Bioterrorism Act Archives - Customs & International Trade Law Firm

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?

For a limited time, registration is FREE!
You have the ability to hear DIRECTLY from CBP and 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 the Centers of Excellence and Expertise (CEE) and Antidumping & Countervailing Duties (AD/CVD) for CBP, and food importation/FSMA related questions for the FDA. Please email your questions today to info@diaztradelaw.com!

Full details including registration information for BOTH seminars are below. […]

By Jennifer Diaz|2017-04-21T20:28:06-04:00April 20, 2017|AD/CVD, Bioterrorism Act, CBP 28, CBP 29, CEE, Events, FDA Issues, FDA Notice of Detention, Food, FSMA, International Law, International Trade, Pre-compliance, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments

New FDA TOOL for Importers

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.

You can easily register with the FDA on the new www.FDA-USA.com website and if you are a foreign facility, can request that my firm act as your U.S. agent.

Remember, all food facilities which are required to register with the FDA will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. Meaning, the clock is currently ticking, you only have until December 31 to assure your biennial registration is completed or risk FDA cancelling your registration and losing your ability to import into the U.S.!

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October – December registration renewal period.

Have questions? Contact me anytime at jdiaz@bplegal.com.

By Jennifer Diaz|2022-07-08T16:54:59-04:00October 30, 2014|Bioterrorism Act, Import, U.S. Food and Drug Administration (FDA)|0 Comments

MANDATORY BIENNIAL REGISTRATION RENEWAL TO TAKE PLACE OCTOBER-DECEMBER 2014

Mandatory 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.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October– December 2014 registration renewal period.

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve […]

By Jennifer Diaz|2022-07-08T16:52:54-04:00September 11, 2014|Bioterrorism Act, Food, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Extends Until January 31 for Food Facilities to Re-Register

Below are the latest and greatest updates regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA’s extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration – meaning they can NOT import into the U.S. FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Re-Inspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted […]

By Jennifer Diaz|2022-07-08T15:53:43-04:00December 18, 2012|Bioterrorism Act, Enforcement, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

Don’t Let Your Bioterrorism Act Registration Lapse

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biannual Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biannual registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

live or maintain a place of business in the U.S. and
be physically present in the U.S.

The U.S. Agent is also responsible for the payment of “reinspection fees” of foreign […]

By Jennifer Diaz|2012-09-04T14:00:00-04:00September 4, 2012|Bioterrorism Act, Food, U.S. Food and Drug Administration (FDA)|0 Comments