The FDA has proposed regulating the cosmetic industry, says Dr. Zoe Diana Draelos in her monthly Dermatology Times column, "Cosmetic Conundrums." This month Dr. Draelos examines three key questions about cosmetic safety.
Q. What tests do manufacturers perform to ensure cosmetic safety?
Zoe Diana Draelos, M.D.Cosmetic safety is very important since these products are used by millions of people worldwide. Think of all the cosmetic products in your bathroom and how many of them have caused problems through years of repeated use. The majority of people have never experienced a skin problem related to cosmetic use, which attests to the excellent safety track record of this industry.
Most cosmetics for national or international distribution have undergone a series of testing prior to market release. Stability testing is one of the frst activities performed where the packaged product is subjected to accelerated stability testing by cycling the product through heating and cooling cycles. After going through multiple cycles, the product is cultured for bacterial and fungal growth. Once stability testing has been completed, a small product batch is manufactured for repeat insult patch testing. Here the product is placed on the back of volunteers under an occlusive cloth bandage that is loaded with product and changed three times weekly for three weeks. If no allergic or irritant contact dermatitis has appeared, the product is then put into use testing where volunteers use the product in its intended fashion for one to three months, depending on the company standard operating procedures. Only after completing this minimal testing, will the product be launched for general sale.
This testing concept has worked well and provided products that are safe for general population use. This attention to detail may account for the low incidence of adverse cosmetic reactions.
Q What are GRAS ingredients?
Another way cosmetics insure their safety is by adhering to a list of substances known as GRAS ingredients. GRAS stands for “Generally Recognized as Safe” and indicates ingredients that are currently widely used in the marketplace without safety issues. Products using only these ingredients do not require as extensive testing since safety can be assumed from prior exposure, nevertheless quality companies test every new formulation whether it contains GRAS ingredients or not.
Recently, the FDA proposed regulation of the cosmetic industry by considering the filing of a document similar to an NDA (New Drug Application) for all new cosmetic ingredients.
For example, if a new silicone derivative were introduced beyond dimethicone that is currently in the marketplace, it would require approval via some sort of f ling. This would slow down cosmetic innovation and probably dramatically increase the cost of cosmetic products. It is also doubtful that much improvement in consumer safety would result as few problems have occurred in the past. The added government regulation would be costly, but it might also provide a new government income stream, as surely a filing fee would be assessed similar to that currently paid by pharmaceutical companies wishing to obtain approval of new drug.
Q How are cleansers tested to ensure they do not damage the skin?
Cleansers are routinely tested prior to commercial release for mildness with the Forearm Controlled Application Technique (FCAT). This human test simulates exaggerated washing to determine if irritation occurs. Usually around 20 subjects are enrolled and the left forearm is moistened with warm (90-100 degree Fahrenheit) tap water. A wash technician wets a piece of soft towel with warm water, then squeezes the towel gently to remove excess water. The moistened towel is rubbed in a circular motion on a wetted test bar for six seconds to generate lather and applied to the test site for 10 seconds. The lather remains on the application area for ninety seconds followed by rinsing with warm tap water for fifteen seconds. The arm is patted dry. Sometimes the procedure is repeated for a total of two washings.
The controlled washes are performed twice daily for four days spaced by a minimum of three hours.
Cleansing products that produce no irritation with the FCAT are considered suitably mild for market release.