What “not evaluated by the FDA” actually means

Almost every supplement label in the United States carries a sentence like this: these statements have not been evaluated by the Food and Drug Administration, and this product is not intended to diagnose, treat, cure or prevent any disease.

It reads like legal boilerplate, and it is, but it also tells you something useful about how the system works.

Supplements are not approved before they are sold

In the US, dietary supplements are regulated as a category of food, not as medicines. Unlike a prescription drug, a supplement does not need FDA approval for safety or effectiveness before it goes on sale.

The company that makes or sells the product is responsible for making sure it is safe and that the label is truthful and not misleading.

What the FDA does do

The FDA can take action against a product after it reaches the market if it is unsafe or misbranded. It also sets rules for labelling, including the Supplement Facts panel and the claims a product may make.

A product also may not claim to treat or cure a disease. That is the reason for the second half of the disclaimer.

What this means for you as a shopper

Because there is no pre-sale approval, the label and the company behind it carry more of the weight. Look for a clear Supplement Facts panel with specific amounts, an allergen statement, and a way to contact the company.

Be sceptical of any product that promises a cure, and be careful with testimonials, which describe one person’s experience rather than a result you should expect.

Three common misunderstandings

First, “not evaluated” does not mean a product is unsafe. It means the FDA did not review it for approval before sale. Second, “natural” does not automatically mean safe, because many natural substances have powerful effects or can interact with medicines. Third, a clean-looking label is not independent proof of quality, since the label is the company’s own statement.

A quick label checklist

Check that the Supplement Facts panel gives a serving size and the amount of each ingredient. Look for an allergen statement and a list of other ingredients. Make sure there is a way to contact the company, and be wary of any claim that sounds like a cure.

Finally, if you take medicines or have a medical condition, show the label to a pharmacist or doctor. They can tell you things that no article can.

And talk to a professional

The FDA recommends speaking to a health professional about supplements you use, particularly if you take medicines or have a medical condition. A supplement is not a substitute for medical care.