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A businessman got more publicity than he bargained for when he appeared on the cover of a Dallas magazine to promote his product for attention deficit disorder (ADD). The close-up of the product caught the attention of federal and state health officials and eventually led to a nationwide recall.
Gary Lewellyn, former chief executive officer of Performance Nutrition Inc., of Carrollton, Texas--a Dallas suburb--was on the cover of the June 27, 1996, Dallas Observer, holding a can of Kids Plex Jr., a powder his company purportedly sold as a food supplement. A label claim, "for hyperactive A.D.D. children," was clearly visible.
ADD, which falls under the umbrella of attention-deficit/hyperactivity disorder (ADHD), is typically diagnosed in children who show signs of inattentiveness, impulsivity and sometimes hyperactivity. FDA has approved only prescription medicines for these disorders.
"We knew immediately it was a disease-related claim subject to FDA regulation," said Reynaldo Rodriguez, a compliance officer in FDA's Dallas district office. The Texas Attorney General's Office brought the photo and accompanying article to FDA's attention in July 1996.
The FDA inspections and warning letter that ensued led the company to voluntarily recall in September 1997 five lots of Kids Plex Jr. and a similar food supplement, Plex, because they had been distributed with literature containing disease-related claims. At press time, the company, now under new leadership, was still trying to retrieve the mislabeled products distributed throughout the United States and remove the literature before redistributing the product.
The Dallas Observer article also led to Lewellyn's dismissal from Performance Nutrition after the company's shareholders learned about his criminal past, Rodriguez said. The article reported that Lewellyn had served five years in prison for embezzlement, had been barred permanently from the brokerage business by the Securities and Exchange Commission, and remained under investigation by the SEC for securities fraud.
"The magazine article got him in more trouble than FDA ever did," Rodriguez said.
The article described the marketing strategy behind Kids Plex, which the company was promoting on radio and TV as a possible treatment for ADD.
During an inspection July 12, 1996, Dallas Gilbreath, an investigator with FDA's Dallas district office, learned in an interview with a company consultant that the company, a dietary supplements distributor, bought pre-made powder and tablets from a California company and labeled them under its own name. Two of its products, Plex and Kids Plex, contained various vitamins and minerals, amino acids, and undefined ingredients, such as "ergogens" and "lipotropics," according to the labeling.
Responding to questions from Gilbreath, Lewellyn and the company consultant denied saying that Kids Plex would cure ADHD. They said it was the news media that was carrying the message after hearing stories about how well their product had helped children.
However, in promotional materials that Gilbreath collected, several references to ADHD were made, indicating that the company was touting the product for the disorder.
For example, a press release described Kids Plex as a "safe, effective approach that may bring relief from the over prescription of the mind altering drug," a reference to Ritalin (methylphenidate), which is approved for ADHD. A brochure said "Kids Plex Jr., because of its fortification with inhibitory amino acids, has the potential to help children with Attention Deficit Disorder ...." And a script for a 60-second radio spot said, "... you know those hyperactive and attention deficit problems we hear so much about? For a lot of children, Kids Plex is helping, naturally, without drugs."
Based on these claims, FDA said in a Dec. 4, 1996, warning letter to Performance Nutrition: "Kids Plex is a 'new drug.' ... It may not be legally marketed in this country as it is not the subject of an approved New Drug Application." The letter also declared the product misbranded because it failed to give adequate directions for use and contained misleading information about its role in treating ADHD.
Following a meeting with FDA's Rodriguez and officials of the Office of the Texas Attorney General, the company's new president and chief executive officer, Anthony Roth, informed FDA in a Dec. 14, letter that the company had destroyed "all promotional literature previously utilized by prior management." Roth also submitted new literature for FDA's review with all references to ADHD and related disorders deleted.
"They were very interested in achieving compliance," Rodriguez recalls.
In early fall 1997, the Texas Attorney General's Office notified FDA that a member of the Attorney General's Office, while shopping in a local health food store, had found containers of Plex and Kids Plex that appeared to have the old insert under the plastic cap. FDA confirmed the state's suspicions, when, in an inspection of the company's warehouse, an investigator found the offending literature on products in stock.
