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Mid-Year Regulatory Developments in APAC’s Supplement Sector

Here’s a summary of the key developments in the regulation of health supplements and traditional medicine in the Asia-Pacific region:

Major Developments

  • China and Taiwan: China approved new joint health claims, while Taiwan proposed reclassifying Traditional Chinese Medicine (TCM) ingredients under a revised regulatory framework.

Safety Evaluations

  • Regulatory Scrutiny: Countries like Australia, India, and South Korea are increasing scrutiny on botanicals such as ashwagandha and andrographis due to rising adverse events.
    • India: The Food Safety and Standards Authority (FSSAI) banned the use of ashwagandha leaves in food products, sparking industry debate and a legal challenge that temporarily halted the ban.
    • Australia: The Therapeutic Goods Administration (TGA) issued a safety advisory regarding ashwagandha and proposed removing andrographis from low-risk ingredient lists due to potential risks.

New Approvals

  • Expanded Use Guidelines:
    • Coenzyme Q10 and melatonin can now be formulated as oral liquids in China.
    • 3’-sialyllactose (3′-SL) is approved for use in infant formulas, joining other human milk oligosaccharides (HMOs).

Labeling Updates

  • Health Claims: China permits joint health claims, including those supporting bone and joint health, reflecting growing demand.
  • Australia/New Zealand: New rules require advisory statements for sport nutrition products containing caffeine, addressing concerns for breastfeeding women.

Traceability and Advertising Controls

  • Singapore: Plans to implement a health supplement notification system to improve product traceability.
  • Vietnam: Launched an online traceability platform to combat counterfeit products after a series of scandals.
  • China: Authorities are working with livestream commerce platforms to enforce stricter advertising regulations.

These developments indicate a significant shift towards tighter regulations, safety evaluations, and improved product traceability in the health supplement sector across the Asia-Pacific region.

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