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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 643.100 Oral Iron Products for Baby Pigs March 1995

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

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


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
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Rockville, MD 20852

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Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
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