Readers of the Milex website (1) will still find a proclamation there that Milex is a quality driven “private company founded in 1937.” In reality, on February 3, 2004 the publicly traded corporation, Cooper Surgical, bought Milex for $26 million dollars in cash. With this purchase came a history of regulatory problems with one of Milex’s most widely distributed products, Trimo-San Vaginal Jelly.
Trimo-San is marketed as “A Unique Vaginal Product” and a 4-ounce tube sealed in plastic and distributed along with every Milex pessary to prolapsed women throughout the developed world. Trimo-San was reformulated in 1977 to include its primary active ingredient and has remained unchanged since that time.
That active ingredient, 8-hydroxyquinoline sulfate, is one of a family of coal tar derivatives first manufactured in 1899. The compounds from which 8-hydroxyquinoline sulfate is made are known as quinolines and isoquinolines, and are similar in chemical structure to benzene rings.
8-Hydroxyquinoline sulfate is claimed to have antiseptic properties and has been used throughout the past century as a topical antiseptic in livestock and has historically been used in the production of human food, medicine and cosmetics. However, there are currently no FDA approved over the counter (OTC) uses for 8-hydroxyquinoline sulfate. The historically approved uses as a topical skin protectant and antifungal have been withdrawn and are now classified as “Category II” or “Not generally recognized as safe and effective or misbranded.” Only one prescription drug listing exists for human use, which is the injectable form compounded with Indium 111 for radiologic studies.
In 1992, the Cosmetic Ingredient Review Expert Panel reviewed the safety of 8-hydroxyquinoline sulfate for use as a fungicide and bactericide in cosmetic formulations in concentrations less than or equal to 1.0 %. The panel reported that available carcinogenicity data were insufficient to support a conclusion on the safety of this chemical.
Although labeled a “mutagen” by the National Institute for Occupational Safety and Health because it is known to cause genetic damage in human blood cells (2), 8-hydroxyquinoline sulfate is not generally reported as a carcinogen. The International Agency for Research on Cancer states this is because the few studies that have been carried out on 8-hydroxyquinoline sulfate have proven to be “of limited value.” (3)
A 2001 document on the effects of 8-hydroxyquinoline sulfate on livestock prepared for the USDA by the Organic Materials Review Institute states that “Although it is not generally reported as a carcinogen or teratogen, a test of the food additive formerly used as cheese preservative (8-hydroxyquinoline sulfate) found tumors in the bladder, brain, and uteri of rats and mice when administered intervaginally.” (4)
The FDA issued a warning letter to Milex on November 24, 1999 citing several regulatory breeches involving the manufacture of their product. Central to these citations was a review of the labeling of Trimo-San:
“Trimo-San Vaginal Jelly is labeled for use three times daily during the first week of treatment and two times a week thereafter. The labeling does not include any time limit when the product should be used. Based on the intended uses cited above, this product is a drug within Section 201(g) of the Act. We do not have any information which shows that your product or similarly formulated and labeled OTC products were marketed as OTC drugs in the United States before December 4, 1975. We do not know of any substantial scientific evidence that demonstrates that this product is generally recognized as safe and effective for its intended uses.”
No subsequent changes were made in either the formulation or labeling of Trimo-San and in June of 2004 Cooper Surgical petitioned the FDA to include 8-hydroxyquinoline sulfate in the OTC drug monograph for vaginal lubricants and moisturizers. A review of current FDA approved OTC drugs and their active ingredients confirm that Cooper’s request for classification remains denied.
While the 19th century gave rise to the industrial revolution, there was little consciousness into such processes as carcinogenicity. It was during the later half of the 20th century that modern societies began to understand the cause and effect relationship between environmental substances such as quinolines and human cancers. How shocking that in the year 2006 a substance so questionable as to be unregulated by the United States government for topical use on livestock is permitted to exist as the only widely distributed vaginal lubricant prescribed to prolapsed women in unlimited doses!
(2) National Institute for Occupational Safety and Health 1997. Registry of Toxic Effects of Chemical Substances:
(3) International Agency for Research on Cancer. http://www-cie.iarc.fr/htdocs/monographs/vol13/hydroxyquinoline8.html
(4) OMRI NOSB Tap Materials Database: