The Consumer Advertising Law Blog wishes all of our US readers a happy Independence Day. As you look forward to a long weekend with family grilling, at parades or waiting for fireworks, we also wanted to remind you not to forget your high SPF sunscreen. And for those reading our blog this weekend using our mobile app, things are heating up in the sunscreen legal world and we wanted to share some timely developments.
Earlier this month, the FDA announced new regulations, which will take effect in 2012, governing how sunscreen manufacturers label and advertise their products to consumers. Janet Woodcock, from the FDA’s CDER, described the benefits for consumers, “These changes will help people make better-informed decisions about how to use sunscreens and allow them to more effectively protect themselves and their families.” Some of the key changes in the new regulations include:
- A standard test for over-the-counter sunscreen to determine whether products can be labeled as “Broad Spectrum,” a label indicating that the product protects against both ultraviolet A (UVA) and ultraviolet B (UVB) rays
- A proposed regulation that would limit the maximum label on sunscreen products to SPF 50+, because the FDA lacks data demonstrating that products with values higher than 50 provide any additional protection
- A regulation prohibiting manufacturers from labeling their products as “waterproof” or “sweatproof” or “sunblock”
- Water resistance claims on the product’s front label must inform consumers how much time they can expect to get the declared SPF level of protection, with permissible durations of 40 or 80 minutes
The FDA is also issuing draft guidance to help sunscreen manufacturers understand the final and proposed regulations and to assist them in properly labeling and testing their products.
In related news, a Delaware federal district court declined to enter a permanent injunction in a Lanham Act false advertising case involving two sunscreen manufacturers. Schering-Plough, the plaintiff, and manufacturer of Coppertone sunscreen, brought claims for false advertising against Neutrogena. Schering-Plough alleged that Neutrogena’s print advertising and packaging for its Ultra Sheer Dry-Touch Sunblock SPF 100+ product falsely claimed that the product contained helioplex, a photo-stabilizing agent. In May, the district court granted partial summary judgment for Schering-Plough, on the basis that lots of defendant’s product shipped in 2009 and 2010 did not contain DEHN, a component of helioplex. Thus, the claim “with helioplex” misrepresented the qualities of the sunscreen and therefore was literally false.