The Avalon Effect Inc., a Franklin, TN-based company, has run afoul of the U.S. Food and Drug Administration (FDA) for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease and other diseases.
An FDA Warning Letter advises company CEO Mike Haarlander that the company's Quantum Series Personal Wellness Pack is a medical device under the Federal Food, Drug, and Cosmetic Act (Act) because it is intended to prevent, diagnose, treat, or cure a disease, or to affect the body.
Multiple violations alleged
According to the letter, claims on the company's Website and other linked Websites cause the product to violate the Act because the company does not have an approved application to market the device or an exemption to investigate the device for purposes of safety and effectiveness.
The device also is misbranded because, the FDA maintains, the company did not submit a 510(k) notifying the FDA of its intent to introduce the device into commercial distribution.
"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," said Steve Silverman, director of the Office of Compliance at FDA's Center for Devices and Radiological Health. "Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective. Consumers should carefully evaluate and discuss the claims with their health care providers."
Illegal marketing
The FDA notified the company of possible marketing violations on Aug. 15, 2012. In its Sept. 21, 2012, response, The Avalon Effect said that the company did not intend for any of its products to be used in the treatment, cure, mitigation, prevention or diagnosis of any disease.
But FDA says a review of the company's Website and directly linked Websites identified specific claims regarding the Quantum Series Personal Wellness Pack causing it to meet the device definition. Because the device is not cleared or approved, the product is being marketed illegally.
The agency says the company needs to take prompt action to correct the violations and warns that failure to do so may result in a regulatory action being taken against it.
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