This is according to regulatory consultancy firm Hangzhou Reach Technology Group (CIRS) which held a webinar titled “The development of Foods for Special Medical Purposes (FSMP) in China” recently.
Ever since the State Administration for Market Regulation (SAMR) was in charge of approving FSMP product registration in 2016, a total of 18 products have been approved.
Notably, most of these products – 15 of them are catered to premature and/or low weight birth infants, while only three are for consumers aged one and above.
“The demand for FSMP is increasing due to the ageing population and the market needs to cater to this group of individuals,” said the webinar speaker, Wing Yu, who is the technical manager of the food business division at CIRS.
On the other hand, the bulk of approved products,13 of them, are foreign brands, while five came from three Chinese companies.
Overall, Abbott dominated the FSMP sector, with a total of six approved products.
As for product format, she noted that most products approved come in powder or liquid form.
According to the current registration list, no product in the form of gel capsule nor human milk fortifier product has obtained the registration certificate.
In China, FSMP is meant for fulfilling the nutritional needs of patients who have problems 1) ingesting food 2) digesting food and/or suffering from 3) metabolic syndromes and 4) specific illnesses.
As for the suitable age of consumption, FSMP products are categorised into two groups: 1) for infants aged 0 to 12 months and 2) for individuals aged one and above.
Unlike health supplements, FSMP and general foods are not allowed to bear functional claims. Only health supplements can claim to produce functional benefits.
Transition period ends
From Jan 1 next year, FSMP products that are produced in or exported to China, need to apply for FSMP registration certificates. The product label and user manual should also state the certificate number.
FSMP products that are produced in or exported to China before Dec 31 could be sold within China until the product expiry date ends.
“The transition period is until Dec 31 and it will not be extended any further,” Yu noted.
“This is because the regulations for FSMP product registration have been introduced (by the SAMR) since year 2016 and the guidelines are becoming more comprehensive and holistic,” she explained.
She also cautioned that the Chinese authorities would conduct sample testing of FSMP products that have already secured registration certificates. Thus, manufacturers who have received the FSMP registration certificates should remain conscientious.
History
FSMP first entered China in the 1980s as a type of pharmaceutical product and the sector was dominated by major MNCs such as Nestlé.
From 2012 to 2015, it could be categorised as a pharmaceutical, FSMP, health food or general food, depending on the product type and product purpose.
However at present, FSMP can no longer be categorised into multiple groups and strictly falls under the FSMP catgory.
In July 2016, the authorities also implemented new regulations, and mandated FSMP manufacturers to obtain product registration certificates from China Food and Drug Administration (CFDA) - which is the current State Administration for Market Regulation (SAMR).
“As compared to the Western countries, our FSMP sector is still under development,” Yu concluded.