Consumer Health Digest #10-45

Your Weekly Update of News and Reviews
November 11, 2010

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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 decision-making.

FDA proposes new tobacco warning strategy. The U.S. Department of Health and Human Services has unveiled a comprehensive tobacco control strategy that includes a proposed rule for conspicuous warning statements and graphic images for cigarette packages and advertisements. [HHS announces new tobacco strategy and proposed new warnings and graphics for cigarette packs and advertisements. FDA. HHS press release, Nov 10, 2010] The proposed statements are:

WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your health.

Public comment on 36 proposed images will be accepted through January 9, 2011. The current schedule calls for the FDA to make the final selection by June 22nd and require cigarette packages to display the new warnings by October 22nd. The proposed images are posted to the FDA Web site. The Family Smoking Prevention and Tobacco Control Act gives the FDA the authority to regulate the manufacture and marketing of tobacco products. The act requires that the warnings occupy at least the top half of the panels front and rear panels of each cigarette package and at least 20% of all cigarette ads. The proposed images to the right depict a coffin, a man having a heart attack, and a terminal cancer patient who is bald and is lying in bed. The New York Times has reported that several tobacco companies are stepping up efforts to fight restrictive marketing rules overseas. [Wilson D. Cigarette giants in a global fight on tighter rules. New York Times, Nov 13, 2010]


Court upholds $48 million damage award against infomercial scammers. A federal appeals court has upheld a decision in favor of the Federal Trade Commission. In 2008, the U.S. District Court for the District of Massachusetts found that Donald W. Barrett, Robert Maihos, and their two companies had deceptively claimed Supreme Greens and Coral Calcium could treat, cure, or prevent cancer, heart disease, diabetes, arthritis and other diseases. In 2009, the court ordered Barrett, Maihos, and their two companies—Direct Marketing Concepts, Inc. and ITV Direct, Inc.—to pay $48.2 million. The district court also barred them from making unsubstantiated claims about any health product or billing consumers or charging their credit or debit cards on an ongoing basis without their consent. [Appellate court upholds order requiring promoters of Supreme Greens and Coral Calcium dietary supplements to pay $48.2 million for deceptive ads. FTC news release, Oct 29, 2010]

Despite his legal difficulties, Barrett recently began airing a misleading infomercial for a high-dosage vitamin D supplement. Many people may benefit from taking supplementary vitamin D. However, the dosage should be based on proven value and should depend upon how much is needed. Barrett's infomercial overstates the potential benefits, exaggerates the need, promotes a high dosage that is not supported by current evidence, downplays the possibility of adverse effects, and offers a "free lifetime supply" that costs considerably more than similar products available elsewhere. [Barrett S. Donald Barrett's "free vitamin D" is overhyped and overpriced. Infomercial Watch, Nov 12, 2010]

Meta-analysis examines stroke risk with Vitamin E supplements. Researchers at Harvard Medical School have examined the relationships between cerebrovascular accidents (strokes) and vitamin E supplementation. To do this, they searched for randomized, placebo-controlled trials with a year or more of follow-up investigating the effect of vitamin E on stroke. Nine trials were included, with a total of 118,765 participants (59,357 randomized to vitamin E and 59,408 to placebo). In hemorrhagic stroke, an artery ruptures so that blood flows into the surrounding brain tissue and compresses it. In ischemic stroke, blood supply is cut off by blockage (usually due to a blood clot) within an artery that supplies part of the brain. The researchers concluded:

[Schurks M and others. Effects of vitamin E on stroke subtypes: meta-analysis of randomized controlled trials. British Medical Journal, Nov 4, 2010]

Detox footpad marketers curbed. A federal judge has approved a stipulated agreement under which the marketers of Kinoki Foot Pads—Yehuda Levin and his company, Xacta 3000, Inc.—are barred from promoting or selling any dietary supplement, food, drug, or medical device, and from helping others do the same. [At FTC's request, judge imposes ban on marketers of "detox" foot pads: Advertising claimed "ancient Japanese secret" could treat medical conditions. FTC news release, Nov 4, 2010] In 2009, the FTC charged the marketers with falsely claiming that when applied to the soles of the user's feet at night, the pads would remove toxins, metabolic wastes, heavy metals, and chemicals from the body; treat headaches, depression, parasites, fatigue, insomnia, diabetes, arthritis, high blood pressure, cellulite, and a weakened immune system; and cause weight loss. The defendants agreed to a judgment of $14.5 million, which represents the total revenues from the sale of the pads. However, based on their inability to pay, the entire judgment is suspended but will become due if they are found to have misrepresented their financial condition. Device Watch has additional information about the foot pads.

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This page was revised on November 14, 2010.