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.
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Note: This article is part of a series which also includes an interview with a lead FDA official.
* 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.
Caveat lector! Let the reader beware.
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: The FDA has extended the comment period through May 29, 2007.]
Here are links to the notice in the Federal Register and to the Guidance for those wishing to ask for an extension, or to comment.
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.
1. The FDA Document
Image Alternative Medicine Integration Group is an Integrator sponsor. On February 27, 2007, the US Food and Drug Administration (FDA) announced in the Federal Register that it had "seen increased confusion" as to whether certain products used in complementary and alternative medicine (CAM) are subject to regulation by the FDA or Public Health Service Act. They announced a draft publication entitled Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.
The 14 page document uses the NIH National Center for Complementary and Alternative Medicine (NCCAM) categories or domains for describing products and services, describing in each case the kinds of situations where they view the FDA reach as extending. These domains are biologically-based practices, energy therapies, manipulative and body-based methods, mind-body medicine and a category called "whole medical systems." Many people learned of the document when the NCCAM announced the opportunity to comment in their March NCCAM Update, e-mailed on March 12, 2007. The comment period is to last until April 30, 2007.
2. The Internet-Based "Health Freedom" Campaign
Not long after, the Natural Solutions Foundation (www.healthfreedomusa.org) began fomenting opposition. The group is strongly Libertarian in its leanings, opposing and fearful of government of any sort. These are frequently opposed to licensing of practitioners, those that are seeking licensing dismissed as "carving out their piece of the pie." The not-for-profit organization both requests donations and sells vitamins on its website. It is led by a controversial anti-NAFTA and anti-CODEX activist, psychiatrist Rima Laibow, MD. Laibow works closely with vitamin attorney, Ralph Fucetola, JD. Writer Mike Adams of NewsTarget also promotes the agenda. Among the so-called "health freedom" claims made by them or their associates in their campaign, and widely distributed, are:
* "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.
An interview with Fucetola revealed very strong libertarian views, suggesting that any government regulation of health care might be as vociferously opposed. Fucetola is proud of drawing the connection with religious practices. Laibow fans the flames by labeling all FDA action as "ominous." She indirectly accuses the FDA of shutting down access to her website. In these tellings, life, liberty and the pursuit of happiness are at stake. Hearing these dire warnings, as of April 18, over 90,000 individuals had filed protests with the FDA 2007, according to Fucetola.
3. Interview with FDA Senior Scientific Adviser Philip Chao
With a list of these concerns, and those expressed by the organizations below, I repeatedly interviewed Philip Chao, a senior scientific adviser to the FDA's office of policy and planning. Chao was a co-author of the Guidance document. Chao clarified that the FDA position was just as it had explicitly stated on the document. For instance, he dismissed the concern over a "new category," noting that "CAM products" was, as noted in the document, a term of convenience. He also made clear that the FDA is not in the business of regulating practitioners or their uses of drugs or products. Chao equated the medical and therapeutic use of foods, juices, dietary supplements and any other devices not approved as drugs to "off-label" uses of drugs by allopathic doctors - which the FDA does not regulate.
The composite Integrator interview with Chao is posted as The FDA's CAM Guidance: Interview with the FDA's Co-Author and Senior Scientific Adviser Philip Chao.
4. Perspectives of Better Known "Health Freedom" Organizations
To be clear, the principal promoters of this frenzy of fear and antagonism are not the more visible, policy-involved, "health freedom" groups. The positions of these two organizations are as follows.
* 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.
William Duncan, a lobbyist for AAHF, played an important role in shaping the NCCAM legislation during his 10 years of work as a congressional aide. He provided the Integrator with recent evidence of why the mistrust many feel toward the FDA extends well beyond the health freedom community. Duncan argues that FDA has an "attitude" which frequently leads to interpretations of the law which many in Congress believe are well beyond the FDA's statutory authority. An example is a case before the US Supreme Court in which the FDA considers a food supplement ingredient an adulterant, according to Duncan. Says Duncan: "This is part of the reason that Congress and the FDA are often at odds as much as they are." He adds, citing another case, this one involving the New Mexico Board of Pharmacy: "The FDA is supposed to comply with its own laws and regulations. When it clearly does not, as in the case of dental compounds that contain mercury, it is very difficult for Congress to trust the agency."
Buster of the quackbusters, Tim Bolen, captures the mistrust this way: "It is a good idea to mistrust the FDA. They've worked hard to earn that mistrust, and they deserve the results of their work."
5. Other Perspectives: AANP, Selected Companies, IHPC, ABC, AAAOM
Image 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 with an acknowledgment that "explanations (for the Guidance] range from conspiracy theorists that it is an inside play by Big Pharma companies to more mundane descriptions by industry insiders that it is a good sign that the agency is (finally) beginning to codify the results of the many discussions that have taken place over the past ten years."
