Hi everyone.  I've heard some confusion recently about the FDA's role in skin care safety and thought I should help clear things up.  Some people assume that in the United States, the FDA ensures that every skin care product is perfectly safe for babies, adults, and pregnant women.  That's really just not true. 

The U.S. Food and Drug Administration was established in 1927 with the responsibility of ensuring that foods and medications were not misbranded, fraudulent, or injurious to human health.  The agency gained authority over the cosmetic industry in 1938 when Congress passed the Food, Drug, and Cosmetic Act. 

While the FDA has earned a reputation for its strict safety regulations on medications (both prescription and over-the-counter), and to a lesser degree the safety of our food supply, it has continued to be extremely lax in its control of cosmetics.  There are probably two main reasons for this.  One, back in 1938 scientists didn't realize how well the skin could absorb topical substances.  Two, because so many problems had been linked to bad foods and harmful medications, it made sense for those areas to receive the vast majority of the FDA's budget.  The result for the cosmetic industry was the loose set of guidelines and regulations that we see today. 

The FDA defines a cosmetic product not by its biological effect on the human body, but by the marketing intent of the manufacturer.  Cosmetics are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance".

Cosmetic products do not have to be approved by the FDA before they are sold to the public.  In fact, no formal approval process even exists.  A manufacturer may voluntarily register their products with the FDA, but it is not required.  The FDA does publish a list of banned cosmetic ingredients that includes only 13 chemicals.  By comparison, many hundreds of ingredients are banned by the European Union, Canada, and Japan. 

For the thousands of other cosmetic ingredients available in America, the FDA's regulations merely state that it is the responsibility of each manufacturer to ensure the safety of their own products, and no guidelines are given as to how they should do it.  There are no specific requirements to examine the toxicology or teratology (birth defect) research, consult with physicians, or even to do irritation or allergy testing.  

If a skin care company doesn't specifically say what steps they have taken to reseach the safety of their ingredients, then you should assume they haven't done anything at all.  

In other words:  Buyer Beware.