As a response to any of you who recently received e-mails concerning the FDA Federal Register Notice, stating that you must contact the FDA immediately and voice your concerns over the "Guidance" that will regulate CAM/alternative practices, please do not waste your time on this issue.

This is old news and was sent out back in December of 2006 by the same group and the information is not correct.

From the NHF lobbyist, Lee Bechtel, on the topic in question:

The following, from the Guidance document -

On Page two

"When this guidance mentions a particular CAM therapy, practice, or product, it does so in order to provide background information or to serve as an example or illustration; any mention of a particular CAM therapy, practice, or product should not be construed as expressing FDA's support for or endorsement of that particular CAM therapy, practice, or product, unless specified otherwise, as an agency determination that a particular product is safe and effective for its intended uses or is safe for use." (as in making a drug claim, my comment)

And, on Page 15, of 17, on Dietary Supplements

"A detailed discussion of the Act's dietary supplement provisions is beyond the scope of this guidance document. However, anyone intending to market CAM products that might be subject to regulation as a dietary supplement should familiarize himself or herself with the Act's dietary supplement requirements, particularly with respect to safety and labeling." (i.e. a therapeutic drug claim)

In short, again, this is a guidance document for comments and suggestions, and not a regulatory proposal with FDA enforcement authority applying to CAM providers-of all types-docs, etc., unless they are cooking stuff up in their offices for general distribution to the public at large. They would then be manufacturing.

Could it be used as such in the future? The safe response is Maybe?, but most likely NOT. It has guidance and no specificity.

The FDA could make changes from what it has proposed in this document, but not any time soon?

The issued DRAFT Guidance may be viewed at this link ( DRAFT Guidance )


April 12, 2007

Additional information on this issue:

A valid observation on the "CAM Product" term of art-verbiage was made by some but definitions were not listed from the NCCAM legislation of 1997, NIH (National Institute of Health), which falls under the PHS, on what Complementary and Alternative medical practices are. Could there be the creation of a new FDA category, with the use of this language, a valid observation, but thin, as the FDA does not regulate the practice of medicine, nationally? State Boards of Medicine do for physicians who practice CAM. Secondly, and more to the point, the FDA could not create such a category without a change in the FDCA law-Food, Drug, Cosmetic Act. This would require Congressional action.

The bigger, and always ongoing issue, is when a supplement manufacturer makes a "medical curative" product marketing claim for a supplement. The FDA can act on such, as it has.

The FDA cannot regulate what a physician, or other medical provider, does, or says, about drugs, supplements, or the combined use of both, in their practices with individual patients, even if they call drugs and supplements CAM products in a Guidance document.

It is not unexpected, from my point of view, that the FDA bureaucrats who drafted up the Guidance, did not know, or consult the NCCAM law from 1997. But again, it is a Guidance document. It expresses their thinking, which everyone knows is, especially with regard to supplements, is incorrect because it is uninformed. That is what us taxpayers get from our government.

National Health Federation members may contact Lee with any further questions on this topic if necessary.
Lee Bechtel
BALobby@aol.com