As of now, there is no such paper trail, and therefore an FDA-approved fluoride tablet does not exist. So if a company was selling FDA-approved fluoride tablets in the US, there would be a publicly documented paper trail. While we will keep working with the FDA regarding toothpaste tablets with fluoride, we are proud to say that nHAP is not only an excellent alternative option to fluoride but offers many benefits in its own right.įDA approval has a strict and well-documented process. However, we have been told there is no record of a formal FDA approval for any toothpaste tablet with fluoride in the US. We are currently working with several FDA consultants and FDA representatives to continue pursuing the best possible product. If there were these companies, they would not be complying with the FDA’s rules and standards. This is because the definition of gels and pastes is very different from that of a pressed powder tablet.Īre there other companies selling fluoride toothpaste tablets in the US? As far as we know and according to the FDA, there are not. It would be a stretch for us to make the case that our tablets were, in fact, a paste or gel. This means that there are no FDA-approved testing protocols we could follow for tablets specifically, and any changes to the test would have us immediately denied. Okay, so could it count as a paste? Not so fast.īecause the paste is made of up to 40 percent water, the testing protocols limit the amount of water that is allowed to be used within a product. You might be thinking: isn't a tablet just a compressed form of powder? Yeah, that was our first thought too.īut 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 the same. The accepted forms of fluoride dental dentifrices (fancy name for fluoride oral care products) in the FDA Fluoride Monograph are powder, paste, and gel. While this may not seem like a big deal, it’s all about semantics and technicalities. It doesn't say that they aren't allowed, but it doesn't explicitly say that they are either. The issue here is that tablets are not included in the monograph. Įvery little detail of the monograph must be followed, and there are no substitutions or alterations allowed. Fluoride in a Toothpaste Tablet Is Currently Illegal in the United Statesīy adding fluoride to toothpaste in the US, the product becomes a drug that is regulated by the United States Food and Drug Administration (FDA).Īll 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-selling a product that does not follow the necessary FDA monograph or without obtaining FDA approval is against the law. We ultimately would like to be able to provide you with the choice of fluoride in your toothpaste Bits, which brings us to our other two reasons. That being said, it's also important to us that we can offer the products that are best for you. 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. 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'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. 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. It has proven to be effective in oral care time and time again. NHAP has been used in oral care in Japan for the past 40 years and is extensively studied. By doing this, it strengthens enamel and decreases tooth sensitivity." - Samantha Tillapaugh, DDS. Nano-hydroxyapatite, nHAP for short, "is a calcium crystal that replenishes minerals that are lost in enamel. However, while working with dentists to get our fluoride line, we were introduced to nano-hydroxyapatite. TBH, we weren't expecting to come across something that was proven to be comparable to fluoride while also helping to tackle tooth sensitivity. Nano Hydroxyapatite Solves Multiple Problems The F Word: 3 Reasons Why Our Bits Are Fluoride FreeĪfter two years of formulating and testing (through lab smears and cycling models, never on animals) we finally created a fluoride toothpaste tablet that we have had to put on hold indefinitely for three important reasons.
0 Comments
Leave a Reply. |