Prohibited listings for sale per FDA regulations

Prohibited listings for sale per FDA regulations:

  • Diabetic test strips that are pre-owned or test strips not authorized for sale in the U.S.
  • Products that have been altered to change the product's performance, safety specifications, or indications of use
  • Products that the FDA has determined present an unreasonable risk of injury or illness, such as:
    • Ear candle
    • Zappers
  • Products for which a premarket notification or premarket approval is required but have not yet been FDA cleared or approved
  • Products that are not appropriately listed in the FDA’s Establishment Registration & Device Listing database
  • Products that have passed their expiration or "use by" dates
  • Products labeled as "tester", "not for retail sale”, or "not intended for resale"
  • Products that are marketed as unapproved or unregistered medical devices, such as:
    • Psoriasis lamps
  • Certain menstrual cups, such as:
    • Monzcare R-cup and LadyCup
    • Rainbow and iCare menstrual cups
  • Products that have been the subject of criminal enforcement, injunctions, seizures, or warning letters, such as:
    • Lelo LunaBeads and Tor II
    • WaxVac Ear Cleaners
  • Products that incorporate Class IIIB lasers, such as laser light show projectors and Class IV lasers, such as industrial lasers
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans unless the claim is cleared or approved by the FDA, or do not require such approval. For example, most Class 1 devices, such as:
    • Chelation products, including metal detection test kits
    • Advanced Formula EDTA Oral Chelation
    • AlkaLife Alkaline Drops
    • Beyond Chelation Improved
    • Bio-Chelat Heavy Metal Chelator
    • Cardio Chelate
    • Cardio Renew
    • Cardio Restore
    • Detoxamin Oral
    • Detoxamin Suppositories
    • EBN Detoxifying Bentonite Clay
    • Kelatox Suppositories
    • Keto-Plex
    • Kids Chelat Heavy Metal Chelator
    • Kids Clear Detoxifying Clay Baths
    • Miracle Mineral Solutions
    • Rife Machines
    • Sexually Transmitted Disease (STD) Test Kits
    • Testosterone test kits
  • Products that are adulterated or misbranded
  • Products that contain mercury, such as thermometers and batteries
  • Used and refurbished medical devices
  • Products that improperly claim to be "FDA Cleared", "FDA approved" or products that include the FDA logo in associated images.



Products that have been classified by the FDA as medical devices that require FDA clearance or approval that have not been cleared or approved by the FDA for over-the-counter use, such as:

  • Acupuncture/intradermal needles
  • Anesthetic vaporizers
  • Asthma inhalers
  • Bacteriostatic water
  • Cancer tests,Examples of cancer tests are:
    • Cardiac monitor
    • Cavity varnish
      Examples of cavity varnish are:
      • Chin-up strip
      • Circumcision devices
      • Contact lens cases (unless cleared for over-the-counter use)
      • Contact lenses, including both cosmetic and corrective lenses.
      • Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and certain accessories,Examples of Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories are:
        • Cranial electrotherapy stimulators
        • Defibrillators (unless approved or cleared for over-the-counter use)
          Examples of defibrillators (prescription dental devices) are:
          • Dental burs
          • Dental X-ray units
          • Denture relining, repairing, or rebasing resin, such as dental handpiece or dental drill
  • Electronic stethoscopes
  • Electrosurgical cutting and coagulation devices
  • Fetal Dopplers
  • Home HIV test kits, with the exception of the Home Access HIV-1 Test System, which has been approved for over-the-counter use by the FDA
  • Hypodermic needles and insulin injectors, such as Monoject Safety Syringes
  • Infant heel warmers
  • Implantable devices, such as pacemakers
  • Infusion pumps and their accessories (with exception of batteries, which are permitted)
  • Infusion set
  • Insulin pumps
  • Laser combs
  • Mandibular advancement devices
    Examples of mandibular advancement devices are:
  • Mesotherapy products
  • Nebulizers and their accessories, such as holding chambers
  • Oral cavity abrasive polishing agents, such as oxygen concentrators, compressors, conservers, generators, condensers and their accessories, such as Hyperbaric chambers
  • Penis enlargement devices
  • Pinhole eyewear that makes unapproved medical claims
  • Prescription eyewear
  • Polar Care Cold Therapy System products manufactured by BREG
  • Pulse oximeters. In order to be listed and sold by sellers outside of the Professional Health Care Program, pulse oximeters must be either (a) clearly labeled and consistently marketed as “for sports or aviation use only” or "not for medical use", or (b) cleared by the FDA for OTC purchase and marketed accordingly
  • Radiesse
  • Resin tooth bonding agents, such as seizure bite sticks
  • Skin glue
  • Surgical kits
  • Surgical sutures
  • Ultrasound therapy and ultrasound pain relief devices
  • Vaginal pessary devices
  • Ventilator machines
  • Vitros Immunodiagnostic, integrated, and chemistry systems


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