Monthly Archives

May 2012

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‚Äźday", "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!

U.S.Customs

How I Helped Release $2.5 Million Stuck in Customs

posted by Jennifer Diaz May 3, 2012 0 comments

Jennifer DiazBefore beginning a career in international trade, I did not ever stop to think that the t-shirt I was wearing or dishes I was using were likely made elsewhere, and went through a long complicated logistics supply chain in order to reach my local store. Little did I know that when anything goes wrong in that complicated supply chain, it would be my job to help. Recently, a client had over 2.5 million dollars worth of electronic merchandise on hold by U.S. Customs and Border Protection (Customs) for alleged intellectual property rights violations. In plain English, Customs was under the impression my client was trying to import goods with trademarks or logos they did not have the authorization to import.

When you see the symbols below, make sure you think about LICENSES to use them!!

For this client, this was a lot of money at stake, and it could have put them out of business if we did not come up with a quick solution. Instead of thinking of the band aid type solution, to solely fix this issue, we came up with a compliance plan for the client to use going forward, that would also help solve the current issue.

The compliance plan involved both a short term and long term solution. In the short term, the goal was to have the 2.5 million dollars worth of merchandise released ASAP. To accomplish this goal, we had to prove to Customs that our client had the appropriate authorization from the relevant trademark holders. (Good time for you to check over your trademark licenses, are they all in place?  Do you have easy access to them if Customs comes a knockin’?)

For the long term solution, we began to work with Customs to prove that the client was a reputable importer. In this case, actions spoke much louder than words. Instead of telling Customs our client was compliant, we were able to produce documentation, and develop a relationship with the appropriately picked personnel in Customs. Through this relationship, we started a new process where the client utilized a pre-compliance program with Customs for all new products the client would import. This pre-compliance program included Customs review and internal track keeping of the client’s new products and relevant license agreements. This way, Customs had a first hand sneak peak at the new products and any potential issues would be addressed before, not after importation.

I am happy to report that all of my clients 2.5 million dollars worth of merchandise was released, and in a relatively short period of time. To date, all products that were pre-approved by Customs are typically immediately released by Customs and do not go through additional timely intensive exams.

Have you ever had a shipment on hold? What type of compliance programs do you have in place? I’d love to hear your stories, email me!