FDA Issues Draft Guidance Broadly Affecting the Probiotic and Complementary and Alternative Medicine Products Industries

On February 27, FDA announced a draft guidance, titled Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (CAM Guidance).  The CAM Guidance was prepared by the Office of Policy and Planning within FDA’s Office of the Commissioner with assistance from the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Food Safety and Applied Nutrition.  The CAM Guidance is FDA’s attempt to clarify within which FDA regulatory schemes (i.e., food, drug, device, biologic, cosmetic, or dietary supplement) the wide range of complementary and alternative medicine products might fall.  The areas addressed in the CAM Guidance include biologically-based practices, energy therapies, manipulative and body-based methods, and mind-body medicine.

The trade press has noted FDA’s statements that probiotics could be regulated as dietary supplements, foods, or drugs.  In its CAM Guidance, FDA also suggests that “the bacteria used in a probiotic could make the product a ‘biological product’ subject to the [Public Health Service Act].”  This statement appears to relate to the potential for probiotics to contain bacteria that might cause communicable disease.  However, the guidance should be clarified on this point to make sure it is consistent with other statements in the CAM Guidance that recognize the longstanding principle of intended use as the determining factor in the regulatory status of a product.

Companies developing complementary and alternative medicine products should read carefully the CAM Guidance, as it is not directed solely at probiotics and other foods.  For example, the CAM Guidance suggests that FDA may regulate equipment used and products applied in manipulative and body based-practices, such as massage devices, lotions, creams, and oils.

Comments regarding the CAM Guidance must be submitted to FDA by April 30, 2007.

By Bryon F. Powell