Last summer, the FDA gave sunscreen manufacturers a new set of sunscreen label guidelines—which included updates to better protect consumers—but last week, they announced that they’d pushed back the deadline another six months. So labels should be more accurate by…next winter.
The new label requirements would require a standardized test for products labelled “broad spectrum,” to indicate that they protect against both UVA and UVB rays. They would also bar companies from using the terms “sweat-proof” and “waterproof” (to dispell misconceptions that the products don’t need reapplication to provide proper protection), and require products with SPF 2-14 to include a warning sign explaining the dangers of sun exposure and limited protection offered by such low SPF.
These and other new FDA guidelines were due to be enforced by June 17 of this year, but due to manufacturer complaints about the deadline, they pushed it back another six months. So, consumers can expect better labels just in time for…winter.
The FDA’s official statement about the pushback reads as follows:
The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule’s compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule’s requirements for all affected products will require an additional 6 months. This final rule is part of FDA’s ongoing review of OTC drug products.
Which basically sounds to me like sunscreen manufacturers lobbied really hard to save themselves from taking a major loss in profits for 2012.
Rhode Island Senator Jack Reed , who wrote the Sunscreen Labeling Protection (or SUN) Act to prod the FDA to strengthen sunscreen labeling standards, would tend to agree. In a statement he said:
Quality sunscreen offers critical protection, particularly during the summer months when millions of Americans head outdoors and to the beach. The FDA simply isn’t giving consumers the protection they deserve. For too long the FDA has allowed manufacturers to get away with inaccurate claims about sun protection. The FDA has been considering regulations to restrict these claims since 1978. It is time for them to stop dragging their feet and put the new sunscreen safety and labeling standards into effect. This is a public health issue and a situation where consumers deserve to know that the sunscreen products they purchase are safe, effective, and easy to understand so they may better protect themselves and their children from the sun’s harmful rays. The FDA today took a major step backwards and as a result, more consumers will likely get burned this summer. I will continue to monitor this process closely to ensure the FDA and manufacturers are held accountable.
Which pretty much says it all.