Consumer Health Digest #10-39
Your Weekly Update of News and Reviews
September 30, 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.
Three companies ordered to stop making unproven mouth rinse claims. The FDA has ordered three manufacturers to stop claiming that their mouth rinse products remove plaque above the gum line or promote healthy gums. Warning letters were sent to Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action). These products contain the active ingredient sodium fluoride, which is effective in preventing cavities but has not been proven effective in removing plaque or preventing gum disease. Under federal law, a company cannot claim effectiveness in treating a disease unless those claims have been approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph. In a press release, the FTC indicated that the products may still be useful for for cavity prevention without risk of injury but should be aware that the agency has no data to show that these products can prevent gum disease.
FTC sues pomegranate juice marketer. As part of its ongoing efforts to stop over-hyped health claims in food advertising, the Federal Trade Commission has charged the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements with making false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction. [FTC complaint charges deceptive advertising by POM Wonderful: Agency proceedings will determine whether health claims for pomegranate products are false and not supported by scientific evidence. FTC news release, Sept 27, 2010] The FTC complaint charges that POM Wonderful LLC, sister corporation Roll International Corp., and principals Stewart Resnick, Lynda Resnick, and Matthew Tupper violated federal law by making deceptive disease prevention and treatment claims. The ads in question appeared in publications such as Parade, Fitness, The New York Times, and Prevention magazines; on Web sites such as pomtruth.com, pomwonderful.com, and pompills.com; on bus stop signs and billboards; in newsletters to customers; and on tags attached to the product. The juice is widely available at grocery stores nationwide with a 16-ounce bottle retailing for about $4. POMx pills and liquid extract are sold via direct mail, with a one-month supply costing about $30. The FTC complaint alleges:
- The heart disease claims are false and unsubstantiated because many of the scientific studies conducted by POM Wonderful did not show heart disease benefit from use of its products.
- The prostate cancer claims are false and unsubstantiated because, among other reasons, the study POM Wonderful relied on was neither "blinded" nor controlled.
- The erectile dysfunction claims are false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.
In a related case, Mark Dreher, POM Wonderful's former head of scientific and regulatory affairs and expert endorser, has signed a consent agreement that bars him from making any treatment or prevention claims in advertising for a POM Wonderful product unless the claim is not misleading and comports with FDA requirements for the claim.
Texas court restricts chiropractic diagnosis. A district court judge has ruled that chiropractors must limit their diagnoses to biomechanical conditions of the spine and musculoskeletal system. The judge's reasoning is spelled out in the decision letter issued in August. The final order ended a four-year lower-court battle that pitted the Texas Medical Association (TMA) and Texas Medical Board against the Texas Board of Chiropractic Examiners (TBC) and Texas Chiropractic Association (TCA). The TMA initiated the suit in 2006 to block TBC rules that would permit chiropractors to perform clinical needle electromyography (EMG) and spinal manipulation under anesthesia (MUA), which the TMA charged were beyond the chiropractors' lawful scope of practice. The TMA also challenged whether chiropractors should have the right to "diagnose" medical conditions. MUA has some respectable use for treating frozen shoulder or knee problems, but spinal MUA has none. Aetna's Clinical Policy Guide provides a detailed discussion of MUA. In November 2009, the judge ruled that Texas law prevents chiropractors from performing EMG or MUA. The chiropractors have notified the court that they will file an appeal. The TCA Web site, which is seeking donations to help pay for the appeal, claims that the adverse ruling has the potential to wipe out the entire chiropractic profession.
This page was revised on October 2, 2010.