A Canadian company selling massage devices as over-the-counter medical treatments in the U.S. has drawn the ire of the Department of Justice (DOJ) and the FDA.
The products -- Dr. Ho's Double Massage and Dr. Ho's Muscle Massage -- were sold by a company calling itself Universal Academy, according to DOJ statements posted June 8 and 12 on the FDA website.
Neither the FDA nor the DOJ would discuss how U.S. distribution of the unapproved devices was uncovered.
Between August 2005 and January 2006, GRE Fulfillment in Buffalo, N.Y., received 200,000 of the products with an estimated retail value of more than $2.7 million, the DOJ said.
The units were assembled at GRE and transferred to Fosdick Fulfillment Corp. in Meriden, Conn., from which they were shipped to consumers throughout the U.S., the DOJ added.
After filing legal complaints in district courts June 7 and 8, the FDA and U.S. attorneys general for the District of Connecticut and the Western District of New York seized the unapproved devices.
There are three primary reasons for the FDA actions, according to the agency's Center for Devices and Radiological Health's (CDRH) Office of Compliance. Sources at the branch of orthopedics, physical medicine and anesthesiology in the office's enforcement division told FDAnews that:There is no premarket clearance or approval for the devices; The uses for which they are promoted fall outside FDA regulations; and The instructions for their use are inadequate. The products would need to be labeled "For prescription use only" to be compliant.
Furthermore, the devices "are not being used by consumers by an order of a licensed manufacturer" and are "misbranded because they were manufactured at an unregistered facility," according to the DOJ statement. ()a href="http://www.fdanews.com/ddl/33_25/" target=_blank>