SnL 2016

Karl Popp, KPopp Consulting, LLC

Potential US Cosmetic Regulations

In today’s business environment, one must be able and willing to compete within the global market. That means companies must be compliant with not only regulations at home, but abroad too.

The objective of this presentation is to share the salient aspects of the current legislation impacting cosmetics pending before the US Congress. The Cosmetic Modernization Act of 2015 (H.R. 4075) and the Personal Care Products Act of 2015 (S.1014) will be discussed.

In most foreign markets, cosmetic companies are expected to comply with GMP regulations stated in ISO 22716. In June 2013, the FDA published its draft Guidance for GMPs for Cosmetics. The FDA did not embrace all of the ISO standard. An overview of the proposed US GMP regulations for cosmetics will be covered.

Bio

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to pharmaceutical, cosmetic and allied industries. He also is a licensed pharmacist.

From 1989 to 2008 he was associated with Stiefel Laboratories as Director of Product Development, and later as Senior Director of Special Projects coordinating external manufacturing, global research activities, and managing the corporation’s intellectual property estate. Prior to joining Stiefel in 1989, he was a Scientist and Project Manager for the Sterling-Winthrop Research Group. During his career he has been responsible for the development of products that have generated over $2 billion in sales. Karl also is Vice President of Pharmapotheca A, LLC, a company focused on developing and commercializing pharmaceutical technologies for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) in adults and children.

He earned his B. S. in Pharmacy from the Albany College of Pharmacy, an M.B.A. from Rensselaer Polytechnic Institute and is licensed to practice pharmacy in NY. Karl is a member of the Society of Cosmetic Chemists.

He has been active in the SCC in coordinating local educational seminars, served on the National Committee on Scientific Affairs and as the Society’s President in 1999 and was a past Chair of the New England Chapter. Karl was elected a Fellow of the Society in 2002 and Emeritus Member in 2015.

He is an inventor, an author and a scientist. His interests encompass topical, oral, inhalation, and drug delivery dosage forms in addition to various therapeutic categories. During his over 40 years in the industry, Karl Popp has lectured around the globe on new product development activities including GMPs, regulatory strategies, product pipeline efforts, process validation, product life cycle management, and management of intellectual property.

Martin S. Vethamuthu, PhD, Ashland Specialty Ingredients

Developing Skin Cleansing Compositions with Care and Beauty Benefits: Challenges and Opportunities

The skin represents a potent barrier towards the environment and is composed of finely separated surface layers collectively called the ‘stratum corneum’. Under normal conditions, there is a substantial gradient in water between the water-rich inside of the body to the upper stratum corneum and environment outside. Similarly, the skin is exposed to other gradients such as metabolic gases, light, temperature, pH, product application, and cleansing processes on a regular basis. Variation in the degree of hydration along the skin is dynamic in nature, and may positively or adversely affect the structure and function of skin after product application or wash. For example, a moisturizing body wash is composed of ingredients such as petrolatum or natural oils that are effective in limiting water transport out of skin during and after rinse-off.

This presentation would critically review the current state of science and innovations within the personal cleansing category of products that claim to provide care and beauty benefits beyond general cleansing, such as skin moisturization, skin lightening, anti-aging etc. Many studies have shown that gradients due to controlled product application across skin can increase permeability of the skin barrier to ‘active ingredients’ particularly under wet or hydrated conditions. The impact of numerous moisturizing ingredients, emollients, penetration enhancers, structuring and deposition polymers used in cleansing formulations globally will be discussed. These studies aim to understand how molecular diffusive transport occurs through the semi-permeable stratum corneum and how transport properties can be maximized under steady state and realistic rinse-off conditions.

This talk will also focus on key challenges and opportunities associated with developing such innovative personal cleansing products in terms of product microstructure, product format, rheology, storage stability, foaming performance, and potential for enhancing the efficiency for deposition / delivery of benefit ingredients during the non-equilibrium wash-off process.

Bio

Dr. Martin Vethamuthu is a Principal Scientist at Ashland Specialty Ingredients, and an Adjunct Professor in Chemical Engineering at the University of Delaware. He received his Bachelor and Masters degree in Physical Chemistry from University of Poona, India, and a PhD from Uppsala University in Sweden.

He brings over 17 years of experience in R&D, including 14 years of research in skin cleansing applications and other areas of corporate research at Unilever. He is the author/co-author of over 20 publications, including book chapters, and has many patents on skin cosmetic compositions.

Dr. Vethamuthu’s main research interests are in Colloid and Surface Science specifically in the area of complex formulation design, rheology, processing and developing technologies for retention and release of benefit agents on skin during rinse-off applications.