By Feb. 22, 2019, former FDA has publicized registration details on a total of 24 foods for special medical purposes (FSMP) for public reference[2]. We discovered that an additional 6 products have been granted registration approval by the State Administration for Market Regulation (SAMR), although their registration information hasn’t been publicized yet.
The 6 registered pediatrics FSMPs are all imported products
Similac HMFortifi manufactured by ABBOTT is the first breast milk nutrition to be registered. At this stage all 6 categories of pediatric FSMP have been registered and are now available in China. Periflex Ad by SHS became the first registered 10+ FSMP designed for those with errors of metabolism (e.g. phenylalanine hydroxylase deficiency- PKU) which cannot metabolize specific amino acids and for which certain amino acids become essential (tyrosine in PKU).
| Formula type | Product name | Manufacturer | Country of origin |
| Premature or low birth weight infant formula food | 早启能恩 | Nestlé Deutschland AG | Germany |
| Breast milk nutrition | 喜康宝贝添/Similac HMFortifi | ABBOTT NUTRITION | USA |
| Partially hydrolyzed milk protein formula food | 超启能恩/NAN H.A. | Nestlé Deutschland AG | Germany |
| Lactose free formula food | 安儿宁能恩 | NESTLE NEDERLAND B.V. | Netherlands |
| Extensively hydrolyzed milk protein formula food | 蔼儿舒/ALFARE | Nestle Nederland B.V. | Netherlands |
| Nutritionally incomplete formula food for people with errors of metabolism | 纽贝臻/Periflex Ad. | SHS International Ltd | UK |
19 of 24 registered products manufactured by overseas enterprise
Only 5 FSMPs are domestic, 1 by Beingmate，2 by Synutra (China) and 2 by Hengrui Health (a little known Chinese company established in 2016). Though many Chinese companies are eager to get in on the FSMP market, stringent regulations and lack of technical and R&D capacity hold them back.
ABBOTT has 7 registered products, ranking #1 in terms of number of registered products. Nestle and SHS each has 5, taking the second and third places.
Regulations stymieing domestic interests
The administration system for FSMP mainly includes production licensing and product registration. On Feb. 1st this year, SAMR launched Detailed Inspection Rules for Production Licensing of FSMP[3], finalizing China’s first effective regulatory system for administrating the FSMP sector since the designation of FSMPs as foods (formerly classed as pharmaceuticals) in China’s 2015 Food Safety Law. These stringent regulations have seen many manufacturers look to the lower hanging fruit of related food categories with lower market entry barriers and corresponding regulatory obligation[4]. One Shanghai supplier of oligopeptides told ChemLinked, “The whole FSMP regulatory system is just too strict to comply with and we only supply ordinary food manufacturers with oligopeptide.” Given the current imbalance between domestic and international stakeholders in terms of total registered products, Chinese regulators may well reconsider regulations which are placing their domestic industry at a considerable disadvantage. It is also possible that we will see a situation unfold which mirrors developments in China’s infant formula sector, where the market was initially dominated by international players but through strategic capital investment, regulatory reform and technology transfer, parity is restored over the course of several years.
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