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A 52-year-old California man is serving a 16-month sentence at Federal Prison Camp, Boron, Calif., for helping to sell and distribute an illegal drug touted for weight control, bodybuilding, and insomnia.
Frank Richards Zenker, also known as Frank Richards, formerly of Villa Park, Calif., now of Laguna Beach, Calif., was sentenced Oct. 27, 1994, for conspiring to illegally distribute gamma hydroxybutyrate, or GHB. His co-worker, Lance Crews Griffin, 46, was sentenced March 28, 1994, to two years, nine months.
GHB is legally allowed as an investigational new drug for treatment of narcolepsy, a rare sleeping sickness. Illegally, it has been promoted for strength training, muscle building, weight loss, and as a replacement for L-tryptophan, a food supplement used as a sleep aid FDA ordered removed from the market in 1989, after it was linked to a rare blood disorder. GHB also is used illegally as a hallucinogen.
GHB can cause severe stomach pain, low blood pressure, irregular heartbeat, vomiting, dizziness, seizures, respiratory arrest, liver failure, and coma. Health authorities have received reports of illnesses in at least 30 people in California, Florida and Georgia since 1991.
Under the name Omniopathy Products, Zenker and Griffin sold GHB in bulk powder and capsule form, bottled and falsely labeled as another illegal product, glutathione, from a fictitious company named RTL Labs of Oakland, Calif. They distributed the product throughout the United States and abroad.
FDA learned about the men's illegal activities through "Operation Big Mouth," a massive effort by FDA, the U.S. Customs Service, the U.S. Attorney's Office, and other government agencies to identify and prosecute illicit drug traffickers. It was so named because defendants cooperated with authorities by admitting guilt and identifying other drug traffickers. Cooperating defendants also helped FDA make undercover purchases of illegal drugs.
Armed with information about Omniopathy, in March 1991, FDA investigators went to the business address at a residence in Villa Park, Calif., where they spoke to Griffin. (This address was later identified as also being Zenker's residence.)
Griffin identified himself as company owner and said he founded the company--a pharmaceutical distributorship--in 1988. He said he had more than 800 customers and the company made about $350,000 a year. He also told investigators he stopped selling GHB in 1991, after FDA issued a warning about the drug.
FDA learned that Zenker worked for Omniopathy part time and was one of six employees. None of the employees was a licensed pharmacist and none had FDA approval to receive, make or distribute drugs.
In August 1991, FDA investigators tracked the business to a new site in Santa Ana, Calif. Searching through trash at the new location, investigators found invoices and other documents showing Omniopathy was selling GHB. One invoice included the typed statement "Dr. Thatcher, the Oxy-Sleep is the product that we had discussed before (GHB, relabeled), an outstanding product for sleep plus for its growth hormone properties."
In January 1992, an undercover FDA investigator called Omniopathy's toll-free number and talked to a person who identified himself as Frank Richards. They discussed the company's "Oxy-Sleep." According to the investigator, Richards said the product's active ingredient was gamma hydroxybutyrate, which he acknowledged was "off the market."
The investigator ordered and received various dosage forms of Oxy-Sleep. FDA analyses showed the product contained GHB.
In other undercover telephone calls, FDA ordered, received and tested additional supplies of Oxy-Sleep, which also tested positive for GHB.
In February 1992, investigators, armed with a warrant, searched the premises in Santa Ana. Among items seized were:
During the search, investigators extracted from computer data information about the Villa Park site, which led FDA to obtain a second search warrant for that site. There, investigators found 645 kilograms of GHB and various other illegal drugs.
In interviews with Omniopathy employees and business associates, FDA learned that Griffin bought GHB and placed it in unlabeled bottles and jars stored at Zenker's Villa Park residence. Griffin then had labels made and had an unindicted co-conspirator of his and Zenker's put the labels on the bottles and jars. The labels identified the product as Oxy-Sleep and falsely stated that the active ingredient was the illegal drug glutathione. Also, the labels did not give adequate directions for use and warnings.
From his home, Zenker helped fill and ship GHB orders via the U.S. Postal Service and from assorted private mail drops.
In June 1992, a grand jury for the U.S. District Court for the Central District of California handed down a six-count indictment against Zenker and Griffin. Because of health problems, Zenker was tried separately from Griffin in June 1994, at which time the jury found Zenker guilty of all counts.
In addition to prison, Zenker was sentenced to two years' probation. He is eligible for parole in 1996.
Paula Kurtzweil is a member of FDA's public affairs staff.
Combine modern technology with instant gratification, and it was bound to happen--a video production of little Susie or Sammy even before their actual debut into the world. Recently, companies with names like Womb With a View and Peek-A-Boo Baby have sprung up, offering expectant moms and dads ultrasound images of baby still in the womb.
