First electrolyte beverages recognised as FSMP in China under new rules, while Nestlé also makes debut

30-Jul-2018 - Last updated on 30-Jul-2018 at 06:46 GMT

China's State of Administration for Market Regulation has announced a new batch of products approved as FSMP last week. ©Getty Images

Two electrolyte beverages have been accepted as Foods for Special Medical Purpose (FSMP) by China's State Administration for Market Regulation (SAMR) — the first time electrolyte beverages were approved.

The products are manufactured by Chinese firm Suzhou Hengrui Health, a subsidiary of Jiangsu Hengrui Medicine.

NutraIngredients-Asia understands that the two electrolyte drinks are targeted at patients suffering from gut problems and Suzhou Hengrui Health is waiting for authorities' approval before it can begin commercial manufacturing.

Including the electrolyte beverages from Suzhou Hengrui Health, a total of four products were approved as FSMP during the latest round of announcement on July 23.

Prior to the announcement, only eight products were approved during the period between November 2017 and last month.

China and pharmaceutical firms to catch up?

This is the second time that a China firm has entered the FSMP list. Hangzhou-based Beingmate was the first China firm to enter the list largely dominated by foreign firms during February this year.

“Before year 2013, we rely heavily on imports for FSMP. Now that Hengrui Health is on the list together with Beingmate, we see that there is a huge potential for nationally produced FSMP,”Cathy Yu, general manager of food business division at Hangzhou REACH Technology Group Co., Ltd. (CIRS Group), a consultancy firm told NutraIngredients-Asia.

Yu also noted that as compared to other companies on the list, Suzhou Hengrui Health is also the first firm that does not have prior experience in producing infant formula milk, and believes its status as a pharmaceutical company could give it an edge over the others.

“Pharmaceutical companies will have certain advantages when it comes to the FSMP market. Firstly, in terms of product development and clinical trials, pharmaceutical companies are relatively experienced. Secondly, pharmaceutical companies have more developed distribution channels for FSMP.”

“CIRS believes that pharmaceutical companies will occupy the bulk of enterprises that have products approved as FSMP.”

Nestle’s debut entry

Besides Suzhou Hengrui Health, Nestlé is another firm to enter the list for the first time.

It gained entry via through its PreNAN infant milk formula for pre-term and low-birth weight infant.

The fourth product to be approved as FSMP came from Mead Johnson’s Enfamil lactose-free infant milk formula. The firm already had a partially-hydrolyzed lactoprotein infant formula approved four months ago.

The FSMP status for these four products would be valid until 22 July 2023.

Nestlé’s ambition to scale up its FSMP offerings was made known earlier in May. It planned to launch more than 20 FSMP products in China over the next two years, including formulations to target specific diseases like diabetes.

FSMP are made from special processing formula, intended to meet the needs for people who have limited feeding, digestion absorption disorders, metabolic disorders or specific disease condition.

It is classified into two categories, namely 1) FSMP for infants aged 0-12 months and 2) FSMP for those who are at least one year old.

The registration procedures include feasibility analysis, sample test, dossier preparation, application submission, technical review, on-site inspection.

Abbott topping the chart

Abbott tops the chart with four products approved as FSMP.

Mead Johnson, Danone and Suzhou Hengrui Health trail behind, with each of them gaining approval for two of their products, while Beingmate and Nestlé each has a product approved as FSMP.

As of 23 July, 12 products were approved as FSMP, of which, only three came from local China firms.

Cost and timeline

Under successful conditions, enterprises will need to spend three years (including development, preparing documents for registration, conducting clinical trials, and approval from SAMR), Yu said.

Cost wise, enterprises can expect to spend approximately one million RMB which is inclusive of examination fees and agent registration fees when going through the registration process, she added.

As some of the domestic companies are from a pharmaceutical background, they may not have prior experience in going through the FSMP process.