The U.S. Food and Drug Administration recently delayed the implementation of new sunscreen labeling requirements that were set to go into effect on June 18, 2012 for at least an additional six months. The new sunscreen labeling rules will ultimately bar manufactures from making certain claims about the protections afforded by the sunscreen and require the sunscreen to meet certain benchmarks before information may be placed on the product’s label. United States Senators Kristen Gillibrand and Charles Schumer authored a letter to FDA voicing their collective displeasure with the delay. The Senators’ belief is that the sunscreen industry has a history of misleading consumers which must be corrected immediately and, in particular, before the summer begins in earnest. Despite the letter, the FDA has stood by its decision to delay the implementation of the new sunscreen labeling requirements.
The new sunscreen labeling requirements underscore two important issues. First, any sunscreen manufacturer must be readying itself for complying with the new federal labeling regulations; while manufacturers were given a bit of a reprieve by the FDA’s recent decision to delay the implementation of the new labeling requirements these rules are still set to go into effect. A manufacturer that ultimately fails to comply with the new labeling requirements, once they are put into effect, may potentially face substantial administrative penalties. Second, sunscreen manufacturers must carefully ensure that the labels on their products do not contain any false or otherwise misleading information. Class action claims brought on behalf of consumers are regularly based upon assertions that products were marketed using false or misleading information. In fact, class action claims have already been filed against sunscreen manufacturers founded on the allegedly false information contained in the product’s label.
For more information, please contact any member of Goldberg Segalla’s Global Insurance Services Practice Group.