Dietary Supplement Health and Education Act
1994 U.S. law that defined dietary supplements and established the regulatory framework treating them more like foods than drugs.
Also: DSHEA
Under DSHEA, manufacturers must ensure supplements are safe before marketing but do not need FDA approval. Structure/function claims are allowed without pre-approval if labeled with the disclaimer that the product is not intended to diagnose, treat, cure, or prevent disease. The FDA can act only after a product is shown unsafe. DSHEA has been criticized for weak premarket oversight.
How one textbook covers it
Krause and Mahan's Food and the Nutrition Care Process, 16th ed. — Chapter 11
Under DSHEA, manufacturers must ensure supplements are safe before marketing but do not need FDA approval. Structure/function claims are allowed without pre-approval if labeled with the disclaimer that the product is not intended to diagnose, treat, cure, or prevent disease. The FDA can act only after a product is shown unsafe. DSHEA has been criticized for weak premarket oversight.
Related terms
Dietary Supplement, GRAS, Health Claim