The FDA and Supplements
Key points from this section:
- The FDA does not approve supplements (sometimes also referred to as: dietary supplements, vitamins, multivitamins, nutraceuticals, etc.).
- The FDA classifies supplements as a subset of food products, not as pharmaceutical drugs.
- Considering that supplements are classified as a subset of food products, and not pharmaceutical drug products, supplements cannot make any claims to diagnose, treat, cure, or prevent any disease.
- Any supplement that makes claims with respect to the structure and/or function of the human body, must include a specifically stated FDA disclaimer.
When visiting websites of supplement products, you may often find the following disclaimer somewhere on the product's webpage, or printed on the bottle's label:
"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."
Although this disclaimer may seem odd to some, it is important to note that the inclusion of this statement is a standard practice and is often a requirement from the U.S. Food and Drug Administration (FDA). The FDA is federal administration that regulates products for public health such as food, cosmetics, pharmaceutical drugs, medical devices and other consumer goods. According to the FDA, supplement products are considered a subset of food and nutrition products. That being said, in the U.S., supplement products are not grouped with pharmaceutical drugs, which have their own FDA regulatory authorization processes for claims validation, efficacy, safety, etc. According to FDA regulations, supplement products have their own specific labeling requirements, and cannot claim to diagnose, treat, cure, or prevent any disease. Furthermore, the Dietary Supplement Health and Education Act of 1994 (DSHEA) states that supplement companies cannot imply, insinuate or state that their product diagnoses, treats, cures, or prevents disease of any kind. This is often why many supplement products may seem fairly vague in their descriptions. Supplement products may however make claims about affecting the structure and/or function of the human body. If any such claims are made, the supplement company must include the disclaimer stated above wherever any structure and/or function of the human body claims are presented. Lastly, it is also important to note that although the FDA may approve pharmaceutical drugs, the FDA does not approve any supplement product, in the same way that they do not approve of any food products.
We hope that this helps to offer an understanding of why we have an FDA disclaimer on our website and product label. If you have any further questions, please feel free to contact us.