Fungal Meningitis Cure Claims
Written by Faith Anderson on November 8, 2012
Company’s Claims Violate Federal Act
In its letter to The Avalon Effect, the FDA warns that claims made on the company’s website and on other linked websites violate the Act, because the firm does not have an approved application to market the product, nor does it have an exemption to investigate the safety and effectiveness of the device. The FDA warning also indicates that the medical device is misbranded, since The Avalon Effect did not submit a 510(k) form notifying the agency of its intent to introduce the product into commercial distribution.
Advertisements for Cures During Crises
“Consumers should be aware that, especially during disease outbreaks [like the recent fungal meningitis crisis] 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 the FDA’s Center for Devices and Radiological Health. “Bogus medical claims can actually cause harm to 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 healthcare providers.”
FDA May Take Regulatory Action Against Company
The FDA first notified The Avalon Effect of possible marketing violations on August 15, 2012. In its September 21, 2012 response, the company said that it did not intend for any of its products to be used in the treatment, mitigation, cure, diagnosis or prevention of any disease. However, a recent FDA review of the company’s website and websites directly linked to the company identified specific claims regarding the Quantum Series Personal Wellness Pack that cause the product to meet the agency’s definition of a medical device. And, because the device has not been approved by the FDA, it is being marketed illegally by The Avalon Effect. It its November 5, 2012 warning letter, the FDA urged the company to take prompt action to correct the violations, as failure to do so many result in regulatory action.