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State of the Cosmetic Industry, Part 1

By: Rachel L. Chapman
Posted: August 21, 2008, from the September 2008 issue of Skin Inc. magazine.
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Animal testing. Questions have been raised about whether REACH is compatible with the European Union (EU) ban on the testing of personal care ingredients on animals. Although it is generally agreed that the ultimate goal is to reduce the usage of animals for testing, this topic of debate is yet another challenge the industry continues to face and must strive to improve upon. Whereas the EU protests the use of animals for the testing of cosmetic ingredients, the U.S. Food and Drug Administration (FDA) requires such testing be performed before a product is deemed safe for human use and approved for sale on the market.

In a step to close this catch-22 gap, a Transatlantic Economic Council (TEC) meeting was held Nov. 9, 2007, in Washington, D.C., with the hopes of moving toward harmonization between the EU and the FDA. It aimed to reduce regulatory barriers to trade, protect intellectual property rights, ensure secure trade, integrate financial markets, promote innovation and technology, and encourage investment. Reportedly, a special focus was given to the development of animal testing alternatives, and the need to intensify efforts internationally to ensure effective validation and acceptance of alternative testing methods.

Sun protection. Country to country, regulating bodies cannot agree about sunscreen actives and their allowable combinations, making the concept of globalization nearly unreachable. In consideration of the many factors relating to sun protection—such as whether or not UVA and UVB exposure should be measured separately, in vivo versus in vitro testing, the relevance of the standardized dose used to test sun protection compared with actual product use by the consumer, and how to label a sunscreen so that the consumer understands it—the FDA released its long-awaited proposed changes to the final sunscreen monograph.

Industry expert David Steinberg covered the proposed changes at the Florida SCC Sunscreen Symposium held in September 2007. The biggest changes relate to testing requirements and labeling, explained Steinberg. The FDA now requires companies to run both in vitro and in vivo tests. In addition, the definition of SPF has been amended to mean sunburn protection factor, and a new four-star rating system will be used to make the claimed product protection easier for consumers to understand. In addition, if a sunscreen product does not provide at least a low level (one star) of UVA protection, the FDA is proposing to require the product to bear a “no UVA protection” marking on the front label near the SPF value.

Also, a “Warnings” statement in the “Drug Facts” box will be required from all sunscreen product manufacturers. The warning will say: “UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.” The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.