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27 March 2009

Should Allertherapy be Marketed as a Homeopathic Medical Treatment for Food Allergies?

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?


Anonymous said...

Allertherapy sounds so wrong on so many levels it is hard to know where to begin. As a mother of child with multiple food allergies I do use an Osteopathic practioner (in conjunction with an allergist at the Mt. Sinai dept. of ped. allergies) who offers homeopathic treatment to my son.

Ovet the past three years I have learned that Homeopathy is an incredibly misunderstood and potentially helpful science BUT only in the hands of those qualified to offer it. It is based on indviuality, not mass marketing and to offer a blanket remedy is actaully not a true homeopathic method.

And then there are all the other issues....

Unknown said...

Susan, thanks so much for your comment. Well said, and thank you for providing a bit of clarification on homeopathy.

Jenny said...

This product sounds horrifying and should be illegal. What's the point? That's the thing about these immunotherapy studies being so widely broadcast--you'll probably see a bunch of these questionable remedies become available.

Let's hope that parents of food-allergic kids know enough to avoid this! Most of us have had caution taught to us the hard way, so I hope that holds true for this product!

It should not be available OTC--no way, nohow. Thanks for the alert!

groan said...

This is terrible. How can anyone be allowed to sell something, that is currently in the process of federal testing, has so many unknowns and contains so many allergens that could easily cause someone taking this uncontrolled to have an attack.

Unknown said...

It's a mystery to me too. Anyone have any friends at FDA or know any attorney practicing food&drug law? It'd be interesting to hear what the FDA is doing about it. Quite impossible to get through to a live person in the Denver office.

Unknown said...

Did you see FAAN's comments about Allertherapy? Stay away!

Check out:

Anonymous said...

Homeopathy is not has horrifying as you may think. Those of you that are not familiar with its concepts should do some searches about it to learn that it is not dangerous with such dilute potencies of these allergens. The regular homeopathic remedies are so dilute they are not comparable to concentrations in allergy shots. I would be in favor of it over the desensitization used for sulfa or penicillin allergy treatments as those are a lot more dangerous and escalate the potencies much more rapidly leading to failures. Of course there should be close monitoring by a health practitioner while using these types of homeopathic peanut-allergy desensitizing regimens just to be cautious. I am an FDA- Pharmacist that took an 8-week homeopathy course and am familiar with allergy extracts and desensitization regimens. Please don't discount this homeopathy as dangerous and worthless until you know more. It may be safe and effective and you can't say it isn't without getting more information.

Unknown said...

Thanks Anonymous, for your comment. I surely don't know much about homeopathy. My son reacts to minute trace amounts of peanut, so the over-the-counter aspect of this Allertherapy treatment concerns me.

It would be interesting to learn more about homeopathy.

Anonymous said...

I have just now been advised by the daughter of a homeopathic doctor to take a derivative of heney bee venom for the water retention around my abdomen. I told her about my apparent allergies to bees and wasps but she still thought it the best course to take!

Tara said...

honey and bee stings are not necessarily the same allergy. I am allergic to eggs, but not chickens, and milk, but not cows. :)