The U.S. Food and Drug Administration is investigating the claims of a new product intended to treat allergies naturally and without the need for physician supervision.
But some allergy experts dismissed the treatment, called Allertherapy, fearing that people with allergies could fall prey to false hope and increase their risk for life-threatening allergic reactions.
Allertherapy is a homeopathic treatment for seasonal and food allergies available for purchase online, according to the company Web site. The medication, which consists of diluted quantities of dozens of allergens, is applied under the tongue and is meant to help the body "quickly build immunity and reduce targeted allergies," according to a press release from ProActive Remedies, the company that manufactures Allertherapy.
But many allergists, homoeopaths and people with allergies are not impressed with Allertherapy's treatment rationale or lack of evidence showing its safety and efficacy.
"A legitimate [pharmaceutical company] has to spend $1 million to get a drug approved by the FDA, and these people can make these outrageous claims without any required testing," said Dr. Harold Nelson, an allergist and professor of medicine at National Jewish Health in Denver. "The system is seriously flawed."
While the FDA considers homeopathic medications "drugs" and provides guidelines for manufacturing and testing them via the Homeopathic Pharmacopeia of the United States, rules concerning what is and is not a medication are not as stringent as for a typical drug.
Homeopathy is a healing technique that uses highly diluted substances to cure ailments that those same substances, at toxic levels, would produce. "Official" homeopathic drugs are those whose ingredients are part of the Homeopathic Pharmacopeia, a compendium of substances proven to have a homeopathic effect, and are available over the counter.
"Non-official" homeopathic drugs, whose ingredients are not part of the Homeopathic Pharmacopeia, are also available over the counter. Many of the ingredients in Allertherapy's food allergy mix, which includes fruits, vegetables, grains, dairy, fish, shellfish, nuts and meat, are not listed in the Homeopathic Pharmacopeia.
"Medicines not contained in the pharmacopeia are not necessarily illegal or unofficial or non-homeopathic," said Mark Land, president of the American Association of Homeopathic Pharmacists. "It's up to the manufacturer to show that it truly is a homeopathic product."
The manufacturers must offer proof of safety and efficacy -- in the form of clinical trial data -- for examination by the FDA and the Federal Trade Commission.
"But generally, manufacturers are not going to make that information available to consumers," said Land, adding that someone who wanted such information would have to contact the manufacturer directly.
Allertherapy does raise safety concerns because people with severe allergies can react to allergens in quantities as small as one part per million -- the dosage of each allergen in the Allertherapy cocktail.