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Wednesday, 7 November 2012

Meningitis: FDA Warns of 'Light Therapy' Claims





A Tennessee company made false claims that its "light therapy" has benefits for fungal meningitis, the FDA said.

The Avalon Effect, of Franklin, Tenn., has been illegally marketing the Quantum Series Personal Wellness Pack -- which its website says emits "non-invasive, stress reducing light" -- with claims to cure disease, the agency said.

In particular, the FDA said, the Quantum Series device was claimed to be able to "cure or treat" the symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.

In a warning letter sent Monday, the agency told Mike Haarlander, chief executive officer of the company, that claims on the website about the device violate the Federal Food, Drug, and Cosmetic Act.

The CDC has reported more than 400 infections, including many cases of fungal meningitis, caused by a contaminated steroid, as well as some 30 deaths.

"Consumers should be aware that, especially during disease outbreaks or other public health crises, they may see opportunistic advertisements for products touted as cures or treatments," according to Steve Silverman, director of compliance at the agency's Center for Devices and Radiological Health.

07/11/2012  :  By Michael Smith  /  MedPage Today.


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