Exam 44: Consumer Protection

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FDA was empowered by Congress to enforce the Food, Drug, and Cosmetic Act to regulate the testing, manufacture, and distribution of foods, medications (including over-the-counter medications and prescription drugs), medical devices, and cosmetics. A major component of the act is the requirement that makers of certain food ingredients, additives, drugs, or medical devices obtain formal FDA approval prior to selling the product to the general public. When the FDA has approved a drug for public use, any advertising for the drug is subject to FDA regulation in terms of what representations may be made and what disclosures must be included.FDA regulations also govern the labeling of food packages. FDA regulations define specific food safety processes, procedures, and standards, such as the requirement that employees handling food wear rubber gloves and hair netting. The statute also sets out a broader catchall standard by outlawing any generally adulterated food that has potential for public harm. The FDA defines adulterated food as that which contains a "filthy, putrid, or decomposed substance" or any food "unfit for consumption."The FDA also investigates any public outbreaks of illness related to food contamination. During its investigation of such outbreaks, the FDA uses its broad enforcement powers to detect and prevent any further contamination. These powers include seizure of contaminated products, mandatory recalls, civil enforcement lawsuits, fines, and criminal prosecution for egregious cases.