FDA Issues Archives - Page 26 of 32 - Customs & International Trade Law Firm

On February 1, 2013 Many Food Facilities Face Suspension

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in 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, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA.

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 summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration […]

By Jennifer Diaz|2013-01-22T21:40:00-05:00January 22, 2013|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

FDA Biennial Registration is Up and Running

Biennial Registration Renewal for Food Facilities is now available, as of October 22, 2012.

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.

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 summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. If your not re-registered by December 2012, FDA will cancel your Bioterrorism Act registration and your importations will be delayed.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) 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 […]

By Jennifer Diaz|2022-07-08T15:52:37-04:00October 8, 2012|FDA Issues, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

As U.S. Imports from China Intensify so does CBP Enforcement

Co-authored by Michael De Biase.

With the concentration of US imports from China increasing in parallel with intellectual property rights seizures, companies rely heavily on the government, specifically on US Customs and Border Protection (“CBP”) to help protect and enforce their intellectual property rights (“IPR”).

According to Global Sources, a leading business-to-business media company and a primary facilitator of trade with Greater China, “US imports from China [are] more concentrated than ever“.

Data from the U.S. Department of Commerce establishes that importation into the U.S. is a concentrated field, with the top 500 U.S. importers – 0.4 % of all importers – comprising roughly 68% of all imports by value in 2010. Imports from China, although somewhat less concentrated, are still dominated by larger enterprises, as companies with more than 500 employees – 4% of all importers from China – account for 60% of all imports from China. As concentration increases, the opportunity to trade in quantities that take advantage of China’s economies of scale decrease; thus, heightened concentration is not a good thing for Chinese manufacturers.

While the import concentration from China is growing, CBP is reporting a record number of IPR seizures. From 2010-2011 alone, IPR seizures increase by 24%, and have nearly doubled since 2009. Considering that China is the number one source company of imports, it should come as no surprise that it also accounts for the largest number of IPR seizures, with 62% of […]

By Jennifer Diaz|2022-07-07T09:24:36-04:00September 18, 2012|Best Practices, China, China Trade War, Counterfeits, Import, Import Alert, International Business, International Law, International Trade, IPR, Trademarks and Logos, Supply Chain, U.S. Customs and Border Protection (CBP)|0 Comments

Don’t Let Your Bioterrorism Act Registration Lapse

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 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