Episode 4

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Published on:

11th Aug 2025

04: TOOTHPASTE SECRETS EXPOSED!

Episode Summary

In this episode of the Dental Formulator’s Playbook, Dr. Rob and Tami dive deep into the science and regulations behind toothpaste and mouthwash formulation. From FDA monographs and ADA approval to the complexities of ingredient selection and quality control, they break down what it really takes to bring an effective, safe, and compliant oral care product to market. Whether you're a formulator, brand owner, or curious consumer, this episode provides a behind-the-scenes look at the industry’s most critical—and often misunderstood—processes.

Highlights

  • Discussion of oral care formulations, particularly toothpaste and mouthwash
  • Overview of regulatory aspects governing oral care products, including the roles of the FDA and ADA
  • Historical context of fluoride toothpaste development and its significance in oral care
  • Explanation of FDA monographs and their importance in product formulation and marketing
  • Differences between OTC drugs and cosmetics in terms of regulation and claims
  • Challenges faced by manufacturers in ensuring product safety and efficacy
  • Importance of ingredient interactions and quality control in formulation
  • The role of clinical studies and testing in validating product claims
  • Insights into the complexities of using different fluoride compounds in toothpaste
  • The impact of marketing and consumer awareness on regulatory practices in the oral care industry

Connect with Dr. Rob (Robert L. Karlinsey, PhD)

🌐 Website: https://customdentalformulations.com/meet-dr-karlinsey

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About the Podcast

Dental Formulator's Playbook
The Dental Formulator’s Playbook is where science meets strategy in the world of oral health innovation. Hosted by Dr. Rob Karlinsey, a seasoned dental researcher and independent formulator, this podcast is your behind-the-scenes pass to what really goes into creating cutting-edge dental products.

Whether you're a dentist, a dental brand, or just someone curious about how toothpaste, rinses, and other oral care products are developed, you'll find practical insights and real-world takeaways in every episode. Dr. Karlinsey keeps it straightforward and engaging—no fluff, just clear, thoughtful explanations based on years of experience in the lab and the industry.

This show is all about helping dental professionals and product developers think differently, make better decisions, and stay ahead of the curve. If you care about science, results, and doing things the right way, you're in the right place.

About your host

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Robert Karlinsey

Dr. Robert L. Karlinsey is a scientist and formulator with almost 20 years’ experience in dental research. He earned a BS in Physics (University of Scranton) and PhD in Chemical Physics (Indiana University), with postdoctoral work in physical chemistry (Indiana University). As a visiting assistant research professor at the Indiana University School of Dentistry, his research led to an impactful encounter with Dr. George Stookey, and shortly thereafter, the formation of Indiana Nanotech, LLC (now known as Custom Dental Formulations, LLC), of which he spearheaded all research and small-scale manufacturing efforts. Dr. Karlinsey is the inventor of Nanotech’s functionalized tricalcium phosphate systems, which continue to help generate over $100MM in global product sales for a major dental manufacturer. As Principal Investigator, his work has received significant funding through Federal (National Institutes of Health), State (Indiana and Texas), and industry grants and contracts. His research in patented calcium phosphate technologies continue to help generate over $100MM in global product sales. Previously, Dr. Karlinsey has served as Chief Scientific Officer at Therametric Technologies, Inc, and adjunct professor of chemistry at the University of Indianapolis.

Dr. Karlinsey addresses clients’ needs in preventive and cosmetic dentistry, including fluoride- and fluoride-free remineralization, antiplaque/gum health, whitening systems, and more. He is actively involved in clinical and laboratory research designs and performance-backed, customized oral care formulation solutions. And, whenever possible, he favors natural, nature-derived, and/or sustainably sourced ingredients