Memorandum of Understanding
The Federal Trade Commission
The Food and Drug Administration
SUBJECT: MOU with Federal Trade Commission Concerning Exchange of Information (FDA-225-71-8003)
This Memorandum of Understanding updates and replaces:
A. "Working Agreement Between the Federal Trade Commission and the Food and Drug Administration-June 1954."
B. "Liaison Agreement Between the Federal Trade Commission and the Food and Drug Administration-January 23, 1958."
A. It is agreed that the common objective of preventing injury and deception of the consumer requires that the statutory authorities and procedures, and the manpower and other resources available to each agency are so employed as to afford maximum protection to the consumer. This means joint planning of coordinated programs, exchange of information and evidence to the extent permitted by law, by the staffs of both agencies in appropriate undertakings, and the careful selection of the procedure of either agency (or simultaneously by both) promising greatest benefits to the public.
B. In order to provide for exchange of complete information so that both agencies will be utilized to the maximum effectiveness in the public interest, each agency will designate a liaison officer to serve as the primary source of contact. These liaison officers will be responsible for currently informing each other of proposed proceedings and of internal developments in areas of joint concern to the extent that such information is not privileged.
II. Designated Liaison Officers
A. Federal Trade Commission
The Assistant to the General Counsel of the Federal Trade Commission
B. Food and Drug Administration
The Associate Commissioner for Compliance of the Food and Drug Administration.
III. In order to facilitate the purposes of this agreement, it is specifically agreed that:
A. With exception of prescription drugs, the Federal Trade Commission has primary responsibility with respect to the regulation of the truth or falsity of all advertising (other than labeling) of foods, drugs, devices, and cosmetics. In the absence of express agreement between the two agencies to the contrary, the Commission will exercise primary jurisdication over all matters regulating the truth or falsity of advertising of foods, drugs (with the exception of prescription drugs) devices, and cosmetics;
B. The Food and Drug Administration has primary responsibility for preventing misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce. The Food and Drug Administration has primary responsibility with respect to the regulation of the truth or falsity of prescription drug advertising. In the absence of express agreement between the two agencies to the contrary, the Food and Drug Administration will exercise primary jurisdiction over all matters regulating the labeling of foods, drugs, devices, and cosmetics;
C. The initiation of proceedings involving the same parties by both agencies shall be restricted to those highly unusual situations where it is clear that the public interest requires two separate proceedings. For the purpose of avoiding duplication of work and to promote uniformity and consistency of action in areas where both agencies have a concern and the actions of one agency may affect proceedings by the other, it is recognized that such liaison activity is required in instances where:
1. The same, or similar claims are found in both labeling and advertising;
2. Written, printed or graphic material may be construed as either advertising or as accompanying labeling or both, depending upon the circumstances of distribution;
3. The article is a drug or device and appears to be misbranded solely because of inadequacy of directions for use appearing in the labeling for conditions for which the article is offered in advertising generally disseminated to the public.
IV. It is further agreed that:
Regulations promulgated under section 5 of the Fair Packaging and Labeling Act by the respective agencies for the commodities for which they have jurisdiction under that Act, shall be as uniform as possible.
V. Meeting to be held:
The respective liaison officers will hold meetings from time to time to discuss matters of concern to each agency and that they will be accompanied by whatever staff they may deem appropriate and necessary.
VI. Period of agreement;
This agreement, when accepted by both parties, covers an indefinite period of time and may be modified by mutual consent of both parties or terminated by either party upon thirty (30) days advance written notice.
Approved and Accepted
Signed by: Miles W. Kirkpatrick
Date: May 14, 1971
By direction of the Commission dated September 9, 1971.
Charles A. Tabin
Approved and Accepted
Signed by: Charles C. Edwards, M.D.
Date: April 27, 1971