Connecticut Attorney General's Office
Attorney General Says Sunscreen Labeling Rules Fail To Prevent False Claims, Urges FDA To Update, Enforce Regulations
July 7, 2006
Attorney General Richard Blumenthal today urged the Food & Drug Administration (FDA) to implement and upgrade long-delayed rule changes for sunscreen labeling, saying current regulations fail to prevent false and misleading claims.
The FDA in 1999 updated - but stayed - its sunscreen labeling rules, which would prohibit sunscreen makers from claiming that their products have Sun Protection Factors (SPFs) greater that 30-plus. The extra protection from products with SPF ratings over 30 provided is so tiny, it is insignificant.
Other banned claims would have included: blocks "all harmful rays," provides "all day protection," and is "waterproof." The FDA never implemented the rules, so some sunscreen makers have continued to make the false claims.
Current SPF ratings measure a sunscreen's protection against Ultra Violet-B (UVB), rays that cause visible sunburns, but do not rate a product's protection against Ultra Violet-A (UVA), which penetrates deeper into the skin and also causes skin cancer.
The FDA pledged in 1999 to develop a system of rating for UVA, but has so far failed to do so.
"The FDA's outdated, inadequate standards unwittingly enable sunscreen products to make false and misleading claims about blocking all the sun's harmful rays - giving a false sense of security about the durability, duration and degree of protection," Blumenthal said. "The FDA has specifically found that SPF ratings do not reliable measure for UVA radiation protection, and indeed that there is no accepted system to measure the degree or level of UVA screening. But its current rules allow companies to market and promote their products as providing blanket protection against both UVA and UVB rays.
"Current labels promote a false sense of security because they use misleading SPF ratings, and because a product that blocks UVB may stop burning or visible effects, so people believe they are protected and spend more time in the sun. SPF ratings only measure a product's protection against UVB, leaving consumers uniformed and unwarned about also harmful UVA rays, which penetrate to deeper layers of skin where they can cause melanoma and other cancers. FDA's inaction allows sunscreen makers to make dubious and deceptive claims - inflating SPF ratings far beyond 30, calling products 'waterproof' when they dissipate in water and claiming 'all day protection.'
"The plain fact is that SPF ratings higher than 30 are virtually meaningless and misleading. The claims about waterproof are mostly truth-proof. The FDA's failure to update these rules creates a marketing Wild West: sunscreen makers can make claims that are unproven and untrue.
"The FDA has developed more accurate and demanding standards, but has failed to imposed them - leaving consumers to rely on SPF ratings that measure only UVB radiation, not UVA rays that can also cause cancer. The FDA's procrastinating on updated, upgraded warnings is unconscionable and unacceptable.
"The FDA has an obligation to block false and misleading claims, just as sunscreen should block damanging ultra violet rays.
"As we face a spreading epidemic of skin cancer, the FDA must act immediately to impose an effective UVA rating system and implement the 1999 rules prohibiting SPF ratings of more than 30 and other false claims. Indeed, these standards must be upgraded in light of stronger scientific evidence about sunscreen ingredients. I will fight to assure that consumers have the accurate information they need to forestall the sun's potentially deadly effects."
In a letter to the FDA, Blumenthal called on the agency to immediately require sunscreen manufacturers to clearly warn consumers they must reapply supposedly "waterproof" sunscreens, and to cease unsupported claims of SPFs over 30-plus - especially high SPFs that falsely claim or imply that a sunscreen filters out dangerous UVA rays.
FDA rules for sunscreen labels were last fully updates in 1993.