Sec. 643.100 Oral Iron Products for Baby Pigs (CPG 7125.16)
BACKGROUND:
Pigs are born with only a limited store of iron. The sow's milk is low in this element,
and unless piglets have access to outside sources, iron deficiency anemia may develop in
two to three weeks following birth. This happens mainly when baby pigs are kept indoors on
concrete floors; a common practice. The hemoglobin levels decrease in the baby pig from
8-12 grams per 100 ml of blood at birth to as low as 2-3 grams in three to four weeks.
Feeding iron salts to sows during gestation has not been effective in increasing reserves
in newborn pigs.
Since the time that commercial iron injectable preparations were introduced for
prevention and treatment of iron deficiency anemia, the use of oral preparations in baby
pigs (iron solutions, tablets and pastes) has declined. The injectables are new animal
drugs, as described in 21 CFR 510.440. Various oral preparations, however, continue to be
marketed. They are formulated using different iron compounds and many are fixed
combinations with minerals, vitamins, or other substances in various dosage forms, doses,
and dosing intervals. *CVM* is not aware of information that the dose, dosage internal,
and iron bioavailability for most of these products are adequate when label directions are
followed. Nor are we aware that any product fed to pregnant or nursing sows will
significantly increase the iron content of sow's milk or prevent iron deficiency anemia in
baby pigs.
POLICY:
*CVM* considers all oral iron preparations labeled for the prevention or treatment of
iron deficiency anemia in suckling pigs to be new animal drugs which may not be marketed
unless approved by an NADA. We would not, however, object to the marketing of oral iron
preparations as foods, labeled as nutritional supplements. Such products should provide
nutrient levels consistent with the suggestions of recognized authorities and may not bear
any drug claims, e.g., iron deficiency anemia.
Recommendations regarding unapproved oral iron preparations represented or implied to
prevent baby pig anemia may be submitted to *CVM* (HFV-236) for regulatory action under
501(a)(5). *Warning* letter is the initial action of choice.
*Material beteween asterisks is new or revised.*
Issued: 12/1/82
Revised: 3/95