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Health Food Regulations in China 2014

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Health Food Regulations in China 2014

  1. 1. Recent Regulatory Developments of Health Food Regulations in China September 4, 2014 Jenny Li Keller and Heckman LLP The Bund Center, Suite 3604 222 Yan’an Dong Lu Shanghai, China 200002 86 21 6335.1000 li@khlaw.com www.khlaw.com Washington, DC ● Brussels ● San Francisco ● Shanghai
  2. 2. Food and Drug Practice ƒ We evaluate and defend products made by the spectrum of industries regulated by: • China Food and Drug Administration • U.S. Food and Drug Administration • European Commission and Member States • Similar authorities throughout the world ƒ The products we evaluate and assist to get onto the market include: • Food (e.g., health foods) and food additives • Pharmaceuticals • Medical devices • Veterinary products • Dietary supplements • Cosmetics 4 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  3. 3. Topics ƒ What is health food? ƒ How is a health food regulated currently? ƒ What has been proposed to amend the current health food system? ƒ What would be the impact on industry? ƒ How can you prepare for the changes? 5 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  4. 4. What is health food? ƒ “Health foods” are foods which make specific health functions (e.g., the relationship between the food and a physiological function of the body or a reduction of disease risk), or the foods which are intended to supplement vitamins and minerals (i.e., nutrient supplements). 6 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  5. 5. Two categories of health foods Regular health foods Nutrient supplements 7 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  6. 6. How is a health food regulated? ƒ China Food and Drug Administration 8 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  7. 7. How is a health food regulated? 27 health claims Registration Costly Local data Lengthy 9 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  8. 8. Proposed amendments (1) 10 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  9. 9. Proposed amendments (2) A health food using a new ingredient A health food Imported for the first time Registration 11 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  10. 10. Proposed amendments (3) Notification/ Filing system 12 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  11. 11. Impacts Filing Registration If a product is eligible for “filing”, registration is not required 13 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  12. 12. How can you prepare for the changes? ƒ Revisit product formulations currently sold in China or at the R&D process to determine whether any of them may benefit from the new filing system ƒ Revisit the claims made on the labels ƒ Closely follow up on regulatory developments especially the implementing regulations 14 │ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2014
  13. 13. Thank you! Jenny Li Legal Consultant Keller and Heckman LLP The Bund Center, Suite 3604 222 Yan’an Dong Lu Shanghai, China 200002 86 21 6335.1000 li@khlaw.com www.khlaw.com Washington, DC ● Brussels ● San Francisco ● Shanghai

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