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From January 25 to January 27, 2018, CFDA Health Food Review Center has published several Notices about the filing information of imported health food. This is the first batch of imported products obtaining the filing certificates, which include 18 nutrition supplements in total. Among them, 5 products got the filing certificates in the end of 2017, and the other 13 products were filed in early 2018.

1. Imported Filing Products Information

According to CIRS count, the 18 approved filing products come from 4 overseas applicants, namely,

Meganutra,Inc., with 6 products;
BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED, with 6 products;
Mega Health International, Inc., with 5 products;
A&Z Pharmaceutical, Inc., with 1 product.

Excepting “BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED”, the other 3 applicants are all American enterprises. In addition, the manufacturers of all 18 products are from America. These show the leading speed of American enterprises in obtaining imported health food filing approval.

The dosage forms of the 18 approved products include tablet, soft capsule, drop, oral liquid, etc. Detailed filing information is as follows:

S.N.	Product name	Applicant	Manufacturer	Filing number
1	Nature´s Nutra Zinc	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201700000001
2	NATURE’S BOUNTY® C	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201700000002
3	NATURE’S BOUNTY® Vitamin D Calcium	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201700000003
4	NATURE’S BOUNTY®Folic Acid	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201700000004
5	NATURE’S BOUNTY®D3	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201700000005
6	D-Cal® Calcium and Vitamin D3 Nutritional Supplement Chewable Tablets	A&Z Pharmaceutical, Inc.	A&Z Pharmaceutical, Inc.	食健备J201800000001
7	Infantum Zinc	Mega Health International, Inc.	Healthy Solutions, LLC	食健备J201800000002
8	Infantum Calcium	Mega Health International, Inc.	Healthy Solutions, LLC	食健备J201800000003
9	Infantum Vitamin D3	Mega Health International, Inc.	Healthy Solutions, LLC	食健备J201800000004
10	Nature´s Nutra Vitamin A&D	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201800000005
11	Infantum Iron	Mega Health International, Inc.	Healthy Solutions, LLC	食健备J201800000006
12	Nature´s Nutra Sunshine Vitamin D3	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201800000007
13	Infantum Vitamin AD	Mega Health International, Inc.	Healthy Solutions, LLC	食健备J201800000008
14	Nature's Nutra Prenatal Folic Acid	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201800000009
15	Nature´s Nutra Iron	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201800000010
16	Nature's Nutra Calcium	Meganutra,Inc.	Healthy Solutions, LLC	食健备J201800000011
17	NATURE'S BOUNTY®E	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201800000012
18	NATURE'S BOUNTY®K2	BOUNTY OF HEALTH (HONG KONG) COMPANY LIMITED	Robinson Pharma, Inc.	食健备J201800000013

Concerning the health function, 4 approved products are intended to “supply 2 nutrients” (2 products of supplying vitamin D +Ca, 2 products of supplying vitamin A +D), and the other 14 products are all intended to supply single vitamin or mineral. For the moment, there is no imported filing product with the function of “supply multivitamins and/or minerals (3 or more vitamins or minerals) published by CFDA Health Food Review Center. In summary, the health functions of the 18 approved products are simple.

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2. CIRS Comments

Health food filing is unprecedented in China. It shortens the application time and reduces the enterprise burden. With the smooth publishing of the first batch of imported health food filing certificates, CIRS speculates that more and more imported health foods will get the filing certificates successfully in the near future.

In order to enter China market as soon as possible with legal status, relevant nutrition supplement enterprises are recommended to further study on the requirements of China health food filing, carry out the filing feasibility analysis before filing application, and submit health food filing application to CFDA at the earliest. More regulatory compliance questions about the health food filing in China, please contact us at service@cirs-group.com.

Reference

Information on the 18 Imported Nutrition Supplements

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18 Imported Nutrition Supplements have Obtained the Health Food Filing Certificates in China