This document was issued in June 2005.
Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition to Assist FDA in Implementing DSHEA Regarding Products that Bear Structure/Function and/or Disease Claims
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 assigns lead Center status for the regulation of certain products that bear structure/function and/or disease claims. It is intended to achieve a more efficient allocation of resources and better coordination of regulatory actions concerning products that purport to be dietary supplements but for which disease claims are made. The agreement does not apply to products purporting to be dietary supplements that are subject to the jurisdiction of other Centers (CBER, CVM, or CDRH).
This agreement is intended to assist FDA in implementing DSHEA and the structure/function rule 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 implementation of the structure/function rule or the regulation of dietary supplements. The agreement does not formally bind FDA and creates no new rights or obligations for FDA or any regulated entities.
For further information contact either:
Office of Compliance
Center for Drug Evaluation and Research
11919 Rockville Pike
Rockville, MD 20852
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740-3835
EFFECTIVE DATE AND REVIEW/RENEWAL
This agreement takes effect on June 1, 2005. CFSAN and CDER will evaluate this agreement on a tri-annual basis and make appropriate modifications.
CDER is generally the FDA's lead Center for the regulation of human drugs, as defined in Section 201(g) of the Act. CFSAN is the Agency's lead Center for the regulation of human foods, as defined in Section 201(f) of the Act, and dietary supplements, as defined in Section 201(ff) of the Act.
The Dietary Supplement Health and Education Act (DSHEA) added Section 403(r)(6) to the Act. This section provides that the label or labeling of a dietary supplement may bear a claim that, among other things, "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans" or that "characterizes the documented mechanism by which a nutrient or a dietary ingredient acts to maintain such structure or function." Such statements are generally referred to as "structure/function" claims. In addition, the definition of a drug in Section 201(g) was amended by DSHEA to establish that a dietary supplement is not a drug solely because the label or labeling makes these structure/function claims.
Accordingly, the label and labeling of dietary supplement products may bear structure/function claims for which no prior FDA review or approval is required. However, DSHEA does not permit any statement in the product's label or labeling that claims to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. These claims are generally referred to as "disease claims" and cause products associated with these claims to be regulated as drugs under Section 201(g)(1)(B) of the Act. Disease claims may be explicit or implied if such claims refer to identifiable characteristics of a disease from which a disease may be inferred. In order to help define the types of claims that are valid structure/function claims under Section 403(r)(6) of the Act, and to distinguish these claims from disease claims, FDA published a final rule on January 6, 2000 (65 FR 1000), known as "the structure/function rule." This MOU will not affect CDER's lead responsibility, as stated in the joint CDER/CFSAN letter of February 29, 2000, for distinguishing between "disease" and "non-disease" states or conditions in implementing the structure/function rule.
CFSAN DESIGNATION AS LEAD CENTER
Under this agreement, CFSAN is designated as the lead Center for regulatory action for certain products for which the labeling includes disease claims if such products also conform to each of the elements of the dietary supplement definition that appears in Section 201(ff) of the Act. Likewise, CFSAN is designated as the lead Center for regulatory action for certain products for which the labeling includes disease claims, but which do not bear the term "dietary supplements," provided that the products conform to all other elements of the dietary supplements definition that appears in Section 201(ff) of the Act and the products are labeled for marketing purposes as dietary supplements. Furthermore, CFSAN will be the lead Center if the sole reason for the product being subject to the drug requirements is that its labeling includes a disease claim rather than a structure/function or other appropriate dietary supplement claim.
As the lead Center for the products described above, CFSAN will have the authority to include appropriate drug charges (including sections 502 and 505 of the Act) in any regulatory action concerning a product associated with a disease claim. CFSAN agrees to consult with CDER, as appropriate, to ensure consistency when pursuing regulatory action based upon these drug charges.
CDER will retain concurrent jurisdiction to assert drug charges in pursuing regulatory actions against certain types of products for which CFSAN is the lead Center. In these cases, CFSAN will retain the right of first refusal for regulatory action. In these designated areas, CDER may pursue regulatory action for which CFSAN has declined to exercise its authority as lead Center. CDER agrees to consult with CFSAN and provide adequate advance notice before pursuing regulatory action under these circumstances.
CDER's action in these cases will be limited to drug charges and will not include any food charges. The designated areas are for products with disease claims that otherwise conform to each of the elements of Section 201(ff) of the Act, but raise unique issues for which CDER's historical role or medical expertise adds value to the Agency's regulatory action. The designated areas are limited to the following:
- Products containing hormones, including their metabolites and precursors;
- Products that have longstanding use as drugs and are widely recognized as drugs, even though they might be marketed purporting to be dietary supplements; and
- Products for which CDER has identified serious health hazard concerns.
CFSAN will also be the lead Center for regulatory action concerning conventional foods, medical foods, foods for special dietary use, and infant formula, even if disease claims are made for such products.
CDER DESIGNATION AS LEAD CENTER
The following are the types of products, with disease or structure/function claims, for which CDER will serve as lead Center because the products do not qualify as dietary supplements under Section 201(ff):
- The product is labeled as an over-the-counter or prescription drug and the product is not labeled as a dietary supplement.
- The product is not "intended to supplement the diet" under Section 201(ff)(1) of the Act (e.g., street drug alternative products, GHB/GBL).
- The product does not bear or contain any of the designated "dietary ingredients" under Section 201(ff)(1)(A)-(F) of the Act.
- The product is not "intended for ingestion" under Section 201(ff)(2)(A)(i) (e.g., topicals, inhalants, suppositories, etc.).
- The product contains a component, under Section 201(ff)(3)(B)(i), that is an article approved as a new drug that was not marketed as a dietary supplement or a food before such approval (e.g., lovastatin).
- The product contains a component, under Section 201(ff)(3)(B)(ii), that is an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not marketed as a dietary supplement before such approval.
CDER will continue to serve as the lead for combination drug and dietary supplement products, such as:
- products that contain a drug and a dietary ingredient in a single product (assuming CDER supports a drug charge);
- products that consist of co-packaged individual drug and dietary supplement products; and
- dual labeled products
CDER and CFSAN agree to promptly establish necessary procedures to ensure adequate communication and a consistent approach to the interpretation and application of this agreement.
Steven K. Galson, M.D., M.P.H.
Acting Center Director
Center for Drug Evaluation and Research
Robert E. Brackett, Ph.D.
Center for Food Safety and Applied Nutrition