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The maker of unapproved new drugs promoted for the treatment of cancer, heart disease, diabetes, and other serious conditions lost its fight for the return of $600,000 worth of illegal products seized at FDA's request.
In a March 1997 order, Judge Lloyd George of the U.S. District Court for the District of Nevada ruled that International Nutrition Inc. of Las Vegas was not entitled to the return of the products sold under the Hans Nieper label, even if the company intended to relabel the products and remove the unsupported drug claims. The judge agreed with FDA that the return of the goods would allow the company and its president, Gene Sylvester Oden, to profit from their past illegal activities.
International Nutrition and Oden said they wanted the products back so they could relabel them and sell them as dietary supplements. But FDA stated in its brief to the court that the company "cannot plausibly argue that a mere change in the labeling today will undo the effects of several years of unsubstantiated therapeutic claims."
The products were mostly orotates, which are made up of orotic acid and various minerals, such as calcium, magnesium, zinc, potassium, and lithium.
"Oden said that orotates were the best thing ever discovered for cancer and other serious diseases," says FDA investigator Luis Chavarria of the agency's Las Vegas resident post. "He said their unique transporter system could carry nutrients through the cell wall faster than anything available on the market."
FDA received no reports of injuries from the Hans Nieper products made by Oden. But, as Chavarria points out, the heavy promotion--and subsequent use--of these products for serious ailments could endanger the public health.
"For example, you could have a diabetic substituting these unproven products for the insulin their body depends on," he says.
FDA began looking into Oden's business practices after receiving reports in 1992 and early 1993 from consumers and drug manufacturers about the sale of unapproved Hans Nieper products in the United States.
Since 1987, FDA had been aware of fraudulently promoted products manufactured in Europe by German physician Hans Nieper and sometimes shipped into the United States. But FDA knew of no U.S.-manufactured Hans Nieper products until FDA's Orlando district office traced some products seen during a plant inspection to a manufacturing facility in Pahrump, Nev. Based on this lead, Chavarria inspected Oden-owned Ramona Manufacturing Inc. in Pahrump in March 1993.
"When I confronted Oden about the illegal manufacture of orotates, he totally denied making them at his plant," Chavarria says.
But two Ramona employees who were present during the inspection secretly phoned Chavarria later and told him the plant did manufacture orotates. The informants also told Chavarria that while he was inspecting the plant, one employee ran out the plant's back door carrying boxes of orotates, while another ran into the women's bathroom and hid the products' labels behind a paper towel machine.
On April 30, 1993, an investigator with FDA's Minneapolis district office placed an anonymous order for Hans Nieper products with International Nutrition. Within two days, the district office received shark cartilage and colamine phosphate drugs from International Nutrition, as well as promotional literature with unsubstantiated medical claims sent by another company owned by Oden, Papillon Botanicals Inc.
"To try to circumvent FDA's regulations," Chavarria says, "Oden had set up several companies besides International Nutrition to distribute the literature with the medical claims."
From June to August 1993, FDA investigators and U.S. marshals searched seven Oden-owned facilities, including Ramona, Papillon, and International Nutrition, and seized the unapproved drugs.
Both Oden and International Nutrition pleaded guilty in June 1995 to selling unapproved new drugs across state lines. Oden was sentenced to five years' probation and fined $5,000, and his company received five years' probation and a $60,000 fine.
Almost two years later, FDA was in court with International Nutrition again, this time opposing the company's bid to get back its seized products. "Based on Oden's track record, we were very concerned that if he got the seized items back, he would turn around and continue the criminal enterprise he had been involved in," Chavarria says.
The court, sharing FDA's concern, stated in its order denying return of the products, "International Nutrition's request ... is akin to the creator of a seized pipe bomb asking for the return of the pipe with the promise that the pipe will be used for plumbing, or the manufacturer of seized illegal firearms asking for the return of the metal with the promise that it will manufacture the metal into legal firearms."
The seized drugs will be crushed at a landfill, Chavarria says. To FDA's knowledge, Oden has stopped manufacturing the illegal Hans Nieper products. He still owns International Nutrition Inc., which he has relocated to a town near El Paso, Texas.
Tamar Nordenberg is a staff writer for FDA Consumer.
On March 31, Judge Joseph Kinneary, of the U.S. District Court for the Southern District of Ohio, granted FDA's motion for summary judgment and ordered the destruction of almost $26,000 worth of WRM-RID, previously seized by the government. The court agreed with FDA that the product was illegal because the company never submitted data to show safety or effectiveness of the product as required by federal law. The company had argued that its product was legal because it had been on the market before effectiveness data became a requirement for approval of new animal drugs.
