Final answer:
A dietary supplement gets pulled off the market by the FDA once it is proven to be hazardous, typically after reports of health issues associated with its use. The burden of safety was shifted to manufacturers with the enactment of DSHEA in 1994, which means supplements can be sold without FDA approval unless they contain new dietary ingredients.
Step-by-step explanation:
The U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating dietary supplements to ensure the safety of consumers. Although dietary supplements are regulated more like food than pharmaceuticals, they must adhere to the FDA's Good Manufacturing Standards. However, unlike drugs, dietary supplements are not subjected to rigorous pre-market approval processes. Instead, supplement manufacturers are tasked with ensuring the safety of their products.
When a dietary supplement is suspected to be hazardous, it is the FDA's responsibility to prove the potential harm. This action typically follows reports of health problems linked to the supplement, which could include but are not limited to adverse health effects like liver damage, blindness, or other serious conditions. Noteworthy examples include bodybuilding supplements like Craze, found to contain amphetamine-like compounds without proper disclosure.
DSHEA, the Dietary Supplement Health and Education Act of 1994, shifted the responsibility of determining the safety of dietary supplements from the government to the manufacturers, allowing products to be sold without FDA's approval unless they contain new dietary ingredients. It is only after a product is demonstrated to be harmful that the FDA can take action to remove a supplement from the market. When considering supplement use, individuals should critically evaluate claims, understand potential interactions with medications or food, and assess the supplement's necessity for health and safety.