Food and Drug Administration officials this week sent a warning letter to the leaders of The Avalon Effect, a Cool Springs-based company that markets the Quantum Series Personal Wellness Pack, saying it can reduce stress in and boost the energy of people who use it. Avalon Effect President Tom Haarlander and his team in September told the regulators they don't intend for their products to be used to treat any one condition, but the FDA says a review of the company's website says some of the claims made there cause the Wellness Pack to meet the definition of a medical device.
“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.”