A collection of new sunscreen regulations scheduled to go into effect today have been delayed for six months by the U.S. Food and Drug Administration (FDA). The labeling requirements, announced last year, have had their effective date moved from June 18, 2012 to December 17, 2012, after manufacturers complained that they would not be able to meet compliance in time.
Announced on June 14, 2011, the new requirements provide updated guidelines for claims made on sunscreen labels. Products that pass tests for blocking both UVA and UVB forms of radiation will be labeled as providing “Broad Spectrum” protection, while those that only block UVA radiation or have SPF levels below 15 will need to print warnings about risk of sunburn (which is caused primarily by UVB radiation), including premature aging and skin cancer.
In addition to the Broad Spectrum changes, manufacturers will also need to be more truthful in claims they make about their products. FDA studies show no evidence of SPF levels above 50 proving additional protection, so the labels may now only print “50+” as the maximum strength-printing higher numbers will be banned. Claims such as “waterproof” and “sweat-proof” will be similarly prohibited, and a “Drug Facts” label will be required on the container.
The FDA announced in May that it would delay the new labeling requirements for six months following industry recommendations. Manufacturers suggested that they would not be able to meet the compliance requirements by the initial deadline, which would result in a shortage of skin-protection products just as the summer season arrived.
“It’s not a simple redesign of the label,” said Farah Ahmed, vice president of the Personal Care Products Council, in an interview with NPR. “We’re talking about a huge number of products. Companies would need to order new components; they would need to perhaps get new molds. So that requires a re-engineering of manufacturing equipment.”
Promotional products suppliers and distributors who sell sunblock need to remain aware of the impending regulations. In addition to being accountable for compliance, the provisions require including a much larger amount of information on the label which can impact imprint areas.
Fortuantely, suppliers who spoke with Promo Marketing said they have been preparing since the regulations were announced last year. “When we reworked our templates, we were able to make everything fit without affecting our imprint areas,” said Megan Ludlow, marketing manager for SnugZ USA, based in Salt Lake City. “We have been compliant for the last few months.”
Distributors who sell sunscreen will not have to worry for this summer, but it is still important to verify that the products they are selling are fully compliant. Ask suppliers if their products have been tested and if their labels have been updated to reflect the latest regulations. For more information on what is required on sunscreen labels, visit the FDA’s website.
