Written by Lori Jo Vest
Fact checked by The Brain Blog Team
FDA stands for U.S. Food and Drug Administration. It’s the organization that is, as described in its mission, “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation" among other duties related to public health, the food chain, and the medical industry in the United States. The agency is housed within the Department of Health and Human Services.
The FDA classifies supplements under nutrition, aka food, so they don't regulate it nearly as heavily as medications and pharmaceuticals. However, they act as a regulator and enforcement agency with the ability to define and enforce the specific claims that a supplement manufacturer can make about their product, specifying how it is made (safe/hygienic processes), and ensuring the safety of the ingredients.
The FDA looks out for public health by defining Good Manufacturing Processes (GMPs) for supplement manufacturing operations. They enforce their guidelines through in-person inspections and can prosecute those who aren't following regulations. They can even seize products to remove them from consumer access if the supplement or ingredients are dangerous. They can also recognize a supplement with a Generally Recognized As Safe (GRAS) label after reviewing the science, research, and other evidence about the supplement.
You've probably already noticed that most supplements are labeled with the disclaimer, "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” It makes you wonder, doesn't it? If the FDA doesn’t approve a supplement, does it work? Has it been adequately researched?
The reality is, this FDA required disclaimer is on all wellness-related products that are considered supplements because the FDA doesn't actually "approve" any dietary supplements. It doesn't approve foods, and supplements are considered food. They only approve pharmaceutical products.
The FDA does, however, monitor the manufacture and label aspects of the supplement industry. The inspect companies to make sure their manufacturing and safety processes comply with all FDA requirements. If they don't comply, their product can be banned from sales in the U.S.
If there are no FDA approved supplements, how do you know if a supplement will work, or at least, that it won't harm you? That's a great question. With so many supplements sold online and many suppliers shipping illegally into the U.S. from websites, you have to do your due diligence and research your options and the manufacturer of any supplement you're considering.
Here are some tips for making sure that any supplement you take has been well-researched and is both safe and effective:
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