FDA Issues

Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements

posted by Jennifer Diaz May 23, 2012 0 comments

This Friday, May 25, 2012 is officially designated as Don’t Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn’t want you to fry either. On June 18, 2012 the FDA’s new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013.

Here are some major changes you should see as a result of the new requirements:

  1. The terms "sunblock", "sweatproof", "waterproof", "all‐day", "instant protection", and "extended wear" will be eliminated from your beach-going vocabulary. The FDA found these claims to be false and misleading to consumers and they are now prohibited for sunscreen labeling. A word of caution: these or similar claims will cause the product to be misbranded under section 502 of the FD&C Act (21 U.S.C. 352).
  2. A plain statement of "water resistant" is not going to be sufficient, either. There are newly required label statements regarding the length of time a sunscreen product is truly water resistant. This is to ensure that the consumer is aware of how long the sunscreen will last in the water. But how will a manufacturer know how much water resistance is provided in terms of time? There are new FDA effectiveness testing requirements to determine water resistant sunscreen times.
  3. Are you used to buying the sunscreen with the highest SPF number? A combined ‘‘Broad Spectrum SPF’’ statement is now required on the principal display panels [PDP’s] for sunscreen products. If the sunscreen does not pass the broad spectrum test, or it is broad spectrum with an SPF value of less than 15, the product will bare a required skin cancer and skin aging warning label in bold, indicating the adverse consequences of spending time in the sun. What does that mean for consumers? The broad spectrum labels and warnings will make shopping for sunscreen more apples-to-apples. It will be easier to determine which different types of sunscreen are really protecting your skin from the sun the way you need them to, and which ones don’t go the distance.

For more information regarding all the new changes to sunscreen product testing and labeling, please visit Federal Register’s "Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use".

For assistance in complying with these new requirements, please contact Jennifer R. Diaz, senior attorney in the customs and international trade division of Becker & Poliakoff, P.A. at (305) 260-1053, or by email at JDiaz@becker-poliakoff.com.

Here’s to not frying this Memorial Day weekend!

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