Final answer:
Dietary supplement manufacturers do not need FDA approval before producing or selling their products. The FDA regulates them similarly to foods and not as strictly as pharmaceutical drugs. Supplements can be sold without prior approval unless they contain new dietary ingredients.
Step-by-step explanation:
False. Dietary supplement manufacturers are not required to get FDA approval before producing or selling dietary supplements. The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), but it does so more similarly to foods than to pharmaceutical drugs. Supplement manufacturers must comply with the FDA's Good Manufacturing Practices, and they are responsible for ensuring the safety of their supplements. New dietary ingredients not previously sold in the United States before 1994 must be notified to the FDA, but otherwise, dietary supplements can be sold without prior agency approval.
When dietary supplement manufacturers make claims about their products, such as reducing the risk of a disease or targeting specific body systems, these claims are not vetted by the FDA. Products making structural and functional claims must carry a disclaimer stating they are not intended to "diagnose, treat, cure, or prevent any disease." It's also important to note that dietary supplements are only removed from the market after the FDA has proven them to be hazardous.