Sec. 605.100 Use of Statements Regarding NADA Approval by FDA in Labeling and
Advertising of New Animal Drugs (CPG 7125.01)
BACKGROUND:
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.
POLICY:
1. Labels and package labeling may be revised only on the basis of a supplemental NADA
approval.
2. The label and package labeling may bear only the statement, "NADA #_____,
Approved by FDA."
3. 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.
4. 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).
5. The statement may not be placed to obscure or otherwise render less conspicuous any
necessary information on the labels or labeling.
6. The statement may be used in promotional labeling or advertising for approved products.
7. 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.
Issued: 10/1/80
Revised: 9/1/86