FDA Proposes Regulation of CAM Deadline for Comments: April 30

Under new U.S. Food and Drug Administration (FDA) guidelines, products commonly used in massage and bodywork—including lubricants and handheld tools—could become regulated by the FDA. Also at risk of FDA regulation are other complementary-and-alternative-medicine (CAM) products, including supplements such as vitamins, minerals, herbs and amino acids—and even vegetable juice.

The agency is accepting public comments on its guidelines until April 30, here: www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?
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The FDA's Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf) explains in detail what products would become regulated.

For example, the guidelines note that if vegetable juice "is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would … be subject to regulation as a drug."

The guidelines' section on massage and bodywork reads: "To the extent that manipulative and body-based practices involve practitioners physically manipulating a patient's body, without using tools or machines, we do not believe that such practices are subject to regulation under the Act or the [Public Health Service Act of 1999]

"If, however, the manipulative and 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."

Under these guidelines, any product that makes a claim of addressing, for example, arthritis pain, could be regulated as a drug.

The public can comment on the guidelines here: www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?
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