Title: Take a Label Claim, and Pay Me in the Morning: A Challenge to FDA's Argument that its Final Rule (Jan. 2000) on Structure/Function Claims for Dietary Supplements Does Not Constitute a Compensable Regulatory Taking Under the Fifth Amendment (2000 Third Year Paper)
Author(s): William D. McCants
Subject & Subject keywords: Food and Drug Law "" "FDA" "" "DSHEA" "" "disease" "" "claims" "" "drugs" "" "" "" "Fifth Amendment" "" "" "" "Final Rule"
Abstract:On January 6, 2000, the Food and Drug Administration ("FDA") published its final rule prescribing the kinds of statements which can be made about the effect of a dietary supplement on the structure or function of the body ("structure/function" claims), in accordance with the Dietary Supplement Health and Education Act of 1994 ("DSHEA"). Under DSHEA, dietary supplements can bear structure/function claims without prior FDA review. But they cannot, without such prior review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease ("disease claim"). One of the most controversial aspects of the final rule, and the subject of this paper, is FDA's regulation of what the agency chooses to call "implied disease claims": The final rule precludes express disease claims ("prevent[s] osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains aspirin), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims ("maintains a healthy circulatory system"), other non-disease claims ("for muscle enhancement," "helps you relax,"), and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes").