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January 14, 2002
WASHINGTON--Last July, as part of theFederal Trade Commissions (FTC) Operation Cure.All, the agency went afterChristopher Enterprises Inc., a manufacturer and marketer of a variety ofproducts containing the herbal ingredient comfrey, for both external andinternal uses. In particular, FTC had taken exception with the companyspromotional materials that stated comfrey-containing products were safe to takeorally, as suppositories, or to be applied to open wounds. According to a Dec. 6press release from FTC, the case known as FTC v. ChristopherEnterprises Inc., et al, has closed.
In a stipulated permanent injunction filed in federal court, Springville,Utah-based Christopher Enterprises Inc. (www.drchristopher.com)and its principals have agreed to stop marketing comfrey products for internaluse or on open wounds, and the company will also include warnings on itstopical, non-wound. comfrey-containing ointments. In addition, ChristopherEnterprises will stop making the safety and health benefit claims the companyhad been using on its comfrey products, and it will pay $100,000 for consumerredress. In an interview with INSIDER in July 2001, thecompany stated that it had agreed to stop marketing comfrey products intendedfor internal use or for topical use on wounds as part of a preliminaryinjunction. Products such as Calc Tea for bone health and Resp Free capsules forrespiratory support were reformulated to be comfrey-free and hit store shelvesin late May and early June last year.
According to FTC, the company alleged that its comfrey products could treatsuch ailments as asthma, arthritis, cancer, herpes simplex, multiple sclerosis,paralysis and tuberculosis. Now, for those topical comfrey products thatChristopher Enterprises and its principals, Norman Bacalla and Ruth ChristopherBacalla, continue to sell, the following warning label must be affixed:
WARNING: External Use Only. Consuming this product can cause seriousliver damage. This product contains comfrey. Comfrey contains pyrrolizidinealkaloids, which may cause serious illness or death. This product should not betaken orally, used as a suppository, or applied to broken skin. For furtherinformation, contact the Food and Drug Administration: http://vm.cfsan.fda.gov.
Additionally, the order requires the company notify its distributors thatunsubstantiated claims violate the law. Part of the letter that ChristopherEnterprises will send to distributors reads: We request your assistance byasking you NOT to use, rely on, or distribute any advertising or promotionalmaterials containing unsubstantiated claims and NOT to make unsubstantiated oralrepresentations. The stipulated order includes a suspended judgment of $1.4million, payable if the court finds that the defendants made materialmisrepresentations or omissions on their financial statements.
Since 1993, the American Herbal Products Association (AHPA) (www.ahpa.org)has advised members that comfrey should only be used externally. Today, AHPAmembers are advised to label their products for external use only.
Judy Shepard, an FTC attorney who worked on the case, advised that othermanufacturers that are producing or thinking about producing comfrey productsfor oral consumption should not do so unless they know that the products aresafe. If a company is engaged in legitimate business, it is our goal to makethem stop the unlawful conduct and, if possible, to provide some [monetary]benefit to consumers who have been injured [by the company's product], shesaid. We believe the $100,000 in redress [that was levied by the court] wasappropriate in this case.
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