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Kaiser Daily Women's Health Policy
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Bioethics & Science | FDA Approves Tampon That Releases Lactic, Citric Acids To Prevent Vaginal Infections
[Jul 22, 2004]

      Tampon manufacturer Rostam has received approval from FDA to market a tampon that releases natural supplements into the vagina to "ward off" infections, the Wall Street Journal reports. Rostam's Ela tampon absorbs menstrual fluid but also releases lactic and citric acids to maintain higher levels of acidity during menstruation. The acids are woven into a natural fiber strip in the tampon. Vaginal pH levels can fluctuate throughout the menstrual cycle, and an increase in pH levels can result in a less acidic environment. A decrease in acidity can negatively affect the growth of "friendly bacteria" and can lead to infection. According to some doctors, the Ela tampon could maintain pH levels during menstruation and prevent common vaginal infections, the Journal reports. "We're at the very beginning of the road," Jack Sobel, chief of the Wayne State University School of Medicine's Department of Infectious Diseases and member of Rostam's advisory board, said, adding, "Whether it will stand the test of time, only the research and data will show." Rostam intends to have Ela tampons in U.S. stores in approximately one year, according to the Journal.

FDA Approval
Ela tampons have been categorized by FDA as a medical device, not a new drug. Rostam, therefore, did not have to show that Ela could treat a specific medical condition, but rather the company had to demonstrate that the product was as effective and safe as other tampons. The acids used in Ela tampons are classified as natural supplements, a category that is not strictly regulated, according to the Journal. The company will market the tampon as a "wellness product" because FDA regulations prohibit it from making specific health claims without further studies. Rostam is currently developing a tampon with painkillers to treat menstrual cramps and another that contains antifungal medication (Wall Street Journal, 7/21).

For current women's health policy news, visit the National Partnership for Women & Families' website.


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