This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a revised CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. This guidance document represents the agency's current thinking on animal products containing ethylenediamine dihydroiodide (EDDI) or feeds containing unapproved new drugs under the provisions of the Federal Food Drug and Cosmetic Act. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.
EDDI has been incorporated into animal feed and drug products for many years for both nutritional and therapeutic purposes. It has been formulated in salt/mineral mixtures and in liquids and powders for adding to feed or drinking water. EDDI has been used as a supplemental source of iodine and is considered generally recognized as safe (GRAS) for nutritional purposes when used at levels consistent with good feeding practices (21 CFR 582.80). EDDI products also have been marketed with claims for the treatment and prevention of certain diseases in several animal species, but primarily for "foot rot," soft tissue "lumpy jaw" and "wooden tongue" in cattle. However, all such EDDI products (including feeds) bearing therapeutic claims now are considered adulterated under sections 501(a)(5) or 501(a)(6) of the act.
All animal products containing EDDI that bear claims for treatment or prevention of any animal disease (other than the prevention of iodine deficiency) are considered unapproved new animal drugs or feeds bearing or containing unapproved new animal drugs and are adulterated under section 501(a)(5) if an unapproved new animal drug or section 501(a)(6) if a feed bearing or containing an unapproved new animal drug of the Act.
Cattle products that do not bear claims for treatment or prevention of animal disease and are formulated to provide 50 mg or more/hd/day of EDDI will be evaluated on a case-by-case basis and may be considered adulterated food under section 402(a)(2)(C)(i) if they raise safety concerns.
REGULATORY ACTION GUIDANCE:
The Center for Veterinary Medicine should be contacted for consultation before considering any possible regulatory action on animal products containing EDDI.