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Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. However, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such claims for dietary supplement labels. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim. Further information regarding structure/function claims can be found in FDA's January 9, 2002 Structure/Function Claims Small Entity Compliance Guide: http://www.cfsan.fda.gov/~dms/sclmguid.html.
Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.
For more information see 21 CFR 101.93 entitled " Certain Types of Statements for Dietary Supplements," and the January 6, 2000 Federal Register (65 FR 1000) that describes the types of claims that can and can not be made for dietary supplements. It can be found on the Web at: http://www.cfsan.fda.gov/~lrd/fr000106.html.
Structure/function (S/F) claims and disease claims for conventional foods focus on effects derived from nutritive value, while S/F claims for dietary supplements may focus on nutritive as well as non-nutritive effects. FDA is likely to interpret the dividing line between S/F claims and disease claims in a similar manner for conventional foods as for dietary supplements.
FDA does not require conventional food manufactures to notify FDA about their S/F claims and disclaimers are not required for conventional foods.
For more information see 21 CFR 101.93 entitled " Certain Types of Statements for Dietary Supplements," the January 6, 2000 Federal Register (65 FR 1000 at 1034-35) final rule entitled "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Fuction of the Body," and September 23, 1997 ( 62 FR 49859 at 49860, 49861, and 49864) final rule entitled "Food Labeling: Nutrient Content Claims, Halth Claims, and Statements of Nutrtiional Support for Dietary Supplements
