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### Viewing cable 03OTTAWA1528, CEREAL FORTIFICATION - CANADA DEFERS AUTHORIZATION

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Reference ID | Created | Released | Classification | Origin
--- | --- | --- | --- | ---
03OTTAWA1528 | 2003-05-29 19:37 | 2011-04-28 00:00 | UNCLASSIFIED//FOR OFFICIAL USE ONLY | Embassy Ottawa

`

    This record is a partial extract of the original cable. The full text of the original cable is not available.

` `

    UNCLAS OTTAWA 001528

    SIPDIS

    SENSITIVE

    DEPT FOR WHA/CAN (NORMAN)
    DEPT PASS TO USTR SCHANDLER, STROJE AND SBOMER
    USDA FOR FAS, INTERNATIONAL TRADE POLICY (SHEIKH, SIMMONS)
    COMMERCE FOR CBUSQUETS AND GWORD

    E.O. 12958: N/A
    TAGS: ETRD EAGR CA
    SUBJECT: CEREAL FORTIFICATION - CANADA DEFERS AUTHORIZATION
    FOR U.S. NUTRIENT LEVELS

    REF: 2002 OTTAWA 3225

    This Cable is Sensitive but Unclassified; please handle
    accordingly.

    ¶1. (SBU) Summary - Health Canada has once again deferred
    making a final decision on General Mill's August 2001
    application for temporary marketing authority to sell
    breakfast cereals with U.S. vitamin fortification levels in
    Canada.  After their own analysis indicated that high levels
    of folic acid could mask a B-12 vitamin deficiency in
    children, Health Canada decided to wait for the results of an
    Institute of Medicine Study on the tolerable upper levels of
    nutrient intake before making a final judgment on General
    Mill's application.  This will delay a decision on General
    Mill's submission until fall 2003, at the earliest.  End
    Summary.

    ¶2. (U) Due to regulatory differences, American manufacturers
    must currently do separate production runs for the Canadian
    and U.S. markets in order to comply with different limits of
    vitamin and micro-nutrient fortification in each country.
    Both Health Canada and USG agencies are sponsoring a
    long-term study of Dietary Reference Intakes by the U.S.
    Institute of Medicine (IOM).  When all phases of the study
    are completed in 2004, it will provide a common baseline for
    each country to review nutrient levels and harmonize
    nutritional standards.  The IOM study is one element of an
    ongoing GOC review of Canada's food fortification policy.

    ¶3. (SBU) In August 2001, General Mills applied to Health
    Canada for a Temporary Marketing Authorization Letter (TMAL)
    to allow sales of their 19-product range of breakfast cereals
    in Canada at U.S. fortification levels.  The TMAL would
    provide General Mills with immediate, but short-term
    regulatory relief to sell cereals fortified at U.S. levels
    while the IOM study and Canada's fortification policy are
    completed.  TMALs are used to permit temporary marketing
    authorization when the benefits of a product are clear but
    the potential risks are still under study.  TMALs have been
    granted by Health Canada for numerous products including
    calcium-enhanced orange juice and Omega-3 eggs.  General
    Mills provided all the information requested by Health
    Canada, and even voluntarily changed fortification levels on
    zinc to Canadian standards.  Well into the review process
    Health Canada raised additional concerns about the levels of
    folic acid and requested further studies.  General Mills
    supplied additional data on folic acid in February 2003.  As
    of mid-May, General Mills had heard nothing from Health
    Canada and asked the Embassy to intervene, which we did.

    ¶4. (SBU) On May 28, Health Canada Deputy Minister Ian Green
    informed the DCM and General Mills representatives of the
    results of their analysis of General Mill's data on folic
    acid.  The Health Canada panel which reviewed the data is
    concerned that the levels of folic acid permitted under U.S
    regulations could mask a vitamin B-12 deficiency in children.
     Green noted that studies on the upper levels of intake from
    other countries, including one from the United Kingdom, have
    raised similar concerns.  Health Canada has decided to put
    off a final decision on General Mill's TMAL until after the
    publication of an IOM study on the upper reference levels of
    nutrients, which is due to be completed by September 30,
    ¶2003.  This study is part of the larger IOM review of dietary
    reference intakes.  Green promised to provide General Mills
    and the Embassy with a copy of the panel's report.

    ¶5. (SBU) Comment - We have been extremely frustrated by
    Health Canada's lack of transparency throughout the TMAL
    review process.  Our numerous efforts to seek clarification
    from Health Canada on both the process and timing of their
    review have been regularly ignored or belatedly answered with
    bureaucratic doublespeak.  General Mills has complained that
    Health Canada has repeatedly raised the bar as to what is
    required for approval of the TMAL.  The current delay pending
    final results of the IOM study would appear to run counter to
    both the letter and spirit of the TMAL process. In our
    conversation with Green we stressed the importance of
    ensuring that Health Canada takes a final decision on the
    TMAL shortly after the release of the IOM report.
    CELLUCCI

`