Nasal-Xylitol.com - Nasal Wash and the FDA

When I first found out what using this spray did for children with recurrent ear infections, people with sinus disease, allergies and asthma I was really excited. I wanted to share it with everyone. I thought the FDA would be just as excited because this is a safe and effective way to help wash the nose – it's not even absorbed.

When I told them of my experience they said the spray was a drug. Essentially anything that is used to diagnose, treat or prevent a medical condition is defined as a drug.

So I filed an Investigational New Drug Application with the FDA and for two years I tried to find a pharmaceutical company interested in making xylitol into a drug. But as long as xylitol is available on the open market there is no pharmaceutical company interested in spending the money needed to make and promote it as a drug. Doing so would only promote people buying saline and xylitol and mixing it on their kitchen counter.

After two years of frustration I consulted an attorney familiar with such problems. His advice was very simple: "Sell it as a nose wash."

I do believe that the FDA was supportive; it's just that the bureaucratic definitions and regulations got in the way. Their primary concern is one of safety and in my application I pointed out that a person using this spray every hour, 24 hours a day, both sides of the nose, would get about half a plums worth of xylitol, and that would wind up in the stomach because it was not absorbed in the nose. Another way to look at the safety is with the accepted dose of xylitol when it is given intravenously. The usual dose is 0.25 grams per kilogram per hour and the safe dose is double that. That means that a 20 kilogram child (about 45 pounds) would usually get 0.25X24x20 or 120 grams of xylitol every day, and could safely get 240 grams. That safe dose is about 500 plums or about 1000 times more than they would get by spraying their nose every hour. When I withdrew my application they stated they were impressed with the safety data.

When the FDA was established the soap industry did not want to be included as a drug even though good hygiene, soap and water, is the most effective way to block the spread of disease. And they won. The cosmetic department deals with cleaning the body and this product is properly classified as a cosmetic – it cleans the nose.

The spray described in these pages is not a drug. This means that the people manufacturing this spray cannot advertise what the spray does to prevent disease and illness. The spray only helps to clean your nose. The benefits come from a clean nose. The only way people will learn about this practical and sensible way to help the immune system wash pollutants from the back of the nose is by interested people, like you, sharing this information.

If you have family or friends with any of these problems, they may benefit greatly from your sharing this information with them.

Links in the other sections, referring to a person or study, will take you to a Medline summary, from the National Library of Medicine, of the article in question.

This spray is protected by United States and international patents. While careful reading of these pages will tell you how to mix this spray yourself we request that you do not sell such spray on the open market. Such sales would be prohibited by the above mentioned patents.

Disclaimer: All material provided in this web site is provided for educational purposes in the hope of improving our general health. Access of this web site does not create a doctor-patient relationship nor should the information contained on this web site be considered specific medical advice with respect to a specific patient and/or a specific condition. Copy sections of this page and discuss them with your physician to see if they apply to your own symptoms or medical condition.

Dr. Jones specifically disclaims any liability, loss or risk, personal or otherwise, that is or may be incurred as a consequence, directly or indirectly, of use or application of any of the information provided on this web site.