A2M the a2 milk company limited

I think you may be misunderstanding what BUB has. Either way it...

  1. 4,824 Posts.
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    I think you may be misunderstanding what BUB has. Either way it is worthwhile restating as the confusion seems to come up alot.

    To import infant formula through official channels into China and the USA, there are separate accreditations 1) for IF production facilities and 2) for the IF products themselves.

    Synlait and MVM have facilities that have received both the FDA accreditation and SAMR (China) accreditation. BUB only has the FDA accreditation for its facility.

    SAMR facility accreditation is a necessary precursor to applying for and registering infant formula in China, just as FDA facility accreditation is necessary precursor to applying to import and market infant formula in the USA.

    Of the three, only Synlait has gotten a product registered for China importation (A2's China label). None of the others have products approved by SAMR.

    None of these three (BUB, Synlait, or MVM) have recieved any product approval from the FDA through its standard registration process (the long 2-3 year one you mentioned, which involves clinical trials, submissions about quality etc.)

    BUB began importing toddler formula into the USA, rather than infant formula, because toddler formula does not require any approval from the FDA.

    Now, BUB has applied for and received permission to import through the temporary import scheme put in place by the FDA, which is in effect for 180 days. After that, unless there is a wholesale longer term change to the way the USA regulates IF imports, it will go back to having no FDA approval for any of its infant formula products.

    It's hard to be sure how this temporary process operates in terms of who gets approved, but I think it is likelier than not that A2M and Fonterra will receive a similar temporary approval.
    Last edited by werdplaya58: 31/05/22
 
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