How does the FDA review herbal supplements versus prescription drugs before market availability?
FDA does not approve supplements for safety or effectiveness prior to being sold.
Prescription drugs must undergo a rigorous, mandatory process where regulatory bodies, such as the Food and Drug Administration (FDA), must approve both their claimed safety profile and their documented effectiveness before they are legally permitted to enter the market. In contrast, many herbal products are categorized as dietary supplements. For these items, the FDA's requirement for pre-market clearance concerning safety and efficacy is waived. The onus falls upon the manufacturers to self-regulate and ensure their products are safe before distribution. This regulatory structure means that issues like contamination, inaccurate labeling regarding active ingredients, or wildly varying concentrations often go unchecked until adverse events prompt regulatory action.
