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FDA IssuesFoodFSMAImport

FSMA: Stay Complaint with DTL’s ‘PICTURE’!

posted by Jennifer Diaz January 12, 2017 0 comments

FSMA todo listEach year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
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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 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.

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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MANDATORY BIENNIAL REGISTRATION RENEWAL TO TAKE PLACE OCTOBER-DECEMBER 2014

posted by Jennifer Diaz September 11, 2014 0 comments

Manuf foodMandatory 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.

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FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

posted by Jennifer Diaz July 8, 2014 0 comments

GFAccording to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

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FDA Released Draft Guidance on Prior Notice of Imported Foods

posted by Jennifer Diaz April 7, 2014 0 comments

For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry.  We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.

The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”.  Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”

FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004.  The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA.  The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Although pursuant to 21 CFR 10.115(g)(5), comments can be made on the guidance at any time, in order to ensure that the FDA considers your comments on this draft guidance before it begins to work on the final version of the guidance, your comments must be submitted either electronically or in writing within sixty (60) days from the date in which the notice announcing the availability of the draft guidance is published in the Federal Register, or March 31, 2014.  If you have questions on FDA’s FSMA or on submitting a comment, please feel free to contact me at (305) 260-1053 or via email at JDiaz@bplegal.com.

FDA IssuesFoodFSMAImport

Join FDA in Miami to Discuss Major FSMA Proposed Rules

posted by Jennifer Diaz September 26, 2013 0 comments

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA – if you have not met your manufacturer yet, now is the time! 

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.  

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules. 

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA.   

These two added meetings will take place in Miami, FL and Long Beach, CA.  

Register here!

  • Miami meeting October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

 

October 11, 2013

8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting – October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

 

October 23, 2013

8:30 a.m. – 12:30 p.m.

 

A sample agenda from the meeting that took place in Washington, D.C. on September 19-20, 2013, may be found here (we anticipate the same content being included for the Miami meeting).

 

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

 

  • Meeting in Miami, FL
    • September 24, 2013: Closing date for request to make oral comment
    • September 24, 2013: Closing date to request special accommodation due to a disability
    • October 1, 2013: Closing date for advance registration
  • Meeting in Long Beach, CA
    • October 1, 2013: Closing date for request to make oral comment
    • October 1, 2013: Closing date to request special accommodation due to a disability
    • October 8, 2013: Closing date for advance registration
  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

FDA IssuesFoodFSMAImport

Miami CANCELLED by Government Shutdown – LA WILL Go On – FDA to Discuss Major FSMA Proposed Rules

posted by Jennifer Diaz September 26, 2013 0 comments

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA – if you have not met your manufacturer yet, now is the time! 

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.  

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules. 

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA.   

These two added meetings will take place in Miami, FL and Long Beach, CA.  

Register here! (FDA HAS INDICATED THE LONG BEACH SEMINAR WILL GO ON).

  • Miami meeting October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

 

October 11, 2013

8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting – October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

 

October 23, 2013

8:30 a.m. – 12:30 p.m.

 

A sample agenda from the meeting that took place in Washington, D.C. on September 19-20, 2013, may be found here (we anticipate the same content being included for the Miami meeting).

 

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

 

  • Meeting in Miami, FL
    • September 24, 2013: Closing date for request to make oral comment
    • September 24, 2013: Closing date to request special accommodation due to a disability
    • October 1, 2013: Closing date for advance registration
  • Meeting in Long Beach, CA
    • October 1, 2013: Closing date for request to make oral comment
    • October 1, 2013: Closing date to request special accommodation due to a disability
    • October 8, 2013: Closing date for advance registration
  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.