Menstrual cups and reusable menstrual pads have been labeled as “medical devices” by the Food and Drug Administration (FDA) for a number of years, but a growing number of small businesses report receiving demands to pay a “premarket notification fee” to continue the sale of these products, according to Medical Daily.
Reusable pads are made from absorbent fabric, such as cotton, and can be washed and reused. Menstrual cups fit inside the vagina and catch the flow. Many women use these products as an environmentally friendly alternative to disposable pads, Medical Daily reports. The fees are due before Dec. 31, 2014 and many small business owners are struggling 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 is “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 considered medical devices.
Denelle Philemon from MotherMoonPads, a small company that sells these products, said the fee represents a significant portion of her company’s income, Medical Daily reports. She said the pads are a safe choice for a woman’s menstrual needs. “Requiring cloth menstrual pad companies to register with the FDA will take away those choices to women all over the world.”