Food and Drug Administration
As a food additive, the FDA has classified certain aluminum compounds used in food, medicines, health supplements and packaging materials as GRAS (Generally Recognized as Safe).
The uses of aluminum in manufacturing processes are said be regulated by the FDA under the provisions of the Good Manufacturing Practice (GNP) Regulations. However, a close examination of the regulations disclosed that these are general provisions that pertain to process validation, equipment verification, complaint handling, personnel qualifications, record keeping, cleanliness, and sanitation as guidelines to be observed by manufacturers.
In addition, the regulations appear as open-ended statements that give the manufacturer's flexibility for compliance, in the way they deem it as best practice, albeit using up-to-date technologies that will prevent contamination and/or errors.
The FDA requires all drug manufacturers to maintain no more than 25 micrograms per liter and the label and package must state the amount of aluminum used. The following warnings should be carried in the warning section of the labels and package inserts;
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.