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M-I-03-6: Evaluation of M-I-92-13

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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.fda.gov/food at a later date and should be widely distributed to

Norris A. Robertson, Jr.
Milk Safety Branch

CAPT Robert F. Hennes, RS, MPH
Chief, Milk Safety Branch