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6 Foods for Special Medical Purposes Granted Approval

  •   25 Feb 2019
  •    Anne Peng
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    • Up to now, 24 FSMPs have been registered [1]and all 6 types of pediatric FSMP categories now have a representative registered product eligible for market circulation and consumption.

    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 typeProduct nameManufacturerCountry of origin
    Premature or low birth weight infant formula food早启能恩Nestlé Deutschland AGGermany
    Breast milk nutrition喜康宝贝添/Similac HMFortifiABBOTT NUTRITIONUSA
    Partially hydrolyzed milk protein formula food超启能恩/NAN H.A.Nestlé Deutschland AGGermany
    Lactose free formula food安儿宁能恩NESTLE NEDERLAND B.V.Netherlands
    Extensively hydrolyzed milk protein formula food蔼儿舒/ALFARENestle Nederland B.V.Netherlands
    Nutritionally incomplete formula food for people with errors of metabolism 纽贝臻/Periflex Ad.SHS International LtdUK

    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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    ChemLinked Editor

    Expertise in Chinese food regulations and import issues and with insights into the market, especially in those sectors: dairy products, baby foods, beverages, health and nutrition foods.

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