On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that The Avalon Effect Inc. failed to submit a 510(k) notifying the Agency of the Company’s intention to introduce the device into commercial distribution. Accordingly, because the Company does not have an approved application, or Premarket Approval, for its medical device and because no 510(k) notification was submitted, the FDA deems the medical device misbranded under the FFDCA.
Medical devices are classified under federal law as those products that are “. . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . .” and “which [do] not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h). While the FDA explains that the Company’s initial response notes it “did not intend for any of its products to be used in the treatment, cure, mitigation, prevention or diagnosis of any disease,” thus rendering its product outside of the purview of the medical device definition, the FDA reaffirms its stance that the statements made in the Company’s marketing, including its website, cause the product to be considered a medical device. Because products are regulated based on their intended use, it is important to understand the effect that marketing alone may have on the way a product is regulated. More information about the FDA’s regulation of medical devices may be accessed at our previous post, found here.
In addition to understanding how the FDA regulates medical devices, it is critical to understand the FDA’s various enforcement mechanisms, both informal and formal. In particular, warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency, or they may be subject to further agency action, including formal enforcement measures. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further issue. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at email@example.com.