Sunscreens

The Food & Drug Administration still has not approved the sunscreen effectiveness ratings used in the rest of the world. And partly because of this shortcoming, some sunscreen formulators are caught in a legal bind.

"Sunscreen is the snake oil of the 21st century," says Samuel H. Rudman, a partner in the law firm Lerach, Coughlin, Stoia, Geller, Rudman & Robbins. His firm, along with another law firm, Abraham, Fruchter & Twersky, filed class-action lawsuits against top sunscreen formulators in the California Superior Court for Los Angeles contending that they deceptively promote their products as protection from harmful sunrays.

"False claims such as 'sunblock,' 'waterproof,' and 'all-day protection' should be removed from these products immediately," Rudman adds. Several cases that Rudman and his partners are pursuing were recently consolidated in the Los Angeles court at the end of March. They want an injunction against the manufacturers' claims, compensation for consumers, a public education program concerning sun protection, and other remedies.

Manufacturers named in the suit are Schering-Plough, the maker of Coppertone; the Sun Pharmaceuticals division of Playtex, maker of Banana Boat; Tanning Research Laboratories, maker of Hawaiian Tropic; Johnson & Johnson, maker of Neutrogena; and Chattem, maker of Bullfrog. The sunscreen makers contend their products comply with FDA regulations. Schering-Plough adds that it vigorously disputes the allegations.

It is now seven years since FDA promised manufacturers and formulators that it would advise them on an acceptable measuring system to let consumers know how effectively a sunscreen formulation blocks UV-A rays. Those are the rays scientists believe cause skin wrinkling and contribute to skin cancer. The Sun Protection Factor (SPF) ratings that appear on bottles of sunscreen in the U.S. indicate a formulation's ability to block UV-B, the rays that cause sunburn.

FDA had promised to publish proposed UV-A testing and labeling rules toward the end of last year (C&EN, April 11, 2005, page 18). Formulators are still waiting.

Without such a protocol, formulators can only indicate that their products give some UV-A protection, a limitation that has led to confusion. The California lawsuit claims that Schering-Plough advertised its Water Babies product as providing "45 times your child's natural sun protection." That number is based on the SPF for UV-B rays, and the lawsuit contends that Schering-Plough "knew or should have known that the product did not provide protection against UV-A rays as it did against UV-B rays."

The Skin Cancer Foundation, a nonprofit organization largely supported by pharmaceutical and cosmetic firms, says the California suits are "especially disturbing because they may cause people to stop using sunscreen." The foundation says people should cover up and seek shade, but they should also continue to wear sunscreen to help prevent skin cancer. The organization also calls on FDA to "finalize its monograph governing sunscreen use and marketing, including designation of a method for measuring UV-A protection."