Semple promoted WRM-RID for parasitic tapeworm, hookworm and roundworm infestations in dogs and cats. These infestations can cause vomiting, diarrhea, loss of appetite, weight loss, anemia, and death.
The two active ingredients in WRM-RID are piperazine phosphate and arecoline hydrobromide. Piperazine phosphate is approved for roundworm infestation in dogs and cats. Arecoline hydrobromide is not approved at all.
The combination of the two drugs in one product is not approved "nor is it recognized by the veterinary profession for any use," Susan Homire, D.V.M., an FDA veterinarian, told the court. She added that an extensive scientific literature search produced no published studies on the safety or effectiveness of WRM-RID or any product with the same combination of active ingredients for the uses recommended in the product labeling.
FDA has inspected Bingman Laboratories periodically since it began marketing WRM-RID in the 1950s but did not cite the company for any deficiencies until April 9, 1991, when FDA's Cincinnati district office informed Semple by letter that the agency considered WRM-RID an unapproved new animal drug. FDA based its decision on, among other things, the fact that there was no new animal drug application on file with respect to the product's use or intended use.
Semple responded in letters dated April 17 and Aug. 26, that WRM-RID was not subject to the requirement for a new animal drug application because it had been on the market before an Oct. 10, 1962, amendment to the 1938 Federal Food, Drug, and Cosmetic Act added a requirement for effectiveness for all drugs.
Although discussions with staff from FDA's Center for Veterinary Medicine did not convince Semple that WRM-RID was a new animal drug, he told agency investigators during inspections in August and November 1992 that he would stop making the drug until the issue was resolved.
Members of the center's division of compliance and surveillance met with Semple again in April 1993 to discuss the need for a new animal drug application for WRM-RID, but no progress was made in changing Semple's mind.
During an inspection in March 1994, Diane McDaniel, an investigator with FDA's Columbus resident post found that the company was still making WRM-RID. When McDaniel asked for production records, the plant manager said he would first have to talk to Semple, who conducted business from his home in Florida.
Semple called McDaniel the next day and told her that he kept all production records at his home and would send her current labeling and production records for the most recent batch of WRM-RID. McDaniel returned to the plant to collect a sample.
Within a week, McDaniel received a letter from Semple, but the labels and production records he said he would send were not included. Instead, Semple wrote, "For your information, there has been no change in the WRM-RID formula, manufacturing process, label claims and dosage directions since 1955."
In April 1994, Evelyn Forney, a compliance officer with FDA's Cincinnati district office recommended that the agency seek seizure of the product because Semple continued to deny that WRM-RID was covered under the 1962 amendment.
The Center for Veterinary Medicine agreed with Forney's recommendation, and in August, the U.S. Department of Justice, at FDA's request, filed a complaint for forfeiture and condemnation. On Sept. 12, U.S. marshals seized 154 kilograms (339 pounds) of WRM-RID, as well as labels and packaging for the product, at the Sarahsville plant.
Semple filed a claim for ownership Sept. 22, and on Oct. 13, he filed an answer to the government's complaint. He continued to assert that WRM-RID was on the market before the 1962 amendment and therefore exempt from FDA approval under a "grandfather clause."
For Semple's assertion to be true under the 1962 amendment he had to prove that the current WRM-RID was:
In addition, the grandfather clause could be considered only if the documentation submitted to FDA or available in the scientific literature showed that WRM-RID was considered safe before the date of the 1962 amendment. Safety has been a requirement for all drugs since the 1938 Food, Drug, and Cosmetic Act.
Semple did not submit any evidence proving safety, and an FDA literature search did not find any data to support product safety. Although FDA has no record of WRM-RID ever causing any problems or injuries, that is not considered documentation.
On April 23, 1997, Semple filed an appeal to prevent destruction of the seized product. At press time in July, the appeal was pending.
--Isadora Stehlin
Earlier this year, investigators with FDA's San Francisco district office confirmed Schmit's findings of lead-soldered canned food on some area retail shelves, even though FDA had banned the cans for food use two years ago and required their removal from commerce by June 1996.
Most of the San Francisco-area stores found with illegal lead-soldered cans, imported mainly from southeastern Asia, were small ethnic groceries specializing in imported foods. Almost all of the cans have since been removed from store shelves, according to Richard Jacobs, Ph.D., a research chemist and metal specialist in FDA's San Francisco district office who participated in the inspections.
