Acupuncture Devices By Any Other Name . . .
FDA Consumer, June 1990The Taiwanese supplier wrote to the American importer that the supplier had not applied for approval of its product by FDA, "though we have met the standard." But, the supplier continued, according to past experience, if documents say 'stimulator' instead of 'acupuncture,' sale of the devices will be allowed.
On July 24, 1989, 955 of the 1,000 imported "stimulators" were seized at FDA's request because—by any name—the devices were being sold in violation of the law.
A complaint to the Office of the Attorney General in Montgomery, Ala., in February 1989 set the wheels of the investigation in motion. The Alabama State Board of Chiropractic Examiners objected to an advertisement for a "Jupiter Electronic Acupressure Model 707"—promoted to cure just about everything from asthma to vertigo—in which the device was referred to as a natural chiropractic product."
At the request of the attorney general, FDA's Nashville district office followed up on the complaint. Unable to locate the device importer through the address listed on the firm's medical device registration form, Birmingham resident post inspector Ronald Ramsey traced the importer's identity and location through a post office box number listed on promotional literature. On April 5, Ramsey visited the importer, Joseph Lockett, to conduct an inspection and examine the device.
During the inspection, Lockett said that he preferred to call the product a stimulator." Ramsey concluded that this designation was probably for "FDA consumption only, as labeling of the device repeatedly uses the term 'acupuncture.' Ramsey said that "acupuncture" would be misleading because the electrodes of the unit examined were "far too blunt to effectively puncture the skin without serious trauma, nor did the literature describe procedures to puncture the skin.
The literature did, however, state: "This instrument can cure the disease by applying in a 'low frequency pulse' which, when applied to the body, the nerve wave in the body will be activated, the equivalent of traditional acupuncture therefore is approached" (sic).
During the interview, according to Ramsey, Lockett said the "electronic stimulator can't do anything." Yet his advertisement suggests the device is effective treatment for "migraine headaches, arthritis, toothache, sciatica, disc problems, nausea, hypertension, bronchitis, vertigo, asthma, gynecological distress, intestine illness, liver and kidney disease, enuresis, palsy of upper extremities," and more.
During an interview on April 21, Lockett contended that since he offers the unit through his advertising with a money-back guarantee, he was not fraudulently promoting the product. Lockett had received one shipment of the devices containing 1,000 units. About 15 were sold and 30 were given away. On July 19, FDA requested that the district attorney for the Northern District of Alabama file for seizure of the remaining 955 devices on several grounds:
- The units require pre-market approval, which Lockett had neither obtained nor applied for.
- The labeling contains false claims suggesting the devices are effective for treating various illnesses and conditions, including convulsions, shock, diabetes, hypertension, tinnitus, paralysis, dysentery, kidney ailments, and others.
- The labeling does not provide adequate directions for use, nor can adequate directions be written for consumers or for licensed personnel.
- The labeling does not provide adequate warnings for the hazards and risks it poses when used as suggested, nor for possible adverse effects associated with long-term use.
On Jan. 26, 1990, Ramsey accompanied U.S. marshals to a local steel mill to witness destruction of the 955 Jupiter Model 707s in a gas-fired furnace.
This article was posted on February 18, 2005.