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FDA Examines Concerns Regarding Use of Cosmetic Products

Written by Rayna E. Kessler, Esquire

During the last decade, the cosmetics industry has grown exponentially with annual sales totaling approximately $60 billion dollars in the U.S. alone. The Food and Drug Administration (FDA) is the U.S. agency that oversees the safety of cosmetics. Yet, the U.S. cosmetics industry has remained largely self-regulated. For example, the FDA regulations prohibit only ten (10) types of ingredients in cosmetic products due to safety concerns, including chloroform, methylene chloride, and mercury-containing compounds. In contrast, the European Union bans more than one thousand (1,000) ingredients. Additionally, cosmetic companies are not required to disclose their cosmetic product ingredients to the FDA. As a result, only one-third of cosmetic manufacturers are estimated by the FDA to voluntarily disclose the cosmetic ingredients in their products to the agency.

Recently, the FDA has expressed safety concerns over the alarming increase in the number of cosmetic products and ingredients made available to U.S. consumers without any additional premarket testing. On April 20, 2012, the FDA issued recommendation steps for changes in the treatment of certain cosmetics. The FDA’s primary concern is the increased use of “nanotechnology” in cosmetic products. Nanotechnology is a new but quickly evolving area of science that changes the physico-chemical characteristics of already known ingredients, for the purpose of allowing products to be absorbed deeper below the skin’s surface. The small size and exceptional mobility of these “nanoparticles” present unknown health risks that may alter the safety, effectiveness, performance, or quality of products.

Specifically, the FDA is currently examining the toxicity of nano-sized metal oxides used in some topical cosmetics and whether these ingredients may pass through the blood-brain barrier. Similarly, there is concern that if nanoparticles are ingested, they have the potential to gain access to organs or other areas of the body, resulting in potential adverse effects on the respiratory system, the central nervous system, and the immune system. The FDA’s recommendation encourage manufacturers to consult with the agency before bringing their nanomaterial products on the market.

Certainly nanotechnology is only becoming a larger part of the cosmetics industry. Indeed, almost all of the major cosmetic manufacturers already use nanomaterials in their products. Therefore, the FDA is justified in calling for continued testing and transparency regarding these product’s use, safety, and long-term effects.

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