Something about this Allertherapy Homeopathic Medical Treatment doesn't sit right with me. I don't like how it is being marketed to food allergic individuals. There is no treatment for food allergies approved by FDA yet. The Allertherapy press release states "Food allergy sufferers now have a treatment option that builds immunity to food allergens from the comfort of home...It quickly builds immunity to allergens and maintains it over time. The easy-to-use oral spray uses a low, homeopathic allergen strength of one part per million to allow for safety of use in most allergy sufferers. The food mix contains many of the most common allergy-causing foods. Users can quickly build immunity and reduce targeted allergies."
That sounds dangerous to me. Do we really want people with life threatening food allergies experimenting with desensitization at home? I don't think so. They say it's in such diluted form that it has no dangerous effect. Really? Does that mean FDA has finally established thresholds for safe levels of allergen in foods and medicines? No, there are still no thresholds. That's why we see products such as Tofutti Cuties labeled as milk-free while they actually contain traces of milk! Why is FDA permitting this to be marketed as a safe, at-home OTC treatment for food allergies? Something's not right about this.
Take a look at FDA's Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15). Here's an interesting snippet: "Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products. Those products that are offered for treatment of serious disease conditions, must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC...Homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products. " Wouldn't potentially life threatening food allergies be considered "serious disease conditions" requiring the "care of a licensed practitioner"? Surely, such allergies aren't "self-limiting conditions" suitable for OTC (over-the-counter) remedies. While some people do grow out of allergies, many do not. In addition, it does not appear that one can predict if an allergy will go away over time, one can only hope that is the case. It seems to me that Allertherapy is improperly being marketed as OTC.
Now, let's consider the active ingredients of this "treatment". All of the active ingredients are foods, many of which are among the 8 most common allergens as defined by FDA. In fact, this treatment contains all of the 8 most common allergens. Hmm. So, what they're selling is an allergy treatment containing fish to people with life threatening allergies to fish? And it's being sold OTC? I think I've heard enough! At a minimum, FDA needs to investigate this product a bit more.
The contact address for ProActive Remedies, the manufacturer is in Fort Collins, Colorado, so I've put in a call to the Denver, Colorado FDA District Office. The telephone number for FDA's District Office is 303.236.3017. There is also a form to request FDA investigate of a web site selling medical products. To complete and submit FDA's complaint form, go to http://www.fda.gov/oc/buyonline/buyonlineform.htm.
You know where I stand on this. What's your opinion? Should Allertherapy be marketed as OTC for at home food allergy desensitization treatment?