Sometimes on dietary supplement websites you’ll see 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." For many, this statement might look a little suspicious. But it’s actually perfectly normal and required by the FDA in the world of supplements. So what exactly is the government's role in the supplement industry, and what does this statement even mean? Let’s find out.
What is the FDA?
The U.S. Food and Drug Administration is a federal agency responsible for regulating products that impact public health, such as food, pharmaceuticals, medical devices, cosmetics, and tobacco. 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.
What is the FDA's role with supplements?
In the dietary supplement industry, the FDA acts as an enforcement agency. This includes defining and enforcing the types of claims supplement companies can make about their products.
To ensure public safety, the FDA has defined Good Manufacturing Practices (GMPs) that it enforces through inspections, and has the authority to prosecute, seize and remove dangerous products from the market. The FDA can also determine if a product is Generally Recognized As Safe (GRAS) after reviewing the evidence it has.
What’s the difference between a drug and a supplement?
According to the FDA, drugs are for treating, preventing, mitigating, diagnosing or curing diseases. Clinical trials on human subjects must show that a pharmaceutical drug is safe and effective for its intended use, and so they are heavily regulated. Then, the drug must be manufactured under controlled conditions and packaged to meet strict labeling standards before it’s pre-approved by the FDA for consumer use.
Unlike drugs, the FDA says that supplements are for nutritional purposes. Because supplements are not considered drugs, they are not monitored in the same way. While the FDA has regulations for manufacturing and labeling, dietary supplements have different guidelines for testing, safety, and efficacy than pharmaceutical drugs. Unlike drugs, supplements do not require pre-approval by the FDA before they are released for sale to the consumer.
Sounds scary? That is why we at completeblue believe that consumers need to go with a brand they trust for their supplement needs.
How does this affect what supplements are allowed to claim?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined the role of supplements and outlined what dietary supplement companies can legally say about their products. The act dictates that because supplements are not drugs, supplement companies cannot imply, insinuate or state that their product diagnoses, treats, cures, or prevents disease of any kind.
The FDA has further interpreted some normal conditions as disease precursors or markers. This is why you may see some vague wording about what a supplement does—it’s done to comply with FDA’s guidelines on approved dietary supplement claims.
The disclaimer shown above is mandatory for dietary supplements if they make any claims about affecting the structure and/or function of the human body—and the FDA enforces claims to make sure they are following approved guidelines for dietary supplement allowable claims.