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Chemical Reaction: The Basics

Steve Herman

One who asks a question is a fool for five minutes; one who does not ask a question remains a fool forever.— Chinese Proverb

I recently received an e-mail from an Ohio high school senior. She found my name on the New York Society of Cosmetic Chemists Web site (, and she had questions toward fulfilling her vocational studies senior project: cosmetic chemistry. A number of her questions closely reflect issues that many consumers wonder about, and others are frequently asked by students interested in cosmetics as a profession but who have no idea how to enter the field.

In addition, reaching students such as this and mentoring them through entry level job opportunities or through formal academic programs is an important way to provide the fresh blood needed to keep the cosmetic industry staffed with intelligent and motivated scientists for the future.

Below is our correspondence.

1. How long does it normally take and what are the processes of getting products approved by the FDA?

The FDA does not approve products. The two key laws concerning cosmetics marketed in the U.S. are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act are subject to regulatory action. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.

Cosmetic companies are responsible for substantiating the safety of their products before marketing. Failure to do so causes the product to be misbranded, unless the following warning statement appears on the product’s label:

“Warning: The safety of this product has not been determined.”1 For OTC products such as sunscreens, antiperspirants and antidandruff shampoos, there are FDA monographs. As long as the monograph is followed, the products can be placed on the market with no specific approval.

2. What makes certain products hypoallergenic?

The answer is not what most consumers assume, but is readily accessible on the FDA Web site:

“Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products … There are no Federal standards or definitions that govern the use of the term ‘hypoallergenic.’ The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to the FDA.”2

3. What are different ways to test products?

Common testing procedures involve product performance, stability or safety. Product performance often involves comparison to benchmark products that are currently market leaders. Stability, typically, involves testing at elevated temperatures in the final packaging or exposure to UV light—at the least. One unofficial method is the “UPS test”: determining how a product stands up to shipping and storage conditions simulated to match real-world conditions as closely as possible.

Safety testing is not always done on finished products. Individual raw materials have known safety profiles, and the CIR (Cosmetic Ingredient Review) provides this information.3 A summary of CIR assessments is shown in the sidebar on the next page.

4. When mascaras are [claimed to be] lengthening or thickening, for example, what makes them work? Is it true and is the chemical [construct] really any different?

No, mascara cannot lengthen or thicken hair—the hair is dead. Some mascara can create the appearance of longer or thicker by depositing a polymer.

For example, mascara that contains nylon fibers can give lashes a fuller and longer appearance because it clings to the lashes like mini extensions.

The patent literature is an essential place to look for information on any technology. The United States Patent and Trademark Office Web site ( is an excellent reference, and alternatives such as Google Patents provide different search options. [Editor’s Note: C&T magazine also includes patent information.]

5. What makes makeup waterproof?

Some makeup is inherently waterproof, either because it is anhydrous or it is a water-in-oil emulsion. Aqueous systems can be made waterproof by adding materials such as polymers or dimethicone copolyols.

6. What are some basic, important ingredients common in different cosmetics?

The most universal ingredient is water. Not only does it moisturize the skin and dissolve many important ingredients, but it is extremely cost-effective.

The magic engine for many products are amphiphilic molecules, with structures that partly love oil and partly love water. The specific version called “emulsifiers” makes creams and lotions stay together. The ones called “surfactants” are used to create foamy products, such as soaps, shampoos and bath gels.

7. Are there major differences in [luxury] brands and [mass] brands of cosmetics?

Yes, but more in aesthetics than basic functionality. For example, “luxury” skin care products can use multiple humectants and emollients for cushion and overall feel. A less expensive shampoo or lotion will clean hair or help moisturize skin but may lack refined properties.

8. Do most companies test on animals?

No, animal testing has been phased out of all major companies. Many regulations and company guidelines explicitly ban the use of animal testing. Johns Hopkins is the home of the Center for Alternatives to Animal Testing (CAAT), a leading example of the commitment to finding new approaches to safety. CAAT has many resources online, including videos.4

9 . How many people are involved in creating a product at an average company?

The basic process usually involves marketing and R&D, but the number of individuals varies greatly from one company to another. One good chemist at the bench can create a formula, while a large multinational will employ hundreds in R&D, all contributing expertise to create a state-of-the-art product.


The author thanks Ken Klein for his insight.


Steve Herman is president of Diffusion LLC, a consulting company specializing in regulatory issues, intellectual property, and technology development and transfer. An adjunct professor in the Fairleigh Dickinson University Masters in Cosmetic Science program, his book, Fragrance Applications: A Survival Guide, was published by Allured Business Media in 2001. A former chairman of the SCC’s New York chapter, he was elected to fellow status in 2002.

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CIR Expert Panel Safety Assessments

Safe ingredients — Ingredients safe in the practices of use (product categories) and concentrations of use for each product category as documented in the safety assessment.

Unsafe ingredients — These are ingredients with specific adverse effects that make them unsuitable for use in cosmetics.

Safe ingredients, with qualifications — The Panel may reach the conclusion that an ingredient can be used safely, but only under certain conditions. Qualifications frequently relate to maximum concentration, but may also address rinse-off versus leave-on uses and other restrictions.

Ingredients for which the data are insufficient — If the Panel reaches an “insufficient data” conclusion, it does not state whether the ingredient is safe or unsafe. The Panel is, however, describing a situation in which the available data do not support safety.

The specific data that would allow the Panel to complete its assessment always are identified.

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