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Kyla S. Kaplan

SEC Stock Promotion Scheme Charges Against the Cannabis Industry

Cannabis, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

In October, the United States Securities and Exchange Commission (SEC) announced that it would be charging two (2) cannabis companies, Emerald Health and HighTimes, and six (6) associated individuals who worked with the companies, for their involvement in “stock promotion schemes.”   Stock promotion schemes are “fraudulent schemes to promote the securities of issuers that were […]

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FDA Warning Letters to Walmart and Amazon for Selling Drug Products Deemed Illegal

FDA /

On October 28, 2022, the United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) issued warning letters to both Walmart Inc. and Amazon.com, Inc. (collectively, “the Warning Letters”) for selling on their websites drug products deemed to be illegal under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In

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Federal Cannabis Updates: New Cannabis Policy Expert at FDA and Executive Announcement on Marijuana Reform 

Cannabis, FDA, Government Relations /

At the end of September, the United States Food and Drug Administration (FDA) hired cannabis policy expert Norman Birenbaum as a Senior Public Health Advisor at FDA’s Center for Regulatory Programs. Mr. Birenbaum comes to FDA with a deep background in regulation in several state cannabis departments.  Most recently, in New York State he served

Federal Cannabis Updates: New Cannabis Policy Expert at FDA and Executive Announcement on Marijuana Reform  Read More »

August Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing /

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 August that we took note of. If you have any questions or would like more information, please

August Food and Agriculture Regulatory Recap Read More »

OFW Law Lawyers Recognized in the 2023 Edition of Best Lawyers in America

OFW Law News /

OFW Law proudly congratulates three of our lawyers, Brett Schwemer (Managing Principal), Marshall Matz (Chairman), and Stephen Terman (Principal) for being recognized in the 29th edition of the Best Lawyers in America®. Mr. Schwemer and Mr. Terman are recognized for their high-caliber work in FDA Law. Mr. Matz was recognized for his high achievements in Agricultural

OFW Law Lawyers Recognized in the 2023 Edition of Best Lawyers in America Read More »

Proposed Rule: 2020 Annual Updates of List of Bioengineered Foods and Next Steps for Regulated Entities

USDA /

On July 22, 2022, the United States Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS or, the agency) published a proposed rule in the Federal Register, “2020 Annual Updates to List of Bioengineered Foods” (the Proposed Rule). The Proposed Rule is part of the agency’s annual requirement to consider updates to the List of Bioengineered

Proposed Rule: 2020 Annual Updates of List of Bioengineered Foods and Next Steps for Regulated Entities Read More »

July Food and Agriculture Regulatory Recap

FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing, USDA /

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 July that we took note of. If you have any questions or would like more information, please

July Food and Agriculture Regulatory Recap Read More »

USDA Publishes Annual Summary of Foodborne Illness Outbreaks Investigated During FY2021

Food Manufacturing, Processing, and Marketing, USDA /

As of July 2022, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS or the agency) has made publicly available the agency’s annual summary of foodborne illness outbreaks investigated last year (i.e., FY2021). The summary reports on all outbreaks that were investigated by FSIS during FY2021 and includes the following key

USDA Publishes Annual Summary of Foodborne Illness Outbreaks Investigated During FY2021 Read More »

June Food and Agriculture Regulatory Recap

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

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 June that we took note of. If you have any questions or would like more information, please

June Food and Agriculture Regulatory Recap Read More »

As Operational Guidance Becomes Available; The Uyghur Forced Labor Act Goes Into Effect

Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

The  “Uyghur Forced Labor Prevention Act” (the UFLPA) went into effect this past Tuesday, June 21, 2022. The UFLPA creates a rebuttable presumption that “any goods, wares, articles, and merchandise mined, produced, manufactured wholly or in part” in the Xinjiang Uyghur Autonomous Region (Uyghur Region) of China are produced with forced labor and therefore are

As Operational Guidance Becomes Available; The Uyghur Forced Labor Act Goes Into Effect Read More »

