Integrator Special Report: The FDA's Guidance on CAM - What is the Appropriate Response?

Summary: In recent weeks, a growing crescendo of concerned queries reached the Integrator about the US Food and Drug Administration (FDA) document entitled Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Is the FDA really trying to squelch health freedoms, stamp out dietary supplements, put alternative therapies and natural health care under the control of allopathic doctors and harm religious practices? Are these claims grounded? Others ask: What does the FDA's document really mean? Here is an attempt through a score of interviews with concerned parties, the FDA, flame throwers, and numerous legal and policy experts, to get to the bottom of these claims and counter claims.

• Caveat #1: Certainty of meaning is impossible if one party does not trust the other.
• Caveat #2: Such certainty is more elusive if one party is viewed as habitually and unilaterally contravening that meaning. 

Abstract of Findings

Here are my basic conclusions:

• 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.
  
• The April 30, 2007 date for ending the comment period should be extended to at least the planned 90 days to give all interested organizations an opportunity to thoroughly prepare comments in a complicated arena. [Note: As of May 8, the FDA has APPARENTLY NOT extended the comment period as I had reported. Sincere apologies.]
  

1. The FDA Guidance  document.
   
2. The claims of the Natural Solutions Foundation and their associates, Rima Laibow, MD and Ralph Fucetola, JD.
   
3. Interview with the FDA's Philip Chao, a senior scientific advisor and co-author of the Guidance.
4. Perspectives of better known "health freedom" lobbying organizations organizations, the American Association for Health Freedom and their lobbyist and former congressional staffer William Duncan, PhD; and from the National Health Freedom Coalition and its founder Diane Miller, JD.
   
5. Other organizational perspectives, including the Integrated Healthcare Policy Consortium and the American Botanical Council, the American Association of Naturopathic Physicians.
   
6. Perspective of attorney-observer Michael Cohen, Esq, author of a half-dozen CAM-related books including Healing at the Borderland of Medicine and Religion.
7. A note on hysteria, appropriate action and crying wolf.

Alternative Medicine Integration Group is an Integrator sponsor.

On February 27, 2007, the US

• "FDA trying to kill natural medicine supplements again."
  
• "All healing will be restricted to allopathy."
  
• "... reveals plans to reclassify virtually all vitamins, supplements, herbs and even vegetable juices as FDA-regulated drugs."
• "This is a sinister plot to destroy natural medicines."
• "This is a well crafted sneak attack on our health and health freedom."
• "FDA guidelines threaten religious freedoms."
• "You see the game very easily: this is a competition squash."
• " ... establishing allopathy as the state system of healing, and forbidding all others."
• "Holy water could be regulated as 'drugs' and rosaries as 'medical devices.'"
• "Massage oils and massage rocks will be classified as 'medical devices' and require FDA approval."
• "FDA is setting the stage for another push to control and restrict CAM practices."
• All natural therapies will come under control of medical doctors.
• Supplements will be re-classified as drugs.
  

To be clear, the principal promoters of this frenzy of fear and antagonism are not the more visible, policy-involved, "health freedom" groups.

• The American Association for Health Freedom and its allied Health Freedom Foundation (www.healthfreedom.net) are known for 15 years of activism in helping create NCCAM, establishing the Integrated Healthcare Policy Consortium, promoting the Access to Medical Treatment Act and filing legal challenges to the FDA. The position expressed by AAHF is one of strong concern, while clarifying that "much of the regulation proposed in the document has already been claimed by the FDA." AAHF notes concern with the potential of a "CAM products" category. Yet the organization underscores that the issues here are chronic rather than acute:  "The FDA’s 'way of thinking' will need a stronger course of action and we are prepared to follow though." Change must come through Congressional action and members of Congress, rather than the FDA, should be the target of citizen concern. The AAHF tells its members that statements such as the Guidance are very complex and "must be carefully examined and responded to in writing." The AAHF has officially requested the FDA extend the deadline for comment to July 31, 2007. They urge grassroots efforts in areas where action may have more impact at the present time.

• The National Health Freedom Coalition (www.nationalhealthfreedom.org) along with its lobbying organization, National Health Freedom Action (NHFA) have been principal backers of "health freedom" laws to protected the rights of unlicensed practitioners. The first was passed in Minnesota. Leader Diane Miller, JD posts the following on the FDA topic: "We at NHFA do not consider this FDA draft guideline document to be an immediate threat but rather it educates about existing law." NHFC is clear that it has long-standing disagreements with the FDA, but repeatedly underscores that there is little new here: "The document is an attempt to educate and put citizens on notice about existing FDA and PHS law." The NHFC position parallels that of the AAHF in expressing concern about the meaning of "CAM products" and in asking for an extension. The organization plans to file its comments by May 15, 2007. In addition, the organization urges activists to turn their attention to more pressing issues, including health freedom laws in various states.

Karen Howard, the executive director of the American Association of Naturopathic Physicians (AANP) shared with the Integrator a brief advisory sent to the organization's members. The note starts

"it is our position that this guidance is designed to serve as an advisory document and constitutes no immediate or direct threat to CAM products of CAM practitioners. Nonetheless, we recognize that this document will serve to anchor key concepts and definitions, and be a reference for upcoming policy discussions." AANP is working on their formal response.

The Integrated Healthcare Policy Consortium began looking at the issue immediately after the NIH NCCAM notice in March. The organization quickly put in a request for an extension. Janet Kahn, PhD, the organization's executive director, said IHPC has "consulted with a number of attorneys" and concluded that

Mark Blumenthal, executive director of the American Botanical Council, the leading educational organization regarding botanicals, notes that ABC shares concern that the FDA may be establishing a new category with their "CAM products" designation. Said Blumenthal: "It appears the FDA may be trying to create a new class of regulated items." He adds that the ABC is exploring whether the FDA document may also suggests that botanical "might be being classified as biologics."

An attorney working with ABC, Holly Bayne, JD, underscored the importance of guaranteeing that any organization have time to prepare their responses: "The entire document needs to be looked at in the context of the broader agenda of the FDA." She adds that some are concerned about whether the bio-tech industry may have an imprint in this document. She believes more time is necessary to appropriately explore both of these questions.

6.    Perspective of Michael H. Cohen,  Esq.

Commentator Michael Cohen, Esq.

Attorney and author Michael Cohen, Esq. has been a participant-observer in many of the more significant federal government activities related to CAM over the past decade. (

"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."

My own sense was that the Natural Solutions Foundation's Libertarian agenda, and calling attention to itself, may be more important to it than providing clarity of thought and action on the Guidance document. If the FDA was found to show as selective a memory of facts as Natural Solutions Foundations leadership shows in its emails, this organization would be sending Paul Revere on another ride through the internet's ethers. Yes, caveat lector.

Long-time FDA watcher Candace Campbell

"The (natural health) community only has so much energy. We have to be judicious in how we use it. Concerned citizens need to write to members of Congress, not to the FDA. It is the elected officials who are more likely to be responsive to consumers, to voters. The FDA wants to hear from medical societies and organizations, because it is only these groups that have the power to hurt them."