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.
You have probably seen this warning many times, but perhaps never paused to consider what it meant. Or, maybe you haven’t seen it, because it usually appears in very fine print and is only obvious if you are looking for it.
What is it, what does it mean, and why is it important?
In 1994 congress enacted the Dietary Supplement Health and Education Act (DSHEA), effectively allowing any product under the broad classification of “dietary supplement” to be manufactured and sold to the American public with little or no regulation.
Peter Lipson, MD, a contributor to one of my favorite blogs, Science-Based Medicine, calls the DSHEA “a travesty of a mockery of a sham.” (Cynics will tell you that the act was sponsored by congressmen with ties to Herbalife and other supplement manufacturers.)
The gist of the DSHEA is that the makers of dietary supplements are able to sell their products without the expense and burden of obtaining approval from the Food and Drug Administration (FDA).
Consumers—all of us—must therefore take it on faith that such supplements are safe and their advertised claims are honest.
As another Science-Based Medicine writer puts it, “The fox guards the hen house.”
Supplements include vitamins, minerals, herbs, enzymes, amino acids and any number of metabolites. Often such products are labeled as “all natural,” implying they are safe. Unlike drugs that are regulated by the FDA, dietary supplements do not need to include warnings about negative side effects.
Clever marketing uses vague phrases such as “supports the immune system” or “enhances memory function.” A product cannot claim to treat a disease, so even though it’s implied, a label cannot say “cures a cold” or “prevents Alzheimer’s.”
And as long as the manufacturers include a generic disclaimer—the Quack Miranda Warning —with the products, they are in compliance with the woefully inadequate stipulations of the DSHEA.
Some supplements, such as vitamins and minerals, have a quantity of supportive research, but even then there can be considerable confusion about proper dosage. Many more supplements have little or no research to back up their claims.
In worst-case scenarios, these dietary supplements prove to be harmful, or even deadly. In 2004, the popular performance-enhancing and weight loss supplement, Ephedra, was banned after a number of heart-related deaths. Technically, Ephedra was an herbal supplement and fell under the rules of the DSHEA.
Last year more than $30 billion was spent on supplements. Look for the Quack Miranda Warning, and if you see it think twice (or more) about purchasing the product, at least until you have done a little more research on your own.