Category Archives: Imports/Exports

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“The White Sauce” Decision (International Custom Products, Inc. v. United States) Highlights Importance of Administrative Procedures for Food Importers

The Court of Appeals for the Federal Circuit decision, International Custom Products, Inc. v. United States, 2015 U.S. App. LEXIS 11170 (Fed. Cir. June 30, 2015), was ten years in the making and provides a stern lesson for importers of food products to follow U.S. Customs and Border Protection’s administrative procedures carefully.  If not, importers … Continue Reading

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing … Continue Reading

U.S.-China Commission Study Provides Policy Recommendations to Help U.S. Exporters Compete in China’s Growing Medical Device and Pharmaceutical Market

A recent report issued by the U.S.-China Economic and Security Review Commission (USCC)[1] highlights why the Chinese market is central to the business strategy of many U.S. companies that manufacture and market pharmaceuticals, medical devices, and other healthcare products.  The Congressionally-mandated report[2], issued in November 2014, addresses in detail the opportunities and challenges surrounding access to … Continue Reading

Not So “COOL”: WTO Meat Labeling Dispute Moves One Step Closer to Canadian and Mexican Retaliation Against U.S. Exports

On October 20, 2014, a World Trade Organization (“WTO”) Compliance Panel ruled that the U.S. Department of Agriculture’s (“USDA’s”) revised country-of-origin labeling (“COOL”) regulations for meat are inconsistent with U.S. obligations under the WTO.  The panel found the amended rulings – which were revised to include information about where each of the production steps, including … Continue Reading

Potential for Delays at West Coast Ports As Labor Negotiations Continue

Importers and exporters are to be advised of potential delays at many West Coast ports caused by ongoing contract negotiations between International Longshore and Warehouse Union (ILWU) and the Pacific Maritime Association (PMA).   Negotiations between the union and association will resume tomorrow, July 11, but U.S. importers and exporters are urged to develop contingency plans … Continue Reading

FDA Releases Draft Guidance on Proper Labeling of Honey and Honey Products

The FDA today released a Draft Guidance that offers a definition for “honey” without formally establishing a standard of identity and cites to existing laws and regulations to respond to questions regarding the proper labeling of honey and honey products. The Draft Guidance follows FDA’s 2011 denial of a petition for a standard of identity … Continue Reading

Taking Advantage of the Korea-U.S. Free Trade Agreement

March 15, 2014 was the second anniversary of the implementation of the Korea-U.S. Free Trade Agreement (“KORUS”).  This agreement is a tremendous opportunity for companies trading in the food, drug, medical device, and cosmetics industries.  South Korea is the seventh largest trading partner of the U.S. and the U.S. is the third largest trading partner … Continue Reading

Bulk Drug Importer Sues FDA For Refusing Entry of 20,000-Kilogram API Shipment

Recently, H&M USA, an importer of  periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful.  The FDA issued a Notice of Refusal, alerting the company that it had failed to … Continue Reading

Honeygate II Highlights Supply Chain Risks For U.S. Buyers Of Imported Goods

Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation. The takeaway: Not being the importer of record for fraudulently … Continue Reading

FDA Announces $750,000 Grant to WTO Standards and Trade Development Facility

The Food and Drug Administration (FDA) has announced its intention enter a cooperative agreement with the World Trade Organization’s (WTO) Standards and Trade Development Facility (STDF). Under the cooperative agreement, the FDA will award STDF a grant of $750,000 to support STDF activities for one year, with the possibility of additional support for four more … Continue Reading

NMFS Issues Final Rule Updating Dolphin-Safe Labeling Requirements

The National Marine Fisheries Service (NMFS) has issued a final rule updating the requirements for voluntarily labeling tuna as dolphin-safe. Under the updated rule, tuna products intended for labeling as dolphin-safe must be accompanied by a certification from the captain of the vessel that harvested the tuna and a certified and qualified observer that no … Continue Reading

TTB Promulgates Final Rule Establishing Standard of Identity for Pisco as Type of Brandy

The Alcohol and Tobacco Tax and Trade Bureau (TTB) released today its final rule that amends TTB standard of identity regulations for distilled spirits to expressly list Pisco as a type of brandy. Under the Federal Alcohol Administration Act, TTB prescribes requirements for the packaging, marking, branding, labeling, and quality of alcoholic beverages. Pursuant to … Continue Reading

