A businessman in the USA has been jailed for selling unapproved medical devices which he claimed could cure diabetes and stroke.
James Folsom has been sentenced in a San Diego federal court to serve 51 months in prison and pay a $250,000 fine following his conviction on 26 felony counts relating to the sale of unapproved devices.
The devices, marketed under the brand names NatureTronics, AstroPulse, BioSolutions, Energy Wellness and Global Wellness, consisted of a micro-current frequency generator with a digital display, two steel cylinders and associated items of equipment.
Users were provided with a list of digital settings for treatment of specific conditions including diabetes, stroke, AIDS and ulcers. They were told to connect the cylinders to the machine and touch them to the body.
Between 1997 and 2008, Folsom sold over 9,000 units to distributors for $1000–1200 and to retail customers for $1995, with total sales above $8 million. The devices were manufactured by him and others in a location not registered with the FDA as a device manufacturing establishment. He used false names for sales, distribution, storage and bank accounts.
The devices were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an FDA electrical performance standard. They did not bear the manufacturer’s name or address.
The case reflects the fact that it is still possible to circumvent regulatory processes in the manufacture and sale of medical devices – but the cumulative breaking of many regulations may carry serious penalties.