1
BASIC DEFINITIONS. CLAIMS. CLASSIFICATION OF COSMETICS AND OTC DRUG–COSMETIC PRODUCTS

LEARNING OBJECTIVES

Upon completion of this chapter, the reader will be able to

1. define the following terms:

   Application surface

   Claim

   Cosmeceutical

   Cosmetic science

   Cosmetics

   Cruelty‐free

   Dietary supplement

   Drugs

   FD&C Act

   FDA

   Halal

   Hypoallergenic

   Ingredient claim

   Intended use

   Natural

   Organic

   Performance claim

   Personal care product

   Safety claim

   Soap

   Sustainable

   Target group

   Toiletries

   Vegan

2. discuss why cosmetic science is a science.
3. discuss what knowledge and background education are necessary if one wants to work in the cosmetic industry.
4. differentiate between a cosmetic and a drug in the United States (US).
5. explain what the main factor is that legally differentiates cosmetics and drugs in the US.
6. explain how certain products can be both drugs and cosmetics in the US.
7. explain how a cosmetic product’s intended use is established in the US.
8. list ways of how cosmetics and OTC drug–cosmetic products can be classified.
9. list some examples for each of the following: target groups of cosmetic products, application surfaces of cosmetics, and functions of cosmetic products.
10. distinguish between ingredient claims, safety claims, and product performance claims.
11. explain the truth‐in‐advertising rules in the US.
12. discuss if dietary supplements are cosmetics or not in the US.
13. explain what the following terms mean and how their use is regulated in the US: organic, natural, vegan, clean, halal, sustainable, hypoallergenic, cruelty‐free, preservative‐free, dermatologist recommended, clinically proven, patented formula, and pH balanced.
14. explain how soaps are regulated in the US.

KEY CONCEPTS

1. Cosmetic science is a real science, and it is a multidisciplinary field since it includes basic knowledge and a wide range of information from a number of different fields. Additionally, some nonscience areas are also an integral part of cosmetic science.
2. Cosmetics are (i) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (ii) articles intended for use as a component of any such articles; except that such term shall not include soap.
3. Drugs are (i) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (iii) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (iv) articles intended for use as a component of any articles specified in (i), (ii), or (iii).
4. The legal difference between a cosmetic and a drug in the US is determined by a product’s intended use, i.e. what the product is used for.
5. In the US, certain products can be cosmetics and drugs at the same time since they meet the definitions of both cosmetics and drugs.
6. A cosmetic product’s intended use can be established in a number of ways, including claims, consumer perception of the product, and the history of an ingredient.
7. Cosmetics and OTC drug–cosmetic products can be classified based on the target group, product form, legal status, application surface, function, and many other ways.
8. Many claims commonly used today on cosmetic products are not defined by the FDA and have only limited scientific evidence behind them. However, the use of these words is not prohibited, which is why they are used.
9. True soaps are regulated by the Consumer Product Safety Commission and not the FDA.

1.1 WHAT IS COSMETIC SCIENCE?

Generally speaking, science is the organized body of knowledge that is derived from a systematic observation of natural events and conditions, and that can be verified or tested by further investigations [1]. Examples of sciences include chemistry, biology, and physics. Is cosmetic science considered a real science? When trying to answer this question, we tend to think of information we saw, heard, or read in the news or on TV. In addition, public opinion and religion may also influence the perception of what constitutes a real science. Today, there are a number of doubtful consumers and even professionals who are wondering what cosmetic science is all about. Depending on the source of information, cosmetic science has been identified as follows:

• Commercial science that tries to find reasons for selling a product.
• Comparative science based on the fact that many manufacturers compare their own products to other manufacturers’ products and try to convince consumers why to buy their products instead of other companies’ products.
• Traditional science, such as chemistry or physics, where there are hypotheses and scientists try to justify or deny them by performing a number of tests and reactions.
• Borderline science as it is a transition among many different scientific fields, including pharmacy, chemistry, dermatology, and marketing, among others.
• Some consumers believe that it is really not a science [2].

Let us review which subject areas contribute to cosmetic science.

• Biology: Biology is the science of life and living organisms. Cosmetics are applied to biological surfaces; therefore, it is important to understand the structure, i.e. anatomy and function, i.e. physiology of these surfaces, including the skin, hair, teeth, and nails. Additionally, cosmetics have the potential to become contaminated and grow microorganisms, which is to be avoided. It is important to study microbiology – the science of microorganisms – to understand why some microorganisms are dangerous in products and learn how to test preservative efficacy. It should be noted that some microorganisms are beneficial, for example, probiotics, and are used in cosmetic products. Microbiology covers all aspects of microorganisms. Pharmacology is the science of drugs and their effect on living systems. Understanding the potential effect(s) of active ingredients and cosmetic ingredients on the target surface is important when selecting ingredients and designing formulations. Toxicology is a field of science that studies the safety and biological effects of drugs, chemicals, and other substances on living organisms. Cosmetic products have to be safe for consumers, and therefore assessing the safety of ingredients and products is a vital part of product development and testing.
• Chemistry: Chemistry is the science of substances. Chemistry deals with the composition and properties of substances, changes substances undergo, and the natural laws that describe these changes. Cosmetics are made up of chemicals; therefore, it is necessary to study various types of chemistry to be able to select ingredients that are compatible with each other and will fulfill the goals of a product, and to be able to formulate effective, stable, high quality, and safe products that have appealing aesthetics, appropriate performance, and compatibility with the application surface. Types of chemistry important for cosmetics include organic chemistry, inorganic chemistry, colloid chemistry, polymer chemistry, biochemistry, and analytical chemistry.
• Physics: Physics is the science of matter. Physics studies motion, forces, energy, heat, sound, and light. There are a number of physical principles that are important to understand when formulating and testing cosmetic products. For example, principles of light reflection are important for makeup products, or physics of energy absorption and reflection are the basis of how sunscreens work.
• Mathematics: Mathematics is the science of numbers and their relationships. Mathematics and statistics, i.e. a form of math that deals with the collection, analysis, and interpretation of data, are essential when formulating cosmetic products to figure out the correct amount of ingredients to make a certain sized batch; and during clinical studies to evaluate if the new product is better than the benchmark, for example.
• Formulation science: Formulation science deals with the knowledge and hands‐on skills of mixing various chemicals to create finished products. Formulators need to understand the different types of product forms they can create as final products. Additionally, they have to learn the various formulation techniques and use instruments to create the final products.
• Regulatory science: Regulatory science is a scientific and technical field that deals with developing new tools and standards to assess the safety, quality, and efficacy of products and ensure compliance with the current regulatory requirements. Formulators focus on science, but they have to stay within a legal framework. It goes without saying that basic knowledge and understanding...