The United States Food and Drug Administration is the federal agency charged with, among other responsibilities, ensuring the safety of most foods, the safety and efficacy of all prescription drugs and the safety and proper labeling of dietary supplements. Weight-loss products can fall into any one of these categories with its attendant laws. Always consult your doctor prior to starting any new treatment or diet.
Legislation
More than 200 laws codified in Title 21 of the Code of Federal Regulations now govern the U.S. Food and Drug Administration, one of the world's most inclusive and successful systems of public health administration and consumer protections. Specific requirements pertain to foods for special dietary use, dietary supplements and prescription weight-loss drugs. The full text of these regulations is available on the FDA's website.
Foods for Special Dietary Use
Any food that claims to be for special dietary use due to its usefulness in maintaining or reducing body weight must adhere to specific labeling requirements. In addition to standard nutritional labeling, these products must also bear a conspicuous statement of the basis for such claims. Terms such as "low calorie," "reduced calorie" and "no added sugar" must comply with specific criteria set forth for each of these, as well as other similar statements.
Dietary Supplements
The FDA regulates dietary supplements as foods, rather than drugs. Consequently, supplements are not subject to safety and effectiveness testing, and there are no approval requirements beyond some labeling constraints. Nonetheless, the FDA has noted an emerging trend concerning certain products that are marketed for promoting weight loss. Frequently represented as dietary supplements, these over-the-counter products may contain hidden ingredients that could be harmful to your health. The FDA warns, "Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients." FDA enforcement actions are limited to only a small percentage of those tainted products that are already being marketed, so do your research prior to taking any supplements and be sure to consult your doctor.
Prescription Weight Loss Drugs
The FDA's Center for Drug Evaluation and Research evaluates each new prescription drug before it can be sold. The CDER ensures that new drugs have the effect(s) they claim to, and that these health benefits are not outweighed by any known risks. By law, the FDA follows strict procedures with respect to reviewing applications for a new drug, from ensuring that adequate and well-controlled studies have been performed to the review of prospective labeling.
References
- US FDA: Legislation
- US FDA: Code of Federal Regulations - Foods for Special Dietary Uses
- US FDA: Code of Federal Regulations - Dietary Supplements
- US FDA: Prescription Drug Development and Approval Process
- US FDA: Prescription Drugs - Laws, Regulations, Policies and Procedures
- Government Printing Office Access: Applications for FDA Approval to Market a New Drug
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