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This document outlines a working agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). The agreement clarifies the Centers' authority over certain products that are intended to affect the structure or function of the body of man or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The agreement is intended to achieve a more efficient allocation of resources and better coordination of regulatory actions for products that purport to be cosmetics but meet the statutory definition of a drug. The agreement does not apply to products purporting to be cosmetics that are subject to the jurisdiction of other Centers (CBER, CVM, or CDRH).
This agreement is intended to assist FDA in implementing the cosmetic and the drug provisions of the Federal Food, Drug, and Cosmetic Act by clarifying program responsibilities in light of overlapping jurisdiction between CDER and CFSAN. The agreement is entirely procedural in nature and is not intended to affect the Agency's approach to the regulation of cosmetic products. The agreement does not formally bind FDA and does not affect the rights or obligations of any regulated entities.
For further information contact either:
Directoror
DirectorThis agreement is hereby renewed effective on June 1, 2006 for a three year term, at which time CFSAN and CDER will re-evaluate the agreement and make appropriate modifications. To ensure that this review occurs within three years, this agreement will expire pending renewal on June 1, 2009. The agreement remains renegotiable upon request by either Center prior to its expiration.
CDER is generally the FDA's lead Center for the regulation of human drugs, as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). CFSAN is the Agency's lead Center for the regulation of cosmetics, as defined in Section 201(i) of the Act.
Under section 201(i) of the Act, the term "cosmetic" means "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles . . . ." If a product purporting to be a cosmetic is intended to affect the structure or any function of the human body or is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, that product is subject to regulation as a drug. Intended use refers to the objective intent of the persons legally responsible for the labeling of the product. The intent may be determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may also be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. See 21 C.F.R. § 201.128.
Under this agreement, CDER and CFSAN shall have concurrent jurisdiction over a product which purports to be a cosmetic, but meets the definition of drug. Both CDER and CFSAN may bring regulatory action relating to such a product. CFSAN will not include drug charges (including sections 501, 502, and 505 of the Act) in such an action without first notifying CDER of the charges that will be included. CDER will not include cosmetic charges (including sections 601 and 602 of the Act) in such an action without first notifying CFSAN of the charges that will be included.
Each Center agrees to provide advance notice to the other Center before pursuing regulatory action under this agreement and also agrees to consult regularly with the other Center to ensure consistency.
CFSAN will not make any formal pronouncements (e.g., in guidance documents) about the meaning of the term "drug" or the concept of intended use as applied to drugs without first obtaining CDER's concurrence.
In order to ensure adequate communication and a consistent approach to the interpretation and application of this agreement, appropriate representatives from CDER's Office of Compliance and CFSAN's Office of Compliance and/or Office of Cosmetics and Colors will meet:
In order to avoid duplication of effort, each Center will notify the other in advance of expending significant resources on a matter subject to this agreement that is likely to result in an untitled letter, a Warning Letter, import alert, seizure, injunction, or prosecution.
Appropriate experts in CDER's Office of New Drugs will be asked to perform health hazard evaluations, when necessary and appropriate, in connection with cases subject to this agreement, whether the lead Center for the case is CDER or CFSAN.
Prior to the expiration of this agreement, CDER will determine whether substantial CDER resources have been consumed in the implementation of the agreement. If CDER determines that substantial CDER resources have been consumed, then CDER will provide CFSAN with a written explanation of the extent of the consumed resources and the ways in which they were consumed. Unless the resources consumed by CDER were negligible (as determined by consensus between the Centers), CFSAN shall reimburse CDER for the resources expended.
