Table 4. Regulatory and quality landscape of the US herbal supplements.

DSHEA: Dietary Supplement Health and Education Act, DS: Dietary Supplement, FDA: Food and Drug Administration, cGMP: current good manufacturing practice, PO: Per Os (by mouth)

Regulatory authorization	Premarketing safety data	cGMP	Label requirements	Permissible health claims
DSHEA of 1994 classifies herbs as DS (intended for PO) and restricts FDA from strict premarketing regulation	Only for ingredients introduced after 1994	➤Manufacturing ➤Packaging ➤Labeling	➤ Name of each ingredient ➤ Quantity of each ingredient ➤ Manufacturer’s contact information ➤The statement: “Not evaluated by the FDA. Not intended to diagnose, treat, cure, or prevent any disease”	➤Not required to be preapproved ➤Characterize how DS maintains normal structure or function in humans