Fluoride Free Toothpaste Bits: Why It's Important

The F Word: 3 Reasons Why Our Bits Are Fluoride Free

We went on Shark Tank and said Fluoride Toothpaste Tablets were illegal in the United States. Well, after years of formulating and testing (through lab smears and cycling models, never on animals), we finally launched our Toothpaste Bits with Fluoride - one of the only fluoride toothpaste tablets made in the U.S.

It took us a lot longer to get here than we expected. When we originally wrote this post, we had actually put our fluoride formula on hold indefinitely for three important reasons. Here’s what happened, what we learned along the way and how we ultimately brought fluoride Bits to life.

1. Nano Hydroxyapatite Solves Multiple Problems

TBH, we weren't expecting to come across something that was proven to be comparable to fluoride while also helping to tackle tooth sensitivity. However, while working with dentists on our fluoride line, we were introduced to nano-hydroxyapatite.

Nano-hydroxyapatite, nHAP for short, "is a calcium crystal that replenishes minerals that are lost in enamel. By doing this, it strengthens enamel and decreases tooth sensitivity." - Samantha Tillapaugh, DDS.

nHAP has been used in oral care in Japan for the past 40 years and is extensively studied. It has proven to be effective in oral care time and time again. As a matter of fact, a fluoride-free nHAP toothpaste was approved by Health Canada (the Canadian version of the FDA) as "anti-cavity" in 2015.

We're all about multitasking, so an ingredient that can strengthen enamel, provide plentiful cavity prevention properties, and kick tooth sensitivity is right up our alley.

nHAP proves that fluoride is not the end-all-be-all of effective oral care, and we are so excited to be using this dentist-recommended ingredient.

We understand that many people may still be unfamiliar with nHAP here in the US, and we want to continue to work with dentists to get the word out about how nHAP is a great fluoride-free option. That being said, it's also important to us that we can offer the products that are best for you.

That’s why we never stopped working on fluoride. Today, we’re proud to offer both our original fluoride-free Toothpaste Bits with nHAP and Toothpaste Bits with Fluoride, so you can choose the formula that works best for you.

2. Fluoride Toothpaste Tablets Didn't Fit Neatly Into U.S. Regulations

By adding fluoride to toothpaste in the US, the product becomes a drug that is regulated by the United States Food and Drug Administration (FDA).

All FDA drugs in the US must comply with the corresponding FDA Monograph, which is basically a super strict recipe to make and sell the product in the US.

Every little detail of the monograph must be followed. When we first started developing fluoride Bits, the challenge was that tablets weren't specifically included in that framework. The accepted forms of fluoride dental dentifrices (fancy name for fluoride oral care products) in the FDA Fluoride Monograph were powder, paste, and gel.

You might be thinking: isn't a tablet just a compressed form of powder? Yeah, that was our first thought too.

But because the monograph has specific dosing directions, powder (which is used by sprinkling on top of your toothbrush) actually is required to have a higher fluoride percentage because it's assumed that some of the powder will fall off your brush - meaning a tablet (which will have a consistent dosage due to its form factor) isn't exactly the same.

Okay, so could it count as a paste? Not so fast.

Because paste contains water and tablets don't, the existing testing protocols weren't designed specifically for a dry, pressed tablet format either.

Basically: we were trying to make something that didn't fit neatly into a regulatory framework built around traditional toothpaste.

We worked with FDA consultants, testing partners and regulatory experts to figure out a path forward. It took years of formulation and testing, but we got there.

Today, Bite makes one of the only fluoride pressed-powder toothpaste made in the U.S. Our fluoride Toothpaste Bits are made with 0.76% sodium monofluorophosphate, providing 0.14% fluoride ion, and are made in California.

3. Animal Testing Was a Non-Negotiable

Another major roadblock was testing.

When we originally began working with FDA consultants and reps, we were told that meeting the fluoride monograph could involve biological testing requirements, including the rat caries test.

Fair warning: If you're not okay with reading about the harsh realities of animal testing, I recommend skipping down to the "Where We Stand Now" section of this article.

The rat caries test involves young rats being kept in a lab while their teeth and bacteria levels are studied. After several weeks, the animals are killed so their jaws can be examined under a microscope.

The rat caries test is not only profoundly unethical; there have also been efforts to establish alternative ways to determine the effectiveness of fluoride products.

In 2017, the American Dental Association (ADA) petitioned the FDA regarding alternative testing requirements. The monograph also provides for alternative testing, including an intraoral appliance model (IOA).

For us, one thing was always clear: we were absolutely against animal testing and would not test our products on animals or compromise that standard to launch fluoride.

So we kept working.

We ultimately found a path to launch our fluoride Toothpaste Bits while staying true to our commitment to cruelty-free products.

Where We Stand Now

If you’ve stuck around this long; first of all, hello. I know this is a lot. Legal stuff is fun, isn’t it?

When we originally wrote this article, we ended it by saying fluoride Toothpaste Bits weren't currently a possibility for us. We're very happy to say that's no longer true.

After years of formulation, testing and navigating a regulatory system that wasn't exactly built with toothpaste tablets in mind, Bite officially launched Toothpaste Bits with Fluoride.

Our Fluoride Toothpaste Bits contain 0.76% sodium monofluorophosphate (0.14% fluoride ion) and are one of the only fluoride toothpaste tablets made in the U.S.

And our original nano-hydroxyapatite Toothpaste Bits aren't going anywhere.

We still believe nHAP is an incredible fluoride-free option, but we also know many people want fluoride or have dentists who specifically recommend it. Now, you get to choose.

So yes, fluoride toothpaste tablets do exist in the U.S. And we're very proud to make one of them.

Shop Toothpaste Bits with Fluoride →

Shop Fluoride-Free Toothpaste Bits with nHAP →