FDA WARNING_LETTER - The Avalon Effect - November 05, 2012

On November 5, 2012, the FDA issued a Warning Letter to The Avalon Effect, Inc. regarding their Quantum Series Personal Wellness Pack. The FDA determined the product is a "device" under the Federal Food, Drug, and Cosmetic Act due to claims made on the firm's website and linked sites (e.g., Tumblr, Facebook, YouTube, Twitter) indicating its use for diagnosing, curing, mitigating, treating, or preventing diseases (e.g., fungal meningitis, MRSA, lupus, cancer) or affecting body structure/function (e.g., pain relief, muscle relaxation, joint flexibility).

The FDA's review found that The Avalon Effect, Inc. was marketing the device without required marketing clearance or approval. This constitutes violations of the Act: the device is adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded under section 502(o) for failing to notify the agency of intent to introduce the device into commercial distribution (510(k) premarket notification).

Despite previous correspondence on August 15, 2012, and the firm's September 21, 2012, response denying intent to make disease claims, the FDA's subsequent review confirmed the continued presence of such claims. The firm is required to cease marketing the Quantum Series Personal