USCHPA submits regulatory paper to China’s FDA
The association is happy to see China reforming the supplement industry
The US–China Health Products Association (USCHPA) submitted its regulatory question and comment paper to China’s Food and Drug Administration (CFDA).
The association’s regulatory paper was in response to CFDA’s release on 28 July 2015 regarding three draft documents (below) scheduled to restructure the health product (dietary supplement) industry.
- Health Function Claim Directory and Material Inventory
- Measures on Management of Health Food Labelling
- Measures for the Registration and Filing of Health Food.
The translation of the above documents can be viewed on the association’s website under 'regulatory updates' here.
The association is happy to see China reforming the supplement industry. It has been a chaotic and extremely difficult regulatory system to follow for all involved and has been in desperate need of restructuring.
The two most important changes that CFDA will be implementing is the creation of a product filing system and an approved raw ingredient catalogue.
The filing system is supposed to be akin to a type of notification system. However, only vitamins, minerals and some other select nutrients will be allowed to use the filing system. This should help to increase transparency and speed entry to market. Unfortunately, it looks as thought products containing complex formulas, especially those containing botanicals, will still have to go through the current registration process, which typically costs in excess of $80k per SKU and can take up to 3 years to finalise. USCHPA is hoping this registration process will also see some streamlining and much needed transparency.
The approved raw material catalogue will be created by CFDA in conjunction with the National Health and Family Planning Commission. This list will help industry to better understand exactly what ingredients they are allowed to use when formulating their finished products.
Among the many questions and comments USCHPA posed to CFDA, the two that stand out would be the need of imported products to have a record of sales and marketing of at least one year in the country of origin prior to attempting entry. As well as showing the results of three consecutive batch records. This is not obviously required for domestic companies and is a form of non-tariff barrier to trade.
Furthermore, there is wording that states, imported products are expected to follow China’s quality standards and that on-site inspections would not be out of the question. This wording needs clarification, but could require foreign manufacturers to follow Chinese GMP standards for health food products, which would certainly be problematic.
Those wishing to keep up on the latest developments in China’s health food product regulations as well as be a part of the ever-growing team of international companies that make up the association should consider joining USCHPA.