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Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

posted by Jennifer Diaz May 27, 2021 0 comments

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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OPPORTUNITIES IN AGRICULTURE – WHY CHOOSE THE CARIBBEAN?

posted by Jennifer Diaz September 28, 2020 1 Comment

Because of its production limitations, the Caribbean has become a growing market for U.S. suppliers. As one of the most diverse regions in the world, the islands of the Caribbean attract a lot of visitors. With the development of tourism comes an increased demand for imported products from the U.S.—due in part to their perceived higher quality.

 

 

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COVID FLEXIBILITY – FDA Announces Temporary Policy Regarding Certain Labeling Requirements for Foods

posted by Jennifer Diaz May 27, 2020 0 comments

The U.S. Food and Drug Administration is issuing a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The goal is to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic. Fruit-and-Vegetable-Vending-machine-double-cabinets-03-500x500

Entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” this guidance is one of several the FDA has issued to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the pandemic.

 

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Bioengineered Food Labeling

posted by Jennifer Diaz October 30, 2018 0 comments

In our July 27, 2018 blog , we explained what bioengineered (BE) food is and informed you about the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) new proposed rule for BE foods. The new rule is a result of the 2016 amendment to the Agricultural Marketing Act of 1946, which would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. This proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. The standardized disclosure of information will facilitate food purchasing for consumers by eliminating the current uncertainty when purchasing food; effectively improving overall consumer confidence, without harming food manufacturing; and providing farms and production companies a logical, consistent standard for future labeling and packaging. Continue Reading

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USDA Proposed Rule to Inform Consumers of GMO’s (Costing Industry 1.7 BILLION)

posted by Jennifer Diaz July 19, 2018 0 comments

USDADo you want to know if your food contains any GMOs? Do you know what the difference is between a GMO and Bioengineered Food? For the last 2 years, the USDA has been writing new rules for labeling and packaging food with GMOs – learn the latest below!

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Best PracticesFoodImportImport AlertInternational LawU.S. Food and Drug Administration (FDA)

Food Importers – Want to Expedite Your Importations with FDA?

posted by Jennifer Diaz January 23, 2018 2 Comments

 earthOn January 2, 2018, FDA announced that it expects to begin accepting applications in early 2018 for its Voluntary Qualified Importer Program (VQIP), which we first advised you of back in 2015. VQIP is a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. Below are the most important VQIP questions and answers from the FDA. Continue Reading

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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

posted by Jennifer Diaz May 19, 2017 0 comments

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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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
Register Now
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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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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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!