The U.S. Supreme Court recently issued two important opinions for any entity regulated by a federal agency, such as FDA and USDA. 1. Loper Bright Enterprises v. Raimondo, slip op. 22-451, (June 28, 2024) (Loper Bright): For 40 years, Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) required courts to defer […]
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 significant developments from June. If you have any questions or would like more information, please do not hesitate to
June Food and Agriculture Regulatory Recap Read More »
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 significant developments from May. If you have any questions or would like more information, please do not hesitate to
May Food and Agriculture Regulatory Recap Read More »
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 significant developments from April. If you have any questions or would like more information, please do not hesitate to
April Food and Agriculture Regulatory Recap Read More »
As generative artificial intelligence (AI) systems become increasingly powerful and widespread, the United States Patent and Trademark Office (USPTO) is beginning to evaluate the legal implications for intellectual property rights and protection. On March 27th, the USPTO and the U.S. Copyright Office jointly held a public symposium to explore the emerging challenges AI presents across
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 should be highlighted. If you have any questions or would like more information, please do
March Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
February Food and Agriculture Regulatory Recap Read More »
Since the beginning of 2024, our Trade Association professionals have seen an increase in scammers targeting persons who may be attending or have registered to attend trade association events such as meetings, shows, and conferences. These scammers email potential attendees and offer to sell, for a hefty cost, the attendee list and their contact information.
Association Events Targeted for Scams Read More »
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 should be highlighted. If you have any questions or would like more information, please do
January Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
December Food and Agriculture Regulatory Recap Read More »
Beginning January 1, 2024, the U.S. Corporate Transparency Act (CTA) will expect a wide range of small companies to begin filing reports identifying “beneficial owners.” These “Beneficial Ownership Information” reports (BOI Reports) include name, birthday, address, and a unique identifying number and issuing jurisdiction from an acceptable identification document. All companies with fewer than 20
Small Businesses Face Reporting Obligations Under The U.S. Corporate Transparency Act Read More »
As part of its ongoing enforcement against unlawful cannabis-containing foods and dietary supplements, the U.S. Food and Drug Administration (FDA) has recently posted two new Warning Letters against cannabis marketers: Both Warning Letters cite the marketers for promoting and distributing human and animal foods and dietary supplements containing (or that purport to contain) the cannabinoids
CBD AND DELTA-8 THC – UPDATE ON FDA ENFORCEMENT Read More »
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 should be highlighted. If you have any questions or would like more information, please do
November Food and Agriculture Regulatory Recap Read More »
Food manufacturers should be aware of some upcoming compliance deadlines in various states that have banned Per- and polyfluoroalkyl substances (“PFAS”) in food packaging. Although federal regulators, like the U.S. Environmental Protection Agency (“EPA”) and the U.S. Food and Drug Administration (“FDA”), are focused on individual PFAS chemicals (like PFOA and PFOS) due to health
Upcoming State Effective Dates for PFAS in Food Packaging Read More »
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
October Food and Agriculture Regulatory Recap Read More »
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
September Food and Agriculture Regulatory Recap Read More »
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 »
Will we wake up to a federal government shutdown on October 1st? Many of the ingredients required for a shutdown are present. There may be a breakthrough that will allow Congress to coalesce around an approach to appropriations. However, Congress may not get on track to pass all of the appropriations packages by the end
How will FDA and USDA operate during a Government Shutdown? Read More »
Thursday, September 21 from 12:00 – 1:00 p.m. Click here to register for this event. Space is limited. In today’s global economy, the regulatory and legal landscape can change quickly. OFW will provide a high-level review of customs and trade and litigation trends that could affect product compliance and liability, and the ability to market
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 should be highlighted. If you have any questions or would like more information, please do
August Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
July Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
June Food and Agriculture Regulatory Recap Read More »
On Friday, U.S. Food and Drug Administration (FDA) released its first draft guidance on the conduct of clinical trials for psychedelic drugs. The Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations, if finalized, will guide researchers investigating psychedelics as potential treatments for medical conditions. There has been significant media, marketing, and legislative interest
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs Read More »
On June 12, 2023, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for tattoo ink manufacturers and distributors entitled, “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination,” to assist manufacturers and distributors of such products in recognizing when tattoo ink may pose contamination
Tattoo Ink Safety – A Reinvigorated Agency Concern Read More »
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 should be highlighted. If you have any questions or would like more information, please do
April Food and Agriculture Regulatory Recap Read More »
Earlier this year, the U.S. Food and Drug Administration (FDA) concluded that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol” (CBD) and the agency will “work with Congress on a new way forward.” Since this announcement, speculation on how FDA and Congress will work to handle the ever-evolving over $9.1 billion
Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress Read More »
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 should be highlighted. If you have any questions or would like more information, please do
March Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
February Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
January Food and Agriculture Regulatory Recap Read More »
Today, the United States Food and Drug Administration (FDA) announced their conclusion “that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol,” and the agency will “work with Congress on a new way forward.” This position was announced in a Statement by Dr. Janet Woodcock, Principal Deputy Commissioner, who chairs FDA’s cannabis
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.
Frank Yiannas Announces Resignation from FDA Read More »
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 should be highlighted. If you have any questions or would like more information, please do
December Food and Agriculture Regulatory Recap Read More »
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 should be highlighted. If you have any questions or would like more information, please do
November Food and Agriculture Regulatory Recap Read More »
The de novo process employed by FDA’s Center for Devices and Radiological Health (CDRH) is a less frequently used mechanism for the clearance of medical devices. The de novo process employs a risk-based strategy for evaluating applications. It is used for new, novel devices that lack previous classification. These would ordinarily be Class III devices,
On November 1, 2022, the Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock had a virtual meeting on “Regulatory Pathways for Hemp Products, including Cannabidiol (CBD)” with representatives of the U.S. Health and Human Services Office of the Secretary and the Executive Office of the President. This meeting was announced
FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD Read More »
