http://www.ftc.gov/opa/2001/12/chrisenterprises2.htm

December 6, 2001

A Utah-based company has agreed to settle charges by the Federal Trade Commission that the company made unfounded claims about the health benefits of the herbal ingredient comfrey for treating or curing a wide variety of serious diseases and conditions. The FTC charged that Christopher Enterprises, Inc., based in Springville, Utah, and its principals, Norman Bacalla and Ruth Christopher Bacalla, did not have adequate scientific evidence to substantiate the safety or efficacy claims for their comfrey products. In fact, the FTC said, comfrey contains toxic alkaloids and, when taken internally, can cause serious liver damage or death. The defendants have agreed, in a stipulated permanent injunction filed in federal court, to stop marketing the comfrey products for internal use or on open wounds, and to include a warning on comfrey products marketed for external use. They have also agreed to stop making the challenged safety and health benefit claims and to pay $100,000 for consumer redress.

According to the FTC, Christopher Enterprises led consumers to believe that its products could treat such ailments as asthma, arthritis, cancer, colds, coughs, cramps, herpes simplex, infection, multiple sclerosis, paralysis, polio, stroke, and tuberculosis, and that the products were safe. According to the FTC's complaint filed in July 2001, Christopher Enterprises manufactured and marketed a variety of products containing comfrey to consumers throughout the United States by mail and telephone, on the Internet, and through distributors, retail stores, and health care practitioners. The defendants marketed and advertised their products for oral ingestion, for use as a suppository, and for use on open wounds.

The proposed settlement announced today ends the litigation in this case. The stipulated final order would prohibit the defendants 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 that it is safe. The defendants 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 challenged 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 would further require them to notify their distributors that unsubstantiated claims violate the law and that the defendants will terminate distributors who make false or unsubstantiated claims. The stipulated order includes a judgment of $1.4 million, suspended upon payment by the defendants of $100,000 for consumer redress, and a right to reopen provision that would reinstate the judgment if the court finds that the defendants made material misrepresentations or omissions on their financial statements. Finally, the settlement includes various record keeping and reporting requirements designed to assist the FTC in monitoring the defendants' compliance.

The Commission vote to authorize staff to file the proposed stipulated final order for permanent injunction was 5-0. It was filed in the U.S. District Court, District of Utah, Central Division, in Salt Lake City, on November 29, 2001, and is subject to court approval.

 
NOTE: This proposed stipulated final order is for settlement purposes only and does not constitute an admission by the defendants of a law violation. Stipulated orders have the force of law when signed by the judge.