Lead is a known metabolic poison that can damage the kidneys and liver and the nervous, reproductive, cardiovascular, immune, and gastrointestinal systems. It is particularly damaging in children, where, among other things, it can impede intellectual development. Extremely high levels of lead in the body can cause death.
Lead-soldered cans pose a risk because the lead seeps into the food. Until November 1991, when U.S. manufacturers voluntarily stopped producing lead-soldered cans, 14 to 45 percent of lead in food came from these types of cans. In 1995, FDA imposed a mandatory ban that covered not only U.S.-produced canned goods but imported canned food, as well. Many countries still make lead-soldered cans for food use.
Schmit's sixth-grade project got its start during his fourth-grade year, when he came across a news story about FDA's impending ban. For his fourth-grade science project, he decided to see whether he could find lead-soldered cans on Oakland store shelves. He scouted four stores looking for suspect cans with thick wide seams and, sometimes, solder smears.
He ended up buying six suspect cans from two stores. At home, he tested them, using one of several commercial home lead test kits modeled after a lead test developed by FDA, and found that the cans were indeed lead soldered.
His sixth-grade science project updated and expanded the earlier one. Last January, he revisited the two stores where he had previously found lead-soldered canned food. He did not find any lead-soldered cans at one of the stores but found 10 lead-soldered cans--six more than he had found two years earlier--on the shelves of the other store.
With help from his mother, Schmit arranged for a private laboratory to help him test samples of food from the lead-soldered cans. The food samples tested positive for lead.
These findings prompted Schmit in February to contact county and state health authorities, as well as FDA. "I [wanted] to get as many people aware of this health hazard [as possible]," he said. "I had a responsibility to let people know."
Impressed with the quality of Schmit's research and concerned about his findings, FDA, in March, sent four teams of investigators to check out smaller stores specializing in imported foods in Oakland, Berkeley, South San Francisco, and San Francisco. These cities have large ethnic populations served by a number of what Jacobs referred to as "mom-and-pop operations."
The teams visited 24 stores, most of which sold Chinese, Vietnamese, Philippine, or Korean foods. A few specialized in Central and Eastern European food.
The investigators examined thousands of different canned products. All but one proprietor willingly handed over suspect cans for FDA laboratory analysis. The remaining proprietor told investigators they would have to pay for the cans, which they did.
According to Jacobs, the four teams collected "thousands" of suspect products, 64 of which tested positive for lead in the side seam. The Oakland team, which visited five stores, examined 818 cans, 47 (6 percent) of which tested positive for lead-soldered seams.
"Except for a few cases, most of the canned goods that tested positive for lead appeared to be quite old, perhaps manufactured substantially before the prohibition [on lead-soldered cans]," Jacobs said.
According to the labels, most of the canned goods came from China and Taiwan. Other countries of origin included Thailand, India, Japan, Mexico, Chile, Peru, and Canada.
During the search for lead-soldered cans, investigators also came across a number of swollen, leaky cans and spotted rodent droppings, urine stains, and other signs of filth around the cans. "There were really some outrageous conditions," Jacobs said. "I almost got sick in the store."
FDA investigators brought their findings to store owners' attention. In many cases, Jacobs said, store owners were not aware of the ban on lead-soldered cans. Most agreed to remove and destroy illegal products, Jacobs said.
Many of the store owners also appeared unfamiliar with the thick wide seams and solder smears that indicate a can is soldered shut with lead. So investigators instructed store owners on what to look for.
The investigators forwarded their findings to the county and state health departments for follow-up. FDA's San Francisco metals' team plans to reinspect stores found with illegal canned goods, as well.
In addition, FDA's San Francisco and Los Angeles district offices joined together to prepare educational materials on the hazards of lead-soldered cans.
Seventh-grader Schmit helped with educational efforts, too. He appeared on a one-hour Chinese-language San Francisco TV program. Also, his school project was the focus of several local print and broadcast news stories. He was interviewed by National Public Radio and, according to Jacobs, Scholastic News.
His brother, a science major at Northwestern University in Evanston, Ill., got a job with FDA's San Francisco district laboratory this past summer, a feat that the younger Schmit attributed to his involvement with FDA.
Science seems to be his calling, too, he said, citing medicine or laboratory work as possible future fields he will enter. He may even decide to join FDA some day. "That's a consideration," he said.