Resources for Human and Animal Food Producers Affected by Severe Weather Incidents

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing /

On June 6, 2022, the U.S. Food and Drug Administration (FDA) announced it released an online page providing both federal and state resources and contacts available for human and animal food producers who may be “harvesting, mixing, storing, or distributing grains and other foods” prior to and after experiencing a severe or inclement weather event

Resources for Human and Animal Food Producers Affected by Severe Weather Incidents Read More »

May Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Distribution & International Trade, USDA /

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 May that we took note of. If you have any questions or would like more information, please

May Food and Agriculture Regulatory Recap Read More »

FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC

FDA, Cannabis /

On May 4, 2022, the United States Food and Drug Administration (FDA) issued for the first time Warning Letters to companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC). While the FDA has sent warnings to companies utilizing hemp-derived cannabidiol (CBD) before, this is the first set of Warning Letters to those selling delta-8 THC products for

FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC Read More »

April Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, EPA, FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing, 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 April that we took note of. If you have any questions or would like more information, please

April Food and Agriculture Regulatory Recap Read More »

Federal Cannabis Legalization & Regulation: A Timely Discussion of The Mace States Reform Act

FDA, Cannabis, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

Background By the end of 2021, ninety-one percent of Americans reported favoring some form of marijuana legalization. To date, eighteen (18) states and Washington, DC, have legalized adult recreational use of marijuana, and thirty-seven (37) states and four (4) territories have medical use programs. More states will likely be expanding access to marijuana with ballot

Federal Cannabis Legalization & Regulation: A Timely Discussion of The Mace States Reform Act Read More »

New Emergency Livestock Relief Program (ELRP) Phase 1 To Provide $750 Million in Relief to Livestock Producers  

Agriculture & Agribusiness, USDA /

On April 4, 2022, the United States Department of Agriculture’s (USDA) Farm Service Agency (FSA) published a notice in the Federal Register announcing the new Emergency Livestock Relief Program (ELRP). The first phase of ELRP (i.e., Phase 1) will provide payments to producers who faced increased supplemental feed costs as a result of forage losses

New Emergency Livestock Relief Program (ELRP) Phase 1 To Provide $750 Million in Relief to Livestock Producers   Read More »

March Food and Agriculture Regulatory Recap

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

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 March that we took note of. If you have any questions or would like more information, please

March Food and Agriculture Regulatory Recap Read More »

February Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing, Health Care, Public Policy, USDA /

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 February that we took note of. If you have any questions or would like more information, please

February Food and Agriculture Regulatory Recap Read More »

Declaration of a National Emergency Extended; Important Beyond Protecting the Public from the Risks of COVID-19

FDA, Food Manufacturing, Processing, and Marketing, Government Relations, Health Care /

On February 23, 2022, the Administration published in the Federal Register a Notice of “Continuation of the National Emergency Concerning Coronavirus Disease 2019 (COVID-19) Pandemic” to extend the national emergency declaration from  March 13, 2020.  The 2020 Declaration was due to expire on March 1, 2022 and, with this Administrative Order, the national emergency continues,

Declaration of a National Emergency Extended; Important Beyond Protecting the Public from the Risks of COVID-19 Read More »

Farmers and Ranchers Can Now Access Online Reporting Portal to Report Potentially Unfair and Anticompetitive Practices

Agriculture & Agribusiness, Food Manufacturing, Processing, and Marketing, Government Relations, USDA /

Today, the U.S. Department of Agriculture (USDA) and U.S. Department of Justice (DOJ) launched an online reporting portal, located at USDA’s Farmer Fairness website, to advance the goals of the “Biden-Harris Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain” (the Action Plan).   By way of review,

Farmers and Ranchers Can Now Access Online Reporting Portal to Report Potentially Unfair and Anticompetitive Practices Read More »

January Food and Agriculture Regulatory Recap

USDA, Agriculture & Agribusiness, FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing, 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 January that we took note of. If you have any questions or would like more information, please

