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During a trial earlier this year in a federal courtroom in Portland, Ore., people were wearing-with obvious pride-buttons that read: "I EAT ALGAE." In fact, this odd dietary proclamation told only part of the story; these people not only ate the aquatic plants, they profited by them, too. They were distributors of a line of products made of blue-green algae by one of the defendants in the trial, K. C. Laboratories of Klamath Falls, Ore.
At issue in the courtroom was the status of the products. The firm and its distributors insisted that the products were food supplements and needed no FDA approval to be marketed. But FDA contended that the products were drugs because the firm claimed that the algae could be used to treat an array of maladies ranging from Alzheimer's disease to herpes. If the products were drugs, they would have to be approved by FDA as safe and effective before they could be sold.
In the end, the judge in the case agreed with FDA that the products should not be allowed on the market, but the path to that decision was as slippery as the contested water weed itself.
Investigators from FDA's Seattle district office first inspected K.C. Laboratories in 1983 when it was just starting operations. The firm was owned by Victor Kollman. Kollman explained to the investigators that K.C. Laboratories was harvesting blue-green algae from Klamath Lake to be freeze-dried, bottled and sold as a food supplement.
The algae was harvested from the lake when the species Aphanizomenon flos-aquae was predominant. Aphanizomenon flos-aquae has been found to produce a toxin that is a powerful neuromuscular blocking agent. In laboratory studies it has caused animals to stop breathing. The algae produces the toxin during its most active growth state, which is also when it is most likely to be harvested. The district office recomme4ded to FDA headquarters that the products be seized. Legal documents were subsequently filed with the federal court, and a deputy U.S. marshal was instructed to seize the goods.
When the marshal and an FDA investigator arrived at the firm, Kollman met them with undisguised hostility. While the marshal was phoning for assistance, Kollman and his wife locked themselves inside the plant. When they refused to open the doors, the marshal, assisted by several Klamath County sheriffs, shattered the glass entry door with a sledgehammer and entered. They arrested the Kollmans, charging that they had interfered with federal officials, and placed under seizure about $120,000 worth of blue-green algae products, which they took by truck to a public warehouse.
Undaunted, Kollman continued to harvest and process blue-green algae, which he sold under the name Blue-Green Manna. Specialized forms of Blue-Green Manna were advertised in the company's newsletter, 7he Klamath Courier, including Mannacol (recommended for "metabolic dysfunctions"), Mannamist (for allergies), Mannapep (to enhance mental and physical performance), Mannastat (for cuts and bums), and Mannazen (to "establish a balance between physical, intellectual, and spiritual biorhythms").
The products were sold through some 2,500 distributors involved in a multilevel marketing plan. FDA made follow-up inspections at some of these distributors, including an undercover inspection of one such distributor in Everett, Wash. Posing as a potential distributor, a Seattle district investigator found an impressive stack of literature that was to be given out with the algae products. Blue-Green Manna, the literature said, could repair damage to the brain and restore the ability of the body to resist disease. Because the algae itself did not age or get sick, it could act as a "natural healer." One printed sheet called Blue-Green Manna "God's gift to modern man" and claimed it could treat high blood pressure, stomach distress, menstrual discomfort, headaches, skin rashes, blindness, leukemia, sickle-cell anemia, and herpes. Video and audio cassette tapes were also available which extolled the benefits of Blue-Green Manna products.
The proprietor of the establishment explained to the investigator the wondrous powers of Blue-Green Manna. He said it had cured his arthritis and his wife's tonsillitis. He also said that "Dr." Kollman had used the product to cure 100 lepers in India in 90 days. This was a story Seattle district staff had heard before -- but the statistics had changed.
In July 1994, FDA requested the U.S. Attorney's Office to conduct a second seizure of blue-green algae products, this time those in possession of the Everett distributor. The government alleged that the products were drugs because of the way in which they were promoted, but they had not been shown to be safe and effective. Unfortunately, when the deputy U.S. marshal and a Seattle district investigator got to the Everett firm, there were no blue-green algae products and no literature. The proprietor told them that "a little bird" had told him he had better remove the products from sale or he would lose them. He refused to tell the deputy marshal what he did with the algae products.
In the meantime, however, FDA made another move, requesting an injunction against Kollman, his firm, and other companies that contributed to the manufacture and distribution of the blue-green algae products. These other companies were: Manna International Company; K.C. Laboratories Marketing, Inc.; K.C. Laboratories Production, Inc.; Wynetta Spencer-Kollman and her firm, Klamath Publishing Co., which produced promotional materials for the products and sold them to K.C. Laboratories Marketing; D. Raymond Schmidt, head of Schmidt Food Processing Co. (which freeze-dried the algae); Susan E. Davis, vice president of K.C. Laboratories Marketing; and APG Company, Inc., which held a lease from the state permitting it to harvest the algae from upper Klamath Lake.
FDA charged that the defendants were making medical claims for their blue-green algae products, which put them legally in the drug category; however, the firm had not done the necessary studies to prove that the products were safe and effective for these uses. Kollman denied that he had made therapeutic claims for the products and said they were intended as foods, not drugs.
In November 1985, in the U.S. District Court for the District of Oregon, Judge Gus Solomon granted a preliminary injunction against the firms and individuals, barring the manufacture and distribution of blue-green algae products. The injunction had little effect on the distributors, who continued to distribute the products that they had stockpiled or that they had received from a new firm, MultiCellular Biologiks, which purchased the assets and liabilities of the Kollman firms.
In December 1985, the government sought and was granted a temporary restraining order against Multi-Cellular Biologiks preventing them, too, from manufacturing and distributing blue-green algae products. In February 1986, Judge Solomon made the injunction permanent against K.C. Laboratories.
In doing so, the judge said, "Since I issued the preliminary injunction, I have received hundreds of letters from distributors and others who say they have purchased and used the products. . . . They repeat the claims made to the court by Kollman that this is a food and not a drug and they go on to say it has cured them or members of their families of such conditions as Alzheimer's disease, heart trouble, skin disturbances, allergies, prostate problems, lack of sex drive, emotional problems, and alcoholism. . . . All of these actions merely confirm my strong belief that the claims which defendants have made for their products and the publicity given such claims are believed by many people."
Judge Solomon said that in fact the recommended dosage of the product provided little nutritional value and at a price one would scarcely expect to pay for a food -- over $300 a pound. He also added that Kollman had not been honest about his credentials since there was no evidence that he had a doctorate or was entitled to be called doctor, as he claimed.
The defendants were permanently enjoined from manufacturing and marketing any products that contain blue-green algae. The judge also enjoined the production or distribution of literature related to blue-green algae products and ordered Victor Kollman and K.C. Laboratories to recall all blue-green algae products and raw and processed algae produced since Nov. 29, 1985. An order of permanent injunction against Multi-Cellular Biologiks was granted in April 1986.
Carol Ballentine is a member of FDA's public affairs staff. This article is reprinted from the July-August 1986 issue of FDA Consumer.