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FDA Issues

Best PracticesFoodImportInternational BusinessInternational TradeLabelingPre-complianceSupply ChainU.S. Food and Drug Administration (FDA)

FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

posted by Jennifer Diaz May 27, 2021 0 comments

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA)  Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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Best PracticesCustoms ExpertEnforcementEventsExportImportInternational BusinessInternational LawInternational TradeSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

FDA Webinar on Human Drug Importations

posted by Jennifer Diaz March 2, 2021 0 comments

On January 14, 2021, the United States Food and Drug Administration (FDA)  kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference.  The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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Best PracticesCOVID-19Customs ExpertEnforcementExportImportImport AlertInternational BusinessInternational LawInternational TradeMexicoSeizuresSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

FDA Import Alert on Mexican Hand Sanitizer

posted by Jennifer Diaz February 4, 2021 0 comments

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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Best PracticesCustoms ExpertFoodImport AlertInternational TradeIPR, Trademarks and LogosU.S. Food and Drug Administration (FDA)

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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Best PracticesBloombergChina Trade WarCounterfeitsEnforcementExportImportInternational BusinessInternational LawInternational TradeIPR, Trademarks and LogosPenaltyReasonable CareSeizuresSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

USDA & CBP Combat Non-Compliant WPM

posted by Jennifer Diaz January 9, 2020 0 comments

Diaz Trade Law’s President, Jennifer Diaz and Associate Attorney, Denise Calle are enthusiastic to announce that our article USDA & CBP Combat Non-Compliant WPM was published by Bloomberg Law!  Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback! Continue Reading

Best PracticesChina Trade WarCounterfeitsCurrency SeizureCustoms ExpertEnforcementExportInternational BusinessInternational LawInternational TradeInternational TravelIPR, Trademarks and LogosPenaltyReasonable CareSeizuresU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

A Year in Review!

posted by Jennifer Diaz December 20, 2019 1 Comment

2019

DTL saved clients MILLIONS of dollars in 2019. It is with great joy that we finish off 2019 celebrating our fourth anniversary! We would like to thank each of you for being an integral part of making DTL a success.

This year has been filled with numerous achievements and accomplishments. We are grateful for the clients who have entrusted their trade and customs issues to us, and we look forward to assisting you in 2020!

Below we share some of our 2019 success stories with you.

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Best PracticesE-CigaretteImportSeizuresTobaccoU.S. Food and Drug Administration (FDA)

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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ExportU.S. Bureau of Industry and Security (BIS)U.S. Customs and Border Protection (CBP)U.S. Department of Homeland Security (DHS)U.S. Food and Drug Administration (FDA)

Federal Government Shutdown ENDS

posted by Jennifer Diaz October 17, 2013 0 comments

Co Authored by Omar Franco 

Last night Congress voted to end the first federal government shutdown in seventeen years and avert a default on U.S. debt. The deal brokered between Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY) provides government funding through Jan. 15, 2014, at almost the same rate as in FY-2013 after automatic spending cuts. The debt limit would be extended through Feb. 7, 2014, if requested by President Obama. The legislation includes a mechanism to allow Congress to block the suspension through action on a resolution of disapproval. The Health and Human Services Department would be required to ensure that health-insurance exchanges verify the eligibility of all individuals applying for tax credits and cost sharing under the Affordable Care Act. Federal employees would be paid for furlough days resulting from the shutdown and members of Congress would be denied their cost-of-living increase in FY-2014.

The Senate passed the bill first with 81 senators voting in favor and 18 voting against the compromise. The House then passed the legislation 285-144, relying mostly on Democratic votes to pass the bill. Alongside the bill, the Senate agreed to a provision that House and Senate leaders would appoint a conference committee to negotiate a budget agreement by Dec. 13.

 

ExportU.S. Bureau of Industry and Security (BIS)U.S. Customs and Border Protection (CBP)U.S. Department of Homeland Security (DHS)U.S. Food and Drug Administration (FDA)

Impact of Government Shutdown

posted by Jennifer Diaz October 2, 2013 0 comments

Co Authored by Omar Franco 

The impact of the federal government shutdown, which began October 1, 2013, will be deeply felt by importers and exporters alike. Most government services deemed "essential" by the federal agencies will continue, but “non-essential” services will be discontinued until funding is restored. 

