A Case for Symbiotic Success

Approximately 100,000 tampons made from hemp fiber and regeneratively grown cotton are safely sitting in a warehouse in Germany. Whether they will lead a new material innovation, for tampons and beyond, depends on what happens in the next few weeks.

Many women seek a transparent, simple and pure supply chain for their period care products. Frustration over finds of heavy metals and PFAS in those products persist. We believe that our company Trace can lead by example and renew trust and excitement in our category: radical transparency and healthful manufacturing from farm to flow inspired hundreds where we presented our new way forward.

Trace is a woman-founded company innovating in this space like other startups in recent years, e.g. Vyld, Sequel, Hempress. This story told from founder and CEO Claire Crunk gives you an inside look at the challenges and inner workings.

Our industry is full of new, crazy, cool startups - just look at 2024’s INDA Hygienix Innovation Awards finalists. From diaper-eating mushrooms to dissolvable wipes, our intrepid minds blast the status quo with dreams of better products, better business, better ingredient transparency and a better world.

But with aspiration comes perspiration – startups require sweat equity that could saturate a warehouse full of Swoobies. Founding, building, funding, and commercializing groundbreaking ideas takes courage and persistence. It is a risky road with a ridiculous number of roadblocks, and even the brightest-eyed companies run out of gas within a few years 90% of the time. Startups in our hygiene industry and specifically in femcare absorbent hygiene require a special brand of gumption. We face obstacles that startups in SaaS (Software as a Service) companies don’t encounter. There are few startups in our industry due to tedious expensive scientific research, regulatory burdens, legacy conglomerate supply chains, and trying production pilot runs.

Take our company, Trace, for example. Our innovation of using hemp fiber in tampons requires FDA authorization on an extreme scale before the first real customer can even beta test in the U.S. That takes commercial production with a fully developed, proven supply chain with exhaustive, pricey testing of a novel material before gaining even the legal ability to sell (or pre-order, interestingly) a single tampon. This kind of groundbreaking innovation is a million-dollar, four-year journey. And for a consumer product with a shelf price under $10? That’s pretty scary to startup investors who are looking for 10-20x returns in under five years. There’s a bigger investor appetite for SaaS even in the femcare business because of its much shorter timelines and financial risks.

Trace received its early investments on the merit of enthusiasm for solving major anxieties and frustrations about the current menstrual product market. Our friends, female physicians, parents of daughters and crowdfunding micro investors believed in not only in our ability to make the world better for women and the environment but also that the tampon industry needed a big change. That support enabled us to successfully complete commercial production of our hemp tampons and work with FDA to evaluate the first new tampon material in decades. It fueled developing our visionary supply chain and processing method for hygienic hemp and regenerative cotton grown right here in the United States. It led to production of the first consumer products using cotton and hemp made from regenerative agriculture. We won awards and made the news. It kept the lights on for a few years.

But it wasn’t enough. Today, the gas tank is on red, and our company is at a precarious crossroads. Do we keep running the race on fumes alone? Do we suddenly find an investor who can’t accept us leaving? Do we find a strategic buyer? Do we close?

Every year events like RISE and Hygienix in the U.S. or Outlook in Europe, and the rarer IDEA and INDEX expositions, aim to showcase innovations that tackle new technologies or solve new problems and consumer demands. Innovate or perish, I’ve heard it often from colleagues at those events. A majority of innovations fail, often due to misreading the market or cost issues. But I am convinced that our product idea and our mission strongly resonates with women not just in the U.S. but worldwide. Thinking about where Trace is today, and the chapters that I faced along that journey, I conclude that there are deeper explanations. I want to share this because the vitality of (and respect for) our industry depends on it. I believe that long- and deep-held beliefs and behaviors in our industry make it harder for innovative startup and risk disruptions that can harm the future of our industry. I’ve experienced it firsthand.

That said, we, as an industry, can also make it easier for innovative startups to succeed and refuel the long-term success of our industry in a changing world. I’ve experienced that firsthand, too.

I hope that the following examples of our Trace story can inspire the changes and solutions that we need to replenish fresh blood in our industry and keep re-inventing our businesses.

“Women don’t care what’s in their tampons! Call me back when you have two million dollars!”

The first tampon manufacturer I called back in 2020 to share my novel product ideas spoke these actual words to me, in a raised voice no less, before hanging up on me. He scoffed at my idea to use hemp fiber in tampons, claiming that women were perfectly fine with viscose, and made sure I knew that I wasn’t worth five minutes of his time unless I came with a check in hand. Now, how is a startup supposed to raise two million dollars without a manufacturer?

