The Food and Drug Administration (FDA) yesterday confirmed that reusable menstrual cup products might be approved before the end of the year, at the earliest.
As an alternative to disposable pads and tampons, the menstrual cup is a product usually made of medical-grade silicone, placed inside the vagina during menstruation to collect menstrual fluid, and can be reused after the cup is removed, emptied and washed.
Users of the cups say that the product is more environmentally friendly, safer and cost effective than pads or tampons, because a cup can be reused for several years if properly taken care of.
However, menstrual cups are currently listed as class 2 “medium risk” medical devices and have not obtained an FDA permit, so females cannot purchase them online and can only buy them for self-use if they purchase them overseas.
A motion entitled: “For menstrual cups to be allowed to legally sell online, like tampons” was proposed in July by a netizen on the government’s Public Policy Network Participation Platform, and received the support of more than 6,000 people.
FDA Division of Medical Devices and Cosmetics section chief Wu Cheng-ning (吳正寧) said in reference to the US classification, menstrual cups are listed as class 2 medical devices, along with tampons, because they are inserted into the body, and the material must be examined carefully to ensure safety from infections.
She said that as menstrual cups are for personal use, non-implanted and do not require specialist’s instruction or assistance, it is possible that they could be approved for online sales, but there are still some conditions that the products would need to meet, such as obtaining a medical device permit, obtaining registration from local health departments and being sold by dealers with pharmaceutical company licenses.
The FDA confirmed that it has received an application from a local company, and if its products pass reviews, it would be the first company in the nation to obtain a permit for selling the cups.
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