Join FDA in Miami to Discuss Major FSMA Proposed Rules

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

By |2021-11-10T14:12:27-05:00September 26, 2013|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|Comments Off on Join FDA in Miami to Discuss Major FSMA Proposed Rules

FDA Finally Issues Definition of “GLUTEN FREE”!

HOT OFF THE PRESS!!! FDA issued the update below today DEFINING the term "Gluten Free". As a Celiac, this is extremely exciting news! The reason this is a HUGE deal? Us Celiac's need to know we can trust food products that are labeled "gluten free". If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

By |2021-11-10T14:13:47-05:00August 2, 2013|Best Practices, Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Finally Issues Definition of “GLUTEN FREE”!

FDA Discusses TOP Reasons for Detention of Goods

At today's Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA's Joint Team 488 - which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows...

By |2021-11-10T14:22:59-05:00March 20, 2013|Best Practices, Cosmetics, Food, FSMA, Import, Import Alert, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Discusses TOP Reasons for Detention of Goods

FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

Do you manufacture, process, pack or hold human food? If so, you need to keep up with the Food Safety Modernization Act (FSMA). The FDA has proposed a new rule issued under the FSMA that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods. Here's a recap of the proposed rule and your chance to comment to the FDA. You have until May 16, 2013 to submit your comments to the FDA on the proposed rule.

By |2021-11-10T14:26:25-05:00January 30, 2013|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|Comments Off on FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

On February 1, 2013 Many Food Facilities Face Suspension

Are you a company that manufactures/processes, packs, or holds food, alcoholic beverages, and/or dietary supplements for consumption in the U.S.? If so, have you re-registered your food facility with the U.S. Food and Drug Administration (FDA)? 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.

By |2021-11-10T14:27:13-05:00January 22, 2013|Food, FSMA, U.S. Food and Drug Administration (FDA)|Comments Off on On February 1, 2013 Many Food Facilities Face Suspension

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

Are you a manufacturer, processor, packer or holder of food products? If you are, or know someone who is, you need to keep up with the latest and greatest updates regarding compliance with the FDA's Food Safety Modernization Act (FSMA). This post includes a 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.

By |2021-11-10T14:30:26-05:00December 20, 2012|Food, FSMA|2 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 |2021-11-10T14:37:35-05:00October 8, 2012|FSMA|Comments Off on FDA Biennial Registration is Up and Running

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 in place 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. Among the requirements are new rules for Bioterrorism Act registrations. Read on to make sure your registration isn't cancelled unnecessarily.

By |2021-11-10T14:41:11-05:00August 29, 2012|Food, FSMA, Import|Comments Off on Don’t Let Your Bioterrorism Act Registration Lapse

2012 International Boston Seafood Show

The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center. The Show attracts 19,000 visitors, and is the largest seafood show in North America. See www.bostonseafood.com. I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know - now.

By |2012-03-12T07:23:16-04:00March 12, 2012|Food, FSMA|Comments Off on 2012 International Boston Seafood Show
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