FDA Certification

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The FDA (Food and Drug Administration) is the U.S. government agency responsible for regulating the safety of:

  • Food and food-contact materials,
  • Pharmaceuticals,
  • Medical devices,
  • Cosmetics,
  • Certain chemical and biological products.

It is important to note that the FDA does not certify products. Instead, it establishes the minimum safety, purity, and quality requirements that products must meet in order for manufacturers to issue an FDA Declaration of Compliance.

When a company claims FDA compliance, it states that its product or material:

  • Meets the applicable federal regulations outlined in Title 21 CFR (Code of Federal Regulations)
  • Has been manufactured in accordance with Good Manufacturing Practices (GMP)
  • Is safe for its intended use (e.g., food contact, cosmetic use, pharmaceutical application, etc.)
  1. Common FDA Regulatory References
  • 21 CFR 177 → Materials intended for food contact (plastics, coatings, resins, etc.);
  • 21 CFR 110 / 117 → Current Good Manufacturing Practices (cGMP) for food production;
  • 21 CFR 210-211 → GMP requirements for pharmaceutical manufacturing;
  • 21 CFR 820 → Quality system regulations for medical devices.
  1. Contents of an FDA Declaration of Compliance

A typical FDA compliance statement includes:

  1. Company information (name, address, contact details);
  2. Product description (trade name, code, intended use);
  3. Applicable regulatory references (e.g., “Compliant with 21 CFR 177.1520 for food-contact applications”);
  4. Manufacturer’s responsibility statement;
  5. Date, place, and signature of the Quality/Regulatory Manager.
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