What really goes into making a safe, effective toothpaste or mouthwash—and who decides if it measures up?

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