(Saint Petersburg, FL - June 27, 2011)
Up until very recently, FDA only required the industry to test for Ultraviolet B rays, the rays that are known to cause sunburn. That's what the familiar sun protection factor (SPF) measure is based upon.
However, just in time for summer, FDA released regulations requiring sunscreen manufacturers (most of which are regulated nearly the same as pharmaceuticals) to test their products for the ability to block the more dangerous Ultraviolet A rays. Those rays can penetrate glass and pose the greatest risk of both skin cancer and premature aging.
Starting next summer, if sunscreens don't protect against both types of UV rays or have a SPF below 15, those products will have to carry a warning: "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
In addition to this new product testing, the FDA's is also requiring marketing claim overhauls to include, but not be limited to, the following:
- Exaggerated Marketing Claims Such as "Waterproof" and "Sweatproof" Will Be Forbidden From Packaging and Labeling without Adequate Substantiation
- SPF Values Cannot Exceed 50 Without Substantiation
- The 4 Star System for Rating UV Protection Must be Removed from Labeling and Marketing Materials
According to Jonathan Lewis, Principal at Advanced Biomedical Consulting, a leading FDA compliance consulting firm, many of the larger sunscreen companies have already begun to comply with the requirements. However, Lewis states, "The majority of small to mid-sized firms are having difficulty in comprehending all the changes required while keeping costs under control.
(Saint Petersburg, FL - June 27, 2011)