Despite his belief, the fact is that women very much do care about what’s in tampons - so much so that significant numbers of women have switched to the more tedious solution of reusable products like menstrual cups. That’s some pretty drastic behavior change for “not caring.”

Now, five years later, national tampon sales are stalling. Are we surprised?

Perhaps the stagnation comes from our own industry’s complacency. Why invest in change when perpetual demand is built into our very biology? As long as women bleed, they will buy, no matter what the industry chooses to provide her, which are abysmally few. My own local Walmart carries only one non-viscose brand. Why is it that absorbent hygiene is one of the most brand-narrow categories in personal care? Think of what else she buys: toothpaste, deodorant, even bandages – all have double and triple the number of brands on shelf compared to pads and tampons.

So, when we look at these other industries’ proliferation of emerging brands, we must be honest with ourselves. Our lack of options is not because women don’t care or that they aren’t looking for innovative new brands. It’s because we, as an industry, aren’t embracing the change-makers, the disruptors from within, that want to innovate based on early market-change insights.

Inertia of Innovating the Supply Chain

Talking with potential partners and manufacturers for our products, I’ve frequently heard: “Why would we change anything? We’ve used global supply chains for years without any problems”  and “We can’t just source outside of our existing vendors.” Ironically, I heard this during the extreme supply chain disruption from the COVID pandemic. Existing supply chains work until they don’t, and I wonder if some of that instability was self-imposed.

Tragically, reluctance to vet new supply chains has placed the tampon industry in condemning limelight.  A Time magazine article in 2023 summarized findings of PFAS in menstrual products despite those chemicals being criticized for years before. And a study published in 2024, just three years after our new supply chain ideas were rejected, revealed surprising contaminants of lead and other heavy metals in multiple legacy brands of tampons.

Turns out, That Women Should Care About What’s in Their Tampons

With an insider tip from an industry friend, we finally found a small contract manufacturer who was willing to share the risk of running new materials from our novel “farm to flow” supply chain on their machines. Our high targets for fiber quality and diligent work to meet strictest hygiene standards demonstrated the ability to make excellent product. In early 2023, this set us up to work with laboratories in getting the data needed for our class II medical device FDA 510k submission.

A Turning Point 

Much of the money we’d raised was of course dedicated to preparing the FDA 510k submission. After initial conversation with the FDA, we sent our hemp tampon samples to our selected labs and got all the data as described in the ISO 10993 as well as the direct guidance from FDA for menstrual tampons and pads. Progressing through all the data and documentation with our hired expert advisers, it started to feel like a free-throw. Before finalizing our submission, we had another call with our FDA team. We’d addressed, we felt, all the questions about having no cannabinoids present and being equivalent to the chosen predicate device.  We weren’t prepared for a question about what unknown substances could present as yet unknown risks – in technical parlance that is called an exhaustive extraction, which was costing an additional $150,000, which we didn’t have. You’ll say, we have to pivot - and pivot we did.


We got a lucky break by finding a menstrual pad producer in Europe who also was willing to work with our unique supply chain. That’s another delightful story, yet, to make it short, we received a major shipment of hemp fiber and climate-beneficial cotton containing menstrual pads to our specification within half a year of starting this additional product development - as you can still see them on our company website (traceyourtampon.com). Working on a shoestring budget with most of our budget spent on the additional chemical detection and characterization, we aimed at minimal advertising with sufficient revenue growth. Of course, I switched into high gear again to raise more funding and worked across the board with potential investors through private equity, family offices, hemp industry entrepreneurs, development fund applications - a whole new ecosystem that I learned about in raising capital. Those were tough (even tougher) times, but the amazing friendship among fellow startup companies in the hygiene and hemp industry gave me the energy to go into high gear week after week. A whole year flew by with optimism, hard work, quick learning and frequent pivoting and adjusting strategy and plan with Olaf. At the end of that year 2024, we came to the objective, devastating conclusion that we are out of runway. There are many achievements and friendships forged that we are very proud of and keep us thinking of pursuing our Trace mission in other form. Last not least, we have all the chemical extraction data and only need the funding to get it analyzed and assessed for any toxicological risk in a vaginal environment. We’ve created novel IP, know-how of running a tight startup business and precious lessons from our thousand failures. The 100,000 tampons are still safely in the warehouse and our hemp pads in another. Most importantly, we still believe in the role we can play in reinvigorating the absorbent hygiene industry, along with other disruptors—for a vital future of all. I wish we’d found the partnerships needed to succeed months ago, but our story will not and should not be lost.

Trace Femcare, Inc. is currently accepting inquiries from strategic buyers to acquire its asset portfolio of intellectual property and inventory. Contact Claire Crunk, CEO or Olaf Isele, CTO for more information. claire@tracefemcare.com, olaf@tracefemcare.com