The Hill

FDA Classifies Reusable Menstrual Pads As Medical Devices; Retailers Must Pay Fee To Sell Them

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How exactly does the FDA justify labeling reusable menstrual pads as medical devices? Photo courtesy of Shutterstock

Women menstruate. It’s a simple fact of life and usually not too much of an inconvenience to have access to some sort of sanitary product. In the year 2014, women have the choice of a number of products to use during their menstrual periods, and while all do more or less the same job, only menstrual cups and reusable pads require the retailer to pay a fee to the FDA in order to stock them on store shelves. As a number of small businesses raise awareness of this uneven classification of feminine hygiene products, we can’t help but wonder how such a simple product ended up getting labelled as a medical device in the first place.

Menstrual cups and reusable menstrual pads have been labelled as “medical devices” for a number of years, Business2Community reported. In case you're wondering, reusable menstrual pads are the eco-friendly alternative to disposable pads. They are generally made from an absorbent fabric, such as cotton, and are worn in the same manner as traditional disposable pads, only these can be washed and reused. Menstrual cups fit comfortably inside the vagina and catch the woman's flow. However, it’s only recently that a growing number of small businesses have reported receiving demands to pay a “premarket notification fee” to continue the sale of these products. These fees are due before Dec. 31, 2014, which means that many small business owners are scrambling to get cash together.

The FDA defines a medical device as something that is either “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,” or “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” Products such as vaginal speculums and umbilical clamps are also listed in this category.

Any woman who has ever used the simple pads made from cotton or flannel with the sole purpose of keeping dry during her natural menstrual cycle may be confused by this labelling. Still, regardless of personal opinion, the truth remains that if these retailers do not pay the fee by the due date, they may soon be out of business.

“For MotherMoonPads personally, this fee is a large percentage of my income,” Denelle Philemon from MotherMoonPads, a small company that sells these products, told SheKnows.com.

According to the Food and Drug Administration webpage, a premarket notification fee is in accordance with the Medical Device User Fee and Modernization Act of 2002, and since reusable menstruation products are labelled as “obstetrical and gynecological devices,” the fee applies. 

The fee is not incredibly large, $3,646, but still, both large and small retailers of reusable female menstruation products are voicing their disdain with having to pay a fee for what they feel is a mislabeling of their product.

"I feel very strongly that it is important to provide women with safe choices for their menstrual needs," Philemon added. "Requiring cloth menstrual pad companies to register with the FDA will take away those choices to women all over the world. We deserve better."

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