FDA CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)
标准简介
CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)[附网盘链接]](/img/20210914103654o4ln2.jpg)
标准文档说明
标准文档类型为CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) Compliance Policy Guide Guidance for FDA Staff This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this compliance policy guide as listed on the title page. I. Introduction
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 (the FD&C Act). In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. 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 are considered adulterated under sections 501(a)(5) or 501(a)(6) of the FD&C Act. III. 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. They are adulterated under section 501(a)(5) of the FD&C Act if they are an unapproved new animal drug or adulterated under section 501(a)(6) of the FD&C Act if they are a feed bearing or containing an unapproved new animal drug.
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