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.

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?

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! 

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:

MANDATORY BIENNIAL REGISTRATION RENEWAL TO TAKE PLACE OCTOBER-DECEMBER 2014

Mandatory Biennial Registration Renewal for Food Facilities will soon be required, on October 1, 2014 until December 31, 2014. If your facility is not re-registered with the FDA by December 31, 2014, FDA will cancel your Bioterrorism Act registration and your importations will be delayed. A FDA Registration number is mandatory to import food products into the U.S.

Here's what you need to know about FDA's new FSMA requirement on Bioterrorism Act registrations.

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

I'm pleased to be back for my fourth year teaching at FIME! For those of you that don't know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center.  You still have limited time to register to attend the conference and my seminars!

Time to Register - 2014 C-TPAT Conference

It's officially time to register for the 2014 C-TPAT National Conference.

Despite substantial scrutiny and restriction due to Department of Homeland Security (DHS) guidelines for government sponsored conferences, a scaled back C-TPAT conference will go on.  This year’s theme will be “C-TPAT: Partnering in Supply Chain Security and Facilitation for the 21^st Century.”

Here's what you need to know:

Exports from China are on the Rise – What is your IPR Plan?

On April 11, amid a high demand for soccer apparel in preparation for FIFA World Cup, U.S. Customs and Border Protection (CBP) seized counterfeit soccer apparel shipped from China to the Port of Savannah. The value of the seized goods exceeded $1 million in manufacturer’s suggested retail price (MSRP). The apparel seized contained counterfeit trademarks of the following professional soccer clubs: Arsenal, Barcelona, Celtic, Chelsea, Mexican Federation, Paris Saint-Germain, and Real Madrid.  Little did they know they should have tried to import Germany's soccer club's apparel. “You look at that Chelsea patch, and it just looks off,” said Steve Sapp, a spokesman for U.S. Customs and Border Protection. “The last B is smaller than the rest, and that’s the kind of thing you often see with these counterfeit goods. Our investigators know the signs that these goods aren’t real.”  Both images are provided below for you to see for yourself - check out the extra space at the top, and the "u" in club.

White House's OMB Intervenes to Weaken FDA's Proposed Regulation of E-Cigs

On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA "deemed" tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA's original proposal.

Do You Want to be a "Trusted Trader"? C-TPAT is No Longer Enough

U.S. Customs and Border Protection (CBP) recently published the long awaited Federal Register Notice, dated June 16, 2014, discussing the "Announcement of Trusted Trader Program Test." This new "Trusted Trader" program is big news for U.S. and non-resident Canadian importers, and if implemented will combine the Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self Assessment (ISA) programs, making ISA extinct.  CBP is currently recruiting test companies that have to be willing to go through an 18 month program test.