Monthly Archives

August 2012


Don’t Let Your Bioterrorism Act Registration Lapse

posted by Jennifer Diaz August 29, 2012 0 comments

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

  1. live or maintain a place of business in the U.S. and
  2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders.  Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety.  The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year.  For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?
The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

CTPATU.S. Customs and Border Protection (CBP)

CBP Symposium Date Change & C-TPAT Conference Postponed

posted by Jennifer Diaz August 10, 2012 0 comments

REGISTRATION IS NOW OPEN!  Registration opened on August 29, 2012 at 1:00 pm eastern standard time.

Originally CBP planned to hold the CBP Symposium right after the C-TPAT conference from September 24-28th in DC.  I thought that was a great idea and hope it works in the future. For now, the C-TPAT conference is postponed and the CBP Symposium has a new date.

So mark your calendars for the CBP Symposium titled "Transforming Trade for a Stronger Economy", it is now October 29-30 in Washington, DC. CBP is limiting attendance to 3 representatives per company, so plan accordingly. Registration has not yet been announced – but, I will say, you need to act fast, it’s sold out within a day typically. It’s an excellent opportunity to meet with all levels at CBP – take advantage!  The Symposium already took place on the West Coast, for a sneak peak at what to expect in DC, see the agenda here. Questions for CBP about the symposium may be sent to

CBP advised all member of C-TPAT that " C-TPAT will not be holding its 2012 Conference in September due to scheduling and logistics challenges.  We are currently working to revise the planning in order to bring you the conference material at a later date.  We will provide updated information as we get it on both the website and through email messages on the C-TPAT Portal. We apologize for any inconvenience this has caused."

See you at the CBP Symposium!

Medical DevicesSpeaking

Jennifer Diaz Opens Medical Device Seminars at FIME

posted by Jennifer Diaz August 2, 2012 0 comments

Attorney Jen Diaz will be presenting the first seminar "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices" at the FIME Show at 10:00 AM on Wednesday, August 8, 2012 at the Miami Beach Convention Center.  This will be Jen’s third consecutive year teaching at FIME.

After attending this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the "worst case scenarios."  We will discuss how we handle everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP).  FDA issues include what to do if you receive a "Notice of FDA Action" stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a "Warning Letter" that could potential state you must stop producing certain medical devices because they are adulterated or misbranded.   Effectively resolving CBP issues includes the appropriate response when CBP says your goods are under "detention," will be "seized" and "forfeited" or are included in the "detention without physical examination" list and how your company can get off the list.  You will also learn the appropriate response after you receive a "liquidated damages claim" up to $50,000 from CBP.  

FIME brings together the worldwide medical community for the largest and most comprehensive trade show in the United States, and features medical manufacturers from all over the globe. If you can find it in a hospital, surgery center, physician’s office, medical laboratory, or medical supply store, you can find it at FIME.

View the complete seminar schedule for FIME Show 2012 here.

If you want more information about medical device compliance issues with FDA and/or CBP, please contact Jen Diaz at (305) 260-1053 or by email at

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.