The National Toxicology Program (NTP) completed a study in 1998 that found an association between the topical application of diethanolamine (DEA) and certain DEA-related ingredients and cancer in laboratory animals. For the DEA-related ingredients, the NTP study suggests that the carcinogenic response is linked to possible residual levels of DEA. The NTP study did not establish a link between DEA and the risk of cancer in humans.
Although DEA itself is used in very few cosmetics, DEA-related ingredients are widely used in a variety of cosmetic products. These ingredients function as emulsifiers or foaming agents and generally are used at levels of 1 to 5% of a product's formulation.
FDA takes the results of the NTP study very seriously and has made the assessment of public health risk one of the highest priorities for the cosmetics program. To determine whether or not the NTP findings suggest a risk to human health, FDA is in the process of carefully evaluating the studies and test data to determine the real risk, if any, to consumers. This evaluation includes laboratory studies to measure the degree to which DEA penetrates human skin and the amount of DEA found in commercial products.
The Agency believes that at the present time there is no reason for consumers to be alarmed based on the use of these substances in cosmetics. However, consumers wishing to avoid cosmetics containing DEA or DEA-related ingredients may do so by reviewing the ingredient statement that is required to appear on the outer container label of cosmetics offered for retail sale to consumers.
With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient. The following are some of the most commonly used ingredients that may contain DEA:
If FDA's evaluation of the NTP data indicates that a health hazard exists, FDA will advise the industry and the public and will consider its legal options under the authority of the Food, Drug and Cosmetic Act in protecting the health and welfare of consumers.
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Hypertext updated by cjm/dms 1999-DEC-21