October 2014

New FDA TOOL for Importers

Do you import food products (or any FDA regulated product) into the U.S.? I’ve launched a new website (www.FDA-USA.com) to assist you in learning the basic requirements for FDA regulated products. The website features information for importers of food, drugs, cosmetics, medical devices, dietary supplements and alcoholic beverages.

Don’t forget, if you are a registered food facility with the FDA and don’t comply with FDA’s mandatory biennial registration, FDA can cancel your FDA Food Facility Registration. Learn more about the Biennial Registration requirement in my previous post here.

You can easily register with the FDA on the new www.FDA-USA.com website and if you are a foreign facility, can request that my firm act as your U.S. agent.

Remember, all food facilities which are required to register with the FDA will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. Meaning, the clock is currently ticking, you only have until December 31 to assure your biennial registration is completed or risk FDA cancelling your registration and losing your ability to import into the U.S.!

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

Have questions? Contact me anytime at jdiaz@bplegal.com.

NEW CBP Pilot Program Focuses on IPR Pre-Compliance

CBP is currently taking volunteers for a brand new Intellectual Property Rights (IPR) voluntary pre-compliance program.  The Journal of Commerce reported on the new pilot program here. Do you agree with my comments?

CBP is asking for 9 volunteer filers to submit IPR Authenticating data via email into the Document Image System (DIS). Approved IPR authentication data may be submitted as documents via a PDF attachment to an email. IPR Authenticating data may be sent by shipment and is open in all shipping modalities.

Participants will  include those who have previously experienced negative IPR violating exams. A great way to get back on CBP’s good side!

What documents is CBP looking for in advance of importation?

 

  • Licensee Agreements
  • Service Agreements
  • Maintenance Agreements
  • Packing Lists
  • Non-commercial invoices
  • Serial Numbers
  • Bar Codes
  • Photos of product, packaging, container seals,

CBP has already begun accepting volunteers – you have a limited time left to submit your company name.

Why volunteer?

CBP anticipates that this process will improve IPR targeting efficiencies, reduce the rate of negative IPR exams, facilitate authorized trade and increase CBP port productivity. Within one year’s time, CBP will conduct an evaluation of Advance Information on negative exam rate (and I was informed they will actually SHARE this data with participants! – you can finally let upper management know your compliance role has a real impact on your supply chain and saves the company time and money).

Importance of Pre-Compliance!

I created an extremely similar program for my clients years ago, where, through our pre-compliance plan, EVERY shipment […]

Calling ALL Animal Lovers! Walk for the Animals – 2/28/15

Every now and then there is a charity that just plain and simply warms your heart and has you painlessly giving away that money you work so hard to obtain.  The Humane Society of Greater Miami is that charity for me. Both of my precious pets are from the Humane Society – and I am extremely thankful. This is my small way to give back, and I hope you will join me if you are in Miami! 
Proceeds raised go towards:

  • Sheltering more than 250 homeless cats and dogs in their care every day
  • Supporting spay/neuter services, quality adoptions, humane education and pet therapy 
  • Let’s not forget, Humane Society is a NO KILL zone, unlike Miami-Dade County’s Animal Services (despite voter’s wishes).

    Here are the details for my favorite walk – I hope you will join!

    WALK FOR THE ANIMALS IS BACK!!!  

    Join our fuzzy friends for a morning filled with lots of paws and tails! Enjoy scenic Bayfront Park in downtown Miami along with activities, demonstrations and entertainment all to benefit the Humane Society of Greater Miami Adopt-A-Pet. It’s all for the 2,500 animals that make their temporary home at the Humane Society of Greater Miami each year.

    By |2021-03-26T14:10:58-04:00October 10, 2014|Events|0 Comments

    Jen Diaz to Speak on Import Regulations

    The 11th Annual International Business Trade Expo (IBTE), “Expanding Beyond Our Borders,” will be held Thursday, October 16, 2014 at the Broward Center for the Performing Arts. The event promotes international trade and highlights the significant impact that bilateral trade has in South Florida’s economy. IBTE is hosted by the Lauderhill Regional Chamber of Commerce (LRCC) in partnership with: Florida Chamber of Commerce; Enterprise Florida; City of Lauderhill; Broward Center for the Performing Arts; Unique Production International, and MD Marketing Network.

    Business leaders from across the globe will convene to strategize on how to promote and expand bilateral trade between Florida the Caribbean and Latin America. Attendees will hear from experts on trade issues and regulations affecting Florida’s international business economy, and more.

    Featured Speakers, Panels and Workshops are listed below:
    Workshop: Trade Opportunities in Latin America

    • Doreen Hemlock, Business Reporter, Sun Sentinel (moderator)
    • Glenn Wiltshire, Deputy Director […]

    2014 C-TPAT Conference Recap – Time to Join or Cancel?

    The 2014 CTPAT Conference was held in San Antonio, Texas this year – barely. http://www.customsandinternationaltradelaw.com/2014/07/articles/import/time-to-register-2014-c-tpat-conference/

    I was hoping for a lengthy dialogue on the status of the “Trusted Trader” pilot program – but, it barely received a notable mention. http://www.customsandinternationaltradelaw.com/2014/06/articles/import/are-you-a-trusted-trader-c-tpat-is-no-longer-enough/

    2013 highlights included: http://www.customsandinternationaltradelaw.com/2013/01/articles/c-tpat/what-you-missed-at-the-c-tpat-conference/

    So, in 2014… What’s new?

    By |2021-03-26T14:10:07-04:00October 6, 2014|CTPAT|0 Comments

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