Are FDA Approved Supplements a Thing?

The FDA’s Role in the Supplement Industry

December 31, 2020

Written by Lori Jo Vest

Fact checked by The Brain Blog Team

Are FDA Approved Supplements a Thing?   

If you’re serious about your health and wellness, we’re willing to bet you’re serious about your supplements, too. So with all the different types of accreditations and seals of approvals and physician recommendations, is there such a thing as FDA Approved supplements? There’s an easy answer to that question, but let’s dig into a bit of background information before we go there.

Who is the FDA? And What Do They Do?

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.

Can a Consumer Buy FDA Approved Supplements?  

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.

How Can You Tell If Your Supplement is Safe and Effective?  

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:  

  • Check with the product manufacturer or distributor or look them up online. Look into the research they are using to support the claims they're making.  
  • Look for information about the safety and effectiveness of the ingredients listed as being in the product you're considering. Are there studies from highly credible, well-researched sites like Harvard Medical School or the National Institutes of Health?  
  •  Are the claims being made about the supplement credible? Or do they sound far-fetched? If they seem unlikely at first glance, they probably are.  
  • Is there scientific research to support the claims? Or is it based on the less reliable "white paper?" (Did you know that white papers are often written by scientists who are paid by the company that manufactures the supplement?)

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