June 13, 2000 (Washington) -- It is summertime, and for many people that means it is also time to work on their tans -- whether on the beach, in the backyard, or at the park. But sun worshipers counting on U.S. health officials to help them find the right product to avoid the harmful effects of the sun may find themselves lounging in the shade, thanks in large part to a dispute between the FDA and sunscreen makers regarding how sunscreens should be labeled.
"The industry feels that the FDA's final sunscreen rule is a disservice to the consumer," explains Irene Malbin, vice president of the Cosmetic, Toiletry, and Fragrance Association (CTFA), whose organization filed the petition delaying the implementation of an FDA labeling rule aimed at helping consumers pick the right product.
For CTFA, the FDA rule raised some essential issues, Malbin tells WebMD. These include whether manufacturers can claim a product has a sun protection factor (SPF) higher than 30, or claim that sunscreen prevents aging and sunburn without urging consumers on the label to also limit their sun exposure and wear protective clothing.
But dissatisfaction with the FDA rule, originally finalized in May 1999, goes beyond the industry itself. Consumer groups and health care professionals have also taken issue with the FDA rule.
"The extra protection provided by SPFs higher than 30 benefits many people, especially those with very sensitive skin types, who do not tan and who may sustain serious sunburns very easily," says Madhukar Pathak, MD, PhD, chairman of the dermatology department at Harvard Medical School. "If SPFs above 30 are not allowed to be specified in the labeling, packaging, and advertising of sunscreens, consumers who could use extra protection will not be able to identify the most suitable products for their needs," says Pathak, who also serves as chair of the Skin Cancer Foundation's Photobiology Committee.
The Skin Cancer Foundation, an organization devoted to the research and prevention of skin cancers, says the FDA's three newly created categories for SPF are inadequate for effective protection against the sun.
SPF is a measure for determining how much time a person can remain in the sun without burning based upon exposure to short wave radiation, or ultraviolet B (UVB) rays. Under the FDA's rule, there would be three SPF categories: "minimum" sunburn protection for products with SPF factors of 2 to 12, "moderate" protection for products with SPF factors of 12 to under 30, and "high" sunburn protection for products with an SPF of 30+.
"It will be a serious problem if consumers are led to believe that they can rely on products offering 'minimal' sunburn protection or products with 'moderate' protection that have SPFs under 15," says Pathak.