What requirement is laid out by the Dietary Supplement Health and Education Act concerning labeling?

The Dietary Supplement Health and Education Act (DSHEA) establishes guidelines for the labeling of dietary supplements. One key requirement under this act is that dietary supplements must include a statement indicating that the product has not been evaluated by the Food and Drug Administration (FDA) for its safety or efficacy. This disclaimer is crucial as it alerts consumers that the claims made by the manufacturer regarding the supplement's health benefits have not undergone scientific review or governmental assessment. This is particularly important in the context of dietary supplements, which often make various health claims that can be misleading without proper federal oversight.

The other aspects outlined, such as listing clinical studies, needing pharmacist approval, or emphasizing ingredients in bold, do not align with the specific labeling requirements established by the DSHEA. Therefore, the mandated statement about the lack of FDA evaluation is essential for consumer awareness and helps prevent potential misconceptions about the supplement's validity and safety.