Federal officials have warned a Tennessee-based company about claims its light therapy product cures or treats various health problems, including meningitis. The U.S. Food and Drug Administration sent a warning letter on November 5th to The Avalon Effect Inc., located in Franklin, telling the company to stop marketing an unapproved medical device called the “Quantum Series Personal Wellness Pack.” The letter contends the company’s website claims the product can cure and/or treat symptoms of fungal meningitis, concussions and Lyme disease, among other conditions. That violates federal law because Avalon does not have approval to market the device or an exemption to investigate it for safety and effectiveness, according to a statement by the FDA.
The device, known as a “Quantum Series Personal Wellness Pack,” also is misbranded because the company did not notify the FDA of plans to introduce it to the marketplace, the letter said. It is the second time that the FDA said it has warned Avalon. The agency notified the company of possible marketing violations in August. Avalon said then that it did not intend for any of its products to be used to treat, cure, mitigate, prevent or diagnose any medical condition.
But the FDA said a follow-up review of the company’s website and related links showed Avalon was still making those claims, prompting the second warning. Avalon founder Tinka Smith and Chief Executive Officer Michael Haarlander disputed that in a statement issued on November 6th, in which they said:
We simply have no intention to market a device in that manner. We are working with the FDA with full cooperation to clarify this matter. The FDA is essential to our success. We are committed to the long-term health of our company, our product and our clients.
It would certainly seem that two warnings from the FDA would be enough to bring about the needed changes. But if Avalon continues to ignore the FDA’s warnings, the agency must take whatever step necessary to protect the public.
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