Connecticut Attorney General's Office
Attorney General To FDA: End The Delay, Protect Consumers From False Sunscreen Labels
July 6, 2009
"Now is the time to end indecision and delay," Blumenthal said in a letter to FDA Commissioner Dr. Margaret A. Hamburg. "I urge the FDA to immediately implement its new rules and policies to protect consumers from false sunscreen claims -- before another summer spawns countless cancer-causing sunburns."
Sunscreen makers across the board continue to make false claims on labels, including "waterproof," "sweatproof" and SPF (sun protection factors) above 50. Such false claims may falsely convince consumers that they have blanket protection -- or prevent them from reapplying sunscreen, because waterproof and sweatproof claims are false.
"More than three years ago, I first urged the FDA to implement and upgrade long-delayed rule changes for sunscreen labeling, because current regulations fail to prevent false and misleading claims.
"The FDA finally acknowledged my petition last year when it published new sunscreen regulations, but the rules remain unapproved, inactive and unenforceable. As a result, sunscreen manufacturers have unconscionably exploited lack of regulation by making exaggerated and inaccurate claims in their advertising and labeling.
"Skin cancer in this nation has reached epidemic numbers, imposing huge economic costs and human suffering. Most are highly preventable through precautions including proper sunscreen use as one part of a total program. Cancer prevention is undermined by sunscreen labels that continue to dangerously deceive consumers with promises about 'waterproof,' 'sweatproof,' and SPF designations that falsely claim to exceed '50+.'
"Such false promises and promotions lead consumers to rely on ineffective products to protect their children and families, putting them at reprehensible risk.
"The FDA's draft rules -- if implemented -- would prohibit such bogus blanket promises. They would ban broad waterproof claims and SPF designations above 50+, and require additional instructions to warn consumers to reapply sunscreen. The rules would require specific rating systems for UVB and UVA protection. For UVB, the rules will require a specific SPF number and category rating of low, medium, high and highest. For UVA, the rules require a more realistic four-star rating system using four as the greatest protection, and also a category of low, medium, high and highest.
"A year ago I wrote the FDA and strongly urged it to implement the rules without delay," Blumenthal said. "The FDA's inaction and inertia is deeply troubling, raising grave health and safety concerns. Consumers remain at risk -- unfairly uninformed -- while the FDA perplexedly prolongs its review of industry comments on the 2007 amendment.
"This delay reflects a longstanding pattern and practice of FDA inaction on sunscreen protection."
In May of 1999 the FDA issued a final monograph for over-the-counter sunscreen products, and stayed it before the date that it was to become effective. After eight years of FDA inertia, Blumenthal wrote to the FDA in July 2006, urging it to lift the stay on the rule. Three months later, the FDA published an amendment to the final monograph, finally addressing many of Blumenthal's concerns regarding sunscreen manufacturers' efficacy claims. However, the FDA's new rules remain unapproved and unenforceable.