Cosmetic Regulations, Labeling and Safety
How to Ensure Your Products Comply with the US Requirements
Instructors EAS Independent Advisor for Colors and Cosmetics, John Bailey, Ph.D. & EAS Independent Consultant, Catherine Bailey
New dates to be announced soon
Cosmetic products are expected to only exert superficial, not physiological, effects on the human body, meaning they can make no claims that imply treatment of medical conditions or that affect structure or function. Raw materials used as ingredients in cosmetics are also, by law, considered cosmetics. Though there are no formal Good Manufacturing Practice (GMP) regulations for their production, industry standards and practice are applied, and the largely self-regulated industry maintains a good safety track record.
The competition, however, is fierce as new technologies, ingredients and formulations are continually developed to satisfy increasingly demanding consumer expectations. This can exert pressure on manufacturers to stretch the boundaries and greatly increase the risk of FDA enforcement action.
What are legally acceptable formats for the package? How about ingredients, including color additives? What kinds of claims can be made for cosmetics products and how should their labeling and packaging be designed accordingly? How can GMPs be instilled when little prescriptive guidance is available?
Join EAS experts John and Catherine Bailey for a seminar on Introduction to Cosmetic Regulation, Labeling and Safety – How to Ensure Your Products Comply with the US Requirements. Learn what is allowed per the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act and other requirements to ensure a safe and federally compliant product.
Topics covered include:
- Laws and Regulations Applicable to Cosmetics
- Cosmetics Product Labeling – Fundamentals
- Compliance Issues – Adulteration and Misbranding
- Overview of Cosmetics Safety Requirements and GMPs
- Color Additives Overview
- Labeling Reviews and Practical Applications
- John’s Crystal Ball
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About Our Instructors
John Bailey Jr., Ph.D.
John Bailey Jr., Ph.D., is the EAS independent advisor for colors and cosmetics and a former director of FDA’s Office of Cosmetics and Colors. His 34-year agency career began as a chemist in the Division of Colors and Cosmetics. He soon moved to the Division of Color Technology and advanced to become a senior research chemist. He went on to serve in other prominent agency positions including that of director of the Office of Applied Research and Safety Assessment in the Office of Science. After his retirement from the agency in 2002, he joined the Cosmetic, Toiletry and Fragrance Association as director of cosmetic chemistry, and later joined the Personal Care Products Council as executive vice president for science.
Catherine Bailey is an EAS independent consultant and former director in FDA’s Division of Cosmetics and Compliance and serves as the Staff Scientist for the Personal Care Products Council where she participated in preparation of International Color Handbook, 4th edition and International Cosmetic Legal and Regulatory Database. Catherine assists EAS clients with cosmetic labeling issues and filing color additive petitions.