FDA Issues Simultaneous Letter to Industry Warning Against Marketing of Comfrey In Dietary Supplements
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 substancesBpyrrolizidine alkaloidsBthat 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 U.S. District Court, District of Utah, Central Division, in Salt Lake City, on July 3, 2001, and the injunction is subject to court approval.
NOTE: The Commission files a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. The case will be decided by the court.
For More Information
Copies of the complaint and the stipulated preliminary injunction in this case are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad. Additional tips on buying healthcare products on the Internet and using supplements and other healthcare products are on the FTC's Virtual Health Treatments website, www.ftc.gov/healthclaims, and FDA's Buying Medicines and Medical Products Online website, www.fda.gov/oc/buyonline.
(FTC File No. 002-3273)
(Civil Action No. 2:01 CV-0505 ST)
Office of Public Affairs
Bureau of Consumer Protection
202-326-3088 or 202-326-3148
Bradley Elbein or Thomas Carter
Southwest Region - Dallas