FDA Proposes New User Fees to Finance Food & Cosmetic Safety

On April 10, 2013, the U.S. Food and Drug Administration (“FDA”) announced a proposal that could increase the cost of doing business for the food and cosmetic industry. In its budget request for fiscal year 2014, the FDA has proposed two new user fee programs for food companies to help pay for implementation of the … Continue Reading

USDA Proposes Amendments to Country of Origin Labeling Rule

The United States Department of Agriculture (USDA) has published a proposed rule to amend the mandatory country of origin labeling (COOL) provisions for muscle cut covered commodities (beef, including veal, lamb, chicken, goat, and pork; ground beef, ground lamb, ground chicken, ground goat, ground pork; wild and farm-raised fish and shellfish). The proposed rule would … Continue Reading

FDA Releases International Food Safety Capacity-Building Plan

As required by Congress under the Food Safety Modernization Act, the Food and Drug Administration (FDA) released its International Food Safety Capacity-Building Plan on February 28, 2013. The plan outlines how the FDA intends to expand the technical, scientific, and regulatory capacity of foreign governments over the next five years. The plan describes four key … Continue Reading

IOM Report on Counterfeit Drugs Released

On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs. The IOM first distinguishes public health concerns of falsified and substandard drugs from the intellectual … Continue Reading

FSIS Issues Notice Regarding New Methodology for Equivalence Verifications of Foreign Countries

The Food Safety and Inspection Service (FSIS) released a notice on Friday that describes a modified three-part approach to verifying the equivalence of foreign food regulatory systems that export meat, poultry, or processed egg products to the United States. In line with recent trends toward making food regulatory systems increasingly “risk-based,” including FDA’s implementation of … Continue Reading

GAO Report on Safety of Food Imports Recommends FDA Revise Approach to Comparability Assessments of Foreign Governments

In response to a request from Senators Rockefeller, Snowe, Cantwell, and Inouye, the Government Accountability Office (GAO) released a report yesterday addressing obstacles that FDA may face in implementing certain provisions of the Food Safety Modernization Act (FSMA) designed to ensure the safety of food imports. The report identifies several obstacles to the implementation of … Continue Reading

DOJ Is Prosecuting Customs Fraud Through Sarbanes-Oxley’s Obstruction Of Justice Statute

Most products sold in this country – whether imported or made here – are subject to a matrix of federal laws and regulations intended to provide Americans with significant benefits, such as safe food, safe products and a cleaner environment. The compliance costs for producers here and abroad are substantial. Further, imports can be subject … Continue Reading

CFIA Releases Draft Food Inspection Model

The Canadian Food Inspection Agency has released its draft food inspection model. The draft inspection model is of interest to all organizations that manufacture, import or export food in Canada. In particular, CFIA is seeking comments on the following portions of the draft inspection model: Single licensing and registration requirement for manufacturers, importers and exporters; … Continue Reading

FSIS Issues Directive on Import Products When Entry is Refused

The USDA Food Safety and Inspection Service has released a new directive regarding the handling of imported meat, poultry, egg products and shell eggs packed for consumer use that are refused entry into the United States. The directive instructions import inspection personnel on how to identify, control, document and dispose of products that are refused … Continue Reading

Preparing for the New FSMA Food Defense Standards

Protecting the US food supply from intentional adulteration requires coordination at all levels of government and throughout the private sector. Companies engaged in the manufacture, importation, distribution or storage of food for the U.S. market will be interested in a new article published by the Food and Drug Law Institute that provides an introduction to … Continue Reading

USDA Proposed Rule Aligns BSE Import Regulations With International Standards

The Animal and Plant Health Inspection Service of the United States Department of Agriculture (“APHIS”) is requesting comment on a proposed rule to amend the regulations governing importation of live bovines and products derived from bovines. Companies involved in the importation of meat and products derived from meet, including beef processors, dairy operations, and food … Continue Reading

Where in the World is FDA? FDA Submits Report to Congress on Foreign Programs as Required by FSMA

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or … Continue Reading
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