Section 301(l) of the Federal Food, Drug, and Cosmetic Act specifically prohibits any labeling or advertising representation that a new human drug has been approved by FDA under the provision of Section 505 of the Act. There is no similar prohibition pertaining to labeling or advertising of new animal drugs. Section 512(i) of the Act provides that, upon approval of a new animal drug, a regulation shall be published in the Federal Register setting forth the terms of such approval.
FDA approves a new animal drug as safe and effective when used only for the purposes and under the conditions set forth in an NADA. We do not guarantee that every drug manufactured pursuant to the NADA meets all of the requirements of the Act, nor could we do so. Approval of an NADA still leaves open the possibility that the drug in question may be in violation of some other provisions of the law (e.g., it is possible that the drug may be contaminated). The agency is concerned that statements regarding FDA approval may be overly broad and, therefore, could mislead individuals into believing that FDA has approved the drug for conditions and purposes other than those conditions set out in the approved labeling. However, the agency recognizes that an appropriate statement of FDA approval could be useful to users. This policy guide establishes conditions under which reference to FDA approval in labeling or advertising of new animal drugs would be appropriate.
- Labels and package labeling may be revised only on the basis of a supplemental NADA approval.
- The label and package labeling may bear only the statement, "NADA #_____, Approved by FDA."
- The statement should appear at the bottom of the front panel of the label on the immediate container and at the bottom of carton labeling (preferably on the front panel). It should appear at the very top (beginning) or the very bottom (end) of inserts.
- The type, style, size, color or other means of emphasizing the statement should be no more prominent than the least prominent signal word identifying cautionary information appearing on the label (or the text of such cautionary information if no signal word is used to identify it).
- The statement may not be placed to obscure or otherwise render less conspicuous any necessary information on the labels or labeling.
- The statement may be used in promotional labeling or advertising for approved products.
- Any additional statements in promotional material may be directed only to the fact of NADA approval and may not characterize the basis, nature or impact of that approval, either as it applies to a particular product or to other approved or unapproved products. The availability of a Freedom of Information Summary (summary basis of approval) on file with FDA may be noted in promotional material. The specific section of the Code of Federal Regulations which establishes the conditions of approval may be cited.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.