Consumer Protection Agency Implements Strict Regulations on Dietary Supplement Health Claims

The Consumer Affairs Agency announced comprehensive regulations governing health claims for dietary supplements, addressing widespread misleading marketing practices. The new framework requires scientific evidence from human clinical trials for any health benefit claims, with mandatory pre-market review for products claiming specific health improvements. Companies must submit detailed documentation including study designs, participant demographics, and statistical analyses to support marketing claims. The regulations prohibit vague terminology such as 'supports wellness' or 'promotes vitality' without specific measurable outcomes. Penalties for violations include fines up to 300 million yen and mandatory product recalls. The agency established a public database listing approved and rejected health claims, enabling consumers to verify product legitimacy. Online marketplace platforms must implement verification systems to prevent sales of non-compliant products. The regulations include specific provisions for traditional Japanese health foods, requiring evidence-based substantiation while recognizing historical use patterns. Implementation includes a 12-month grace period for existing products to comply or modify claims. This regulatory overhaul responds to increasing consumer complaints about ineffective supplements and aims to establish Japan as a model for evidence-based supplement regulation.