Regulatory Compliance for the Personal Care Products Industry

Jennifer R. Martin

Course description

“Since in many countries, Personal Care products do not require Health Authority review and approval prior to marketing, there is often confusion about what product claims can be made, what labeling is required, and what ingredients cannot be used. Without knowledge of the regulations in each country, non-compliant product is often detected by Health Authorities once the product enters the marketplace. This typically results in a costly product recall.

This intensive accredited ON DEMAND course will provide an in-depth overview of the regulatory requirements for personal care products in the United States and the European Union, including additional requirements in the states.

It will review the regulatory bodies, enforcement tools and the relevant legislation and guidance to inform regulatory compliance. This will include key agencies having jurisdiction over cosmetics, with emphasis on the U.S. FDA, the European Commission, and the state of California, among others.

There will be a detailed discussion of ingredient restrictions based on their function in the finished formulation. In addition to a full review of labeling requirements, we will consider how claims impact a product’s regulatory classification and its acceptability to the regulator, with examples to demonstrate the restrictions, risks and current enforcement priorities.”

Upon completion of this course, you will be able to:

• Compare and contrast the requirements for cosmetics and cosmetic drugs
• Classify a product to know which requirements apply
• Determine the impact of state laws on certain types of products
• Check formulations, labeling and claims for compliance
• Build a testing plan that meets FDA expectations
• Decide whether to report an adverse event
• List the pre-market requirements and in-market controls to avoid regulatory action