- What you need to know first about dietary supplements
- Risks and side effects of dietary supplements
- Dietary supplement advertising and promotion
- Talking with your doctor about dietary supplements
- Common misconceptions about dietary supplements
- FDA regulation of drugs versus dietary supplements
- Manufacturing guidelines for dietary supplements
- Understanding the claims on dietary supplement labels
- Choosing and using dietary supplements safely
- To learn more
Understanding the claims on dietary supplement labels
Before you buy a supplement, read the label carefully (including label claims, packaging, ingredients, and directions for use). It’s easy to misread the claims that are being made about products. The makers of dietary supplements are allowed to make 4 kinds of claims on the labels of their products. These claims are explained below.
Nutritional claims: These are statements about the general effects dietary supplements, vitamins, and minerals have on diseases known to be caused by nutrient deficiency. For example, “vitamin C prevents scurvy.” These claims do not need to be approved by the FDA (US Food and Drug Administration). But the label must also state how many cases of the disease occur in the United States. In this example, consumers must weigh the risk of getting scurvy (which is fairly rare in the US) against the potential risks of the supplement itself.
Claims of well being: These are just that – statements such as “makes you feel better.” These claims do not require pre-approval by the FDA. (See Complementary and Alternative Methods and Cancer and Placebo Effect for more information on these kinds of claims and the effects that supplements and other substances sometimes have.)
Health claims: These are statements about known health benefits of certain compounds. For example, risk-reduction claims such as “folate may reduce the chance of pregnant women delivering an infant with neural tube defects” fall into this category. The FDA must pre-approve all health claims, and requires that they be supported by evidence from scientific studies. Remember that risk-reduction claims are not the same as prevention claims.
Structure or function claims: These are the most confusing claims made to consumers. They are claims about the effect of the dietary supplement on the structure or function of the body. The FDA published a ruling in January 2000 that explained exactly what kinds of structure or function claims were OK for dietary supplements.
Dietary supplements may not make any claims regarding the treatment of disease. But the following descriptions and examples are considered structure or function claims that are OK for dietary supplements:
- The product’s mechanism of action (“works as an antioxidant”)
- The product’s effects on cellular structure (“helps membrane stability”)
- The product’s effects on the body’s physiology (“promotes normal urinary flow”)
- The product’s effects on chemical or lab test results (“supports normal blood glucose”)
- Claims of maintenance (“helps maintain a healthy circulatory system”)
- Other non-disease claims (“helps you relax”)
- Claims for common conditions and symptoms related to life stages (“reduces irritability, bloating, and cramping associated with premenstrual syndrome”)
Structure or function claims are not reviewed by the FDA. In fact, labels that carry them must also include the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The FDA requires this disclaimer on supplement labels because it’s easy for consumers to misunderstand structure or function claims. For example, many consumers believe that a statement such as “helps maintain vision acuity” means the product has been proven to prevent vision loss, or that a statement like “helps maintain a healthy prostate gland” means the product has been proven to prevent or treat diseases like prostate cancer. This is not the case.
Don’t assume that because a product claims to support or promote healthy body function that it prevents or reduces the risk of any disease, including cancer. Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. This means supplements should not make claims, such as “reduces arthritic pain” or “treats heart disease.” Claims like these can only be made for drugs that have been proven to do what they claim.
Products that are proven to have a significant effect on any disease are considered drugs by the FDA and are strictly regulated.
Last Medical Review: 03/31/2015
Last Revised: 03/31/2015