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FTC Announces a Second Case Focusing on Safety Risks of Comfrey Products Promoted via InternetJuly 13, 2001 The Federal Trade Commission today is announcing a second case challenging the marketing and selling of unproven and dangerous comfrey products via the Web, as part of its ongoing and comprehensive "Operation Cure.All" initiative. The target of today's action is Western Botanicals, Inc., a Fair Oaks, California company that manufactured and marketed a variety of products containing the herbal ingredient comfrey, for both external and internal uses. The FTC charges that the company made unfounded claims that the products were beneficial in the treatment of a wide variety of serious diseases and health conditions, and that they were safe. In fact, comfrey contains toxic substances and, when taken internally, can lead to serious liver damage, according to the FTC. Western Botanicals has agreed, in a stipulated permanent injunction filed in federal court, to stop marketing comfrey products for internal uses or on open wounds, and to include a warning on comfrey products marketed for external uses. It has 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, it's also an outlet for unscrupulous marketers who use deceptive promotions to peddle their products. Consumers who delay or forego treatment while using unproven products that promise miracles can increase their health risks unnecessarily." According to the FTC, Western Botanicals, its president, Randy C. Giboney, and vice-president, Kyle D. Christensen, marketed and sold herbal products containing comfrey to distributors and directly to consumers by mail, newsletters, and on the Internet at www.westernbotanicals.com. The products purportedly treated and alleviated symptoms of various diseases and health conditions. In their advertising and promotional materials the defendants represented their comfrey products were safe for consumers, including nursing women, when taken internally or applied to open wounds. The defendants also claimed that their comfrey products, when taken internally, would treat chronic bronchial diseases, gastritis, duodenal ulcers, colitis, rheumatism, arthritis, osteoporosis, multiple sclerosis, amyotrophic lateral sclerosis and other conditions. The FTC alleges that the defendants' representation that their comfrey products were safe is false, and that they did not have scientific evidence to substantiate their safety or efficacy claims. The defendants have agreed to a stipulated final order for permanent injunction to resolve the FTC allegations. The stipulated final order 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 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 further would 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 suspended judgment of $50,800 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 order includes various recordkeeping and reporting requirements designed to assist the FTC in monitoring the defendants' compliance. On Friday July 6, 2001, 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 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 is also 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 FTC also thanks the Texas Department of Health for its participation in this phase of "Operation Cure.All." The Commission vote authorizing staff to file the complaint and proposed stipulated judgment in the Western Botanicals case was 5-0. They were filed in the U.S. District Court, Eastern District of California, in Sacramento, on July 11, 2001. The proposed judgment is subject to court approval. Related Documents: FTC v. Western Botanicals, Inc.; Randy C. Giboney; and Kyle D. Christensen (Eastern District of California). Complaint [PDF 18K] Stipulated Final Order [PDF 35K] The above article was reprinted from an announcement on the Federal Trade Commission web site dated July 13, 2001. Check the FTC web site for any changes to the article. |
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