The safety of cosmetics is one of the biggest successful stories in the history of any manufacturing industry. The cosmetics industry is bound by the US Food, Drug and Cosmetic Act of 1938, which sets forth guidelines for the safe manufacture of cosmetics. There are many ingredients that are incorporated into products for the adornment and care of the skin, hair, and nails. These ingredients allow for the development of complex formulations that improve the quality of human life through the prevention of disease, the maintenance of health, and the preservation of self-esteem. While the cosmetics industry is indeed regulated, only basic guidelines are present and each individual formulation is not put forth for approval. What has been the success of this regulatory approach?
The success record of the cosmetics industry has been excellent. With basic guidelines, the industry has moved forward with quality and innovation. Extensive regulatory oversight is expensive for both the government and consumers. Imagine if every cosmetic product required approval, as is the case in the pharmaceutical world. There are thousands of new product formulations, which would create an unbelievable workload for the federal government using taxpayers' dollars and increasing the cost of cosmetics. The consumer would loose twice.
How has the safety of cosmetics been maintained? It has been maintained through the forces of the free market, which is perhaps the most vigilant regulatory body. Consumers vote each day with their dollars. Products that do not work or cause problems may be purchased once, but are not purchased twice by the consumer. Furthermore, consumers tell their friends about their product purchases influencing others. Products that do not perform are not purchased and removed from the marketplace rapidly. Here, the free market works efficiently without additional cost. Clearly, cosmetics are much different than pharmaceuticals, but this approach to regulation is a model for low-risk products.
There are aspects of cosmetics that are tightly regulated, such as the use of pigments in eye and lip cosmetics. The safety of eye cosmetics is an important consideration as they can be accidentally introduced or migrate into the eye. Eyelid cosmetics have been used by women and men since 4000BC when green malachite powder was heavily applied to the upper and lower eyelids accompanied by dark kohl eyeliner paste composed of powdered antimony, burnt almonds, black copper oxide, and brown clay ocher. Ground beetle shells were added to produce glitter. However, now the coloring agents that can be used around the eyes are strictly regulated. No coal tar derivatives can be used; only approved purified natural colors or inorganic pigments as set forth in the Food, Drug and Cosmetic Act of 1938 are allowed. Table 1 lists the coloring agents that are government approved.
|Titanium dioxide (alone or combined with mica)|
|Copper, aluminum, and silver powder|
|Ultramarine blue, violet, and pink|
|Chrome oxide and hydrate|
|Bismuth oxychloride (alone, or on mica or talc)|
The same types of restrictions also apply to eyelash cosmetics, more commonly known as mascaras. Coal tar–derived colors are also prohibited. Therefore, mascara colorants must be selected from vegetable colors or inorganic pigments and lakes. Colors employed include iron oxide to produce black, ultramarine blue to create navy and umber (brown ocher) or burnt sienna (a mixture of hydrated ferric oxide with manganic oxide), or synthetic brown oxide to create brown.
The safety of the coloring agents used in lipsticks has received a great deal of attention due to the inevitable entry of lipsticks into the mouth. The Food and Drug Administration divides certified colors into three groups: food, drug, and cosmetic (FD and C) colors; drug and cosmetic (D and C) colors; and external drug and cosmetic colors. Only the first two groups can be used in lipsticks. The external drug and cosmetic colors can only be used in locations where they are not likely to enter the mouth.
Control of the cosmetics industry began with the recognition that some products were tainted with lead, mercury, and arsenic. One of the most common bleaching creams, known as skin whitening creams at the time, introduced in the 1930s contained mercury and another contained arsenic. It was the introduction of these dangerous products that led the federal government to recognize the need to protect the common good from these hazards. This type of protection is very important, as the quickest way to whiten skin is to induce a state of anemia, which is how some of the skin whitening products worked!
Perhaps, the biggest area of controversy surrounds the use of preservatives in cosmetics. Animals that are fed large quantities of preservatives typically do not enjoy a long life. This is not surprising as the primary role of antimicrobial preservatives is to destroy bacteria and prevent contamination. The risk of transferring infection from cosmetics contamination is much bigger than the risk of using minute amounts of the preservative on the skin. Most people do not drink their facial foundation by the bottle, which is how animal testing is performed to determine safety and carcinogenicity. Furthermore, the risk of contaminating cosmetics by sticking dirty fingers into the jar or transferring an ocular infection from one eye to the other via a mascara wand is much larger.
There has been a movement as of late to eliminate preservatives from cosmetics; however, it should be recognized that there is no such thing as a preservative-free commercially made cosmetic. Most cosmetics are not used until 3–6 months or longer after they have left the manufacturing facility. This means some form of preservation is necessary. If the product does not contain water, it can be preserved with lower preservative levels, because water is necessary for microbial growth. Many products that label themselves as preservative-free actually contain preservatives, but the ingredient falls under a different category. For example, phenoxyethanol has a lovely rose scent and may be used as a fragrance ingredient when in reality is it a preservative. Many spices, such as clove essences, can be used for a combination of fragrance and preservation. Finally, it is also possible to lower the preservative concentration by special packaging. Many of the newer facial foundations are dispensed from a jar affixed with a one-way valve top. This valve prevents oxygen and anything outside the jar from entering the jar.
Why have there been so few instances of adverse events associated with the use of cosmetics? Because cosmetics are safe. Think of how many people use large numbers of cosmetics on a daily basis and how few problems arise. Why are cosmetics so safe? Because large cosmetic manufacturers spend tremendous resources formulating safe products, searching for quality ingredients, designing packaging to maintain product purity, and writing labeling to insure that consumers use the product properly. Most reputable manufacturers do safety testing on their products prior to marketplace introduction. This safety testing may include eye instillation, repeat insult patch testing, cumulative irritancy testing, and safety-in-use testing. Many companies also test their products on sensitive skin subjects, including those with a variety of dermatologic conditions such as eczema, rosacea, atopic dermatitis.
Why are so many resources devoted to cosmetic testing? Because a product that causes problems in the marketplace tarnishes the reputation of a company and erodes consumer confidence. This means that every product they manufacture is subject to question and results in lost sales and lower revenues. No company wants to loose its reputation on a problematic product. It is perhaps the power of the consumer marketplace that drives cosmetic safety, which is an inherent advantage of an open competitive marketplace.