FSMA Archives | Customs & International Trade Law Blog

FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

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By Jennifer Diaz|2021-10-07T15:02:48-04:00April 22, 2021|Food, FSMA, Import, Import Alert, International Trade, Pre-compliance, Reasonable Care, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Issues Guidance Documents on Food Facility Registration

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Constituent Update

August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).

One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. […]

By Jennifer Diaz|2022-07-15T12:02:14-04:00September 18, 2018|Food, FSMA, Import, Import Alert, International Law, International Trade, U.S. Food and Drug Administration (FDA)|2 Comments

FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements

On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:

Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
Facilities are required to renew their registration every other year.
FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the document.

Diaz Trade Consulting […]

By Jennifer Diaz|2022-07-06T16:21:16-04:00May 29, 2018|Food, FSMA, U.S. Food and Drug Administration (FDA)|2 Comments

FDA Takes New Steps in Oversight of Imported Foods

FDA announced that it has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FDA Food Safety Modernization Act (FSMA). The organization being recognized is ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) based in Milwaukee, Wisconsin. This organization is being recognized because it met the applicable FDA requirements, validated through application review and on-site assessment. FDA is recognizing ANAB for a five year term of recognition. (For more information on FDA’s standards for recognition, see: Key Facts about the Accredited Third-Party Certification Program) […]

By Jennifer Diaz|2021-11-04T15:35:20-04:00February 6, 2018|Food, FSMA, Import, International Trade, U.S. Food and Drug Administration (FDA)|1 Comment

FDA Announces Enforcement Discretion Under FSMA

On January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA), aiming to protect the public by ensuring the U.S. food supply is safe through prevention and enforcement. The FSMA included seven foundational rules, which we summarized in our FSMA: Stay Compliant with DTL’s ‘PICTURE’! blog. […]

By Jennifer Diaz|2021-11-04T15:39:29-04:00January 25, 2018|Food, Import, U.S. Food and Drug Administration (FDA)|1 Comment

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

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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By Jennifer Diaz|2022-07-06T15:47:05-04:00May 19, 2017|Best Practices, Customs Broker, Events, Food, FSMA, Import, Import Alert, Seizures, Speaking, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FREE World Trade Month Seminar on FDA/FSMA COMPLIANCE for Importers

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In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend?

For a limited time, registration is FREE!
You have the ability to hear DIRECTLY from FDA.
We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

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By Jennifer Diaz|2019-10-21T09:08:25-04:00April 24, 2017|Best Practices, Customs Broker, Events, Food, FSMA, Import, Speaking, U.S. Food and Drug Administration (FDA)|4 Comments

World Trade Month Seminar Series for Compliance Professionals

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.
In the first seminar, attendees will learn the ABC’s of Antidumping & Countervailing Duties (AD/CVD) compliance and CBP Enforcement.

In the second seminar, FDA will focus on food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? […]

By Jennifer Diaz|2017-05-09T13:52:45-04:00April 20, 2017|AD/CVD, Best Practices, Customs Broker, Events, Food, FSMA, Import, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

Import Food Products? Deadline to Comply with FSVP is May 30, 2017!

What is the FSVP Rule?

The Foreign Supplier Verification Program (FSVP) was created on November 27, 2015, as “a significant provision of the Food Safety Modernization Act (FSMA)”. The FSVP “shifts the burden of certifying the safety of food imports from [the] FDA to the importers themselves”. This means that importers must set up a program that verifies that both the foreign supplier of the food and the food itself will comply with United States (U.S.) laws.

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By Jennifer Diaz|2021-11-09T14:00:21-05:00April 13, 2017|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|2 Comments

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

Each 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. […]

By Jennifer Diaz|2021-11-09T14:05:54-05:00January 12, 2017|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|2 Comments