200 `C' Street, S.W.
Washington, DC 20204
December 22, 1992
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialist
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Recommended Levels of Vitamins A & D in Milk Products
In response to questions from past regional seminars, we advised that milk fortified with vitamins A & D would be acceptable at levels of 80% - 120% of label claims. This range for acceptable values of vitamins in fluid milk products was based on an estimate of what "Good Manufacturing Practices" could be expected to maintain over time.
Upon further study, we find that this advice is not consistent with current federal regulations. Therefore we recommend a revision of the acceptable range for vitamin A & D in fluid milk products as follows:
|* 100% - 150% of label claims =||(400 - 600 I.U. per quart for vitamin D)|
|(2000 - 3000 I.U. per quart for vitamin A)|
|*within method variability|
In addition, we have requests for guidance on what levels of over-fortification constitute a health hazard. The population that requires the lowest limit for vitamins A & D in fluid milk are infants under 12 months age, because of their high intakes of milk relative to body size. The factors considered in identifying the maximum safe levels are the probable thresholds for adverse effects, the 90th percentile of fluid milk intake, and a reasonable margin of safety. Using these factors, the suggested over-fortification limits are listed below.
vitamin D = 800 I.U. per quart
Fluid milk products with levels of vitamin A or D above these values may create the potential for a public health threat and further distribution should be prohibited.
Fluid milk products found below 100% or above 150% of required values or label claims should be resampled and the cause of the problem determined. Regulatory action may be appropriate if the cause of the problem is not corrected.
Copies of this memorandum are enclosed for distribution to state milk sanitation regulatory agencies and to state milk sanitation rating officers in your region.
Johnnie G. Nichols, Chief
Milk Safety Branch
Center for Food Safety and Applied Nutrition