Wrong flora in Micro-Flora

FDA Consumer, Nov, 1991 by Tom Cramer, Raja Mishra

A California firm that manufactured a product to aid in digestion went out of business after an FDA investigation showed bacterial contamination of some of the product.

The Micro-Flora Corporation of Camarillo, Calif., advertised its Micro-Flora liquid product as "a concentrated liquid form of viable organisms designed to assist in the replacement and maintenance of favorable intestinal bacterial growth."

The product consisted of a liquid growth medium seeded with Bacillus laterosporus bacteria. These bacteria live in the intestinal tract and replace and maintain intestinal bacterial growth, leading to more efficient digestion, elimination of toxins, and restoration of destroyed intestinal flora.

In March 1990, officials from the Canadian Health and Welfare Department informed the Canoga Park resident post of FDA's Los Angeles district office that analysis of a sample of Micro-Flora liquid from lot #0522, obtained from a consumer, showed contamination with Klebsiella pneumoniae bacteria.

Exposure to Klebsiella pneumoniae can lead to an acute infection of the respiratory tract. This can be very dangerous and is often fatal to young children and the elderly.

The liquid was labeled for treatment of ill-defined digestive upsets, as well as gastrointestinal cancer, inflammatory bowel disease, diverticulitis, and other digestive afflictions.

Canadian authorities recalled the product in Canada in March 1990 and requested that FDA's Los Angeles district office investigate further.

Canoga Park resident post investigator Ronald Koller investigated the distributing firm, located in Camarillo, Calif., that month and obtained samples of the product for testing. Laboratory analysis confirmed that lot #0522 was contaminated with Klebsiella bacteria.

The analysis also revealed that a second lot (#0573) was not only contaminated with Klebsiella, but also lacked Bacillus laterosporus, the active ingredient of the product. FDA issue a class I recall of both lots of Micro-Flora liquid on June 22, 1990. (A class I recall means that there is a reasonable probability that use of or exposure to the product under recall could result in serious adverse health consequences or death.) Canadian health officials also recalled lot #0573.

Investigator William Teachworth and microbiologist Richard Ruby, both from the Canoga Park resident post, had conducted a follow-up investigation in May 1990 of the bottler, Cosmtic Development Systems in Newbury Park, Calif., and the manufacturer, John McConville and Associates of Valencia, Calif., to determine the origins of the contamination. The source was found to be the manufacturer. Upon learning that the product was contaminated, McConville voluntarily destroyed his ongoing production of bacteria culture for shipment to Micro-Flora.

On Aug. 31, investigators Ronald Koller and Marvin Walker of the Canoga Park resident post net with Micro-Flora officials at their office and warehouse i n Camarillo, where they were to witness the dumping of all frozen and returned stock of lots #0522 and #0573.

When they arrived, however, Micro-Flora's president, Boyd J. O'Donnell, told them that new information obtained by the corporation proved that the Micro-Flora liquid had not been contaminated with Klebsiella. Furthermore, according to Koller, O'Donnell said he was planning to sue FDA and would not destroy the product because he intended to use it as evidence. All further matters, he claimed, would be handled by his attorney. O'Donnell refused to allow inspection and asked the investigators to leave.

The investigators obtained a warrant for inspection and returned to the Micro-Flora warehouse on Sept. 20. They discovered that lot #0573 had been destroyed, but lot #0522 was still in the warehouse.

The scene at the firm was one of "turmoil," according to Koller. O'Donnell told the investigators that the stockholders of the company had decided to vote him out and that he was no longer acting president. He said he was in the process of vacating the office and claimed that the interim president was Tevis Morrow of Colorado.

The investigators then contacted Morrow, who acknowledged that he was interim president, but said that his primary position was that of president of Boulder Nutrition, a distributor of Micro-Flora. Morrow said he had no knowledge of the Klebsiella contamination of Micro-Flora liquid and could not give the investigators any information about the product, but that he would try to cooperate fully with the agency.

On Sept. 27, Morrow contacted the Canoga Park resident post and informed the investigation team that O'Donnell was involved in litigation with the company stockholders over control of company assets, which were frozen because the company had no product to distribute. He also said he would permit FDA to oversee destruction of the contaminated lot.

On Nov. 26, Koller and officials of the California Food and Drug Administration supervised the voluntary destruction of 3,467 16-ounce containers of Micro-Flora liquid, lot #0522, valued at $70,000.