn supplements into drugs." The interview clarifies a lot of confusion about the FDA guidance. Kudos to the Integrator Blog for responsible journalism.
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies, representing medical doctors, allied health professionals and other clinicians, entrepreneurs, and institutions.
Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploration of legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion, which follows Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).
Health care and corporate lawyer Michael H. Cohen is licensed has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C., and to the Bar of England and Wales as a Solicitor (non-practicing).