FDA Statement
What is the FDA’s stance on the issue of 1,4 dioxane being used in many everyday house hold products?
At the levels found in cosmetic products, 1,4 dioxane does not present a hazard to consumers. 1,4-Dioxane is a contaminant and not an ingredient, so it is not "used" in cosmetic products. It is present because it forms as a byproduct during the manufacturing process of some cosmetic ingredients. This is an old issue and cosmetic ingredient manufacturers have in place procedures for reducing the levels in their raw materials. We have been monitoring the issue since the late 1970's, conducting periodic surveys to assure that levels remain low. We have observed that the changes manufacturers have made in their processes have resulted in a significant decline in the levels present. Results of this work by scientists in FDA's Office of Cosmetics and Colors have been published in the open scientific literature (Journal of AOAC International, 84 (3), 2001, p. 666-670). Additional information is provided on our website.
What is considered to be a harmful amount?
The levels at which a chemical would be considered harmful in a product depend on the conditions of use. The levels of 1,4 dioxane found in cosmetic products are far below those found to be harmful in animal testing.
If you do warn consumers about this issue, how do you do so? Is there a warning clearly displayed for the consumer on any products? If not, why?
We are not issuing a warning to consumers about this issue and there are no warning labels on cosmetic products because the 1,4 dioxane levels we have seen in our monitoring efforts do not present a hazard to consumers. If FDA were to determine that a health hazard exists, the agency would advise the industry and the public, and would consider its legal options for protecting the health and welfare of consumers.
How important is it for the FDA to make consumers aware of this issue?
As explained above, we do not believe that warnings are needed. We do believe that information on a wide variety of cosmetics topics should be available to consumers (and the industry) and we maintain a public website for that purpose.
Do you have tips for consumers about the harmful or unharmful effects of 1,4 dioxane?
The levels in cosmetic products are low and, for the most part, the types of products in which it is found are only in contact with the skin for a short period of time. We also have conducted an experiment to estimate exposure to 1,4-dioxane from a cosmetic product. The 1,4-dioxane was found to evaporate quickly from the product when it was used, so that the levels of 1,4-dioxane that would be available to absorb through the skin were extremely low. Because of all of these factors, we have concluded that 1,4 dioxane in cosmetic products does not present a hazard to consumers.
What is the cost involved with removing it from products?
We don’t know the exact costs but we do know that manufacturers have included steps in their manufacturing processes to remove or significantly reduce the amounts present.
***The law does not provide FDA with premarket approval authority for cosmetics and consequently, FDA does not conduct premarket testing of cosmetic products. Cosmetics manufacturers have a legal responsibility to assure their products are safe under the intended conditions of use and are in compliance with all applicable regulations. FDA does monitor the safety of cosmetic products in the marketplace, however, and does take action to ensure that unsafe products are removed from the market.***
At the levels found in cosmetic products, 1,4 dioxane does not present a hazard to consumers. 1,4-Dioxane is a contaminant and not an ingredient, so it is not "used" in cosmetic products. It is present because it forms as a byproduct during the manufacturing process of some cosmetic ingredients. This is an old issue and cosmetic ingredient manufacturers have in place procedures for reducing the levels in their raw materials. We have been monitoring the issue since the late 1970's, conducting periodic surveys to assure that levels remain low. We have observed that the changes manufacturers have made in their processes have resulted in a significant decline in the levels present. Results of this work by scientists in FDA's Office of Cosmetics and Colors have been published in the open scientific literature (Journal of AOAC International, 84 (3), 2001, p. 666-670). Additional information is provided on our website.
What is considered to be a harmful amount?
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If you do warn consumers about this issue, how do you do so? Is there a warning clearly displayed for the consumer on any products? If not, why?
We are not issuing a warning to consumers about this issue and there are no warning labels on cosmetic products because the 1,4 dioxane levels we have seen in our monitoring efforts do not present a hazard to consumers. If FDA were to determine that a health hazard exists, the agency would advise the industry and the public, and would consider its legal options for protecting the health and welfare of consumers.
How important is it for the FDA to make consumers aware of this issue?
As explained above, we do not believe that warnings are needed. We do believe that information on a wide variety of cosmetics topics should be available to consumers (and the industry) and we maintain a public website for that purpose.
Do you have tips for consumers about the harmful or unharmful effects of 1,4 dioxane?
The levels in cosmetic products are low and, for the most part, the types of products in which it is found are only in contact with the skin for a short period of time. We also have conducted an experiment to estimate exposure to 1,4-dioxane from a cosmetic product. The 1,4-dioxane was found to evaporate quickly from the product when it was used, so that the levels of 1,4-dioxane that would be available to absorb through the skin were extremely low. Because of all of these factors, we have concluded that 1,4 dioxane in cosmetic products does not present a hazard to consumers.
What is the cost involved with removing it from products?
We don’t know the exact costs but we do know that manufacturers have included steps in their manufacturing processes to remove or significantly reduce the amounts present.
***The law does not provide FDA with premarket approval authority for cosmetics and consequently, FDA does not conduct premarket testing of cosmetic products. Cosmetics manufacturers have a legal responsibility to assure their products are safe under the intended conditions of use and are in compliance with all applicable regulations. FDA does monitor the safety of cosmetic products in the marketplace, however, and does take action to ensure that unsafe products are removed from the market.***
