FDA Delays Sunscreen Rules Again

The U.S. Food & Drug Administration (FDA) is delaying issuing sunscreen rules, again. Many feel the government has, yet again, caved to industry requests for additional time to clarify exactly how much protection their sunscreen lotions provide.

The agency directed manufacturers to make changes to their sunscreens last summer, allowing industry a year—the deadline was set for next month—to put revised products on store shelves, said the Associated Press (AP)

Changes are meant to differentiate which products protect consumers from both ultraviolet B (UVB) and A (UVA) rays, said the AP. UVB cause sunburns while UVA penetrates deeper and is linked to skin cancer and skin aging, said the AP. Also, products can no longer make waterproof and sweat proof claims and can only be described as water- or sweat-resistant, which is meant to alert consumers to the need for frequent reapplication.

Sunscreen manufacturers told the government they were unable to make the deadline and the FDA responded by allowing them another six months until December, to make the changes. The move is being heavily criticized given that the change will come after mot of this country’s 2012 sunbathing season. As a matter-of-fact, smaller firms have received an extension until December 2013.

“The FDA took a major step backwards today and as a result, more consumers will likely get burned this summer,” said Senator. Jack Reed (Democrat-Rhode Island). The senator, said the AP, has been seeking FDA tightening of its sunscreen regulations—which have been up in the air for years.

The FDA said that it allowed the extension over concerns that holding manufacturers to the original deadline could result in sunscreen shortages this summer, spokeswoman Shelly Burgess told the AP.

Dr. Joshua Zeichner, a dermatologist at Mount Sinai Medical Center in New York, told the AP that consumers should seek UVA and UVB protection. Although the term “broad spectrum” in the future will indicate the dual protection, for now, look to the ingredient list. Names such as zinc, titanium, avobenzone, or ecamsule, indicate UVA and UVB protection, Zeichner said.

Zeichner suggests applying about a shot-glass full of sunscreen for each application and to reapply frequently and use an SPF of 30 or greater, said the AP. Experts say direct sun should be avoided from 10:00 a.m. to 4:00 p.m.; at the very least, cover up.

As we’ve explained, the new labeling will allow sunscreens labeled as both Broad Spectrum and SPF 15 (or higher) to state that, when used regularly, as directed, and in combination with other sun protection measures, they will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging, said the FDA. In other words, products with SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.