Chapter 16 - Strategic Regulatory Planning—Key to Success in Anti-aging Cosmetic Product Development

Abstract

This chapter provides a comprehensive strategy and tools for product developers and formulators by outlining the most important factors and their complicated inter-relationship for sound business decision making. The biggest distinction between a drug and a cosmetic in the US regulatory environment is that a cosmetic is not allowed to possess any physiological activity as to affect the structure and function of the body. In other words, articles intended to be used externally to improve attractiveness or appearance are regulated as cosmetics. But when the intended use is considered to have the potential to change the structure or function of the body, the product will be regulated as a drug. However, simply incorporating an active ingredient in a cosmetic product does not automatically move it to the drug category. The product only becomes a drug when the chosen active ingredient is well known for its therapeutic uses, and when its name identified in the labeling leads the users to expect therapeutic effect. In this highly regulated and interrelated modern world, a company cannot measure its success simply via its ability to come up with the most scientifically advanced formula with measurable and effective skin care benefits. Product developers and marketers have in their arsenal a diverse variety of market research tools to help them narrow down the playing field. They include market trend analyses, Internet consumer surveys, consumer habits and practice studies, preference surveys, and use tests.