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CONSUMER PRODUCTS
Kinesiology Tape / Wristbands
Rusty LundbergUtah Division of Radiation Control
OAS Annual MeetingAugust 26, 2014
Utah Department of Environmental Quality
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
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
Endevr™ – St. George, Utah
SITE INSPECTIONFebruary 19, 2014
Date Findings
photos
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
K-TAPE / WRIST BANDS
ANALYTICAL WORK
K-tape FDA – WEAC FDA – Health Risk Assessment
Wristbands OAS
VA & CO (UT DRC) NRC – Oak Ridge
ANALYTICAL RESULTS
Percent by Weight of Thorium-232Endevr™ Wrist Band Samples
Gamma Spectroscopy
Analytical Service Provider
Low High
Utah 0.020% 0.090%
Colorado 0.037% 0.176%
Virginia 0.090% 0.170%
NRC – ORISE 0.080% 0.200%
ANALYTICAL RESULTS
Percent by Weight of Thorium-232in Negative Ion Powder*
by Inductively Coupled Plasma-Atomic Emission Spectrometry
Analytical Service Provider
Low High
CITEK** <0.001% <0.01%
*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)
COMMUNICATIONS
NRC to OAS/UDRC
OAS/CRCPD/NRC Monthly calls
FDA to UDRC
FDA analytical results
UTAH ACTIONS
New web page
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
