News & Analysis as of

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

Quickly Take Your Medicine: FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished...

Taking a page from an established Customs program, importers of active pharmaceutical ingredients (APIs) and finished drug products may now have the opportunity to become eligible for expedited entry into the United States. ...more

Advertising News & Analysis - August 15, 2013

In this issue: - Register Now for ERA D2C Convention - NAD Has FTC's Number...And is Not Afraid to Use It - Venable Obtains Decisive Victory for Email Advertisers and Marketers - More on...more

Agribusiness Alert: FDA Proposes Significant Regulatory Rules under FSMA related to Imported Foods, the Accreditation and Auditing...

The Food and Drug Administration (FDA) released for public comment two significant regulations promulgated under the 2011 Federal Food Safety Modernization Act (FSMA). The new regulations relate to food produced and processed...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

11th Circuit Case Signals Split on Law vs. Regulation vs. … Contract?

On February 22, 2013, the U.S. Court of Appeals for the Eleventh Circuit vacated the smuggling and conspiracy convictions of two importers of allegedly tainted cheese products in the case of United States of America v. Yuri...more

Is Your Food Safe to Eat?

According to the U.S. Food and Drug Administration (FDA), one in six people suffer a food-borne illness in the United States each year. Sweeping new rules proposed by the FDA in January are intended to reduce the amount of...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

Physicians and Pharmacies Must Be Aware of the Dangers and Potential Penalties Associated with Importing Prescription Drugs

Introduction - As the price of healthcare continues to increase, healthcare practitioners have become more innovative and creative in their attempts to keep costs affordable for their patients. One technique which has...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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