On February 27, FDA announced a draft guidance, titled Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (CAM Guidance).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

On March 1, 2007, FDA announced that it issued 20 Warning Letters to companies marketing and distributing unapproved drug products containing ergotamine tartrate, a drug used to treat vascular headaches, including migraines. According to FDA’s press release announcing the enforcement action:

In addition to marketing these products without FDA approval, most of the companies receiving warning letters have omitted from their drugs’ labeling critical warnings regarding the potential for serious, possibly fatal, interactions with certain other drugs. Based on recent scientific information, the five marketed, approved versions of ergotamine-containing products have updated their labeling to include a box warning (the strongest agency warning) against using such products when also taking potent CYP 3A4 inhibitors, including some antifungal agents, protease inhibitors, and certain antibiotics.  CYP 3A4 is a metabolic enzyme that helps the body eliminate drugs or other chemicals.  Serious and life-threatening ischemia (a restriction in blood supply), including death and gangrene, have resulted when such products are used together.  Most unapproved versions of the drug do not carry these warnings.

FDA’s enforcement action is another example on a growing list of such actions taken to implement the risk-based enforcement approach described in the Agency’s June 2006 Compliance Policy Guide.  Moreover, it is the opening salvo this year for FDA to make good on its promise “to further accelerate its enforcement efforts against marketed unapproved drugs in 2007.”  As we recently reported in RAPS FOCUS, FDA’s stepped-up enforcement effort might be due to pressure from Congress and the threat of legislation addressing marketed unapproved drugs.

Welcome to the FDA Law Blog, the blog of Hyman, Phelps & McNamara, P.C.  We’ll be covering topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law.

First and foremost, this blog will bring you timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as healthcare fraud and abuse, drug and device reimbursement, HIPAA, and other topics of interest. We encourage you to email us (Jeff Wasserstein or Kurt Karst) with your comments and suggestions.