A Structure That Does Not Function: An Examination of the History and Current Regulatory Status of Dietary Supplements and Their Label Claims

Abstract

After years of ad hoc regulation of dietary supplements, attempting to strictly curtail access to and claims attributed to these products, the DSHEA was a positive step. Both Congress and the FDA were hopeful that it would strike the right balance between ensuring safe, accurate products and information, providing guidance to the industry, and enabling consumers to be more assertive and proactive in making informed health choices. Despite these good intentions and the strong public support for the policy changes the DSHEA suggested, the resulting system fails to fully realize these goals. The resulting consumer confusion prevents them from making informed health choices; lack of adequate industry guidance and regulation enforcement has not entirely produced the “rational Federal framework†that Congress had envisioned. Although the situation is not as dire as attempting to cure all health problems with the untested products of a snake oil salesman, the analogy may still be surprisingly appropriate. Today, consumers continue to rely on confusing and sometimes overstated product claims of often questionable substantiation; now, however, many of them are sacrificing proven medical treatment in the process. The problems in the system, however, are not insurmountable. It is also not possible or realistic to hope to cure all defects and to produce a framework that will satisfy all interests. A solution will likely entail a combination of a variety of factors, including amended regulations, greater FDA funding, legislative action to provide more direction, and consumer or physician education. Given the reward of access to safe, accurate products and information, empowering people to take control of decisions and have better long-term health, it is worth a bit more effort to tweak the system and make it work as planned.