FDAnews
www.fdanews.com/articles/61452-fda-substitute-saliva-is-a-regulated-device-not-cosmetic

FDA: SUBSTITUTE SALIVA IS A REGULATED DEVICE, NOT COSMETIC

August 4, 2006

In a July 10 warning letter, the FDA told the maker of a dry mouth reliever that its product is considered a saliva substitute, and therefore should be regulated as a medical device. The FDA posted the letter to its website July 24.

San Rafael, Calif.-based Parnell Pharmaceuticals said its product, MouthKote oral moisturizer, "relieves dry mouth conditions caused by medications, disease, surgery, irradiation and aging."

As of July 25, Parnell's website said MouthKote can "restore mucous protection function through its exclusive patented formulation closely mimicking glycoproteins found in saliva."

The FDA warned Parnell in a Feb. 27 letter that MouthKote was a device and would be regulated as such. But Parnell responded in a March 7 letter that it believed MouthKote was a cosmetic, not a medical device, stated the FDA letter.

(http://www.fdanews.com/ddl/33_30/)