Which statement describes the rules surrounding dietary supplements and the FDA?

• A. Not intended to diagnose, treat, cure or alleviate effects of disease; Cannot say prevent in relation to disease or conditions; Does not need to prove safety and effectiveness; Does not need to make accurate and truthful claims; Does not need FDA approval before marketing or selling
• B. Must prove safety and effectiveness before marketing; Requires FDA approval for labeling; Regulated as drugs; Must conduct clinical trials
• C. Supplements are regulated as drugs; Must be prescribed; Must be FDA-approved labeling; Must list all side effects
• D. They are not regulated at all; Can claim disease cures freely; No labeling requirements

Answer: (A)

Dietary supplements are regulated by the FDA as foods, not drugs. Under this framework, they do not need to prove safety and effectiveness to the FDA before being marketed, and there is no pre-market FDA approval for labeling. Manufacturers are responsible for ensuring safety and truthful labeling, and the FDA can take action if problems arise after marketing. Importantly, labeling may not claim to diagnose, treat, cure, or prevent diseases; if a product claims disease cures or treatment, it would be treated as a drug and would require FDA approval. So the statement that fits best is that these products are not intended to diagnose, treat, cure, or alleviate disease, cannot say they prevent disease, do not need to prove safety and effectiveness, and do not require FDA pre-market approval.