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FDA's CAM Guidance: Clarity on May 29 & FDA Intent, Plus AHNA, AHPA & ACA Action PDF Print E-mail
Written by John Weeks   

FDA's CAM Guidance: Clarity on May 29, 2007 Comment Closure & FDA Intent, Plus Action from Organizations Representing Holistic Nurses, Chiropractors and Herbal Products Industry

Summary:  The Integrator was told on May 23 that the FDA is open for responses to their Guidance on CAM document until May 29th. There has been significant controversy and uncertainty about the date, originally set for April 30. The FDA's "Special Filing' clarifying this also includes some strong language in response to the overall controversy  ...  Meantime, here also are excerpts from the formal submissions from the American Holistic Nurses Association, the American Herbal Products Association and the American Association of Chiropractic Association.
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Image
The Integrator Special Report onm the FDA's CAM Guidance was accompanied by an interview with FDA official Philip Chao. We discussed the FDA's lack of clarity on the end of the comment period. I suggested it was  discussed as an example of what fosters mistrust of the FDA. The Integrator learned today that the FDA has finally made itself clear that the comment period is open until May 29th and that filings since April 30 will be accepted. They state:

"Given the amount of confusion as to the comment period, we are announcing that we will consider all comments on this draft guidance that are submitted through May 29, 2007 . Previously submitted comments do not need to be resubmitted."
   

FDA Clarity:

Comment period
open until
May 29, 2007


In the Special Filing, the FDA acknowledged that it was in error, having published two separate dates, generating the confusion.  Oddly, the FDA did so with a posting entitled "Special Filing -- Publishing on May 25, 2007." I accessed this May 25 "publishing" on May 23. What? Are we time travelers here? Who's on first?

Those watching the issue closely will be interested in some language toward the end of the Special Filing:

"Additionally, we are aware of considerable confusion about the content of the draft guidance, which has been widely misinterpreted. Therefore, we want consumers and CAM practitioners to understand that the draft guidance does not contain or propose any new regulatory requirements for any complementary and alternative medicine CAM product marketed in the United States and does not affect any state licensing requirements for any CAM practitioner or any consumer's ability to buy or receive a CAM product or be treated by any CAM practitioner.

"Public concern based on misinterpretations of the draft guidance has generated a large volume of comments to the docket. The large volume of comments has impeded our ability to identify and respond to extension requests. Consequently, we are addressing those unanswered extension requests by considering comments submitted through May 29, 2007."
Despite the reassurances, the rift between parts of the public and the FDA, which is purportedly there to serve the people, has certainly left numerous group pleased that they went ahead with their filings of comments.  Here are excerpts from actions of three organizations.

1.    American Holistic Nurses Association (AHNA): FDA fails to recognize the purpose of healing

Image The AHNA approaches their 3-page submission with good bedside manner, as a quiet teacher, instructing the FDA that what goes into healing and what goes into "curing" may be "synchronous" but they are not the same. In addition, while much research is underway, "research focused on the biomedical randomized clinical trial often does not get at the holistic nature of the individual nor the effects of many CAM modalities which address the whole person and focus on healing the whole person as their goal." Then the AHNA drives home its core point, perhaps causing the patient to sit upright:
"Conceptually, paradigmatically and rhetorically, the FDA Guidance Document fails to recognize the purpose of CAM therapies to support and increase individuals’ pursuit of healing, wellness, comfort, and wellbeing. These concepts do not easily fit into the allopathic paradigm and yet are the cornerstone of holistic practices. AHNA agrees that there is a need to insure the safety of CAM therapies and products. However, as the FDA Guidance Document does not articulate a comprehensive understanding of the meaning, intent, experiences, and uses of CAM, one must question (the FDA's) ability to evaluate the safety of CAM."
The AHNA calls on the FDA to appreciate consumer choice. The AHNA comment concludes with a statement that it does not believe that "increasing the scope of FDA involvement in indicating the CAM products that are subject to regulation by the Federal Food, Drug and Cosmetic Act or the Public Health Service Act is the answer."

2.    American Herbal Products Association (AHPA): Withdraw the Guidance!

ImageAmidst all the turmoil at the end of last month (was April 30th the last day to file? was the comment period extended? what does the FDA mean by this?), AHPA came up with a simple suggestion for the FDA in their filing on April 27th: Withdraw it!

In a release, AHPA notes that the FDA stated that one of the primary reasons for issuing this draft "was to respond to what it describes as ‘increased confusion’ about products used by practitioners of complementary and alternative medicine."  Then AHPA executive director Michael McGuffin adds:
“But the publication of this draft has had exactly the opposite effect and both the public and industry are more rather than less confused. This confusion extends to the both the content of the document and to FDA’s intentions in developing it.”
AHPA notes that the FDA is not likely to respond affirmatively to the suggestion to withdraw the Guidance. AHPA's submission then challenges the document on a variety of counts. AHPA asserts that the FDA “does not have jurisdiction over the practice of medicine or healing arts, including advice given by health care practitioners to patients with respect to products dispensed within such practice.” AHPA's McGuffin was the observer, of which the Integrator was aware, to point out that the comment period should be extended to May 29th.  

3.    American Chiropractic Association (ACA): Monitoring for Members

Image In a note to members on April 26, the ACA references the "chatter on various internet forums including the ACA's own list serve" regarding the Guidance.
The ACA works to calm member fears:
"On a reasonably frequent basis, information (and sometimes misinformation/disinformation) circulates throughout the profession concerning so-called FDA plots or schemes to more heavily regulate nutritional supplements. Our review of the most recent FDA circulation verifies that no current law or regulation regarding nutritional supplements will be affected in any way."
The ACA then clarified for its members the way the organization tracks dietary supplement-related issues. While they are of interest to many ACA members, dietary supplements are not ACA's core business. The professional association monitors legislative and regulatory developments through "participation in a coalition of groups dominated by representatives of the nutritional supplement/vitamin industry." The group usually meets "one or more times per month to review Dietary Supplement Health and Education Act related matters." The ACA notes that this broader group does believe that those who are opposed to DSHEA may well "launch some type of legislative effort, and if so, quite possibly before year's end." The ACA promises to keep its members posted.

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