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. 

petition

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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  • Angie

    I guess I just don’t understand why the fee is so high. What does that $4K cover or go towards? How is the FDA using that money to regulate? Even if the regulation is necessary, the annual high fee doesn’t seem so.

    • MaeganB

      This is a good question, and maybe one that should be put to the FDA’s people…US citizens have a right to know about fees collected for government agencies and how that money is being utilized, and if it is being utilized in a responsible manner.

      I can’t think of any products men use that are taxed or regulated at this rate. It feels a little unfair that b/c biology says my body should prepare for childbirth each month…that I must also pay through the nose to get it. People would be in an awful uproar if women simply chose not to use ANY product and either bleed through their clothing, or simply stay home during cycle days (work, school, doctors, nurses, lawyers, cops, firefighters…there are women in all these professions and places…wouldn’t it be a shame to lose them at various times throughout the month b/c they don’t want to pay the high cost of being available to the public??).

      The issue didn’t really resonate with me until I read their article…I’m nursing my third child and haven’t menstruated since April 2012. I won’t menstruate until my milk dries up, which could be months after I wean.

      The cost of being born a woman (something I have no control over) shouldn’t be this high.

    • Freethinker01

      In the simplest terms, you are funding an ever-expanding bureaucracy. It costs money–buildings, paychecks, computer systems, etc.–to push paperwork and enforce new laws. The cycle (no pun intended) literally feeds its own growth.

  • I’ve seen stories and the petition floating around social media recently, and I, like so many others, was outraged! But this post helps put the issue in better perspective for me. I had no idea that this had been an issue for years! And it explains why your products are so expensive. I will be going and signing the petition right away. That fee seems unnecessarily high for a product like this.

  • Period Packs, Inc.

    An incredibly insightful and educational post that helps eliminate some of the recent uproar surrounding FDA compliance. $4,000 seems rather steep, as does its classification for cloth menstrual pads as medical devices. What is extremely encouraging is your perspective, and support of all others in the reusable cloth industry. We’d love to carry some products too.

  • Except…. periods are not a medical condition. This is missing from the discussion. Having to register products regarding menstruation that are for normal, healthy periods undermines the normalcy of our natural body processes. Classifying menstrual products as medical devices which need registration, reusable or not, is ludicrous and, quite frankly, disturbing. As I understand things, it’s not just about the FDA registration, but now the new taxation on medical devices built into the ACA that will now involve the IRS. Seems like way more than a WAHM is going to be able to handle. Perhaps I’ll just start making my own, and bypass the FDA and IRS all together.

    • Kristen2879

      Couldn’t agree more! I have started making my own and love them. Wanted to sell them on Etsy since I have so much fun making them, but after finding about the FDA registration I can no longer do so. Ridiculous

  • Freethinker01

    As a woman, I’m offended that the government feels like it needs to be my “daddy” and take care of my period safety for me. No thanks. I’m mature enough to do that on my own.

  • Pingback: Cloth is a medical device??? | Buying Less and Living Better()

  • csgm321
  • Rachel

    Thank you for sharing this. Are there any other petitions available for this cause? I see that the one linked in the post has expired. I’d love to sign and get my friends and family to sign.

  • Emily

    Is this the same in Canada? I’m interested in selling on etsy or some other local format… But there’s no way I could afford that.