XanGo's Response to FDA Concerns
This is a forwarded message from Bob Freeze, XanGo VP of Public Relations
I wanted to provide you a more complete answer on this issue that has recently gone viral on the internet related to the current FDA Guidance Document on Complementary and Alternative Medicine Products. In recent weeks, misguided rumors have begun to proliferate, fueled by alarmist “health freedom” people, regarding this initiative. Our senior manager of Public Affairs, Debbie Blockinger, has looked into this and has talked both to the FDA and other industry groups and found that the document’s intent is to merely clarify that CAM products are not exempt from current regulations under the Food, Drug and Cosmetic Act (the Act) or the Public Health Service Act (PHS Act). From our investigation, there is nothing here to worry about, and it really is more of a semantics issue rather than anything else.
As the practice of CAM has increased in the United States, so has the number of CAM products being imported into the United States. To clarify increasing confusion as to whether certain CAM Products are subject to regulation under the Food, Drug and Cosmetic Act or PHS Act, the FDA has issued the current guidance document to explain the regulations and what types of products they pertain to. To take our own product for example, XanGo is labeled as a dietary supplement and as such falls under the regulations for a dietary supplement under the Act. Within these guidelines, we can make structure-function claims, but not curative claims. XanGo can aid the body in certain functions, but is not intended to “prevent” or “cure” any type of illness or disease.
The FDA uses cranberries for their illustration, stating that a CAM practitioner can recommend that a client take cranberry tablets to maintain the health of their urinary tract, and those cranberry tablets could be labeled as a dietary supplement. If the CAM practitioner prescribes the cranberry tablets to cure urinary tract infections, or the label reads that taking the tablets would prevent urinary tract infections, then they would fall under the classification of a drug.The document goes on to clarify other types of products used in CAM treatments such as electromagnetic forces, energy fields, etc. Another example is acupuncture needles—they are currently classified as “class II” medical devices and there would be no change to that.
According to the current FDA Guidance document, there is no indication that their clarification of CAM products presents any threat to our product specifically or to the dietary products industry in general. We hope this will clear up any confusion or worry you may have experience over this FDA initiative...
Best Regards,
Bob Freeze
Vice President – Public Relations