Unapproved Dental Drug Goes Up in Smoke
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, Conn., resident post, inspected Altholtz's Dental Clearing House, in Simsbury, Conn., on Jan. 18, 1992, following numerous complaints from health professionals that advertisements claimed the one-step formula "meets FDA standards" and was "FDA sanctioned." Agency records showed no approved new drug application (NDA) on file for the product.
Souza found Altholtz was distributing the formula in 60-gram (2-ounce) bottles of white powder and 30-milliliter (1-oz.) bottles of liquid. One bottle of each was to be mixed at the ordering dentist's office to create the filler.
"Altholtz had the powder and liquid made to his specifications at contract laboratories," Souza says. "The records showed that the liquid contained an approved dental analgesic-antiseptic, eugenol, and some inert ingredients. But the active ingredient in the powder was paraformaldehyde, a toxic preservative that has no approved use in drug products."
A month later FDA wrote to Altholtz, warning him that seizure or other legal action might ensue if he didn't stop selling the unapproved drug and advertising it with statements that imply approval, such as "meets FDA standards."
Altholtz wrote back, saying that an FDA official had told the formula's original owner in a 1982 letter that the agency would take no regulatory action until it reviewed the product to determine its safety and effectiveness.
"If the FDA now feels it is not a safe and efficacious product," he wrote, "I think you should poll some of the dentists who have used it and also the patients who have benefitted from its effectiveness so that you will have a total picture of its place in the modern dental world." He said FDA had suggested the precise formula at that time "so that we would be able to market in interstate commerce without requiring a prescription. ... Our boasting that this is a 'sanctioned' formulation is nothing more than a way of giving credit to the man and the agency which suggested its very makeup."
In an April 2, 1992, letter to Altholtz, FDA pointed out that while the agency official had indeed indicated FDA would defer action until after reviewing the product, the official also had informed the original owner that the product had no approved NDA on file with FDA. "This product still does not have an approved NDA," the agency stated in the letter, "and is in violation of the Food, Drug, and Cosmetic Act when introduced or delivered for introduction into interstate commerce."
The letter further explained that FDA does not "poll" users to determine drug effectiveness. "The responsibility for determining this rests with the drug manufacturer and must have some basis in science not testimonials," the letter stated, adding that adequate and well-controlled studies provide the basis for the agency's evaluation of a drug. The letter also explained that the agency had not suggested the precise formula but had quoted it from a letter from the original owner. "We strongly object to reference that this product is FDA sanctioned because not only is it misleading, it is entirely false." FDA warned, "Continued marketing of this unapproved new drug is at your own risk."
A year later, FDA still had no approved NDA on file for the White One-Step Endodontic Formula. On July 22, 1993, Souza inspected the firm again to determine the product's marketing status.
From the firm's records, Souza learned that in August and September 1992—despite FDA's warning that the formula was an unapproved product—Altholtz had ordered about 3,000 units of the powder, which at the firm's current sales rate amounted to a six-year supply.
"I asked Dr. Altholtz if he was aware that his product did not have an approved NDA," Souza recalled. "Dr. Altholtz explained he thought someone had applied for an NDA, but he wasn't sure." Souza explained to Altholtz that he must apply for his own NDA and that this generally involves animal and clinical testing to prove the product is safe and effective.
Altholtz replied that this would be too costly. He then showed Souza FDA's 1982 letter to the original owner of the formula and claimed that the FDA official's statement about not taking regulatory action until reviewing the product allowed him, Altholtz, to market the product. Souza reiterated that Altholtz needed his own NDA.
Souza collected product samples and promotional literature, noting that, as required for approved drugs, no additional labeling, insert or instructions accompanied the product. He noticed, however, that Altholtz had removed references to FDA in the promotional literature.
On Feb. 25, 1994, at FDA's request, the U.S. attorney in Hartford filed in the U.S. District Court for the District of Connecticut a complaint for forfeiture and a warrant for the arrest of the White One-Step Endodontic Formula. U.S. marshals seized the product March 22 at the Dental Clearing House and ordered the company to detain the product until further court order.
On March 28, 1996, U.S. District Judge Janet Bond Arterton ordered the seized unapproved new drug condemned, forfeited and destroyed and ordered Dental Clearing House to pay all costs.
On June 20, 1996, Russell Sinni, supervisory deputy U.S. marshal, and Patricia Murphy, FDA consumer safety officer, met Altholtz at the site of his now defunct Dental Clearing House to identify the seized product. Jesse McCool, of Clean Harbors Environmental Services, Bristol, Conn., placed the bottles into a 5-gallon drum and sent the drug by truck to Natick, Mass., to be processed. From there, the product was sent to a toxic-waste disposal site in Nebraska, where it was burned in an incinerator and buried.
This article was reprinted from the December 1996 issue of FDA Consumer.
This article was posted on January 3, 2008.