Cablegate: Cereal Fortification - Canada Defers Authorization

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





E.O. 12958: N/A

REF: 2002 OTTAWA 3225

This Cable is Sensitive but Unclassified; please handle

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

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.

© Scoop Media

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