Consumer Health Digest #04-44
Your Weekly Update of News and Reviews
November 2, 2004
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer
Balance Bracelet marketers agree to stop unsubstantiated claims. California-based Media Maverick, Inc., and its officers, Mark Jones and Charles Cody, have agreed to pay $400,000 to settle charges that they made false and unsubstantiated claims that the Balance Bracelet provides fast-acting, effective treatment for many types of pain. The court-approved settlement requires the defendants to pay $400,000, a significant portion of which will be used by the FTC for consumer redress. The Balance Bracelet is a C-shaped metal bracelet that allegedly is "electro-polarized" by an undisclosed process. The defendants used infomercials and the Internet to claim that the bracelet relieves arthritis pain, joint pain, back pain, and injury-related pain. Their ads also claimed that pain is caused by "excess static electricity" in the body, which comes from an "imbalance of positive and negative energy," and that the bracelet returns the body to its natural "ionic balance." The stipulated settlement contains an avalanche clause that requires the defendants to pay $14 million if the court finds that the defendants misrepresented their financial condition. [Sellers of "Balance Bracelet" cannot claim it relieves pain. FTC news release, Oct 25, 2004]
Court dismisses "frivolous" attempt to block medical disciplinary proceedings. A Connecticut court has dismissed a lawsuit filed in attempt to stop Connecticut's Medical Examining Board from holding hearings on whether or not Robban A. Sica, M.D., should be disciplined. Sica, who does chelation therapy and operates the Center for the Healing Arts in Orange, Connecticut, has been charged with questionable management of about 40 patients. When Sica learned that the Connecticut Bureau of Health Care Systems was investigating her, she filed a federal court lawsuit charging that she was being unfairly prosecuted. Federal courts will not intervene in ongoing state regulatory matters unless a plaintiff can demonstrate that the state's action is brought in "bad faith" or involves "extraordinary circumstances." Sica claimed that she was being unfairly prosecuted and that the state's system for physician regulation was severely flawed. However, after considering the meager evidence she presented, a federal judge ruled that the state board procedures would provide Sica with ample opportunity to defend herself and that her argument that Connecticut's regulatory framework was globally flawed was "frivolous." [Garfinkle WI. Findings of fact re: alleged exceptions to Younger abstention. In Sica v. State of Connecticut et al. U.S/ District Court, District of Connecticut, Civil action no. 3:04-CV-23(MRK), Oct 8, 2004] Quackwatch has additional information on Sica's background.
Food labels can discuss relationship between olive oil consumption and heart disease rates. The FDA has approved the use of a "qualified health claim" for monounsaturated fat from olive oil and reduced risk of coronary heart disease (CHD). A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, the labels of olive oil and foods containing it are now permitted to state:
Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product [Name of food] contains [x] grams of olive oil."
The rationale for this claim is detailed in a letter from the FDA to the North American Olive Oil Association.
Former fugitive chiropractor receives prison sentence. Bruce Eric Hedendal, D.C., who pleaded guilty to tax evasion, has been ordered to pay $718,000 in restitution and serve three years of prison followed by three years of probation. Hedendal practiced for many years in Boca Raton, Florida and hosted a syndicated radio talk show that broadcast to a few stations and through the Internet. In 2000, a federal grand jury in West Palm Beach charged him with evading taxes for the years 1993 through 1995. After receiving a summons, Hedendal ultimately fled to Brisbane, Australia, where he practiced under the names Erik Hedendahl and Park Road Holistic Centre and hosted another radio show. He was charged with paying a total of about $180,000 in taxes on income of about $561,000 by failing to file returns and concealing his true income through the use of sham trusts, false entries on business records, and false tax returns for the 3-year period. [Barrett S. Bruce Hedendal, D.C., receives prison sentence for tax evasion. Chirobase Feb 26, 2004]
Another alleged sex-aid marketed as dietary supplement found to contain prescription drug. The FDA is warning consumers not to purchase or to consume Actra-Rx or Yilishen, both of which have been marketed as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance for men. These products contain undisclosed amounts of sildenafil, the active ingredient in Viagra. The FDA has also issued an Import Alert. The agency is concerned because sildenafil can produce serious adverse effects and therefore should not be taken without medical supervision. [FDA Warns Consumers That Actra-RX "dietary supplements" promoted for sexual enhancement contains undeclared prescription drug ingredient. FDA Talk Paper T04-47, Nov 2, 2004]
This page was posted on November 2, 2004.