At some point in our adolescent education, students in the United States learn the process of how a bill becomes a law. Unlike some other topics in the social studies, a good deal of effort is put into teaching the process of making laws. It’s such a major lesson that the good people at School House Rock even created an educational segment about it to help us remember. Though I’m neither a teacher nor a politician, I believe such emphasis is placed on this lesson because the powers that be want to make sure citizens know that laws are not created without a system of accountability. The same is true of the cosmetic industry. Developing a cosmetic finished product is an extensive process that begins with the raw materials. In ode to School House Rock, let’s discover “How a Raw Material Becomes a Cosmetic”.
Raw material is a fancy term for ingredient. Raw material developers have the arduous task of discovering, refining and testing ingredients for use in cosmetic end products. With the demands of consumers ever-growing, suppliers are constantly in the research lab trying to develop new, effective, cost efficient ingredients. You may be wondering: How do these research scientists even know what to try? It all starts with an idea. Scientists, especially researchers, spend an unbelievable amount of time reading new, old and ancient scientific research covering an array of topics. Often, in reading someone else’s study, the researcher will get an idea. The idea is usually based on some key part of the research they’ve read paired with existing knowledge of various scientific (usually chemical/biological) processes. The research scientist takes this idea to the lab and starts experimenting with it until they can prove that it works.
Raw material suppliers have the burden of proving to formulation chemists that their ingredient can actually perform in a cosmetic. The only way to prove anything to a scientist is to present the supporting research. For this reason, raw material suppliers test their ingredients for safety, efficacy, shelf life, etc prior to placing it on the market. Often raw material suppliers will develop a sample product to demonstrate how the ingredient should be used in a formula and how a typical cosmetic is enhanced with the substitution of their ingredient. Only after this burden of proof has been met will a formulation chemist consider using a raw material.
A raw material supplier must also assess and disclose the risk, hazard and toxicity data of an ingredient and provide guidelines for safe handling. This information is documented in a Material Safety Data Sheet (MSDS) which is easily accessible by not only formulators, but the general public as well. A Certificate of Analysis (C of A) is included in the shipment of any raw material. The Certificate of Analysis indicates the properties of the raw material at the point of packaging. Analytical information including pH, color, odor, texture, viscosity, melting point, boiling point, molecular weight, microbial count and so on are listed in the C of A. The raw material supplier also keeps a record of analytical tests such as MS/GC, HPLC, IR, etc to attest to the chemical components of an ingredient.
In the Lab
The basic formula of any cosmetic is the same:
- Active ingredients (optional)—These ingredients have the greatest impact on the skin and go beyond the scope of a cosmetic. Cosmetics that contain active ingredients are also considered drugs and are subject to additional FDA regulation.
- Conditioning ingredients—These ingredients are strictly cosmetic in that when applied topically, they alter the feel of the skin ie; softening, smoothing, soothing, moisturizing, etc.
- Functional/multifunctional ingredients—This is the delivery system that constitutes whether or not a product is a lotion, cream, serum, gel, shampoo or conditioner. Functional ingredients simply determine the product type; whereas multifunctional ingredients also have some sort of conditioning properties.
- Preservatives—Preservatives ensure that a product will remain free of bacteria, yeast and mold over an extended period of time with normal use.
The individual character of a cosmetic is attributed to variations of the above ingredient types. At this stage of product development, the formulator draws on his/her knowledge of raw materials to decide which to play with in the starting formula. The formulator then experiments with the components of the product until they are satisfied with the look, feel, color and texture. It is during this part of development that a formulator will begin to use the product directly. There’s no way a product is making it to the market without someone in the lab giving it a test drive first.
According to the FDA, a product is misbranded if it has not been tested for safety unless it bears the following warning on the label: Warning- The safety of this product has not been determined. The safety of a product is determined by testing the effectiveness of the preservative system and also testing for skin irritation in human subjects. The preservative test calls for the introduction of bacteria, yeast and mold to the samples. The samples are observed and analyzed under varying conditions to determine if and when the contaminants begin to populate in the product. The test for skin irritation requires a number of human test subjects to apply the product in the same spot over an extended period of time. The level of skin irritation is analyzed in comparison with a placebo. In the event that these preliminary tests fail, it’s back to the lab to try again.
The above tests are just the beginning. Emulsified products (oil and water mixtures) such as shampoos, conditioners, lotions, creams, gels and serums must be tested for stability. In stability testing, factors including color, texture and pH are monitored as well as the state of the emulsion (will it separate?). There are also tests to substantiate claims like: sunscreen, skin lightening, anti-aging, moisturizing/hydrating, non-comedogenic, anti-acne, etc. Claims testing can range from clinical trials with human subjects, to analysis with highly specialized equipment. The bolder the claim, the more testing is needed to substantiate. One major factor in profitability for any business is keeping costs down. Cosmetic companies opt to get the testing done because it is by far cheaper than the cost of a recall or lawsuits should the product cause undue harm to a consumer(s).
Truth in Labeling and Trade Secrets
Cosmetic manufacturers are required to list the INCI names of ingredients in descending order on the label. The declaration of ingredients makes it easy for consumers to assess a product for effectiveness and allergens. It also makes a product relatively easy to “knock off”. For this reason, some cosmetic formulators seek to obtain trade secret privileges to avoid disclosing their key ingredient(s). If you’ve ever seen the statement—and other ingredients on the ingredients panel of a cosmetic, then a trade secret is in place. The criterion to obtain trade secret protection is stringent, but may be worth the effort for certain products. In order for a manufacturer to secure trade secrecy, he must prove that a.) The ingredient is not already publicly known as a cosmetic ingredient.
b.) The ingredient contributes a significant value to the cosmetic. Meaning the product doesn’t perform the same without the ingredient in question.
c.) Information about the ingredient as used in the cosmetic is not readily available to the public.
The above must be supported by all “scientific or technical data, reports, tests, and other relevant information” available about the ingredient. Even data that does not support use or trade secret protection of the ingredient must be submitted. Trade secret is only granted once the FDA has reviewed all of the data and found that the ingredient is not only necessary for the success of the product, but is also safe and effective. Read more on trade secrets at the FDA website.
As you can see, a great deal of time, money, effort and above all, science goes into the development of a product before it ever reaches retail shelves. Scientists by nature are very skeptical people. As a result, we experiment and test trial after trial until we have first proven to ourselves the worthiness of a product. After all, we are consumers and so are our loved ones.
Desirée Mattox is the owner and lead chemist of Envié Bath and Body, an emerging contract manufacturing house. Her company assists entrepreneurs in the research and development of new products through contract manufacturing and consulting services. Mattox specializes in developing natural and organic products with special attention paid to the benefits of the ingredients used.