Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order.
The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.
D019587:Dietary Supplements / Q000506:poisoning*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004349:Drug Packaging / Q000331:legislation & jurisprudence*; D006801:Humans; D019266:Iron, Dietary / Q000506:poisoning*; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration
D019266:Iron, Dietary