HHS:PHS:FDA:CFSAN:OC:DCP:MSB 
 
              5100 Paint Branch Parkway 
                 College Park, MD 20740-3835
 
                            M-I-03-6
 
                    April 17, 2003
 
 
TO:  		All Regional Food and Drug Directors 
       Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	Evaluation of M-I-92-13
 
 
Proposal 141, passed at the 2001 National Conference on Interstate Milk
Shipments (NCIMS), recommended that the Food and Drug Administration (FDA)
evaluate M-I-92-13 with regard to the hazard levels of vitamins A and D for
various products, such as eggnog, sour cream, creams, half and half, evaporated
milk and concentrated milk.  The following is the status of the Reference Daily
Intake (RDI) of vitamins A and D from milk and milk products.  
 
The National Academy of Science (NAS) started the 24-month project "Use of
Dietary Reference Intakes in Nutrition Labeling" in October 2001. The final
report from NAS is to be issued in October 2003.  If new values are proposed by
FDA's Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS),
the process for public comment and rule making will not begin until after the
final report is issued.
 
M-I-92-13 lists the acceptable range of 100 to 150% of the "labeled" value of
vitamin A (2000-3000 IU per quart) and vitamin D (400-600 IU per quart).  It
also indicates the levels considered to be over-fortification, as 6000 IU of
vitamin A per quart of milk and 800 IU of vitamin D per quart of milk. These
levels are based on values considered to be a public health risk. Vitamins A and
D may be toxic to humans when consumed at high levels.
 
The current labeling values in 21 CFR 101.9 (c) (8) (iv), Vitamins and Minerals,
continue to be applicable.  Memorandum M-I-92-13, which provides acceptable
ranges for vitamin A and vitamin D in fluid milk and milk products, is still
valid and should remain in effect until after the NAS project is completed and
it is determined whether any adjustments are to be made to the currently
accepted vitamin ranges.
 
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation
Officers and State Milk Sanitation Rating Officers in your region. This
memorandum will also be available on the FDA web site at
http://www.cfsan.fda.gov at a later date and should be widely distributed to
representatives of the dairy industry and other interested parties. 
 
 
 
 
Norris A. Robertson, Jr. 				CAPT Robert F. Hennes, RS, MPH 
Milk Safety Branch  					Chief, Milk Safety Branch
1
 
 
 
M-I-03-6		April 17, 2003