U.S. Food and Drug Administration (FDA)

Food Importers – FDA Issues New Guidance Aimed at Expediting Your Importations

The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. FSMA requires FDA to establish a voluntary, fee-based program, named the “Voluntary Qualified Importer Program” (VQIP) which promises expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

On June 4th, 2015 the FDA published a draft version of “Guidance for Industry: FDA’s Voluntary Qualified Importer Program (VQIP)”.  According to FDA’s website, VQIP will also benefit consumers by enabling the FDA to focus its resources on high risk foods, further protecting consumers from the potential health hazards associated with those foods. In order for a food importer to be eligible for the VQIP program, the importer should:

  1. Have at least a 3 year history of importing foods
  2. Have a Data Universal Numbering System (DUNS) number
  3. Use a paperless filer/broker who received a passing rating during their last FDA evaluation
  4. Import food that is not subject to an import alert or Class 1 recall
  5. Not be, nor any non-applicant entity associated with the VQIP food be, subject to an FDA administrative or judicial action, have a history of significant non-compliance with food safety, or have one or more […]

World Trade Month – Business Opportunities with Cuba – May 14, 2015 – #OWITonCuba

CUBAAre you in South Florida and thinking of doing business with Cuba? Do you want to hear from those already successfully doing business with Cuba? Do you want to fully understand what is legal now?
May 14, 2015, I have JUST the event for you! This is your LAST CHANCE to register!

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Jennifer Diaz to speak at FDLI Annual Conference

I am honored to be a speaker at the Food and Drug Law Institute (FDLI’s) Annual Conference, taking place in Washington DC from April 20-21, 2015. My panel “Moving Food Commodities Across National Borders: Compliance, Tips, and Strategies” will take place on April 21, 2015 from 12:00-12:25 pm. I hope you can join. As an added incentive, use my code below to receive 15% off of your registration cost! 
When registering here use the code ANNUAL2015 to save!
The annual conference will take place at the Grand Hyatt Washington – more information about the location and a link to make your reservation can be found here.
If you fall under any of the following categories, you MUST attend the FDLI annual conference:

  • Regulatory Affairs Professionals
  • Government Affairs Professionals
  • Chief Safety Officers
  • Chief Compliance Officers
  • Food and Drug Attorneys
  • Government Officials
  • Academics
  • Food and Drug Industry Consultants
  • Venture Capitalists
  • Patient Advocates
  • Consumer Advocates
  • Business Development Professionals
  • Global Strategy Professionals
  • Corporate Planning Staff 

The all star agenda line up covers the hottest issues in compliance and enforcement as they relate to food, drugs, devices, tobacco, e-cigarettes and much more. View the full agenda here.
The FDLI posted a breakdown of interest areas for last years conference attendees and fully intends to cover all of these hot topics in 2015!
By |2015-11-30T10:30:16-05:00April 17, 2015|Food|0 Comments

Jennifer Diaz to speak at FDLI Annual Conference

I am honored to be a speaker at the Food and Drug Law Institute (FDLI’s) Annual Conference, taking place in Washington DC from April 20-21, 2015. My panel “Moving Food Commodities Across National Borders: Compliance, Tips, and Strategies” will take place on April 21, 2015 from 12:00-12:25 pm. I hope you can join. As an added incentive, use my code below to receive 15% off of your registration cost!
By |2015-11-30T12:16:43-05:00April 16, 2015|FDA Issues, Food, Speaking|0 Comments

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 info@diaztradelaw.com

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