Imports The United States Food and Drug Administration

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FDA Releases Draft Guidance on its Voluntary Qualified Importer Program

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program (VQIP). The FDA is establishing VQIP to enable the expedited review and...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

FDA Finally Releases Initial Framework for Food Importation “VQIP”

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more

Be Careful What You Wish For!

This oft-stated warning is certainly true for those who engage in international trade. For many years, industry has complained to government about different agencies wanting different information at different times in the...more

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond...more

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

New FDA Strategy Document for FSMA, Food Safety Modernization ACT

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”). The document is intended to “to guide the next phase of FSMA...more

New FDA Food Safety Rules Will Affect Foreign Food Suppliers, Foreign Food Producers, U.S. Food Importers

The U.S. Food and Drug Administration (FDA) has released two proposed rules, one governing foreign supplier verification and the other governing third-party audits and certification. Comments are due by November 26, 2013....more

Split Emerges on Customs Law after Eleventh Circuit Vacates Smuggling Convictions

On February 22, the US Court of Appeals for the Eleventh Circuit held that an indictment charging the unlawful importation of goods into the United States, in violation of 18 U.S.C. §§ 545 and 371, failed to state an offense...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

FDA Seeks Importer and Exporter Input on Food Safety Law Changes

U.S. food importers and foreign companies exporting food to the U.S. will soon be subject to important new requirements under the recently-enacted Food Safety Modernization Act, which the Food and Drug Administration has...more

New Food Safety Law Facing Funding Hurdles

Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the...more

President Obama Signs New Expansive Food Safety Law

In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more

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