Labeling reforms

The US Food and Drug Administration on Tuesday unveiled sweeping regulations that will change how sunscreen makers label their products and market them as shields against skin cancer.

The regulations come after more than 30 years of debate over sunscreen labelling, which critics say has allowed companies to make false promises about the levels of protection they provide.

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The new rules require sunscreens to pass a test showing they protect against ultraviolet A and ultraviolet B radiation and have a sun protection factor greater than 15 to be able to claim that they reduce skin cancer and early ageing risks.

“The FDA has evaluated the data and developed testing and labelling requirements for sunscreen products so that manufacturers can modernise their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, director of the FDA’s centre for drug evaluation and research.

“These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection.”

Sunscreen makers will also have to stop telling consumers that their products are waterproof. Instead, they can label a bottle of sunscreen “water resistant” for a specific amount of time.

The FDA is also considering limiting the maximum SPF rating to 50, noting a lack of evidence showing that higher protection levels reduce the risk of skin cancer.

The Obama administration has been aggressively trying to combat skin cancer, which afflicted more than 1m people in the US last year, according to the National Cancer Institute. Last year’s healthcare legislation targeted tanning salons by imposing a 10 per cent tax on customers that tan indoors.

Healthcare providers praised the rules. “For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk,” said Dr Ronald Moy, president of the American Academy of Dermatology Association.

Companies have criticised the FDA for taking so long to make the rules, which it began considering in 1978.

“As a result of the FDA’s failure to develop clear guidelines for the sun care products industry, consumers have been forced to accept ineffective, chemical sunscreens pushed on them from well-funded marketing machines that moved one day from selling tanning oil to now pushing low quality sun care products with limited UVB and inferior UVA protection,” said Aaron Cohen, founder of Glacier Suncare.

Merck, which makes Coppertone, and Johnson & Johnson, which makes Neutrogena, said they support the new labelling rules.