The Nibz Difference: 3 Reasons Our Tablets are Fluoride-Free
After extensive research and development spanning two years, during which we conducted lab tests and utilized cycling models (never on animals), we proudly introduced our fluoride toothpaste tablets. However, we've had to pause production indefinitely for three significant reasons.
1. Nano Hydroxyapatite: A Game-Changing Solution
Unexpectedly, our journey led us to a breakthrough ingredient that rivals fluoride's effectiveness while addressing tooth sensitivity: nano-hydroxyapatite (nHAP). In collaboration with dental professionals, we discovered that nHAP, a calcium crystal, replenishes lost enamel minerals, strengthening teeth and reducing sensitivity. As stated by Samantha Tillapaugh, DDS, "nHAP strengthens enamel and decreases tooth sensitivity." With over 40 years of use in Japanese oral care and Health Canada's approval as "anti-cavity" in 2015, nHAP has proven its efficacy time and again. Embracing multitasking ingredients aligns with our ethos, and nHAP emerges as a dentist-recommended, fluoride-free option that excites us.
While nHAP may be unfamiliar to many in the US, we're committed to raising awareness with dental professionals and offering you the best-suited products.
2. Legal Roadblocks to Fluoride in Tablets
Adding fluoride to toothpaste tablets in the US classifies them as a drug, regulated by the FDA. Compliance with FDA Monograph guidelines is mandatory, detailing stringent requirements for manufacturing and sale. Unfortunately, toothpaste tablets don't explicitly feature in the Monograph, posing a challenge. While tablets resemble compressed powder, dosing directions and testing protocols differ. Presently, no FDA-approved fluoride tablet exists, and any such product would require rigorous testing. We're actively collaborating with FDA consultants and representatives, yet fluoride tablets remain legally unattainable.
3. Ethical Concerns: Animal Testing
Even if tablets meet Monograph criteria, FDA mandates biological testing, typically involving animal studies such as the rat caries test. This unethical practice conflicts with our values, and we vehemently oppose it. Although alternatives exist, only the intraoral appliance model is FDA-accepted. While some companies may claim cruelty-free status, nuances in compliance raise concerns. We adamantly reject animal testing and refuse to subject our products to such practices.
Where We Stand
Despite legal and ethical challenges, we remain committed to offering fluoride-containing Nibz Bitz. However, given the current landscape and the effectiveness of nHAP, fluoride tablets are not our immediate focus. We encourage you to explore nHAP's benefits, consult your dentist, and thank you for embracing sustainable oral care alongside us!
Explore our range of Nibz Bitz today! Click here
Sources:
(PDF) Remineralization of Early Caries by a Nano-Hydroxyapatite Dentifrice | Research Gate
Fluoride Uses, Side Effects & Warnings | Drugs.com
Drug Applications for Over-the-Counter (OTC) Drugs | FDA
Code of Federal Regulations Title 21 | FDA
Rulemaking History for OTC Anticaries Drug Products | FDA