January Food and Agriculture Regulatory Recap Read More »

Trademark Modernization Act Took Effect December 18, 2021

Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

On December 18, 2021, regulations implementing the Trademark Modernization Act of 2020 (“TMA”) went into effect. By amending the Trademark Act of 1946 (Lanham Act), individuals, businesses, and the United States Patent and Trademark Office (USPTO) now have new tools at their disposal to clear unused trademarks and service marks (hereinafter “marks”) from the Principal/Supplemental

Trademark Modernization Act Took Effect December 18, 2021 Read More »

December Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

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 December that we took note of. If you have any questions or would like more information, please

December Food and Agriculture Regulatory Recap Read More »

FTC Issues Orders to Major Retailers, Wholesalers, and Product Suppliers Regarding Supply Chain Disruptions

Agriculture & Agribusiness, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

On November 29, 2021, the Federal Trade Commission (FTC) ordered nine large retailers, wholesalers, and consumer good suppliers to provide “detailed information” to the FTC.  The FTC explains that it is seeking this information to “shed light on the causes behind ongoing supply chain disruptions and how these disruptions are causing serious and ongoing hardships

FTC Issues Orders to Major Retailers, Wholesalers, and Product Suppliers Regarding Supply Chain Disruptions Read More »

6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate

Agriculture & Agribusiness, CPSC, EPA, FDA, Government Relations, Health Care, Healthcare, Life Sciences, Public Policy, USDA, USDA FSIS /

On November 16, 2021, the Judicial Panel on Multidistrict Litigation, through a lottery system, drew the 6th Circuit as the U.S. Court of Appeals that will hear the consolidated lawsuits against the Occupational Health and Safety Administration (OSHA) Emergency Temporary Standard (ETS) published in the Federal Register on November 5, 2021. The OSHA ETS, which

6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate Read More »

UPDATE: Federal Contractor Vaccine Mandate

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing, Government Relations, Health Care, Healthcare, USDA, USDA FSIS /

Federal Contractors are being given additional time and flexibility to address the vaccination mandate – Employees must be fully vaccinated by January 18, 2022.   The Department of Health and Human Services (HHS) and The United States Department of Agriculture (USDA) Contracting Officers Have Enormous Discretion To Add Vaccine Mandate Clause to Product Contracts.  

UPDATE: Federal Contractor Vaccine Mandate Read More »

OSHA Releases ETS on Vaccine and Testing Mandate

FDA, Government Relations, Health Care, Healthcare /

On November 4, 2021, the Occupational Safety and Health Administration’s (OSHA) released the prepublished version of its expected new emergency temporary standard (ETS). The OSHA ETS (interim final rule; request for comments) was published in the Federal Register on November 5, 2021. The OSHA ETS requires employers with 100 or more employees to mandate that all their

OSHA Releases ETS on Vaccine and Testing Mandate 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 »

FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

FDA, Health Care, Healthcare, Life Sciences /

On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020).    The GGP Rule required: Each guidance document issued by HHS

FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures Read More »

The FOREST Act of 2021 – Senate Bill Prohibiting the Importation of Products Produced on Land Undergoing Illegal Deforestation

Agriculture & Agribusiness, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

Senator Brian Schatz (D-HI) and Earl Blumenauer (D-OR) announced today the introduction of the “Fostering Overseas Rule of Law and Environmentally Sound Trade Act of 2021” (“FOREST Act”). The text of the FOREST Act is available here.  The FOREST Act addresses the environmental and human consequences of illegal deforestation. The addition to the Tariff Act

The FOREST Act of 2021 – Senate Bill Prohibiting the Importation of Products Produced on Land Undergoing Illegal Deforestation Read More »

September Food and Agriculture Regulatory Recap by Kyla Kaplan

Agriculture & Agribusiness /

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 September that we took note of. If you have any questions or would like more information, please

September Food and Agriculture Regulatory Recap by Kyla Kaplan Read More »

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