Consumer (Mis)Understanding of Dietary Supplement Labels

“Helps lower cholesterol levels” and “helps promote healthy cholesterol levels.” Both of these claims are found on pharmacy products. And to ordinary consumers, the message is the same: take this pill and improve your cholesterol. Nevertheless, Congress has placed these statements in two very different regulatory categories. The former is classified as a disease claim, and the latter as a structure/function claim.

Whereas products making disease claims require years of clinical trials and analyses before regulatory approval can be granted, products making structure/function claims do not even require governmental review before they can be sold to consumers. This bifurcated regulatory system and the concomitant lack of oversight regarding structure/function claims has encouraged dietary supplement manufacturers to produce thousands of products that mislead consumers. This Article investigates this phenomenon and proposes a change to the regulation of dietary supplement claims. Specifically, we contend that the Food and Drug Administration (“FDA”) should regulate claims that mean the same thing in the same manner