News & Analysis as of

Imports The United States Food and Drug Administration

Food and Beverage News and Trends - October 2017

by DLA Piper on

FDA formally delays effective date of new Nutrition Facts label. The FDA has extended the compliance deadline for the new Nutrition Facts label until January 1, 2020 for large manufacturers and January 1, 2021 for...more

Food & Beverage Litigation Update | August 2017 #3

As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 5

by Jones Day on

On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing additional time for implementation. The rules were finalized in May 2016 and...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

The First Thing You Should Do…

by Arnall Golden Gregory LLP on

The first thing you should do when considering whether to export your product to the United States is determine whether the product can be marketed or sold in the United States, or if there are license or registration...more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

United States and Australia: Comparable Food Safety Systems

by Jones Day on

On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each other. This is the third time that the FDA has given this recognition to a...more

FDA Issues Further Guidance Related to FSVP

by Jones Day on

On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program ("FSVP") regulation. The three-page...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 3

by Jones Day on

FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more

Food and Drug Administration Attempts to Streamline Review of Imports

by Faegre Baker Daniels on

The Food and Drug Administration (FDA) issued a final rule on November 29, 2016, establishing requirements for the electronic filing of import entries of FDA-regulated products. Once the rule takes effect, the entries must be...more

FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports

by Kelley Drye & Warren LLP on

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program (VQIP), which will provide a mechanism for eligible food importers to expedite...more

What You Need to Know About U.S. Law: Product Regulations and Importing into the United States - What You Don't Know CAN Hurt You...

by Pierce Atwood LLP on

What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2016

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - Office Of Inspector General Considers Pesticide Imports: In a memorandum dated April 22, 2016, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) informed EPA that...more

Donald Trump Proposes Prescription Drug Importation as Element of Health Reform Plan

by Reed Smith on

Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes...more

ACE Deadline Reminder for Imports and Exports

On February 28, 2016, those involved with imports and exports are preparing to undergo a major transition. As of that date, all entries must be filed using the new Automated Commercial Environment (ACE) system. ACE not only...more

FDA Places Ban on Import of GE Salmon

Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in...more

FDA Issues New Food Safety Rules

by Dorsey & Whitney LLP on

The U.S. Food and Drug Administration (“FDA”) issued three new rules on November 13 implementing the 2011 Food Safety Modernization Act. The Final Rule on Produce Safety establishes microbial water quality standards for water...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

by Arnall Golden Gregory LLP on

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Food and Beverage Alert (US)

by DLA Piper on

Former food executive faces possible life sentence for salmonella outbreak. The possible fate of Stewart Parnell, a former president of the Peanut Corporation of America, is being discussed in media worldwide. Federal...more

IP/Unfair Comp. Case Applies Buckman

by Reed Smith on

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

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