The FDA (Food and Drug Administration) regulates over-the-counter (OTC) products in the United States to ensure their safety and effectiveness. OTC products are medications that can be purchased without a prescription from a healthcare provider.
The FDA regulates OTC products through a set of regulations known as the OTC monograph system. Under this system, the FDA evaluates and approves the ingredients, labeling, and packaging of OTC products. This system applies to a wide range of products, including pain relievers, cough and cold medications, and skin care products.
Here are some key aspects of the FDA regulations of OTC products:
- Active ingredients: The FDA evaluates the safety and effectiveness of active ingredients used in OTC products. Each active ingredient is assigned a monograph, which specifies the conditions under which it can be used in OTC products.
- Labeling: OTC products must have clear labeling that includes information such as the active ingredient, intended use, dosage instructions, and warnings.
- Packaging: OTC products must be packaged in a way that is tamper-resistant and protects the product from contamination or degradation.
- Advertising: OTC products must not be advertised in a way that is false or misleading, and all claims made about the product must be supported by scientific evidence.
- Post-market surveillance: The FDA monitors the safety and effectiveness of OTC products even after they are approved and on the market. Manufacturers are required to report any adverse events associated with their products to the FDA.
In summary, the FDA regulates OTC products to ensure their safety and effectiveness. This includes evaluating the active ingredients, labeling, packaging, advertising, and post-market surveillance of these products.
