Are RealDose products FDA approved?

"FDA Approved" is related only to medication/drug approvals.

All RealDose products are considered food /  nutritional supplements. 

ALL dietary and nutritional supplements manufactured within the US are under the guidance of the FDA Nutritional Supplement act, which ensures the safety and accurate labeling of dietary supplements, and all RealDose products strictly adhere to all FDA rules and regulations for nutritional supplements.

While the U.S. Food and Drug Administration (FDA) does not “pre-approve” dietary supplements for sale, it is important to understand that the agency – along with other federal and state agencies – plays a vital role in ensuring supplements sold in the U.S. are safely made, properly labeled and have claims that are supported by research. Based on the regulatory framework in the United States, it’s easy to believe that supplements are not regulated. This is a common misconception. 

As background, the FDA has broad powers of oversight and enforcement (including product seizures and injunctions) that allow the agency to not only permit the sale of safe products, but also ban unsafe products from the marketplace. Other agencies are also involved in the regulation of dietary supplements in the U.S. The Federal Trade Commission (FTC) regulates advertising. The U.S. Department of Agriculture (USDA) regulates the proper use of organic labeling as well as the use of genetically modified and animal-derived ingredients. The Environmental Protection Agency (EPA), together with the FDA, enforces pesticide limits. The Consumer Product Safety Commission (CPSC) has requirements for tamper-evident packaging when appropriate (such as some iron-containing supplements). Finally, state-level agencies have their own prosecutorial powers to ensure dietary supplements sold in their jurisdictions are safe.

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