Latest FTC Case in "Operation Cure.All" Focuses on
Safety Risks of Comfrey Products Promoted Via Internet

FDA Issues Simultaneous Letter to Industry Warning
against Marketing of Comfrey In Dietary Supplements

FTC News Release
July 6, 2001

As part of its latest efforts in its ongoing and comprehensive "Operation Cure.All" to combat Internet health fraud, the Federal Trade Commission today is announcing an additional case challenging the marketing of unproven and dangerous products via the Web. The target of today's action is Christopher Enterprises, Inc., a manufacturer and marketer of a variety of products containing the herbal ingredient comfrey, for both external and internal uses. The FTC charged that the company, its president, Norman Bacalla, and vice president, Ruth Christopher Bacalla, made unfounded claims that the products were beneficial in the treatment of a wide variety of serious diseases and conditions and that they were safe. In fact, according to the FTC's complaint, comfrey contains toxic substances and, when taken internally, can lead to serious liver damage. The defendants have agreed to a preliminary injunction requiring them to stop marketing comfrey products for internal uses or on open wounds, and to include a warning on comfrey products marketed for external uses. They have also agreed to stop making the challenged safety and health benefit claims.

"The Internet is a powerful tool for consumers searching for health information," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "Unfortunately, unscrupulous marketers also use it to peddle products with unproven and false claims.

"Consumers can lose their money and increase their health risk, especially if they delay or forego proper medical treatment," said Beales. "Consumers should avoid websites that promise quick and dramatic cures for serious diseases and they should always consult a physician or other healthcare professional before using any product or treatment," added Beales.

Christopher Enterprises, Inc., based in Springville, Utah, Norman Bacalla, and Ruth Christopher Bacalla, marketed and sold a variety of products containing comfrey to consumers throughout the United States by mail and telephone orders, on the Internet at www.drchristopher.com, and through distributors, retail stores, and health care practitioners.

The defendants stated in their advertising and promotional materials that their comfrey products were safe to take orally, as suppositories, or to be applied to open wounds, and that even pregnant women, infants, and children could safely use their products internally. The defendants also claimed their comfrey products, recommended for internal consumption, were effective in treating and/or curing asthma, colds, coughs, lung congestion, sore throats, emphysema, bronchitis, tuberculosis, broken bones, curvature of the spine, polio, multiple sclerosis, and spinal cancer. In addition, the defendants claimed their suppository products were effective in treating prolapsed bowel and uterus, yeast infection and herpes simplex. The defendants' herbal antiseptic containing comfrey, recommended for application to open wounds or taken internally, was claimed to be effective in treating, preventing, and/or curing thrush, infection, pyorrhea, sore throat pain, and toothaches.

The FTC alleges that the defendants' representations that their comfrey products were safe to use internally are false. In fact, the FTC said, comfrey is not safe for internal use because it contains pyrrolizidine alkaloids which are known to be toxic to the liver, and taken internally such substances can lead to serious illness or death. The FTC further alleges that the defendants did not have adequate scientific evidence to substantiate the safety or efficacy claims they made for their comfrey products.

The defendants have agreed to a preliminary injunction order that would prohibit them from marketing any comfrey product for ingestion, for use as a suppository, or for external use on open wounds, unless they have evidence that the product is free of pyrrolizidine alkaloids and is safe. They would also be required to place the following disclosure warning in any advertisement, promotional material or product label for any comfrey products intended for topical use:

WARNING: External Use Only. Consuming this product can cause serious liver damage. This product contains comfrey. Comfrey contains pyrrolizidine alkaloids, which may cause serious illness or death. This product should not be taken orally, used as a suppository, or applied to broken skin. For further information contact the Food and Drug Administration: http//:vm.cfsan.fda.gov.

In addition, the order would prohibit the defendants from making the specific health claims alleged in the complaint or any unsubstantiated representations about the safety, health benefits, performance, or efficacy of any food, drug, dietary supplement or other health-related product or service. The order further would require them to notify distributors of their products that unsubstantiated claims violate the law and that the defendants will terminate distributors who make false or unsubstantiated claims. The order will remain in effect until further order of the court.

In simultaneous action today, the Food and Drug Administration issued a letter to industry communicating concern about the safety of supplement products containing comfrey. FDA's letter, which has been sent to trade associations and other industry groups, advises that, because comfrey contains certain toxic substances — pyrrolizidine alkaloids — that have been associated with liver damage and other health hazards, it should not be used as an ingredient in supplements. FDA further recommends that firms should immediately stop marketing comfrey-containing supplements and alert consumers to stop using the products. Finally, FDA is urging manufacturers to identify and report any adverse events, including liver disorders that have been associated with comfrey and other ingredients containing pyrrolizidine alkaloids. The letter will also be posted on FDA's website at www.cfsan.fda.gov.

The Food and Drug Administration has been a close partner of the FTC and assisted the agency in today's enforcement action as well as many other aspects of "Operation Cure.All."

The Commission vote to authorize staff to file the complaint and the preliminary injunction was 5-0. The case was filed in the US District Court, District of Utah, Central Division, in Salt Lake City, on July 3, 2001, and the injunction is subject to court approval.

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This page was posted on November 20, 2005.

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