FDA Disclaimer

                                                      FDA

“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.”  In the United States we find this disclaimer on many of our favorite vitamins, minerals and dietary supplements but what is this statement telling consumers?  First, we need to define what Dietary Supplements are.  Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

 

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This disclaimer that the FDA requires on dietary supplements mostly refers to the claims a manufacturer can make regarding what their product does for a consumer.  For instance, it is illegal for a dietary supplement manufacturer to make any claims stating that their product can treat, prevent or cure a disease.  These claims are reserved for pharmaceutical products that have undergone years of extensive clinical, laboratory and safety studies.  These studies are costly and can take decades to complete.  There are, however, a few categories of claims that are allowable in the dietary supplement world. 

 

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 against the potential risks of the supplement itself.

Claims of wellbeing: These are just that – statements such as “makes you feel better.” These claims do not require pre-approval by the FDA.

 

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 OK for dietary supplements are.

 

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”)

 

 

 

The main take away with dietary supplements is to remember that just because a product claims promote a healthy body function that it does not help treat or prevent any type of disease.  Be wary of any dietary supplement that claims to treat heart disease or reduce arthritic pain, for example.  These direct treatment claims are reserved for pharmaceuticals that have been proven to do what they claim.