Hundreds of Personal Care Products Contain Poorly Studied Nano-materials
FDA Concerned About Hazards But Lacks Authority
to Require Pre-market Safety Studies
(WASHINGTON) — An Environmental Working Group (EWG) computer analysis of 25,000 personal care product labels found that more than 250 products on the market today contain one or more of 57 different types of nano-scale or micronized ingredients identified on product labels. Another 9,500 products contain ingredients that are available in nano-form, but were not labeled as either nano-sized or conventional-sized on the label. The absence of a clear government definition for nano-materials makes quantifying their presence in personal care products even more difficult.
None of the nano-scale materials identified have been substantiated for safety by the Food and Drug Administration (FDA) or the industry's own Cosmetic Ingredient Review Expert Panel (CIR). In fact, only 11 percent of conventional chemical ingredients in cosmetics have been assessed for safety by the personal care products industry's own CIR.
"The industry may have the studies to support the safety of these nano-materials, but they are not required to make any of this information available to the public," said Jane Houlihan, vice president for research at EWG, and author of the EWG assessment. "Manufacturers seem to be following the pattern they established with conventional chemical ingredients — put poorly tested chemicals into personal care products and do the science later if at all."
But with nano-sized materials the stakes could be much higher. Nano-materials are potentially quite hazardous and unpredictable because, according to the FDA, their small size and extremely high ratio of surface area to volume can produce chemical or physical properties that are very different from larger materials.
In spite of these potential dangers, FDA cannot require pre-market safety studies of nano-materials used in personal care products under the Federal Food, Drug and Cosmetic Act. While all nano-materials used personal care products must be "substantiated for safety," the FDA has not defined safety for nano-materials, and the industry does not have to disclose the science supporting this claim to the FDA or the public. Typically, the industry relies on its own CIR panel to assess ingredient safety, but to date the CIR has not assessed a single nano-material.
Before industry is allowed to introduce any more nano-materials into personal care products, the FDA must:
· Define, through a public process, what substantiation of safety means for nano-materials.
· Require industry to make public all of the studies it has substantiating the claim that products containing nano-materials are safe.
· Identify the presence of nano-materials in all products.
· Request information on particle size from all personal care product manufacturers.
Please visit ewg.org for a list of nano-materials, micronized ingredients and the products they are found in.
The Environmental Working Group is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment. The Group's research on ingredients in personal care products is viewable online at http://www.ewg.org/issues/siteindex/issues.php?issueid=5005.