Final answer:
The FDA regulates medicines and dietary supplements with varying standards; medicines undergo extensive testing and approval processes to ensure safety and efficacy, while supplements are treated like food products with less stringent requirements but must still follow Good Manufacturing Standards. Claims about supplement effectiveness must include a disclaimer. The regulation protects consumers but can also delay access to new medications.
Step-by-step explanation:
The U.S. Food and Drug Administration (FDA) regulates medicines, dietary supplements, and other products to ensure public health and safety. Medicines, including both prescription and over-the-counter drugs, are subject to rigorous testing and must undergo a New Drug Application (NDA) process before they can be sold. They are assessed on safety and efficacy and, once approved, are considered "safe and effective when used as directed."
Dietary supplements, although regulated by the FDA, are treated more like food products. They must adhere to Good Manufacturing Standards but are not held to the same strict standards as pharmaceutical drugs. However, any claims made on these supplements regarding their effectiveness for certain conditions must be accompanied by a disclaimer indicating that the product is not intended to "diagnose, treat, cure, or prevent any disease."
While the FDA works to protect consumers from harmful substances, this regulatory system can also create challenges. Drug approval processes can be lengthy, potentially delaying access to new, life-saving medications. This raises a question about the potential 'losers' in the regulatory system, referring to those individuals whose access to beneficial medications may be postponed due to the extended review and approval periods required for safety and efficacy assurance.