WASHINGTON, July 13, 2001 --The Federal Trade Commission has challenged another Web purveyor of products made with comfrey, an unproven and dangerous substance that can lead to severe liver damage and death.
The target of the latest FTC action is Western Botanicals, Inc., a Fair Oaks, CA, 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. Last week, the FTC took similar action against Christopher Enterprises.
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.
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.