China Releases First Draft of New Dietary Supplement Law, USCHPA Reports

November 12, 2014

And yes, it does include provisions for a notification-based supplements system.

China has given us the first official glimpse of how the country may rewrite its regulations for dietary supplements. The U.S.-China Health Products Association announced that, on November 5, China’s FDA released two draft documents, “Administrative Regulations for Nutritional Supplements” and “Information Requirement for Nutritional Supplements.”

The drafts confirm that China’s FDA will create a notification-based system for nutritional supplements, instead of the country’s current, problematic “blue hat” product-registration system, as previously reported by Nutritional Outlook, thanks to insights from the USCHPA. This complicated and costly “blue hat” system has stalled the supplements business in China and dampened outside investment in the China health products market.

The new draft documents confirm that the easier-to-navigate notification system would cover only vitamin and mineral supplements, a category whose safety and effectiveness China considers well established.

USCHPA, which has been highly involved in talks with China’s FDA about changing the regulatory framework, says it is in the process of translating the new draft documents and plans to issue comments to China’s FDA by the end of the November. The new regulations could be effective as early as next year, USHCPA says.

 

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com

 

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