Under DSHEA, regulation by the FDA is prohibited unless what condition is met?

The condition under which the FDA is allowed to regulate a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) is if the product is shown to be unsafe. This framework essentially means that dietary supplements can be marketed without prior approval from the FDA, allowing manufacturers to bring products to market without rigorous pre-market safety or efficacy assessments.

However, once evidence emerges indicating that a supplement poses a significant risk to health or safety, the FDA has the authority to intervene. This means that the burden of proof lies with the safety of the dietary supplement. If the supplement is deemed unsafe, the FDA can take action to remove it from the market or require that it be reformulated to ensure consumer safety. Thus, the regulation of dietary supplements is largely reactive, dealing primarily with safety threats rather than proactive scrutiny over their effectiveness or required manufacturing processes.