FDA wants disputed eggs to stay off the table
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The U.S. Food and Drug Administration and U.S. Attorney Mary Beth Buchanan are scrambling to get possession of eggs -- 24.75 tons of powdered ones -- that were the focus of an FDA case against claims the eggs cure disease.
The FDA case against Dr. Marilyn Coleman, 60, of Richwood, Ohio, and Mitchell Kaminski, whose business address is Northfield, Ill., and their company, OvImmune Inc., led to convictions against both and the corporation on charges the egg powder was mislabeled as a treatment or cure for diseases, including AIDS and cancer, without FDA approval.
Dr. Coleman and Mr. Kaminski have appealed their 2001 convictions.
But for two years and counting, the tons of powdered eggs have remained in storage at Allegheny Cold Storage in Pittsburgh, where Dr. Coleman has been paying $478.57 a month while her appeal wends its way through federal court.
And therein lies the problem.
On Monday, the federal government and U.S. marshals -- responsible for assuring the 990 bags and boxes of egg powder, each weighing 50 pounds, are not removed -- published a legal notice of intent to seize the powder and dispose of it.
The notice provides for anyone to challenge the seizure action within 10 days.
Contacted at her home, Dr. Coleman said she was never told the legal notice was published, but said she will challenge it. She said she wants to retain ownership of the eggs, which she said still could be used as food.
She has someone willing to purchase the powder, she said.
But Ms. Buchanan discounted any prospects that the powder could be sold as food.
Prior to seizure of the eggs two years ago, they were stored on Dr. Coleman's farm in what Ms. Buchanan said were "unsanitary and filthy conditions."
"These eggs never were washed after they were laid by chickens," she said. "They contained dirt and blood products and held in conditions where they were in some cases, rotten and moldy," Ms. Buchanan said.
"Then [Dr.] Coleman would invite people to have egg-breaking parties and recover whatever liquid they could recover from the eggs," which was sent to a Zanesville, Ohio, food-processing company to be turned into powder. "Our goal is to destroy these egg products so that no human or animal is exposed to them.
"They are extremely dangerous and contain many types of bacteria and salmonella -- whatever bacteria was in the eggs before they were dried.
"We believe the products are misbranded and adulterated and cannot be returned to her."
A 2001 Associated Press article stated that OvImmune Inc. was marketing a "magic bullet" that could stave off cancer or boost the immunity of AIDS patients, all from eggs. Other claims were made that the powder could treat rheumatoid arthritis, vaginitis, attention deficit disorder, fibromyalgia, chronic fatigue syndrome and toenail fungus.
OvImmune, based in Dr. Coleman's farmhouse 35 miles northwest of Columbus, sold its products nationwide over the Internet. Ms. Buchanan said $33,604 of the product was sold.
But the FDA said the biotech firm's so-called "magic bullet" -- eggs containing antibodies gathered from vaccinated hens -- was an unapproved drug.
Dr. Coleman, OvImmune president since 1992, was an assistant professor in developmental physiology at Ohio State University from 1976 to 1980, she said.
She said her products were dietary supplements that support the immune system.
The AP article stated she said the chickens were vaccinated, then their eggs were dried and sold as a powder with nothing added to them.
On July 31, 2001, federal agents raided Dr. Coleman's farmhouse and seized four boxes of documents, plus notebooks and computer records. A large number of eggs were destroyed and others were placed under quarantine.
The trial lasted five weeks, and Dr. Coleman and Mr. Kaminski were convicted and sentenced to serve six months in halfway houses and five years of probation. They also were ordered to pay restitution.
Dr. Coleman said when first approached by the FDA, she was willing to relabel the product to avoid medical claims, but the FDA raided her farm and seized the product before new labeling could be done.
Although the case was tried in federal court in southern Ohio, the issue of disposing of the eggs fell under Ms. Buchanan's jurisdiction because Dr. Coleman chose to store the eggs in the Pittsburgh facility.
If Dr. Coleman files a challenge, a hearing will be held to determine who owns the eggs.
"It can be used as food, but I won't send it out unless it is tested," Dr. Coleman said. "There is no reason for the government to take it."
Since her conviction, she said, she's been unable to get a job and is barely subsisting on "dandelion greens" so she can pay the storage fee.
But even if Dr. Coleman wins the legal battle to keep the eggs, Ms. Buchanan said the eggs would have to be tested for bacteria and other contaminants under FDA approval.
"The cost would be substantial," she said.
First Published May 18, 2006 12:00 am