Header graphic for print
Customs and International Trade Law Blog News & updates on Customs and International Trade Law

Category Archives: FDA Issues

Subscribe to FDA Issues RSS Feed

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

Posted in Best Practices, FDA Issues, Import Alert, Medical Devices, Speaking

I’m pleased to be back for my fourth year teaching at FIME! For those of you that don’t know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center.  You still have limited time to register to attend the conference… Continue Reading

FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

Posted in Best Practices, FDA Issues, Food, FSMA, Gluten Free, Import, Uncategorized

According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers… Continue Reading

White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs

Posted in E-Cigarette, FDA Issues, Import, Tobacco

On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such,… Continue Reading

Do You Want to be a “Trusted Trader”? C-TPAT is No Longer Enough

Posted in Best Practices, C-TPAT, CBP, CPSC, FDA Issues, Import

U.S. Customs and Border Protection (CBP) recently published the long awaited Federal Register Notice, dated June 16, 2014, discussing the “Announcement of Trusted Trader Program Test.” This new “Trusted Trader” program is big news for U.S. and non-resident Canadian importers, and if implemented will combine the Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self Assessment… Continue Reading

Impact of Government Shutdown

Posted in BIS, CBP, Department of Homeland Security, Export, FDA Issues

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. What does this mean for export licenses and the online version of the HTS?

Join FDA in Miami to Discuss Major FSMA Proposed Rules

Posted in FDA Issues, Food, FSMA, Import

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…

Miami CANCELLED by Government Shutdown – LA WILL Go On – FDA to Discuss Major FSMA Proposed Rules

Posted in FDA Issues, Food, FSMA, Import

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…

FDA Finally Issues Definition of “GLUTEN FREE”!

Posted in Best Practices, FDA Issues, Food, FSMA, Import

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…

FDA Discusses TOP Reasons for Detention of Goods

Posted in Best Practices, Cosmetics, FDA Issues, Food, FSMA, Import, Import Alert, Medical Devices

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…

Jennifer Diaz Speaks After Dominic Veneziano at Global Clinical Sourcing & Supply Summit

Posted in Best Practices, CBP, Department of Homeland Security, Events, Export, FDA Issues, Import, Speaking, U.S.Customs

Are you a Vice President, Director, Manager, or other Senior Executive from a pharmaceutical or biotech company? Do you know someone who is? If so, they must know about the Global Clinical Sourcing and Supply Summit. The Summit includes a FDA Address by Domenic Veneziano, Director of FDA’s Division of Import Operations and Policy, and Industry Perspectives by speakers from Merck, Novartis Pharmaceuticals Corporation, AstraZeneca, and much more. Read on for a discount code…

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

Posted in FDA Issues, Food, FSMA, Import

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.

On February 1, 2013 Many Food Facilities Face Suspension

Posted in FDA Issues, Food, FSMA

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.

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

Posted in Food, FSMA

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.

FDA Biennial Registration is Up and Running

Posted in FSMA

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… Continue Reading

Don’t Let Your Bioterrorism Act Registration Lapse

Posted in Food, FSMA, Import

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.

Jennifer Diaz Opens Medical Device Seminars at FIME

Posted in Medical Devices, Speaking

The worldwide medical community is converging on Miami Beach for the largest and most comprehensive trade show in the United States, featuring medical manufacturers from all over the globe. Attorney Jen Diaz will be presenting the first seminar “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices” at the FIME Show at 10:00 AM on Wednesday, August 8, 2012.

TTB Issues Interim Policy for Labeling Gluten-Free Spirits

Posted in Food

On May 24, 2012, U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages (TTB Ruling 2012-2). Currently, there is no Food and Drug Administration (FDA) regulation that defines the term “gluten-free,” but, it’s good to see that’s not stopping TTB from moving forward.

Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements

Posted in FDA Issues

This Friday, May 25, 2012 is officially designated as Don’t Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn’t want you to fry either. On June 18, 2012 the FDA’s new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013.

Read on to learn of the major changes you should see as a result of the new requirements.

2012 International Boston Seafood Show

Posted in Food, FSMA

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.

FDA Administrative Detention of Food… What can you do?

Posted in Food, FSMA

Just a few weeks ago, FDA investigators ordered an administrative detention of a Maine company’s cold-smoked salmon product, a ready-to-eat food, during an inspection. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision, after inspectors found Listeria monocytogenes within the company’s facility and on its processing equipment.