The AANP affirms the value of clarification, noting that, given all the various FDA actions, "something of its kind is clearly needed." The AANP underscores that "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.
Image 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 given the activism shown by others, the IHPC would let other organizations "take the lead on this." She stated that "our board decided it was critical for us to keep our finite resources focused." IHPC is working on other policy initiatives "that are actionable now," she said. (Kahn said she couldn't say what the main IHPC initiative is until some anticipated Congressional support is confirmed.)
Queries to individual supplement manufacturers produced a similar watchful and concerned but not fearful response. An executive with one company which works principally with practitioners noted that the so-called Guidance was actually mis-leading. This individual believes the FDA document "confuses the reader by seeming to imply that the FDA has regulatory authority over the practice of CAM and its practitioners, which it does not." In addition, "it can be read to imply that a food or dietary supplement can become a drug and therefore subject to drug regulations because of what a person, whether a CAM or allopathic practitioner or not, says about or in recommending a product."
ImageMark 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.
The ABC's Blumenthal points out an important technicality which he learned through research by the American Herbal Products Association and its executive director, Michael McGuffin. If the FDA is to grant a 90 day comment period, as it stated in the document, the commenting should be open at least until May 29, 2007 since the Federal Register reported the Guidance on February 27th. The Integrator brought up this point with an FDA representative, but received a response that no decision to extend had been made. (See the end of the Integrator interview with FDA's Philip Chao, here.)
The American Association of Acupuncture and Oriental Medicine showed little concern about anything new in the Guidance. The AAAOM stated in a letter to members: "The AAAOM has asked several of our expert analysts to review this draft guidance. Based on these reviews, our conclusion is that this document simply reiterates the current regulatory status of CAM products, including herbs. This document contains no new proposed regulations or principles. We see no language that attempts to redefine herbs as drugs or that proposes any new regulation of herbal medicine."
Michael Levin is a member of the Integrator editorial advisory board who frequently helps out on supplement issues. He has been an executive in both Big Pharma and for dietary supplement firms. Levin wrote: "Nothing ground-breaking in this 12/06 Guidance for Industry, other than FDA's public recognition of CAM Products, including such things as mind-body medicine. For those concerned that this may signal a nefarious regulatory attack on CAM services, the Guidance reminds the reader that the FDA regulates products only - not services."
6. Perspective of Michael H. Cohen, Esq.
Image 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. (Another writer, attorney and clinical thinker who as been an exceptional resource for the integrated care field, Alan Dumoff, JD, MSW, has an of counsel relationship with Cohen's law firm). Cohen's work was last see in the Integrator in a review of his 2006 book, Healing at the Borderland of Religion and Medicine. The book deals with many of the challenging themes inherent in the FDA Guidance. Here is Cohen's electronic comment, printed in full. I broke it into paragraphs.
"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."
7. Notes on Hysteria, Crying Wolf and Appropriate Action
Recall caveats #1 and #2 at the top of this article. Without trust about agendas, we cannot have the ground of shared meaning. The FDA's "agenda" is not the only agenda challenged here. 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.
Image Long-time FDA watcher Candace Campbell An important question is whether, with the fury over the Guidance, the FDA or inappropriate crying of wolf may be the bigger challenge to "health freedoms." Other organizations challenge the hoopla over the Guidance as taking energy from more important issues. Bayne, the ABC lawyer, believes that "the over-reaction doesn't do anyone any good." Duncan, the former Congressional staffer now working with AAHF, believes that "there is damage from crying wolf - you get to the point where people don't respond when they need to." Duncan provides a little civics lesson:
"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."
Candace Campbell, a former health freedom lobbyist who is also a co-founder of AAHF and of the IHPC, provides a seasoned perspective, and a story. Campbell notes that the FDA's basic law was created over 40 years ago in a different era. Back then, neither supplements nor the natural health, natural foods and integrated care movements had much of a perch in the United States.
Campbell recalls a story about a Congressional hearing during the Clinton administration in which former FDA Commissioner David Kessler, MD, was testifying. A member of the Congressional panel asked Kessler if he meant to say that if a medical doctor tells a patient to use a bar of soap to more easily give herself a self-exam for breast cancer, that the soap becomes a medical device. Kessler said, yes, that this was so. States Campbell: "Unless the FDA creates a separate category of things like this, of things like chicken soup, we are always going to have these issues."
Disclosure notes: I am on the IHPC steering committee and am a trustee for ABC.
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FDA's Guidance on Complementary and Alternative Medicine Products - What is the Appropriate Response?
By John Weeks
The Integrator Blog, April 18, 2007
Straight to the Source