Consumer Health Digest #11-08
Your Weekly Update of News and Reviews
April 7, 2011
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 warns thermography marketer. The FDA has ordered Central Coast Thermography to stop representing that its FLIR Telethermographic camera is useful as a stand-alone device to diagnose or screen for breast diseases, including cancer. [Silverman S. Warning letter to Central Coast Thermography / Breast Health Imaging Centers, Jan 6, 2011] One blatant statement to which the agency objected was the claim that, "By performing Thermography years before conventional mammography, an at risk patient can be safely monitored and this can increase the patient's treatment options and ultimately improve the outcome." Thermographic devices portray heat emission from body surfaces as images that the practitioner interprets. The images may be in color or in black and white, with each color or shade representing a specific temperature level. The scientific consensus is that thermography adds little to what doctors can readily discern from the patients history, physical examination, and other studies. [Barrett S. A critical look at thermography. Chirobase April 9, 2011]
Irwin Naturals enters $2.65 million settlement. Irwin Naturals, of Los Angeles, CA, has agreed pay $2.65 million to settle a lawsuit filed by the District Attorneys of Orange, Alameda, Marin, Monterey, Napa, Santa Clara, Santa Cruz, Shasta, Solano, and Sonoma counties. The suit, filed about two years ago, charged that the company:
- Violated Proposition 65, which requires a warning label on products that expose the consumer to over half a microgram of lead per day.
- Marketed hoodia products that did not contain the Hoodia gordonii herb. Laboratory testing revealed that certain Irwin Naturals products, Green Tea Fat Metabolizer and Green Tea Fat Burner, contained over half a microgram of lead. Samples of the company's System Six and Green Tea Fat Meltdown dietary supplements tested up to 10 times over the legal limit of lead and Green Tea Fat Burner tested over 14 times over the legal limit of lead.
- Failed to reimburse customers in timely fashion for returned products.
- Charged some direct sales customers for products not ordered.
The settlement requires Irwin to pay $1.95 million in civil penalties, up to $100,000 in restitution to California consumers who did not receive previously request refunds, and $600,000 in investigative costs. Without admitting fault, the company also agreed to injunctive terms that would prevent any future unfair or deceptive business practices. Officials say the outcome is the largest multi-jurisdictional settlement of its kind in California by a dietary supplement manufacturer for unfair business practices. [Dietary supplement distributor to pay $2.65 million to settle historic statewide unfair business practices lawsuit. News release, Orange County District Attorney, Feb 1, 2011]
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This page was posted on April 8, 2011.