The FDA’s classification of menstrual pads as medical devices has left small business owners scrambling to cover a huge registration fee that is now being enforced. Are pads really medical devices?
The Food and Drug Administration has declared that reusable menstrual pads are considered medical devices, and as such, all makers have to pay a yearly FDA registration fee to continue to sell them. The fee of $3,646 may not be a big deal for large corporations, but most menstrual cloth pads are made by small, women-owned businesses. And the even more significant fact is that this fee is due by Dec. 31, 2014 — just a few weeks away.
Reusable cloth pads are used by women who don’t like the disposable options on the market today, most of which are bleached and contain other chemicals that can trigger discomfort, irritation or even allergic reactions. However, there aren’t a lot of large companies that make cloth pads, because the big market is in the disposable option. “Most cloth pad companies are run by woman entrepreneurs,” says Denelle Philemon from MotherMoonPads. “We hand-make our products with care to provide women with the menstrual options they desire — menstrual options that are safe and nontoxic to both the environment and their bodies.”
The FDA regulation enforcement has placed a huge burden on those small business owners. The enormous fee is unattainable by many small pad makers and can effectively drive them out of business. “For MotherMoonPads personally, this fee is a large percentage of my income,” Philemon says. “I am not a large corporation. I do not have a padded budget where I can easily cover this. As a one-woman micro-business who supports her family, paying this fee will mean taking money out of the family budget.”
As Philemon says, menstruation is not a sign of poor health — it is a sign of good health. Menstruation is a normal, healthy part of a woman’s life, and the supplies women use should not be considered medical devices. I completely agree with her. These regulations are suffocating and unfair. “I feel very strongly that it is important to provide women with safe choices for their menstrual needs,” she says. “Requiring cloth menstrual pad companies to register with the FDA will take away those choices to women all over the world. We deserve better.”
There is a We the People petition requesting that the FDA fees for reusable pad makers be reduced or eliminated. If the regulations aren’t changed this year, then maybe change can come before Dec. 31, 2015 for the following year.