The company initiated a recall in September 1997, asking its buyers to return 19,000 16-ounce (448-gram) and 20-ounce (560g) containers of Plex and Kids Plex. The company told FDA that a contract manufacturer had used the literature provided to them under the company's previous leadership.
According to Rodriguez, the company has since assembled a quality assurance committee to prevent any recurrences of labeling violations.
Paula Kurtzweil is a member of FDA's public affairs staff.
Under a consent decree filed Jan. 27, Los Angeles-based Alpha Therapeutic Corp. agreed to improve its manufacturing processes and quality controls with the help of an outside consultant.
FDA investigators became aware of Alpha Therapeutic's deficiencies during a scheduled inspection in April 1996. The inspection revealed wide-ranging problems, including equipment with questionable reliability and inadequate employee training, record keeping, and methods for investigating product failures.
FDA inspected the company again later that year and found continuing manufacturing problems.
"After each inspection, the company submitted proposed actions that looked like they would be adequate to correct the problems," says Anna Flynn, a consumer safety officer in FDA's Center for Biologics Evaluation and Research. "But with each inspection, we found the same types of issues existed."
After another FDA inspection from February through June 1997 showed persistent production problems, FDA pursued a court-supervised agreement, Flynn says. Under the terms of the consent decree, Alpha Therapeutic will strengthen its quality assurance program, review its management structure to ensure that it complies with FDA's requirements, and improve its internal audit system, production processes, and records management, including procedures for tracking products that are recalled or returned to the company for other reasons.
Alpha Therapeutic must regularly submit progress reports to FDA. The agency plans to re-inspect the company to confirm that the called-for corrections are being made.
--Tamar Nordenberg
In an August 1997 plea agreement, Moyco Industries Inc. admitted that it continued to sell the powder even after finding out that the product failed stability tests.
Since 1988, the Defense Department has paid Moyco more than $5 million for Itch-Away Foot Powder, a treatment for athlete's foot, a fungal infection. By selling unstable products, Moyco was providing foot powder that may not have been effective against the infection.
The case unfolded in March 1995, when an anonymous source phoned a Defense Department waste and abuse hot line to complain that Moyco was violating its Defense contract. The contract specified that Itch-Away Foot Powder should be stable for three years.
In January 1996, FDA's Philadelphia district office contacted the agency's Office of Criminal Investigations (OCI) with information on Moyco's suspected illegal activities. The following month, FDA officials met with the Defense Criminal Investigative Service to investigate Moyco jointly.
Early in the investigation, agents interviewed potential witnesses and informants who corroborated the anonymous hot line caller's complaint. In interviews, informants also gave agents information showing that the company continued to sell the product to the Defense Department even after knowing it was unstable. The apparent motive was monetary profit, according to OCI.
In May 1996, the Defense Department and OCI executed a federal search warrant at Moyco's Montgomeryville, Pa., facility. At the same time, after gaining the company's permission, agents searched Moyco's quality control laboratory in York, Pa. Company officials surrendered numerous boxes of Itch-Away Foot Powder and related documents.
Throughout the investigation, FDA's Philadelphia laboratory analyzed foot powder samples, which consistently failed stability tests.
In April 1997, the federal government filed a two-count criminal information in the Eastern District of Pennsylvania charging Moyco with distributing adulterated drugs and mail fraud. The information also charged Jerome Lipkin, Moyco's senior vice president, with mail fraud. Three weeks later, Moyco and Lipkin pleaded guilty to all counts.
In August 1997, Moyco agreed in district court to a settlement in which the company paid the U.S. Treasury $505,000 for civil charges related to distributing adulterated drugs.
Last October, the same court fined Moyco $350,000 and a $400 special assessment and sentenced the company to five years' probation for the criminal charges. As part of the plea agreement, Lipkin received a $15,038 fine, three years' probation, and 120 days of home confinement.
Moyco is now under suspension from contracting with the federal government. At press time, hearings were under way to set the length of the suspension, which could be between three and five years.
--John Henkel
FDA Consumer magazine (May-June 1998)