The industry in June 2011 was given one year to adjust to labeling rules that will no longer allow “sweatproof” or “waterproof” claims, and will require products with sun protection factors below 15 to state that they don’t prevent skin cancer or early aging. The Food and Drug Administration also will require makers such as Johnson & Johnson (JNJ) and Merck & Co. (MRK) to prove claims of sunscreens lasting longer than two hours.
The FDA delayed the rules until December at the earliest after lobbying groups for the cosmetics and over-the-counter pharmaceutical industries said they needed more time to comply. The senators said the delay will expose Americans to another season without accurate information about sun protection.
“Once again, the summer months are upon us and millions of Americans will be spending time outdoors without adequate protection from the sun,” the senators wrote to FDA Commissioner Margaret Hamburg. “FDA’s decision is a major step backward, and we strongly urge you to reverse it.”
Farah Ahmed, chairwoman of Personal Care Products Council sunscreen task force, said consumers would face a shortage of sunscreens without the delay.
The industry needs more than one year to change labeling, particularly to reflect a drug facts box like the one pharmaceuticals bear, Ahmed said in a telephone interview.
The FDA delayed the rules until December for products with $25,000 or more in sales and until December 2013 for products with sales of less than $25,000.
The senators who signed the letter asking for that delay to be overturned are Democrats Charles Schumer and Kirsten Gillibrand of New York, John Kerry of Massachusetts, Patrick Leahy of Vermont and Reed. Senator Bernie Sanders, a Vermont independent, also signed the letter.
Shelly Burgess, an FDA spokeswoman, said the agency would respond directly to the senators.
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