US embassy cable - 03OTTAWA1528

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