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According to Natural Products Insider, health food sales in China are estimated to reach RMB300 billion ($47.5 billion USD) by 2019. More and more Chinese consumers are looking to natural supplements as rates for certain illnesses such as lung cancer and breast cancer are on the rise, and they are looking to purchase foreign health products. It begs the question:

How is a dietary supplement approved in China?

The process is not a simple one. On average, it will take 2-3 years and about 60,000-100,000 RMB ($9-15,800 USD) to approve it. There are
only about 15,000 health products that are approved by the CFDA (China Food & Drug Administration) currently. In 2014, the total number of health products totaled 1,350 products and of those products, 99% of them were domestic. Imported health products only totaled about 1%. Even deeper, they were composed of 28% nutritional health products and 72% health functional products, which is comprised of supplements that “increase the immune system” and “reduce fatigue.”

On October 1st, Chinese officials recently enacted the new Chinese Food Safety law that was passed in April of this year.
It included 13 items related to the regulation of healthy foods. The changes include:

  • A new notification system for products that use dietary ingredients from the health food ingredients catalog and vitamins and products
  • The provincial-level CFDA will oversee the domestic health food product notification

In order to be registered, or “notified” as the CFDA calls it, an imported health food product must be marketed for at least one year in
its producing country and all application materials must be submitted in Chinese, with the original materials attached for reference. A Chinese notary must certify that the translation is consistent with the original.

The CFDA also plans to create a health food ingredient and health claim database that will be filled with a product’s ingredients and its health claims.

The new health product ingredient database will include the following: ingredient name, its formulation, usage amount, permitted health function claims, quality standards, active components, testing methods, and other related information. Only vitamins and minerals that are listed in the database can be combined freely to create “multi-unit” health products. If combining more than two ingredients into one health product, a company must provide scientific justification and historical use in order to do so.

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