Contenu connexe Similaire à Health Food Regulations in China 2014 (20) Plus de Asian Food Regulation Information Service (20) 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. 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
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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?
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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).
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5. Two categories of health foods
Regular
health foods Nutrient
supplements
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6. How is a health food regulated?
ƒ China Food and Drug Administration
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7. How is a health food regulated?
27 health
claims
Registration
Costly
Local data
Lengthy
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9. Proposed amendments (2)
A health food
using a new
ingredient
A health food
Imported for
the first time
Registration
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10. Proposed amendments (3)
Notification/
Filing system
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11. Impacts
Filing
Registration
If a product is eligible for “filing”, registration is not required
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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
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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
