The U.S. Food and Drug Administration was poised to implement new rules on sunscreen labels and marketing this summer, more than 30 years after the first sunscreen labeling rules were introduced in 1978. However, sunscreen manufacturers may keep using misleading language when packaging and advertising their products for at least another six months.
Click here for the full text of the proposed FDA rule on sunscreen labeling and effectiveness testing. Jen Quraishi summarized some key points at the Mother Jones blog last summer.
–all sunscreens must be SPF 15 or higher if they claim to prevent sunburn, early aging, and reduce skin cancer risk. Anything under SPF 15 could only be advertised to help prevent sunburn.
–all sunscreens must provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA) in order to be labeled as “Broad Spectrum.”
–no more labels that market a sunscreen as either “waterproof” or “sweatproof.” The label “sunblock” is also disallowed.
–any product that claims water resistance must also tell consumers how much time they can expect to get SPF protection for while in the water.
–no product can claim to offer immediate protection after application unless they submit data to the FDA and get the FDA’s express approval
–sunscreens in the form of wipes, towelettes, powders, body washes, and shampoo cannot be marketed without approved application.
The Environmental Working Group, which publishes an extremely useful database on sunscreen safety and efficacy, was not impressed by the FDA rule-making. From a June 2011 press release:
Washington, D.C. -The federal Food and Drug Administration’s new sunscreen rules, released today after nearly 33 years of deliberations, fall short.
“FDA’s action offers some noticeable improvements for consumers, such as limiting misleading claims” said David Andrews, Ph.D, a senior scientist with Environmental Working Group. “However, it is clear that FDA caved to industry and weakened its safety standards. Its earlier draft proposed stronger health protections.”
According to Andrews, the agency’s final rule for UVA protection has been substantially watered down from a draft circulated in 2007.
“The agency’s weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” Andrews said. “FDA’s rule will allow most products on the U.S. market to use the label ‘broad spectrum sunscreen,’ even though some will not offer enough protection to assure Americans they can stay in the sun without suffering skin damage from invisible UVA radiation. For that reason, about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.”
The FDA continues to allow oxybenzone, retinyl palmitate and several other ingredients in sunscreens despite scientists’ concerns about their toxicity.
One bit of good news is the agency’s bar on the misleading terms “waterproof” “sweatproof” and “sunblock.” But it is seeking further comments about the additional protection offered by SPF values above 50.
“FDA’s new standards don’t go far enough to protect you from the sun,” Andrews said. “Consumers will have to turn elsewhere, like EWG’s online guide, to find the safest, most effective sunscreens. After 33 years of delay, it is evident people just can’t trust FDA on this issue.”
Even the weaker version of sunscreen labeling rules proved too tough for manufacturers. In typical government fashion, the FDA released the bad news on a Friday, May 11. The Environmental Working Group blasted the FDA’s action.
Washington, D.C. – Under pressure from two cosmetic industry groups, the Food and Drug Administration has decided to delay for six months implementation of pending regulations on how sunscreens are labeled and marketed.
The regulations, issued in June 2011 after more than 30 years of deliberations, will push back enforcement of the rules until mid-December 2012, allowing misleading sunscreen labels to stay on the market for another summer.
“FDA just gave consumers 1,800 more reasons to turn to our sunscreen database,” said Environmental Working Group senior analyst Sonya Lunder. “We are baffled that FDA deems it necessary to delay such weak regulations. The agency has caved to industry pressure every step of the way.”
For six years, Environmental Working Group has taken upon itself to compile and publish an extensive database focused on the safety and efficacy of sunscreens on the U.S. market. The 2012 database of more than 1,800 sunscreens and SPF-rated moisturizers, lip balms and makeup products is scheduled to be released next week.
FDA announced the delay at the request of two trade groups – the Personal Care Products Council and the Consumer Healthcare Products Association – that said manufacturers needed more time to test products and revise their product labeling. The new implementation date is Dec. 17, 2012 for most companies; small companies get another year, the FDA announced Friday, May 11.
EWG estimates that 90 percent of beach and sport sunscreens on the market are already in compliance with the agency’s low-bar regulations on efficacy and safety. The new rules mainly affect product labeling, banning such claims as “sweat-proof” and “waterproof.” Additionally, products cannot claim to provide instant or all-day protection without submitting substantiating data and getting approval from FDA.“Consumers continue to be confused by these overblown claims. They can’t wait another season for these improvements to reach store shelves,” added Lunder.
The 2012 version of the Environmental Working Group’s database on sunscreens is here.
One ingredient of particular concern is retinyl palmitate, a form of vitamin A that is present in many sunscreens and “may accelerate development of skin tumors and lesions when applied in the presence of sunlight.”
Since sunscreens may decrease the body’s production of vitamin D, I often encourage my kids to stay indoors or in shady areas until after 3:30 or 4:00 pm. At that point, they can swim or play in the sun without wearing sunscreens or getting sunburned. The Centers for Disease Control suggest these guidelines for protecting children from excessive sun exposure. Remember, most sunscreens are not suitable for babies under six months old. They should stay covered up or indoors when the sun is strong.
UPDATE: Maddie Oatman wrote an excellent piece on this subject for the Mother Jones blog. Click through and scroll down for a list of the 20 children’s sunscreens that received the best ratings from the Environmental Working Group and a list of eleven children’s sunscreens to avoid.