Light Therapy Company Gets FDA Warning Letter

How The Avalon Effect Inc. of Franklin, Tenn., has marketed its Quantum Series Personal Wellness Pack prompted the Nov. 5 letter, according to the agency.

The U.S. Food and Drug Administration announced it issued a Warning Letter on Nov. 5 to The Avalon Effect Inc., a company based in Franklin, Tenn., "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."

FDA's notice said the letter advises Mike Haarlander, CEO of The Avalon Effect Inc., that the company's Quantum Series Personal Wellness Pack is a medical device under the Federal Food, Drug, and Cosmetic Act because it is intended to prevent, diagnose, treat, or cure a disease or to affect the body. FDA contends claims on the company's website, www.TheAvalonEffect.com, and other linked websites cause the product to violate the act because Avalon does not have an approved application to market the device or an exemption to investigate the device for purposes of safety and effectiveness. FDA also contends the wellness pack is misbranded because the company did not submit a 510(k) premarket submission notifying the agency 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."

FDA said it notified the company of possible marketing violations 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 a recent FDA 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 notice states.

The wellness pack is still promoted on The Avalon Effect's website, where is it described as a "comprehensive package of flexible LED pads [that] provides unlimited positioning to supply the body with non-invasive, stress reducing light. The system is made with Irvisium Superflux diodes, the highest power available, and provides 500 total LEDs of light energy." Posted along with the product's description is this statement: "Please note that light therapy does not work for every person. This system is not intended to diagnose, treat, cure, mitigate or prevent disease. If you have a disease or medical condition, consult with your physician or health practitioner before using The Quantum Series. Use only as directed. Uses for medical indications contrary to the FDA registration are unauthorized and render the warranty null and void. REV. 7/13/10."

A message left by OH&S at the company's posted customer service number was not returned Nov. 6.

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