Handbook of Cosmeceutical Excipients and their Safeties

K Y Heng, T Y Kei, K J Singh, Li Hairui, Poh Ai-Ling, K Lifeng

• Publisher: Woodhead Publishing
• Year: 2014
• Print ISBN: 9781907568534
• eBook ISBN: 9781908818713
• Topic: Medicine
• Subtopic: Pharmacology

Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are being launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of Cosmeceutical Excipients and their Safeties summarises the current evidence relating to cosmeceuticals' side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of Cosmeceutical Excipients and their Safeties includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore. - Focuses on the practical aspect of adverse effects from cosmeceuticals - Explains the regulatory framework of cosmeceuticals - Gives an idea of how excipients and drugs in cosmeceuticals enter the skin and methods of control

1

History of cosmeceutics

Abstract

The rapid increase in usage and varieties of cosmeceutics has brought about a wide impact and change in the life of consumers. Cosmeceutics, being in between the spectrum of an active pharmaceutical product and cosmetics, are very complex and need to have new regulations and guidelines to ensure safe usage of these products. Ways of testing of these products also need to be redefined so that consumers can be better informed to make decisions on usage of cosmeceutics. This chapter will give a brief introduction of the history of cosmeceutics and the impact they have on the economy, regulation and testing methods.

Key words

carcinogens

cosmetics

impact

history

regulation

testing

economy

1.1 Introduction

Cosmeceutics is one of the fastest growing fields in cosmetics with about US$ 124 billion market size (Kumar, 2005). Cosmeceutics is a subset of cosmetics, but while cosmetics are intended for pure aesthetic purposes, cosmeceutics usually exert a minimal amount of systemic effect if not applied excessively on the skin. In this sense, cosmeceutics can also be synonymously defined as skincare products. Preparations such as hand lotion and sunscreens are considered cosmeceutics as they do not contain active pharmaceutical drug compounds that we will be prescribed with if we are ill. On the other hand, some products that contain pharmacologically active ingredients, such as antifungi and hydrocortisone preparation are not considered cosmeceutics because they may be harmful if applied excessively as they contain active pharmaceutical drug compounds. Cosmeceutics is a very new field and definitions may change accordingly due to different regulation context.

1.2 The rise of cosmeceutics

In 1962, Mr Raymond E. Reed (President of the Society of Cosmetic Chemists) coined the term ‘cosmeceutics’. A cosmeceutic is further defined as: a product that produces a useful and desired effect; gives desirable aesthetic properties; meets fixed chemical, physical and medical standards; and is a scientifically designed product to apply to the human body externally.

The definitions give rise to a product which is of higher quality than cosmetics, but lower in standards than pharmaceuticals. Cosmeceutics is in fact a marriage between cosmetics and pharmaceutics, bringing therapeutic effect to mankind.

In 1993, Professor A. M. Kligman further augmented the idea of cosmeceutics being a hybrid of cosmetics and pharmaceuticals. This brought about discussions among physicians, scientists, experts and organizations to further explore this concept and its impact on the industries, regulations and mankind (Saint-Leger, 2012).

1.3 Impact of cosmeceutics

Being the fastest growing type of products in the cosmetics field, the impact of cosmeceutics on mankind will be greater than ever (Kaushik et al., 2005). The compounded annual growth rate (CAGR) of the cosmetics industry had been at 4.88% from 1997 to 2001 with the growth shifting from Western to Eastern countries. In 2002, the global cosmetics and toiletries were worth US$ 175 billion. The top three markets are haircare, skincare and colour cosmetics. The colour cosmetics segment accounted for 14% of the market and was the fastest growing segment with a growth rate of 12.9%. L’Oreal, being the top ranked company worldwide, had a strong output in terms of research and development with laboratories creating more than 3000 formulae a year (Kumar, 2005).

The latest report by GCI® mentioned that the markets in the US, UK, France, Germany, Italy, Japan and Spain were estimated to be worth about US$ 31 billion in 2011 and are projected to be around US$ 42 billion in 2018 with a CAGR of 4.6%. Mainly a few large companies (such as L’Oreal, Procter & Gamble, Unilever and Beisersdorf who own brands such as Olay, L’Oreal, Garnier and Nivea) control the market. It was expected that growing affluent countries such as India and China would attract an even wider audience due to a larger demand for such products (GCI, 2013).

