FDA Warning Letters about Products (2004)

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.

Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped. Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.

This page was revised on May 12, 2009.

Links to Recommended Companies

  • Vonage: Save money on unlimited phone service. Extraordinary value. Free 30-day trial.
  • Netflix: Free 2-week trial of DVD rentals by mail; over 85,000 titles available.
  • PharmacyChecker.com: Compare drug prices and save money at verified online pharmacies.
  • Amazon Books: Internet's leading source of books, electronics, tools, toys, and many other consumer goods.
  • Believe: A hilarious movie about multilevel marketing.
  • ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products.
  • Healthgrades: Check your doctors' training, board certifications, and disciplinary actions.
  • Outdoor lighting by Arcadian: Best prices and services on outdoor lighting fixtures.
  • OnlyMyEmail: Award-winning anti-spam services.
  • Herbal Medicine, 3rd edition. Excellent reference book, discount-priced.
  • 10 Types: Website design, development, and hosting with superb technical support.