FDA updates dietary supplement label disclaimer policy, claims compliance red line remains unchanged

FDA released updated industry policy and exercises enforcement discretion for dietary‑supplement label disclaimers (“These statements have not been evaluated by the FDA”) and revised label layout requirements. Previous rules required the disclaimer to be repeated on every panel carrying functional claims. Under the new policy, enterprises may place the disclaimer in one prominent spot on the label, linked to all structure‑function claims via symbols, without mandatory repetition on every panel.

Important note: Relaxed layout rules do not mean looser supervision over product claims. Enterprises are still prohibited from making disease‑treatment or cure‑related claims. All structure‑function claims must be supported by sufficient scientific evidence. Basic requirements for font size and claim‑disclaimer linkage remain in force. Cross‑border exporters may optimize label formats accordingly, yet shall strictly review all marketing texts to prevent penalties such as warning letters and cargo detention caused by medical‑oriented promotion。