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FAQs

The FDA or the U.S. Food and Drug Administration is a federal agency responsible for regulating products that impact public health, such as food products, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. The FDA plays an important part in ensuring the safety of the products we use every day, but does not give pre-approval for every industry that it oversees.

In the dietary supplement industry, the FDA acts as an enforcement and regulatory agency. This includes defining and enforcing the types of claims supplement companies can make about their products.

To ensure public safety, the FDA can legally enforce through inspections, and has the right to prosecute, seize and remove dangerous products from the marketplace. The FDA can also determine if a product is safe after reviewing evidence.

First, the FDA does not approve supplements because it is a subset of the food category and food is not does not need approval in order to be available in the marketplace.

However, the FDA scrutinizes claims especially claims the FDA hasn’t evaluated yet. Also the FDA does monitor supplement manufacturing and labeling, and regularly inspects companies to ensure that they are complying with all regulations. If a supplement company does not comply with FDA regulations, the FDA can ban them from selling their product.

According to the FDA, drugs are for treating, stopping, alleviating, diagnosing, or healing diseases. Drugs are heavily regulated. Clinical trials on human subjects must show that a pharmaceutical drug is safe and effective for its intended use. The drug must then be manufactured under strict provisions and correctly labeled before it’s pre-approved by the FDA for consumer use.Unlike drugs, supplements are considered nutritional, and they are not controlled in the same way. Supplements do not require pre-approval by the FDA before they are released for sale to the consumer.