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Congressional hearing preparation

Congressional Hearing Preparation for Food Industry Companies: A Legal Guide to Oversight, Investigations, and Witness Defense

Government Relations, Public Policy, Uncategorized /

Congressional oversight of the food industry has intensified. Whether the trigger is a high-profile recall, a food safety outbreak, a supply chain failure, or a policy dispute with a federal agency, food companies increasingly face committee inquiries, document requests, and formal hearing summons. Your regulatory affairs team knows how to manage FDA inspections and USDA […]

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False advertising defense strategies

False Advertising Defense: The Legal Strategies Companies Need When FDA or FTC Enforcement Strikes

Food Distribution & International Trade, Uncategorized /

Your marketing claims meet industry standards. Your labeling passed internal review. Yet you’ve received an FDA Warning Letter, an FTC demand letter, or worse – notification that the Department of Justice is investigating potential criminal misbranding charges. I know this because enforcement against food, supplement, and consumer product advertising has intensified dramatically in 2025-2026. FDA

False Advertising Defense: The Legal Strategies Companies Need When FDA or FTC Enforcement Strikes Read More »

FDA and FTC Issue Warning Letters to Companies Selling Copycat Delta-8 THC Food Products

Cannabis, Uncategorized /

On July 16, 2024, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to six companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (THC) and introducing them into the marketplace, violating the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA highlighted two primary concerns: the

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USTR and the White House Announce the Increase of Section 301 Tariffs on Certain Products, a Limited Exclusion Process, and the Increase of CBP Enforcement

USTR, Customs and Trade, Uncategorized /

Today, the White House and the Office of the U.S. Trade Representative (USTR) announced the results of the USTR’s statutory 4-year review of the tariff actions in the Section 301 investigation of China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation (the China tariffs imposed under former President Trump).  As had

USTR and the White House Announce the Increase of Section 301 Tariffs on Certain Products, a Limited Exclusion Process, and the Increase of CBP Enforcement Read More »

CANNASWEEP

Uncategorized, Cannabis /

WEEK OF APRIL 5, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress. 

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International Travelers Beware: CBP Seized More Than $7 million from Travelers Across the U.S. in October 2023

Customs and Trade, Uncategorized, USTR /

Did you know that if you travel to the U.S. carrying large amounts of money, you are required to report that money to U.S. Customs and Border Protection (CBP)?  Failure to report can lead to the seizure of your money by CBP, with no guarantee that it will be returned to you. The penalties for

International Travelers Beware: CBP Seized More Than $7 million from Travelers Across the U.S. in October 2023 Read More »

Decoding CBP’s Modernized Customs Broker Regulations – What You Need to Know

Customs and Trade, Uncategorized /

U.S. Customs and Border Protection (CBP) issued the final rule modernizing the customs broker regulations 19 CFR 111 with an effective date of December 19, 2022.   Key changes include transitioning to a national permit framework, requiring that a customs broker have direct communication with an importer, revising the standard of care of using responsible supervision

Decoding CBP’s Modernized Customs Broker Regulations – What You Need to Know Read More »

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Medical Devices, FDA, Uncategorized /

The U.S. Food and Drug Administration (FDA) has been actively working to address cybersecurity concerns related to medical devices. On March 29, 2023, FDA published a much-anticipated cybersecurity final guidance regarding cybersecurity requirements for medical device pre-market submissions. Medical devices, like many other modern technologies, are susceptible to cybersecurity vulnerabilities that could potentially compromise patient

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management Read More »

October Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, EPA, FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing, Uncategorized, USDA, USDA FSIS /

OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from October that we took note of. If you have any questions or would like more information, please

October Food and Agriculture Regulatory Recap Read More »

3/19/20 OFW Law Daily COVID-19 News Conference Summary

Uncategorized /

President Donald Trump and Vice President Mike Pence held a press conference beginning at 11:30 this morning. They were joined by FDA Commissioner Stephen Hahn, White House Coronavirus Response Coordinator Deborah Birx, and Surgeon General Jerome Adams. Summary of the President’s remarks and questions: The President announced that he signed HR 6201, the Families First

3/19/20 OFW Law Daily COVID-19 News Conference Summary Read More »

FDA holds public meeting in April 2015

FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance

FDA, For Export, Uncategorized /

FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional Adulteration” (Final Rule), codified at 21 C.F.R. Part 121.  The public meeting is taking place on April 17, 2019, from 8:30 AM to

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FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement

FDA, Uncategorized /

As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for  FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” rule (Produce Rule) are being extended.  Today, FDA published a final rule in the Federal

FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement Read More »

Government shutdowns – Who dreamed up this crazy idea?

Public Policy, Uncategorized /

In all the drama and commotion over the government shutdown, now in its third week, with 800,000 federal employees going without paychecks and services disappearing by the day, all prompted by President Trump’s insistence on funding his proposed Mexican border wall and Congressional Democrats’ refusal to provide it, has anyone stopped to notice how frankly

Government shutdowns – Who dreamed up this crazy idea? Read More »

Opinion: The EU Gene-Editing Decision: Parliament Should Not Let it Stand

Public Policy, Uncategorized /

The European Union Court of Justice’s (ECJ) recent decision that new gene-editing techniques must go through the same lengthy approval process as traditional transgenic genetically modified (GM) plants has sent shock waves around the world and its greatest impact will be on those who are hungry and food insecure. The decision will have a direct

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John Block: Trade

Uncategorized /

Pick up a paper or turn on the TV – It’s all about trade. So that’s the subject I’m going to talk about today. Will there be a trade war? Our agriculture industry that exports 20% of what we produce could get pounded pretty hard. A lot of President Trump’s critics don’t think he has

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John Block: Tariffs

Uncategorized /

By former USDA Secretary John R. Block Just when I was so comfortable with President Trump’s follow through with so many of his campaign promises – conservative judges, tax reform, cuts in regulations, and securing our borders. The stock market has soared more than 30% since he was elected. Suddenly, last week, he announced his plan

John Block: Tariffs Read More »

To Fix FEMA’s National Flood Insurance, Take a Page From USDA’s Federal Crop Insurance (Part 1 of a 2 Part Series)

Public Policy, Uncategorized /

It will take months to calculate the damage Hurricanes Harvey and Irma unleashed on Texas, Louisiana, Florida, and other states this summer: lives lost, homes destroyed, businesses wrecked, property damage in the tens of billions of dollars.  But beyond everything else, these storms and their massive devastation have exposed deep problems in the Federal government’s

To Fix FEMA’s National Flood Insurance, Take a Page From USDA’s Federal Crop Insurance (Part 1 of a 2 Part Series) Read More »

John Block: GE Science

Uncategorized /

By former USDA Secretary John R. Block I am encouraged. I think that we have some pretty strong voices in the Trump Administration speaking out in support of agriculture. Our strongest voice comes from Secretary of Agriculture Sonny Perdue. He said after meeting with 75 Senators “their number-one, two, and three priorities were trade, trade,

John Block: GE Science Read More »

EU-US Regulatory Cooperation: Strides Made, but More Can Be Done

FDA, Uncategorized /

Earlier this week, the George Washington University Regulatory Studies Center released a significant report, “International Regulatory Cooperation:  Benefits, Limitations, and Best Practices.”  This report builds on earlier work done by the Center and examines opportunities to improve regulatory cooperation between the European Union and the United States.  The report is timely because negotiators from the

EU-US Regulatory Cooperation: Strides Made, but More Can Be Done Read More »

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