Washington Consumer Protection News

Federal Government Moves for Seizure and Forfeiture of Unapproved Medical Devices

Kevin J. O'Connor, United States Attorney for the District of Connecticut, and Dr. Andrew C. von Eschenbach, Acting Commissioner of FDA, today announced that the United States has filed a Complaint in the U.S. District Court in New Haven that seeks the seizure and ultimate forfeiture of numerous medical devices and their component parts and accessories that were stored in a distribution warehouse in Meriden, Connecticut. The Complaint, filed on Wednesday, June 7, alleges that the medical devices, which were muscle stimulators being sold as "Dr. Ho's Double Massage" and "Dr. Ho's Muscle Massage," are in violation of a series of Food and Drug Administration (FDA) statues in that the devices are both adulterated and misbranded.

The seized devices are owned by Universal Academy, Inc., an importer located in Markham, Ontario, Canada. Universal Academy, Inc. is associated with a Dr. Ho from China, who has sold various products and has marketed these devices touting miracle cures. On Thursday, June 8, the United States Marshals Service, accompanied by FDA officials and State of Connecticut Department of Consumer Protection Drug Control Agents, executed a warrant to seize the items, which have an estimated retail value of more than $1 million, from Fosdick Fulfillment Corporation in Meriden.

The devices, components, and accessories, are adulterated under the Federal Food, Drug, and Cosmetic Act because they are unapproved class III medical devices and they do not meet mandatory performance standards. In addition, the devices are labeled for use to treat serious medical conditions, including diabetic neuropathy, fibromyalgia, arthritis, and migraine headaches. Since these devices have not been approved by FDA, the safety parameters associated with their use and the efficacy of the devices for use to treat diseases have not been determined. These devices are misbranded because their labeling lacks adequate directions for intended use, they are not labeled prescription use only, and they are not being used by consumers by order of a licensed practitioner. They are further misbranded because they were manufactured at an unregistered facility.

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