But FDA says these "keepsake videos," taken for purely entertainment purposes with no medical need or prescription, are an unapproved use of ultrasound equipment. As of February 1995, the agency had warned seven companies to stop making the videos or face possible seizure, injunction, or other regulatory action. The Texas State Health Department took action against another three firms. By May, five companies had stopped operating, and FDA was monitoring compliance at several others.
Ultrasound imaging is a common diagnostic medical procedure. It uses high-frequency sound waves that generate echoes when they bounce off tissues. The echoes are conveyed to a computer, which translates them into images of the target tissue or organ.
"Obstetricians use ultrasound imaging to check the size, location, number, or age of fetuses, the presence of some types of birth defects, and fetal movement, breathing and heartbeat," says Tom Jakub, chief of the diagnostic devices branch in FDA's Center for Devices and Radiological Health's Office of Compliance. "Ultrasound is generally considered safe when properly used for medical reasons, and often the doctor will give parents a still photo from these tests."
But laboratory studies show that ultrasound can produce physical effects in tissue, such as jarring vibrations and rise in temperature. Although there is no evidence that this can harm the fetus, public health experts agree that casual exposure to ultrasound, especially during pregnancy, should be avoided.
"Viewed in this light, there's no justification for exposing the fetus to ultrasound when no medical benefit is expected," Jakub says. "Furthermore, FDA believes that ultrasound imaging for medical purposes should be done with as low an output of acoustic radiation as possible to get a good image. Keepsake video companies sometimes may use the ultrasound machine for as long as an hour to get a video of the fetus."
FDA first learned about keepsake video operations from consumers in Texas in the early spring of 1994. The Texas Department of Health and FDA's Dallas district office jointly inspected three firms--Baby Images, Inc., in Houston, Peek-A-Boo, Inc., in Plano, and Womb With a View in Dallas. The Center for Devices and Radiological Health then initiated investigations of similar firms in other parts of the country.
In August 1994, FDA wrote of its concerns to 10 health professional organizations and the National Electrical Manufacturers Association, saying, "Persons who promote, sell or lease ultrasound equipment for making 'keepsake' fetal videos should know that we view this as an unapproved use of a medical device, and that we are prepared to take regulatory action against those who engage in such misuse of medical equipment." The agency asked the organizations to have their members discourage patients from having ultrasound procedures for nonmedical reasons and to notify FDA of any keepsake video operations in their communities.
FDA inspections uncovered numerous companies offering a wide variety of ultrasound packages. Romper Womb in Indianapolis, for example, advertised a "Peek-A-Boo Package," priced at $65, consisting of a 10-minute video "for which you may bring a tape or CD to be included as background music." For $90, clients could choose the "Pink or Blue Package," a 15-minute video, also with background music. "See the world within the womb from the perspective of your new baby(s). In this fifteen minutes, we will try and provide you with genitalia visualization," the ad said.
The firm's "Winter Special Package" for $150 provided parents 30 minutes of video divided into two 15-minute sessions or three 10-minute sessions. Also included was "your selection of a customized coffee mug starring your baby or a $50.00 savings bond." And for the "ultimate" package, Romper Womb suggested the "Baby Shower Super Show Package," which "can be shown to all the well-wishers at the baby's shower. You can have your shower here or we can come to a different site where we can show you a 'Womb With a View' that will truly be baby's shower." The cost "varies."
As of May 1995, Wee Imaging, Inc., in Spartanburg, S.C., If They Could See Me Now in Tallahassee, Fla., Peek-A-Boo, Inc., in Plano, Texas, Peek-A-Boo Baby, in Weatherby Lake, Mo., and Womb With a View in Dallas had gone out of business. The FDA district offices are continuing to monitor other firms to ensure they are in compliance.
--Marian Segal
An Ohio judge recently ordered the destruction of 61 Relaxman Synchro-energizers--gadgets consisting of glasses, headphones, and a control box producing sound and flashing light patterns. The manufacturer had promoted and distributed the device as a solution to myriad health problems, without supporting documentation of their safety and effectiveness and without complying with FDA medical device regulations.
On Feb. 23, 1995, Judge Ann Aldrich, of the U.S. District Court for the Northern District of Ohio, ordered the destruction of the unapproved medical devices, manufactured by Meta Brain/Mind Biomedical Research Foundation, Cleveland, Ohio, and worth approximately $30,000.
FDA's investigation of Meta Brain began Sept. 1, 1992, when the agency's San Francisco district office received a consumer complaint that a Synchro-energizer device caused a seizure in a 21-year-old woman. The woman, who had never had a seizure before, had used the device as part of a work-related stress reduction seminar. A physician who examined the woman afterwards confirmed that she had had a seizure.
