Food and Drug Administration certification of approval
Complementary and Alternative Medicine (CAM) products describe a variety of health care practices, products and therapies that are different from conventional or Western medicine. Complementary medicine is defined as therapies working in conjunction with conventional medicine, such as using acupuncture to help lessen pain. Alternative medicine is used in place of conventional medicine; for example, taking red yeast rice in place of a statin medication to lower cholesterol. One-third of Americans use a CAM product, and there is often confusion over what is regulated by the Food and Drug Administration (FDA).
What Is Regulated by the FDA
The FDA ensures the safety of all food (except for meat, poultry and some egg products that fall under the provision of Department of Agriculture). The FDA also ensures the safety and effectiveness of all drugs, biological products and medical devices and the safety of cosmetics and other consumer products.
Dietary Supplement Health and Education Act Limitations
According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA has limited authority to regulate CAM Products. Instead the burden of safety and efficacy of a dietary supplement product rests on the manufacturer. The manufacturer is responsible for making sure the claims on its labels are truthful.
CAM Regulation by the FDA
The FDA does not evaluate claims on dietary supplement products before they are put on the market. It is only when a product has been deemed unsafe that FDA has the authority to take action against a dietary supplement product. The FDA must prove that the claims on the dietary supplement products are false and misleading and the product is unsafe for consumers before the FDA takes steps to remove the product from the market.
Guidance for Industry on CAM Products
As of December 2006 the Department of Health and Human Services and FDA issued "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation." First, depending on the CAM therapy or practice, a product may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements). A substance is exempt from the definition of a food additive if it's generally recognized as safe. For example, cranberry tablets are considered a dietary supplement if labeled "to maintain the health of the urinary tract," but if labeled "to prevent urinary tract infections," the tablets would be considered a drug. The latter label would qualify cranberry tablets to be regulated as a drug because they are "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." Dietary supplements are considered food under the law and don't have to prove their safety or efficacy before going to market. Anyone who intends to market CAM products should review FDA's requirements for safety and labeling of these products.
Tags: dietary supplement, Alternative Medicine, claims dietary, claims dietary supplement, Complementary Alternative