ANSWERS: 1
  • The United States Food and Drug Administration regulates and enforces safety procedures for food, drugs, cosmetics, medical devices, vaccines, tobacco and animal and veterinary products. The FDA is authorized to inspect food, drug and cosmetics manufacturing facilities.

    Safety

    The FDA requires food, drug and cosmetics manufacturers to ensure consumer safety by abiding by its manufacturing, labeling and advertising regulations.

    Food

    Food manufacturers must produce a complete nutrition label detailing calories, fats, carbohydrates, sugars, protein, vitamins and minerals. All ingredients must be listed, including additives, natural flavors and artificial colors. A warning statement must be clearly displayed if the product contains eggs, nuts, shellfish or aspartame.

    Cosmetics

    Cosmetics manufacturers must display a label listing all ingredients according to weight or concentration.

    Drugs

    Prescription, generic and over-the-counter drug labels must inform consumers of the correct or maximum dosage, the purpose of the drug, adverse reactions and warnings. The FDA monitors prescription drug advertisements to ensure that consumers are presented with both the risks and benefits.

    Violations

    FDA regulatory violations are usually met with a warning letter sent to the company's president or CEO. The company has 15 days to respond and take steps to correct the violation. If the letter is ignored or the response insufficient, the FDA may take enforcement actions in the form of product withdrawals, recalls and safety alerts.

    Source:

    FDA: Federal Food, Drug, and Cosmetic Act (FD&C Act)

    FDA: Regulatory Procedures Manual

    eMedicineHealth.com: FDA Overview

    More Information:

    Food and Drug Administration

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