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Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980

This guidance addresses the regulatory requirements and enforcement actions for defective suntanning booths and beds, particularly those manufactured before May 7, 1980. It focuses on products lacking essential safety features like protective eyewear and timers, which are considered serious defects requiring correction under the Federal Food, Drug, and Cosmetic Act (FFDCA).

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the regulatory requirements for suntanning booths manufactured before 1980?

Suntanning booths manufactured prior to May 7, 1980, are not subject to sunlamp performance standards but must comply with defect regulations under 21 CFR 1003 and are considered medical devices under the Federal Food, Drug, and Cosmetic Act.

What constitutes a serious defect in suntanning equipment according to FDA guidance?

The lack of protective eyewear or timer in suntanning booths is considered a serious defect and health hazard requiring correction by the manufacturer under federal regulations.

Who is responsible for correcting defective suntanning equipment in health spas?

The manufacturer is responsible for correcting defective suntanning equipment. Health spa owners/operators are not required to correct defects but should voluntarily withdraw hazardous units until manufacturer corrections are made.

When can FDA initiate detention or seizure of suntanning devices?

FDA can initiate detention/seizure when the product has a Class A health hazard, the owner/operator has been notified in writing to discontinue use, and they fail or refuse to discontinue use until corrected.

What enforcement approach does FDA prefer for defective suntanning equipment?

FDA prefers enforcement under defect provisions of Subchapter C of the FFDCA rather than Section 304. Section 304 detention/seizure is used when manufacturers fail to correct defects or operators refuse voluntary withdrawal.

What documentation is required before FDA orders administrative detention of suntanning devices?

Before ordering administrative detention, FDA requires that HFZ-300 be contacted to discuss details, the owner/operator must be notified in writing, and the device must meet Class A health hazard criteria with misbranding violations.

What You Need to Do 👇

  1. Assess if suntanning booth/bed has required protective eyewear and timer
  2. If defects are found, identify the manufacturer if possible
  3. If manufacturer is known, pursue enforcement under Subchapter C of FFDCA
  4. If manufacturer is unknown or unresponsive:
    • Notify owner/operator in writing about the defect
    • Request voluntary withdrawal of defective units
    • If non-compliant, initiate detention/seizure under Section 304 of FFDCA
  5. Document all communications and enforcement actions
  6. Consult with HFZ-300 before implementing administrative detention
  7. Ensure corrections are made before allowing equipment back into service

Key Considerations

Safety

  • Protective eyewear must be provided with the suntanning booth/bed
  • Timer must be included in the suntanning booth/bed
  • Absence of either protective eyewear or timer is considered a Class A health hazard

Other considerations

  • Products are subject to defect regulations under 21 CFR 1003
  • Products are considered medical devices subject to FFDCA provisions
  • Enforcement actions can be taken under Subchapter C of FFDCA or Section 304 of FFDCA
  • Owner/operator must be notified in writing to discontinue use of defective equipment
  • Administrative detention should be discussed with HFZ-300 before implementation

Relevant Guidances 🔗

Related references and norms 📂

  • 21 CFR 1003: Notification of Defects or Failure to Comply

Original guidance

  • Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
  • HTML
  • Issue date: 2005-02-28
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
  • ReguVirta ID: 0c7dde5a9b1d09ba3beff49e473b2ff0
FDA guidance, Final
Medical Devices Radiation-Emitting Products Investigation & Enforcement
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