Jacobs' comments during the NPR interview indicated he wouldn't mind hiring him: "Too bad he [is] too young to make an inspector because I would really liked to have had him doing some of our work. ... He had a very great interest in this project, and it went beyond just a science project."
A blue-ribbon-winning science project at that.
--Paula Kurtzweil
The drugs were made by Magna-Bon Corp., of Okeechobee, Fla. Magna-Bon president, Kenneth Sorber, developed an antiseptic ingredient he called "Sorber Acid," a combination of sulfuric acid and ammonium sulphate mixed together in what Sorber termed a chemical nuclear reactor using electricity and high heat. He claimed the resultant Sorber Acid was nontoxic, with a pH range of 0 to 0.5. (The pH scale represents the degree of acidity, where a pH less than 1 is very acidic and a pH greater than 13 is very basic.)
But analysis of the samples by FDA's Southeast Regional Laboratory in Atlanta revealed a pH ranging from 0.7 to 1.24. The agency concluded that the drugs were so harmful they posed a Class I health hazard--a reasonable probability of causing serious illness or death.
The products' approval status and safety were first questioned in 1992 by Gary Beers, president of Low Pharmaceuticals Inc., of Wallingford, Conn. Low was Magna-Bon's main distributor. Beers relayed his concerns to Magna-Bon's president.
Dissatisfied with Sorber's response, Beers contacted Victor Spanioli, an investigator with FDA's Miami resident post, in 1992. Sorber's response to Beers' concerns, Spanioli learned, was that the Magna-Bon products were generally recognized as safe and so didn't need FDA approval. Sorber also had advised Beers to distribute the products without delay.
To look into the matter, Lynn Albinson, an investigator with FDA's Florida district office in Orlando, inspected Magna-Bon in December 1992. She learned that the company began business in Okeechobee in December 1990, registering there with FDA in April 1991. Shortly afterward, the company moved to Port St. Lucie, Fla. It moved back to Okeechobee in September 1992 but never re-registered with FDA, according to her inspection report.
Albinson found Magna-Bon to be in violation of FDA's drug good manufacturing practices. In describing Sorber Acid to Albinson, Sorber said that because the acid kills off all bacteria, molds and viruses, he was not concerned with dust and bacteriological controls during the manufacturing process. Also, he kept no written records or procedures, he told her, because of "industrial espionage."
Albinson collected samples and presented her findings to Sorber. "Management stated that they would need an 'exemption' from FDA and could not comply with most of the findings," she recalled.
Based on laboratory analysis of the samples and the inspection report, FDA issued a warning letter to Magna-Bon on March 1, 1993, asking the company to recall its antiseptic cream, antiseptic spray for burns, and facial cream. FDA also asked Magna-Bon to stop distributing the drugs immediately, recall them, and respond to the agency or face possible legal sanction.
FDA concluded that use of the products as labeled could lead to permanent injury and scarring from skin burns, particularly in children with diaper rash involving broken skin. Further, if any of these products got into the eye, they would be expected to cause pain and possibly corneal damage, FDA said.
FDA also told Magna-Bon that the products were:
However, on May 28, FDA's Florida district recall coordinator, Philip Delisle, notified the agency's New England district office that the distribution company Low hadn't returned its products, worth about $430,830.
In September 1993, Magna-Bon regulations' manager informed Delisle that all products returned to the company and any under a "stop-sale" order had been destroyed the day before at a landfill.
In November, John Hollings, an investigator with FDA's Hartford, Conn., resident post, went to Low for a final inventory of Magna-Bon products and found the company "closed, locked up and lights out," he said. A note on the door gave a telephone number and the message, "For info call Larry Zarrella." Hollings called but couldn't reach Zarrella. He finally did get hold of another employee and, with fellow investigator Stephen Souza, met her there on Dec. 6. The drugs were still at Low's.
FDA proceeded to have the warehoused products seized, and on May 19, 1994, a Verified Complaint was filed in the U.S. District Court for the District of Connecticut, New Haven. U.S. marshals seized the inventory in June 1994.
On June 6, 1994, Magna-Bon's lawyer informed FDA that the company had no objection to the destruction of the warehoused products. Four days later, FDA's Hollings accompanied Deputy U.S. Marshal Patricia Henshaw to the warehouse, where the Magna-Bon antiseptic products were seized and then shipped to Hamden, Conn., for storage until U.S. marshals could locate a suitable disposal site.
--Dixie Farley
FDA Consumer magazine (September-October 1997)