This early on, there is no obvious resolution of the budget dispute to tie the FY-2014 government funding to Affordable Care Act (ACA) reforms. Both the House and Senate are entrenched in their positions and they are not scheduled to negotiate any time soon. One side will have to capitulate or bipartisan negotiations will have to lead to a resolution. We feel that negotiations will probably not occur this week as both sides need to assess how the markets and voters will respond to the federal government shutdown. Depending on the public response, we will see movement by one side, probably by Republicans, if the reaction is seen as damaging. As of today, the Dow was up, so the market reaction has been subdued. The reaction from voters is still unknown, but if it is subdued as well, the shutdown will be prolonged. We anticipate the shutdown will last through this week at a minimum.

Some lawmakers are considering broadening the debate by including the debt ceiling. Pressure from resolving the government shutdown could also resolve the debt ceiling issue. The longer the shutdown continues, the more likely the resolution will be tied to the debt ceiling. We do foresee a resolution emerging, however, we do not have any real idea as to what the time frame will be.

To get a glimpse of the impact on the importing and exporting community, we’ve included updates from the BIS and ITC below.

For example, on the export side, the Department of Commerce’s Bureau of Industry and Security (BIS) has this note on its website — they are completely SHUT DOWN, and not accepting licenses – except for emergencies.  See more here: 

The Federal Government is currently shut down due to a funding lapse. As a result, the Department of Commerce’s Bureau of Industry and Security (BIS) is no longer accepting export license applications, classification requests (CCATS), encryption reviews, encryption registrations, or advisory opinion requests. Similarly, BIS will not be issuing any final determinations. The SNAP-R application on BIS’s Website is not available and will not reopen until the Federal Government shutdown ends. All pending export license applications, commodity classification requests, encryption reviews, encryption registrations, and advisory opinion requests will be held without action by BIS until the shutdown ends.

Applicants may request emergency processing of export license applications for national security reasons by submitting email requests to Deputy Assistant for Export Administration Matthew Borman.

The subject line of the email should read "Request for Emergency License" and the email must identify the applicant (including point of contact), intermediate and ultimate consignees, and end user(s), items, end use, and national security justification for the emergency processing.

On the import side, the impacts are distinctly felt with the U.S. International Trade Commission (ITC).  The interactive HTS that I love is not active – and ADD/CVD investigations are tolled.  CUSTOMS Info Global Data Mining has taken the opportunity to present a PDF copy of the HTSUS during the ITC’s hiatus here (note you will have to provide your contact information).

See the latest from the ITC’s website

The U.S. International Trade Commission will shut down its investigative activities for the duration of the absence of appropriation. These activities include, but are not limited to, proceedings conducted under the authority of Title VII of the Tariff Act of 1930, including antidumping and countervailing duty investigations and reviews; investigations and ancillary proceedings conducted under the authority of section 337 of the Tariff Act of 1930; and investigations conducted under the authority of section 332 of the Tariff Act of 1930.

Investigations tolled

During shutdown, the schedules and deadlines for all investigative and pre-institution activities will be tolled. All hearings and conferences will be postponed, subject to the exceptions described below. Once the Commission receives funding and the period of the shutdown ends, all schedules will resume starting with the day on which the Commission recommences operations. For example, if the shutdown lasts four days (e.g., October 1-4), then the deadline for the filing of any document on October 4 would be extended four days to October 8. If a rescheduled deadline falls on a nonbusiness day, the deadline will be extended to the next business day. The agency may reconsider schedules after resuming operations.

Exceptions

Notwithstanding the general tolling of schedules:

The staff conferences in preliminary phase antidumping and countervailing duty investigations scheduled to take place on October 7, 2013 and October 9, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Should the shutdown not end before October 3, 2013, all conferences will be rescheduled pursuant to the general tolling provisions described above.

The hearing in the Hot-Rolled Steel five-year reviews scheduled for October 3, 2013 will take place as scheduled if the Commission resumes operations by October 2, 2013. Otherwise, this hearing will be rescheduled upon further notice.

The hearing for Investigation No. 332-541, Trade Barriers that U.S. Small and Medium-Sized Enterprises Perceive as Affecting Exports to the European Union, scheduled to take place on October 8, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Otherwise, this hearing will be rescheduled upon further notice.

Website

During shutdown, the online services provided on the Commission’s World Wide Web site, at www.usitc.gov, will be unavailable. This includes:

  • USITC website
  • EDIS
  • DataWeb
  • HTS Online Reference Tool
  • All phone communication with USITC staff
  • Restoration of service is expected as quickly as possible after appropriations become available.

If you have an questions on how the shutdown will impact your business contact Omar or me anytime.

FoodFSMAImportU.S. Food and Drug Administration (FDA)

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.