There is an issue about a product you may not even know exists. The product is the reusable menstrual pad. It is an absorbent pad made from fabrics which can be purchased at any fabric store. It is used in the same manner as the common disposable variety. The difference is that it can be used, washed, then dried for reuse (by the same woman). These are preferred by some women over disposable pads for a variety of reasons. Some of these reasons are decreased lifetime cost, less environmental impact, and sensitivity to commercially available disposable devices. 

Because these devices are not readily commercially available, many consumers have turned to handmade items sold by small businesses. A quick search of the website Etsy, which hosts sellers of handcrafted items, will show many makers.

The trouble is this: the FDA considers menstrual pads (even cloth ones) to be a medical device. Therefore, the FDA forces makers, including those that are small, home based businesses, to be "FDA compliant". For 2018, this certification of compliance costs the business owner $4,624 per year. This regulation does not add any additional safety to these products, which are essentially cloth to attach to ones underpants.

There is no "sliding scale" or reduction in cost based on sales. The fee is the same for huge multinational companies as it is for a person making them in a home office. As you can imagine, the fee alone is enough to be a stumbling block for small start-ups. A home-based business would have to sell hundreds of items just to break even on the fee every year.

This regulation is stifling business start-ups without adding consumer protection and forcing established home businesses to close when the FDA comes calling for payment.

We ask for your assistance in eliminating the FDA regulation for reusable cloth pads or modifying the fee structure to ensure affordability for small business owners.