FDA Compliance & The Cost of Doing Business

FDA Compliance & The Cost of Doing Business
There has been a recent flurry of activity on the topic of FDA registration and questions from our customers about whether Lunapads are FDA compliant. The short answer is YES we have been compliant since 2001. Having looked into this subject closely for many years, I have this to add to the conversation:

Medical Device Categorization:

Cloth pads have been considered medical devices and subject to FDA compliance since the 1990's. This is nothing new. Like many cloth pad manufacturers, we had no idea this was a requirement. Once we did, we went through the intense process of obtaining our 510(k) Premarket Notification and paying the Annual Registration Fee. More recently, we had to refile our submission because someone from the FDA noticed that our  product "classification" needed to be defined as "reusable", a classification that didn't even exist when we originally registered!

FDA and Regulation:

We think that it is important that organizations like the FDA exist to regulate products for the safety of the public. But, there is a cost to regulation and we regard the annual FDA registration fee as simply a cost of doing business. We don't love the fact that this cost is beginning to exceed $4,000/year. It is no different than paying for product liability insurance (which costs us a lot more than the FDA fee!) These are costs of operating our business ethically and responsibly in the industry we have chosen to be a part of.

WAHM makers, we feel your pain.

I can relate to the pain that WAHM ("Work At Home Mom"), Etsy & other cloth pad makers are feeling now that they know about this fee. But, it feels only fair that all of us in this industry are treated equally and bear the same costs. We cringe at the criticism we often receive that Lunapads are expensive and told that one can buy cloth pads from WAHM brands for much cheaper. Well, now you know one reason why. Once all WAHM brands start paying these fees and building it into the price of the pads, it will level the playing field a bit.

And, please don't forget that Madeleine and I are moms too: we sometimes work from home and sometimes work at the office. We are working hard to raise our families and struggle to pay our bills just like any entrepreneur. For more on this, see Madeleine's post; Lunapads: big or small business?.

Safety & Compliance:

As feminists, while we don't buy into the notion of menstruation being a medical condition and products like ours being medical devices, we know that menstruation is not always a simple experience. Many people have harsh reactions to certain kinds of menstrual products (such as rashes from pads) and are still reporting to the FDA the affects of Toxic Shock Syndrome. Institutions like the FDA are there for consumers to report adverse effects and hold to account manufacturers for compliance and safety.

Sign the Petition:

We support the We the People Petition to lower or eliminate cloth pads from the medical device classification. Cloth pads are in essence garments and should be exempt; as they are under Health Canada regulation. Why should the FDA feel differently? It is interesting to note that the FDA website specifically states "There are no reductions in annual establishment registration fees for small businesses or any other group." Gee, thanks a lot. 
 
While the petition gathers signatures, we will continue to be compliant with the FDA. We are happy that the level of consciousness has been raised on the issue and now hope that customers have a better appreciation for the challenges that businesses like Lunapads, Gladrags and other WAHM manufacturers face in running a small business.

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