Final answer:
The statement that dietary supplements must go through FDA testing for safety and effectiveness before being marketed or sold in the U.S. is false. Under the DSHEA of 1994, supplements do not require FDA approval prior to being sold, unless a new dietary ingredient is added, making the responsibility for safety and truthful labeling fall to the manufacturer.
Step-by-step explanation:
The correct answer to the statement "In order to be marketed or sold in the U.S., dietary supplements must go through FDA testing for safety and effectiveness" is B. False. Dietary supplements in the United States do not have to go through the same rigorous testing processes that pharmaceutical drugs undergo. The Dietary Supplement Health and Education Act (DSHEA) of 1994 changed the responsibility for determining the safety of the dietary supplements from the government to the manufacturer allowing supplements to be sold without FDA approval, unless a new dietary ingredient is added. It's important to note that while manufacturers are responsible for ensuring their products are safe and their label claims are truthful and not misleading, it is not mandatory for these claims to be FDA approved.
This can lead to products on the market without conclusive evidence of their safety or effectiveness. Supplements must meet Good Manufacturing Standards and can make certain claims about affecting the structure or function of the body but they must also carry a disclaimer that the product is not intended "to diagnose, treat, cure, or prevent any disease." The role of the FDA with regards to supplements is more reactive than proactive; they will remove supplements from the market if they are proven hazardous after they have been sold to consumers.