By Olaf Isele
Head of Strategic Product Development
We made a hemp fiber tampon…yay! What’s next?
So, we’ve designed and produced our hemp & cotton tampon and meet technical requirements. They work so great, and we can’t wait to show you our performance testing (and to have you try them!). We started this journey 5 years ago – to make a natural fiber tampon is safe, has premium function and comfort, and goes beyond sustainable and organic to have positive environmental impact. And here we are! But, there is one giant leap we need to take: get FDA authorization.
Menstrual cups are exempt from testing
As the very first hemp fiber tampon (and the first to introduce a new material since organic cotton tampons came to market over 30 years ago), how can we prove to the Federal Drug Administration (FDA) that this product is safe and worthy of widespread use in the USA? The FDA is in charge of authorizing the sales of new tampons, but they do not for any other period products like menstrual cups, menstrual discs, or reusable period underwear (what?! Crazy).
How a tampon gets FDA-approved…usually
The final step is submitting a Pre-market-notification (510k) request to the FDA because tampons are medical class II devices in the USA. Menstrual cups, discs, pads, and underwear are Class I and are exempt from this process (again, what?!). For class II devices like the Trace tampon, we must include a large set of biocompatibility and other studies, but Trace tampons require even more testing – on par with implantable medical devices like joint replacements!
In principle, the FDA reviews all the data that it requires, and if the device meets technical and medical requirements, it “clears” the notification and can be legally sold. For us trailblazers, though, this isn’t as simple it sounds because we (Trace and our hemp fiber tampon) are the first small business to submit this application and we are the first to submit a hemp fiber product.
The first new tampon ingredient…in decades
This has become an emotional journey to me and my colleague Claire, because it requires more than just skill and expertise. It requires relentless determination and courage to be the first hemp fiber medical device AND the first new fiber tampon presenting to FDA. It reminds me of a race where the distance is not yet revealed…one very expensive race (think hundreds of thousands of dollars).
As the first, we are faced with additional testing requirements not typically requested of other companies. As holistic clinicians and scientists who believe in ingredient transparency and industry revolution, we are here for it. In fact, we believe in testing transparency, too.
What chemicals do we test for?
From dioxins in tampons, pesticide and herbicide residues (yes, even organic cotton tampons can be grown with chemicals!), and other chemicals that we want to make sure aren’t in our tampons, we test and test and test. Nontoxic tampons and pads should be the baseline for the industry, not the exception.
Testing above and beyond what’s typical is 100% worth it – both the financial and the energy investment. And we want to make sure you see those results, too. Check out some of our test results from our most recent manufacturing lot of our hemp and Climate Beneficial™ cotton tampons with an organic cotton tampon removal string.
What other tests do you want to see in your period care? What chemicals in tampons concern you?
Let us know in the comments or by sending us a DM on Instagram.