Rostam, Ltd., has won approval to market the Ela tampon that releases a natural supplement to help ward off vaginal infections. The tampon absorbs menstrual fluid but also releases lactic and citric acids into the vagina. Some research suggests that maintaining higher acidity levels during menstruation might help prevent common vaginal infections. The acids are contained in a natural fiber strip woven into the tampon.
The FDA categorized the tampon as a medical device, not a new drug. Rostam simply had to demonstrate that the product was as safe and as effective as other tampons but did not have to show that it could treat a specific health problem. The key ingredient is a natural supplement, a category that isn’t tightly regulated. canada drugs pharmacy
Rostam plans to position the tampon as a “wellness product,” because FDA rules bar the company from making specific health claims without additional studies.
