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FDA’s Declared War on Sugar

posted by Jennifer Diaz June 3, 2016 3 Comments

Nutrition FactsTake a look at any food label. Check out the back panel entitled “Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars.

On May 20, 2016 the FDA finalized the new Nutrition Facts label final rule for packaged foods. It was the first major update, and regulation, to the nutrition facts label in 20 years. The FDA’s regulation targeted sugars, in particular “added sugars”, and provided a major update to the amount of nutrients people customarily consume. Additionally, the nutrition facts label received a face lift.

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Best PracticesE-CigaretteFDA IssuesImportSeizuresTobacco

The End of Vape Shops, Hookah Shops, & E-Cigs? FDA’s New “Deeming” Laws

posted by Jennifer Diaz May 26, 2016 0 comments

 How to comply

On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.

What Are Tobacco Products and What’s Being Regulated?

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Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

posted by Jennifer Diaz November 6, 2015 0 comments
Do you need to know the current issues affecting importing and exporting for international trade professionals?  What about common compliance issues when importing food, cosmetics, and medical devices?  If you answered yes, you will not want to miss the last of our three-part seminar series that will cover these topics and much more.  Plus, members of supporting organizations, clients of Becker & Poliakoff, and future members and clients, will receive a discount!  Here’s all the information about our upcoming seminar:

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3 Part Compliance Seminar Series You DON’T Want to Miss!

posted by Jennifer Diaz August 24, 2015 0 comments
We are excited to announce our upcoming 3 part seminar series on ImportingExporting, and FDA Compliance! Government and private speakers will participate.  
Each seminar will provide resources for new and experienced international trade
professionals including:

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Best PracticesFDA IssuesMedical DevicesSpeaking

Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME

posted by Jennifer Diaz July 29, 2015 0 comments

If you import medical devices into the U.S. (or want to), FIME is the trade show for you. Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair – and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the
largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.  

I’m thrilled to say I’m speaking again this year. My topic is “How to Effectively Resolve Typical U.S.
Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”. 

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Best PracticesFDA IssuesFoodFSMAImport

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

posted by Jennifer Diaz June 11, 2015 0 comments

GlobalfoodThe 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 voluntary food recalls
  6. Assure compliance with several FSMA regulations
  7. Possess a current facility certification
  8. Have a clear 3 year history with U.S. Customs and Border Protection (CBP), meaning no CBP penalties, forfeitures, or sanctions.
  9. Pay the annual VQIP user fee before October 1st of the intended year of participation (FDA estimated flat fee of $16,400 annually), and
  10. Develop and implement a Quality Assurance Program (QAP)

Having a robust QAP program is one of the most vital components to have in place to qualify for VQIP and will be one of the largest hurdles for eligibility for those that do not have a QAP program in place. QAP is a compilation of the written polices and procedures a food importer will need in order to ensure adequate control over the safety and security of the foods to be imported. The QAP portion of the VQIP application will be time consuming and difficult to navigate, but with expert help, it can be manageable. FDA believes financial benefits of VQIP will outweigh the efforts in the application process.

FDA estimates that the VQIP program will officially commence in January, 2018.

If you have comments about the draft VQIP, especially the estimated annual fee of $16,400, FDA wants to hear from you by August 19, 2015. FDA will review all comments and publish the final fee in a future Federal Register notice at least 60 days prior to the start of the program.

All food importers that want a faster, streamlined supply chain should consider participation in VQIP. For more information on VQIP, or assistance in developing your QAP program, or want to make sure your voice is heard during the comment period, contact me anytime at jdiaz@bplegal.com.

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

posted by Jennifer Diaz May 11, 2015 0 comments
Are 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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FDA IssuesFoodSpeaking

Jennifer Diaz to speak at FDLI Annual Conference

posted by Jennifer Diaz April 16, 2015 0 comments
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!
Best PracticesCosmeticsFDA IssuesFoodFSMAImportMedical Devices

New FDA-USA Website for Importers

posted by Jennifer Diaz October 30, 2014 0 comments
FDA-USA

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.

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