At FDA’s request, the U.S. Marshals Service recently seized and destroyed magnetic devices valued at some $42,000 because the products were being marketed illegally with unsubstantiated medical claims.
The device, known as Elekiban, was a quarter-inch magnetic disk attached to a circular adhesive patch. According to the labeling, users should place the Elekiban patch on their skin at “pressure spots,” similar to acupuncture, where its magnetic force “stimulates the blood circulation and relieves the stiffness in the shoulder, neck and waist.”
Raymond Kent, a compliance officer with FDA’s Buffalo district office, which recommended the seizure, says, “The device was purported to have a beneficial effect through interaction of its own magnetic field with the magnetic field of the Earth. But the misleading claims could pose an unreasonable health hazard if use of the device caused people to postpone necessary treatment.”
Claims also asserted FDA had actually approved the device, which was untrue, Kent says.
The Elekiban stock was destroyed Nov. 3, 1992.
The magnetic disks had been distributed primarily by Physio Meditec Corporation (PMC), an Amherst, N.Y., firm jointly owned by the device importer, UNIC International Corporation, of Canada, and manufacturer, PIP-Fujimoto Co., Ltd., of Japan.
Similar devices had been marketed in the mid to late 1970s as “Mag-U-Dot” with similar claims, including references to acupuncture. FDA informed the distributor at that time, Domenico International Ltd., of Akron, Ohio, that the device was subject to a March 1973 Federal Register notice declaring acupuncture devices investigational, which means theycouldn’t be commercially marketed.
The Domenico president teamed up with other individuals to form ACU-DOT Corporation, in Akron. They changed the device’s name to “ACU-DOT” and dropped acupuncture references from the labeling but continued to market it with unproven medical claims. Mag-U-Dot and ACU-DOT had the same U.S. patent number as Elekiban, and all were made, at least in part, by PIP-Fujimoto.
At FDA’s request, the U.S. Marshals Service seized ACU-DOT devices several times in 1979 and 1980. ACU-DOT contested the seizures, submitting to FDA results of a U.S. clinical study and a survey conducted in Japan. But two FDA physicians and an agency biophysicist determined the submissions were inadequate to warrant agency approval. A judge ruled the devices were misbranded because of the misleading labeling claims.
Later, PIP-Fujimoto met with FDA at headquarters several times. Agency officials explained the requirements for proof of effectiveness for labeled uses for devices FDA designates as “class III devices,” which includes acupuncture instruments. FDA considers such instruments to be investigational devices.
Then, in January 1985, MNS, Ltd., of Hawaii, submitted to FDA an application to market another similar device called Elekiban. The application was submitted under “51 0(k),” the section of the Federal Food, Drug, and Cosmetic Act stating that devices may be marketed without new study data if shown substantially equivalent to products sold before the Medical Device Amendments of 1976. The submission, however, did include two additional clinical studies sponsored by PIP-Fujimoto.
FDA determined that Elekiban was substantially the same as the Mag-U-Dot, a pre-Amendments device, but that the earlier device was misbranded because the claims were false and misleading. FDA also found these studies-like those submitted for ACU-DOT to be inadequate.
According to T. Whit Athey, Ph.D., an FDA senior scientist and expert in magnetic theory, “The submitted material, at best, was misleading and vague, mixing a few well-known facts with many more unsupported assumptions. There was basically no scientific support for the mechanisms put forth.”
In a letter dated April 16, 1985, the agency informed MNS that marketing its Elekiban for any medical purpose would be illegal.
Meanwhile, on June 18, 1984, MNS had petitioned FDA to reclassify Elekiban from class III to class I (which only requires general controls, such as proper labeling and good manufacturing practices), submitting results of the same two studies. FDA replied that the evidence of effectiveness was insufficient.
On Nov. 30, 1987, FDA issued an import alert to detain at U.S. borders all magnetic support medical devices, including Elekiban and similar products.
Early in 1990, representatives of PIP-Fujimoto and Canadian importer UNIC Corp. began promoting Elekiban in the Buffalo, N.Y., area press. In a May 1990 letter to UNIC Corp., FDA advised the firm that Elekiban was misbranded and wouldn’t be allowed into the United States.
In July 1990, FDA Buffalo district investigator Joseph Famiglietti visited Physio Meditec Corporation. While PMC was registered with FDA as a medical device distributor, Famiglietti learned, it had no authority to be marketing Elekiban. What’s more, Famiglietti found that PMC was intentionally misinvoicing the product as “novelty items” at the time of import to avoid detection by U.S. Customs. Famiglietti warned PMC that marketing the device was against the law.
On Jan. 28, 1991, in response to letters from PMC’s attorney concerning the legal status of Elekiban, FDA again warned the firm that it was an illegal device. The U.S. Marshals Service seized all of PMC’s Elekiban stock and labeling on May I, 1991. PMC filed a claim that same day to have the goods returned.
After a lengthy period of meetings, hearings, and legal communications with FDA, the firm’s attorney withdrew from the case. On June 9, 1992, PMC agreed to forfeit its stock. A U.S. marshal removed the product and supervised its destruction.
This article was originally published in the June 1993 issue of FDA Consumer. Dixie Farley was a staff writer for the magazine. William Defibaugh, a compliance officer with FDA’ s Center/or Devices and Radiological Health, also contributed to this report.