Dixie Farley
Root canal filler containing a toxic substance was destroyed under court order at FDA’s request because it was an unapproved drug whose safety and effectiveness had never been established. An environmental services company burned the product in an incinerator. Harvey Altholtz, D.M.D., president of the Connecticut firm that distributed the filler, had asserted that because his White One-Step Endodontic Formula was widely used, it was generally recognized as safe and effective and therefore not a new drug requiring FDA approval. But a U.S. district judge ruled that adequate and well-controlled studies are required to establish drug safety and effectiveness and, since study data on the root canal filler had never been submitted to FDA, ordered the product destroyed. Stephen Souza, an investigator with FDA’s Hartford, …
Under an FDA-requested court order, 78 seized cartons of unapproved medical devices valued at $200,000 were destroyed in Little Rock, Ark., in June 1993 after at least 12 complaints attributed epileptic seizures to their use. The manufacturer destroyed another $200,000 worth of the devices rather than have them seized. The devices were various models of a product called the InnerQuest Brain Wave Synchronizer–headgear (an audio cassette and eyeglasses) that emitted sounds and flashing lights. Sold without prescription and promoted to relieve conditions such as stress, InnerQuest had never been proven safe and effective. On April 22, 1993, Judge Stephen M. Reasoner, of the U.S. District Court for the Eastern District of Arkansas, ordered the devices condemned and destroyed. The court ruled that the products were: …
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 …