1.3.1 Types of cosmeceutics

Cosmeceutic companies have designed many novel and practical products over the years and made them available in local pharmacies and cosmetics shops. These products are skin whitening or de-pigmenting agents, moisturizing agents, antiwrinkle agents, sunscreens, antiphotoageing agents, etc. They serve both therapeutic and aesthetic purposes for mankind (Gao et al., 2008).

1.3.2 Concept of excipient safety

Cosmetics were not under regulation in the US until there were cases of blindness in 1930. Currently, more is known regarding the structure and function of the skin. Cosmetics are generally perceived as safe, however, there are more substances coming to the market that could affect the skin structurally and functionally.

The US Food and Drug Administration (FDA) requires a safety warning to be labelled on the product as long as the final product or its ingredients are untested. However, one should know that the rigour, adequacy and types of tests are at the discretion of the manufacturers. The FDA is also authorized to regulate cosmetics advertising and prevent adulteration of products. It has issued Good Manufacturing Practice guidelines to ensure products are made under appropriate conditions (Kaushik et al., 2005).

In the past, cosmetics were thought to be just for aesthetic purposes. Currently, society holds the view that cosmeceutics have therapeutic value, although they contain no recognized drugs. The simple example, Vaseline®, made from petroleum, is actually used to protect the skin against chemical and physical traumas. It is also a very good moisturizer. An experiment in Professor Kligman’s laboratory realized that Vaseline® can assist in suppressing UV-induced rays. For compounds with antiseptics or even added sunscreen agents, the matrix used to formulate the compound will determine the success or failure of that particular product. The ingredients of the matrices may unknowingly cause allergy, inflammation and maybe cancer (Kligman, 1993).

Because of the impact of the excipients on the overall product outcome, more attention has to be put into testing and regulating these products.

1.3.3 Regulation

The similarity of cosmeceutics to drugs requires a change in the regulation framework. Cosmeceutics should not just fall under the regulation framework of cosmetics. This is due to the fact that more potent compounds are added and there is a claimed effect by manufacturers (Saint-Leger, 2012). This will be addressed in greater detail in Chapter 2.

1.3.4 Testing

Cosmeceutics testing is non-compulsory and is at the manufacturers’ discretion. When there is a conflict of interest, tests for adverse effects, such as genotoxic tests, may not be done. However, we should also note that the proving of claims might be done so as to gain a marketing advantage, but these are very expensive and may not make economical sense for cosmeceutics companies to carry out. For example, Johnson & Johnson was one of the few companies that had published a paper (in March 2010) regarding their new formulation of infant cleansers (Dizon et al., 2010).

T. Joseph Lin, an author for the Journal of Experimental and Clinical Medicine, has mentioned that testing is a matter of ethics (Lin, 2010). An evidence-based approach can allow the public to discern the pros and cons of their cosmetics. As more consumers become educated, better marketing of cosmeceutics requires giving consumers product knowledge that is accurate and easy to understand (Lin, 2010).

1.4 Conclusion

In summary, cosmetics and cosmeceutics have come a long way and have evolved into many new and innovative products. As the impact of cosmeceutics changes, we need to adapt our regulatory and testing frameworks. This is to allow consumers to better understand what they are buying and to assess the long-term effects of the products they use. A cosmeceutic with once unknown ingredients needs to be further explored using a scientific approach.

2

Regulation of cosmetics

Abstract

Cosmetic providers, be it a manufacturer or a distributor, have legal responsibility to ensure the safety and quality of the merchandise. Compliance to the regulation is highly recommended because it ensures product safety and minimizes unintended adverse effects, benefitting both the manufacturers and the consumers. In this chapter, the cosmetic legislation and regulation in major markets will be reviewed to facilitate a greater understa...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright page
• List of figures and tables
• List of abbreviations
• Preface
• About the authors
• 1: History of cosmeceutics
• 2: Regulation of cosmetics
• 3: Skin permeation of cosmetics
• 4: Systemic effect of cosmeceutics – cancer
• 5: Local effect of cosmeceutics – allergic contact dermatitis
• 6: Essential monographs
• Bibliography
• Index