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CONSUMER PRODUCTS Kinesiology Tape / Wristbands

CONSUMER PRODUCTS Kinesiology Tape / Wristbands. Rusty Lundberg Utah Division of Radiation Control OAS Annual Meeting August 26, 2014. Utah Department of Environmental Quality. EVENT. Initial embargo of Kinesiology Tape (K-tape) at the Port of Los Angeles containing Th-232

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CONSUMER PRODUCTS Kinesiology Tape / Wristbands

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  1. CONSUMER PRODUCTSKinesiology Tape / Wristbands Rusty Lundberg Utah Division of Radiation Control OAS Annual Meeting August 26, 2014 Utah Department of Environmental Quality

  2. EVENT • Initial embargo of Kinesiology Tape (K-tape) at the Port of Los Angeles containing Th-232 • Identification of U.S. importer • Endevr™ – located in St. George, Utah • Formerly DBA LifeStrength, LLC • Distributor, wholesale and retail sales (including online) • Also sells silicone wrist bands using negative ion technology • Eventual inclusion of wrist bands

  3. SEQUENCE OF EVENTS • FDA Inspection of Endevr™ • Endevr™ follow-up actions / contacts made • Utah DRC (UDRC) notification • NRC Region 4 (email February 2014) • UDRC • Contacts made with: NRC, FDA, OAS, Endevr™, CA • UDRC Site visit of Endevr™ • Conference calls • FDA, NRC, OAS, CRCPD

  4. Endevr™ – St. George, Utah

  5. SITE INSPECTIONFebruary 19, 2014 • Date • Findings photos

  6. SITE INSPECTION • Findings • No manufacturing of products at site • Exposure rate measurements taken • Warehouse – Background ~ 10 µR/hr • Warehouse – surface box containing about 2,000 wrist bands ~ 60 µR/hr (net) • No removable contamination detected • Collected sample K-tape and wrist bands • Wrist bands analyzed by UDRC & ORAU • Sent report to NRC

  7. K-TAPE / WRIST BANDS

  8. Analytical Work • K-tape • FDA – WEAC • FDA – Health Risk Assessment • Wristbands • OAS • VA & CO (UT DRC) • NRC – Oak Ridge

  9. ANALYTICAL RESULTS Percent by Weight of Thorium-232 Endevr™ Wrist Band Samples Gamma Spectroscopy

  10. ANALYTICAL RESULTS Percent by Weight of Thorium-232 in Negative Ion Powder* by Inductively Coupled Plasma-Atomic Emission Spectrometry *Wrist bands Endevr™ purchases use negative ion powder at a concentration of 3% of the silicone matrix. ** Shenzhen Citek Technology Co., TLD (Zhejiang Province, China)

  11. COMMUNICATIONS • NRC to OAS/UDRC • OAS/CRCPD/NRC Monthly calls • FDA to UDRC • FDA analytical results

  12. UTAH ACTIONS New web page

  13. UTAH ACTIONS • Coordination with Endevr™ • Final disposition of unsold wristbands likely subject to licensing and remaining as stored inventory • Periodic evaluation of products now being sold/distributed with lower source concentration in ion powder

  14. QUESTIONS? Contact Information: Rusty Lundberg Utah Division of Radiation Control rlundberg@utah.gov 801-536-4257

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