Alternative Health Approaches says fulfilled FDA request
requests following a September warning letter concerning the
alleged marketing of its products as drugs.
The Tempe, Arizona-based dietary supplement manufacturer said the problem arose by means of an innocent mistake and that it has contacted the federal authority to rectify the problem. The case brings to light the fine line between raising consumer awareness and false, misleading or illegal advertising. In a letter dated September 24, the US Food & Drug Administration (FDA) told the company: "The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease." The product in question is Virupel, which Alternative Health Approaches (AHA) - in its so-called educational web site - had associated with supporting symptoms relating to conditions such as Avian bird flu. However, AHA says it is in its constitutional rights to provide testimonials or educational materials relating to its product, as long as this is not connected to any web site selling it. "The educational web site was never meant to be connected to the shopping cart site," Lisa Charron, director of operations, told NutraIngredients-USA. "Unfortunately, that was a mistake." Charron pointed the finger at a third party service provider and said that as a young small company with a small budget, it has not overseen all aspects of the web site management. Charron indicated AHA immediately deactivated the link between its sales site the educational site following receipt of the warning letter and subsequently informed FDA of this both verbally and in writing. Based on a phone conversation with an FDA compliance officer in California, Charron said she is confident the matter has been resolved and that the supervisor with whom she spoke "thought we had satisfied requirements". The Virupel web site now informs: "This website has been set up to be educational as well as interactionally informative. Nothing on this website is intended to promote or sell Virupel or any other product. This website's strict purpose is to educate and inform, and submittals to this website must adhere to these purposes."
