April 2007

ACA comments on FDA CAM guidance

The American Chiropractic Association has issued comments on the Food and Drug Administration’s (FDA) draft guidance on complementary and alternative medicine, which has been the subject of speculation among advocacy groups. (See “FDA draft guidance open for comment.”)

Docket No. 2006D-0480, is open for comment until April 30, according to the FDA. Some groups claim the FDA is in the process of making nutritional supplements subject to the same laws and regulations as prescription drugs.

In its weekly newsletter, ACA said it is monitoring the situation. It is filing comments to address specific areas of the guidance. In particular, the comments said:

“[Points in the guidance] seem merely to reflect an obvious and conventional interpretation of existing law — and do not, by themselves, appear to be an assertion, claim, or justification for additional FDA regulatory authority which goes beyond such authorities as already exist under current law.

ACA further states: “If the guidance document were intended, in any way, shape or form, to constitute an expansion of FDA authority beyond long-standing and conventional interpretation of current law to further regulate CAM therapies or products utilized in CAM, such as nutritional supplements, then the ACA would have grave concerns about the proposed guidance document and its potential impact and would oppose any such regulatory activity the ACA believed to be unwarranted or harmful.”

ACA’s comments also identified Section II, C in the guidance that pointed to chiropractic. The proposed guidance states:

“To the extent that manipulative and body-based practices involve practitioners physically manipulating a patient’s body, without tools or machines, we do not believe that such practices are subject to regulation under the Act or the PHS Act. If, however, the manipulative or body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act, depending on the nature of the product and its intended use.”

ACA said, in its comments: “The ACA would oppose any such effort to restrict CAM activities in such a manner and believes that any attempt to do so would clearly fall outside the scope and authority of existing law,  including (with respect to the example of dietary and nutritional supplements) the Dietary Supplements Health and Education Act (DSHEA). We respectfully request, that the FDA take action to further clarify that it is not the intent or purpose of the guidance document or the FDA to restrict CAM therapies and products in this manner.”

To read the FDA’s draft guidance in its entirety, go to http://www.chiroeco.com/news/2007/April/FDA_CAM_Guide.pdf.

Source: American Chiropractic Association, www.acatoday.org

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