Avalon Effect, a medical device manufacturer based in Tennessee, received a formal warning from the United States Food and Drug administration over unregulated treatment claims. According to a report by the FDA, this is the second warning issued to the company over its unproven claims.
The FDA warning states that Avalon Effect made unregulated treatment claims for its light-based therapy systems. According to Avalon, its devices can be used to treat or cure the symptoms of diseases like MRSA, Lyme disease, fungal meningitis and other infectious agents. In addition, the company claimed its light-based therapy system could be used to treat concussions. As of the posting of this article, Avalon Effect appears to have removed the illegal marketing claims from its website.
The company received its first warning from the FDA on August 15th, 2012. However, the company’s response did not satisfy the FDA. According to the FDA, Avalon Effect continued to make illegal marketing claims on its website after it received the first warning.
In prepared statements, FDA compliance director Steve Silverman stated, "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." He continued, "Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective."
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