Compliance Policy Guide
Compliance Policy
Guidance for FDA Staff
Sec.
651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18)
INTRODUCTION:
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.
BACKGROUND:
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.
POLICY:
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.
Issued: 3/1/86
Revised: 5/1/2000
|