In response to the complaint, beginning on Nov. 9, FDA investigators Stephen J. Kilker and Donald F. Fernholz, from the agency's Brunswick, Ohio, resident post, inspected Meta Brain.
During the inspection, the investigators learned that the firm's owner, Krystina J. Rymsky, had not submitted a premarket approval application to FDA for the Relaxman and had not registered the firm with the agency. The investigators explained to Rymsky that because of these violations, FDA could initiate legal action against the goods, the firm, and the responsible individuals.
Rymsky said she would register the company and file premarket approval notifications. However, she never followed through.
During the inspection, the investigators collected labeling and promotional materials for the Relaxman. Jerilyn Glass, M.D., a neurologist with FDA's Center for Devices and Radiological Health, reviewed the materials and found numerous health claims for the device, including control of pain, habits and addictions, and improved digestion and sexual function.
According to the promotional literature, the Relaxman achieved these beneficial effects by changing electrical brainwave activity.
A search of the scientific literature through FDA's Medical Library revealed that no well-designed studies or investigations had been published in peer-reviewed scientific journals to demonstrate the safety or effectiveness of the Relaxman device for these purposes.
In addition, the promotional literature did not adequately warn about the danger of seizure. A statement in the device's user guide did warn that people with "any history whatsoever [of] epilepsy or brain seizures" should not use the device "except under the direct supervision and/or order of [a] licensed M.D., Ph.D., or other qualified health care professional." However, Glass says, the warning was inadequate, because it did not warn that all users, even those with no prior history of seizure or epilepsy, could be at risk.
On Dec. 11, 1992, Evelyn D. Forney, a compliance officer with FDA's Cincinnati district office, recommended to the agency's Center for Devices and Radiological Health that all Relaxman devices in Meta Brain's possession be seized.
The center agreed, but asked that the district verify that the firm was still selling the device. On May 11, 1993, FDA investigator Frederick M. Lochner called Meta Brain and requested information about the Relaxman. He received promotional materials similar to the ones collected during the November inspection.
On July 28, 1993, at FDA's request, a seizure complaint was filed in the U.S. District Court for the Northern District of Ohio. The complaint charged that the devices:
The devices were seized on Aug. 3, 1993. Rymsky filed a response to the seizure admitting that the seized goods were devices, but generally denying the other allegations in the complaint.
On Nov. 22, 1994, the Justice Department, on FDA's behalf, filed a motion for summary judgment requesting the devices be condemned as adulterated and misbranded and be forfeited to the United States. The motion also requested that Rymsky pay all costs and fees as required by law. Rymsky did not respond, and on Feb. 23, 1995, the court granted the government's motion. At press time the devices were in possession of the U.S. marshals, awaiting destruction.
--Isadora B. Stehlin
House of Spices finished reconditioning its rice, lentils, mung beans, spices, and other foods last May 5. The firm paid $10,400 for FDA's supervision of the reconditioning.
FDA Chicago district investigators inspected the firm's warehouse Oct. 13 to 19, 1993, after the State of Illinois embargoed 916,000 pounds of foods packed in cloth, paper and cardboard containers.
"We found flying Indian meal moths all over the place, as well as other grain-type insects such as cowpea weevils and cigarette beetles," said district compliance officer Paul Boehmer.
Because the entire warehouse was infested with insects, at FDA's request, the U.S. Attorney's Office filed a civil suit Oct. 22 in the U.S. District Court for the Northern District of Illinois, Eastern Division, seeking forfeiture and destruction of all insect-susceptible products stored there. The same day, the U.S. marshal seized the products.
For the next three months, House of Spices' attorneys and FDA officials negotiated a consent decree that the firm's manager, Kaushik Shah, signed Jan. 10, 1994. The firm agreed to recondition the products it could and destroy all others, fumigate the warehouse, and maintain sanitary conditions.
On Feb. 8, FDA again inspected the firm's warehouse. Investigators found the warehouse clean with no evidence of insect activity.
House of Spices "fumigated its warehouse, killing all flying insects, and vacuumed everything else," Boehmer said, but added that FDA was still concerned about insects, larvae, eggs, excreta, and other contaminants that remained inside the bagged products. "The bagged products looked good on the outside, but we had to make sure it was clean inside," he said.
Over the next five months, House of Spices' attorneys submitted various reconditioning plans to FDA, but they were inadequate. On July 11, 1994, the agency accepted a detailed phase I reconditioning plan for all of the firm's paper-packaged products.
During the phase I reconditioning, FDA conducted a follow-up inspection from Aug. 29 to Sept. 7. Investigators again found live and dead insects on the exterior of bags in several lots.
The firm again fumigated and proceeded with its phase II plan--screening to separate insect filth from the food products--which FDA had accepted on Nov. 9.
The reconditioning operation was completed on May 5.
--Kevin L. Ropp
FDA Consumer magazine (September 1995)