Regulatory Assessment: GMP Guidelines in South Korea, NMN Regulations in India, and Probiotic Standards in China

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Summary of Recent Regulatory Updates in Health Functional Foods

1. South Korea’s MFDS Regulations:

   • The Ministry of Food and Drug Safety (MFDS) is refining GMP standards and labeling requirements for customized health functional foods until August 31.
   • A focus on better quality management and reprocessing procedures is highlighted.

2. Nicotinamide Mononucleotide (NMN) in India:

   • NMN has been deemed an unapproved ingredient by the Food Safety and Standards Authority of India (FSSAI).
   • Recent notices addressed to companies selling NMN indicate a push for compliance with local regulations.

3. New Probiotic Legislation in China:

   • The State Administration of Market Regulation (SAMR) is consulting on new laws that require more stringent guidelines for probiotic health foods, including minimum CFU and strain specifications.

4. Regulatory Developments in Asia-Pacific:

   • Significant scrutiny of botanicals like ashwagandha due to safety concerns.
   • Additional updates include new health claims approvals and reclassification of Traditional Chinese Medicine in Taiwan.

5. Liver Injury Concerns with Ashwagandha:

   • The Australian Therapeutic Goods Administration (TGA) has reported a rare risk of liver injury associated with ashwagandha, indicating ongoing safety assessments.

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