Frank Yiannas Announces Resignation from FDA
Today, Frank Yiannas announced his resignation, via a letter to Commissioner Califf, as Deputy Commissioner for Food Policy and Response at the United States Food and Drug Administration (“FDA” or “the agency”). Yiannas has been with FDA since December 2018. Previously he was the Vice President for Food Safety at Walmart and Sam’s Club stores.
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December Food and Agriculture Regulatory Recap
The building 2023 Farm Bill pressures coincide with FDA signaling that it will soon be taking significant action on cannabinoids. In addition to the November 2022 warning letters: In December 2022, FDA Chief Scientist Dr. Namandjé N. Bumpus said that “CBD science” is a top priority and that there are broad cross-agency initiatives underway, and
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November Food and Agriculture Regulatory Recap
On November 29, 2022, USDA Agricultural Marketing Service (AMS) announced a forty-five (45) day extension for the submission of comments and information on “Inclusive Competition and Market Integrity Under the Packers and Stockyards Act.” Comments are now due on January 17, 2023. Other On November 18, 2022, USDA-FSIS published a Federal Register Notice, “Expansion
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SEC Stock Promotion Scheme Charges Against the Cannabis Industry
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 conducting
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FDA Warning Letters to Walmart and Amazon for Selling Drug Products Deemed Illegal
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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October Food and Agriculture Regulatory Recap
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 should be highlighted. If you have any questions or would like more information, please do
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Federal Cannabis Updates: New Cannabis Policy Expert at FDA and Executive Announcement on Marijuana Reform
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
September Food and Agriculture Regulatory Recap
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 should be highlighted. If you have any questions or would like more information, please do
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ESG Disclosure/Reporting Continues to Trend Across Food, Agriculture, and Medical Device Sectors
In 2022, Environmental, Social, Governance (ESG) disclosure, claims, and reporting has been a popular topic in the United States. ESG has several definitions, but at its’ core ESG ideals focus on sustainability, diversity, climate and carbon emissions, waste, labor conditions, and ethical governance, among other matters. OFW Law has written about ESG before in the
August Food and Agriculture Regulatory Recap
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
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OFW Law Lawyers Recognized in the 2023 Edition of Best Lawyers in America
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
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Proposed Rule: 2020 Annual Updates of List of Bioengineered Foods and Next Steps for Regulated Entities
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
July Food and Agriculture Regulatory Recap
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
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USDA Publishes Annual Summary of Foodborne Illness Outbreaks Investigated During FY2021
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
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June Food and Agriculture Regulatory Recap
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
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As Operational Guidance Becomes Available; The Uyghur Forced Labor Act Goes Into Effect
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
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Resources for Human and Animal Food Producers Affected by Severe Weather Incidents
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
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May Food and Agriculture Regulatory Recap
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
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FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC
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
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April Food and Agriculture Regulatory Recap
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
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Federal Cannabis Legalization & Regulation: A Timely Discussion of The Mace States Reform Act
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
New Emergency Livestock Relief Program (ELRP) Phase 1 To Provide $750 Million in Relief to Livestock Producers
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
March Food and Agriculture Regulatory Recap
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
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February Food and Agriculture Regulatory Recap
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
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Declaration of a National Emergency Extended; Important Beyond Protecting the Public from the Risks of COVID-19
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,
Farmers and Ranchers Can Now Access Online Reporting Portal to Report Potentially Unfair and Anticompetitive Practices
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, On
January Food and Agriculture Regulatory Recap
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
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Trademark Modernization Act Took Effect December 18, 2021
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
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December Food and Agriculture Regulatory Recap
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
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November Food and Agriculture Regulatory Recap
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 November that we took note of. If you have any questions or would like more information, please
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FTC Issues Orders to Major Retailers, Wholesalers, and Product Suppliers Regarding Supply Chain Disruptions
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
6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate
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
UPDATE: Federal Contractor Vaccine Mandate
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. On November
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OSHA Releases ETS on Vaccine and Testing Mandate
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
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