CTFA Statement on Dioxane
Test results recently released by several environmental activist groups state that some shampoos and bath products contain trace amounts of 1,4-Dioxane, a chemical byproduct that occurs during the manufacture of some raw materials. According to the groups, 1,4-Dioxane was found in concentrations of 1.5 parts per million (ppm) to 23 ppm with an average of 7.4 ppm. The groups assert that some of these findings exceed a limit of 10 ppm set by FDA for cosmetic products.
The groups erroneously claim that in 1985 the U.S. Food and Drug Administration (FDA) asked the cosmetic industry to voluntarily limit dioxane to 10 ppm. However, the FDA has set no limits for 1,4-Dioxane in cosmetics and personal care products, and the levels of 1,4-Dioxane reported in these products present no risk to consumers. Products reported to contain 1,4-Dioxane are safe, and consumers can use them with confidence.
Dioxane is a trace level material found in some raw materials used in the preparation of shampoos and bubble baths. The presence of 1,4-Dioxane is easily controlled, and raw material manufacturers routinely take steps to reduce the levels as low as possible. Shampoos and bubble baths do not result in a significant exposure because they are quickly rinsed off after use. The low levels reported in these products are proof that the cosmetic industry is effectively keeping the levels far below any level that might be of concern.
FDA Authority:
The U.S. Food and Drug Administration (FDA) has broad legal authority to regulate the safety of cosmetic products. The Federal Food, Drug, and Cosmetics Act (FD&C Act) requires that every cosmetic product and its individual ingredients be substantiated to be safe, and that its labeling be truthful and not misleading.
Manufacturers are responsible for ensuring that products comply with the law before they are marketed. This process includes analyzing an ingredient’s testing and safety data. If the manufacturer cannot substantiate the safety of the product, then the product must carry a conspicuous warning.
The law provides severe penalties for products that do not meet FDA standards. Specifically, the law gives FDA the authority:
- To ban or restrict ingredients for safety reasons
- To mandate warning labels
- To inspect manufacturing facilities
- To issue warning letters
- To seize unsafe or misbranded products
- To enjoin unlawful activities
- To prosecute and jail violators
- To work with manufacturers in implementing nationwide product recalls
- To collect samples for examination and analysis as part of plant inspections, import inspections, and follow-up to complaints of adverse reactions.
- To conduct research on cosmetic products and ingredients to address safety concerns.
In addition to the Federal Food, Drug, and Cosmetics Act safety authority, the Fair Packaging and Labeling Act authorizes FDA to require ingredient labeling of cosmetic products sold to consumers. Detailed FDA regulations govern where and how ingredients must be listed on the package.
Cosmetics are among the safest of all consumer products sold in the United States. Their continued safety is ensured by FDA’s authority to regulate and ongoing industry voluntary programs.