FDA issues warning letter to company making illegal claims in support of light therapy device
SILVER SPRING, Md. — The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, 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, concussions, Lyme disease and other diseases.
“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,” stated 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 healthcare providers.”
The warning letter advises Mike Haarlander, Avalon CEO, 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.
The letter warns that claims on the company’s web site 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 company did not submit a 510(k) notifying the FDA of its intent to introduce the device into commercial distribution.
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 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 warning letter issued on Nov. 5, 2012, tells The Avalon Effect to take prompt action to correct the violations. Failure to do so may result in a regulatory action being taken against the company.
iHealth Labs launches latest round of Apple-compatible diagnostic devices
MOUNTAIN VIEW, Calif. — iHealth Labs on Tuesday announced that its latest suite of products will be available for purchase at major retailers and online later this month. The iHealth wireless blood pressure wrist monitor, wireless blood pressure monitor and wireless body analysis scale are already available at Best Buy and iHealthlabs.com, the company added.
"Lifestyle changes, such as utilizing an iHealth blood pressure monitor or body analysis scale, can help equip users to make informed health decisions to significantly reduce their risk [for heart disease]," stated Adam Lin, general manager of iHealth Labs. "By employing these simple-to-use products, which connect with iOS devices to easily show progress, people can vastly improve their health and quality of life."
Supporting both new and existing iHealth products, the newest free app, iHealth MyVitals, brings together all of a user’s iHealth health data into one hub. The app further helps users manage their health through a personal dashboard and share their results with their doctors, on social media networks or with their family and personal trainers.
Suggested retail for the three products ranges between $79.95 and $109.95.
Nutramax fends off faulty class action suit
EDGEWOOD, Md. — Nutramax Laboratories recently announced the defeat of a class action lawsuit brought against the company in a California court. In April, Nutramax was named in a class action regarding its CosaminDS Joint Health Supplement. Plaintiffs claimed the glucosamine/chondroitin supplement did not work in relieving joint pain as advertised.
The federal court, however, agreed with Nutramax Laboratories’ arguments that class certification was not appropriate. Apart from the wealth of scientifically sound, clinical studies that established CosaminDS has beneficial effects, the court agreed that the plaintiff’s allegations did not pass muster.
“We are very pleased to have defeated this lawsuit, but our success in this frivolous action is unfortunately not the norm," stated Robert Henderson, chairman of Nutramax. "The legal system is being inundated by these types of lawsuits brought by lawyers who appear to be driven by the possibility of big settlement payouts" he said. "Going forward, Nutramax Laboratories will reconsider its position to sell our new … products in states such as California, which support these types of anti-business/anti-consumer laws.”