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April Food and Agriculture Regulatory Recap

FDA, USDA /

On April 25, 2023, the USDA’s Food Safety and Inspection Service (FSIS) released the anticipated “Salmonella in Not-Ready-To-Eat (NRTE) Breaded Stuffed Chicken Products; Proposed Determination and Request for Comments” (the Proposed Determination), todeclare Salmonella an adulterant in breaded, stuffed raw chicken products when the chicken component tests positive for Salmonella at 1 colony forming unit (CFU) per gram or greater

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Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress

Cannabis, FDA /

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 »

February Food and Agriculture Regulatory Recap

Cannabis, FDA, USDA /

2022 Achievements – On February 6, 2023, FSIS posted a list of the key achievements in 2022. These include the Agency’s efforts to reduce illnesses linked to Salmonella in poultry, support small and very small establishments, the result of the “Product of the USA” labeling survey, state inspection programs, collaboration, and fostering diversity, equity, and

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January Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, Cannabis, FDA /

On January 4, 2023, the Office of Management and Budget (OMB) released the Semiannual Regulatory Agendas for Fall 2022. All Federal Agency Regulatory Agendas can be found here. On December 20, 2023, the U.S. Federal Trade Commission (FTC) published a regulatory review; request for public comment on “Guides for the Use of Environmental Marketing Claims

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November Food and Agriculture Regulatory Recap

FDA, USDA /

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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Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?

Medical Devices /

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,

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device? Read More »

FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD

FDA, Agriculture & Agribusiness, Cannabis, Government Relations /

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

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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 »

FDA’s Nutrition Initiatives: FDA’s Proposed Rule to Update the Definition of “Healthy”

FDA, Food Manufacturing, Processing, and Marketing /

As mentioned in September’s Regulatory Recap, last week, the Food and Drug Administration (FDA) issued a proposed rule on the “Definition of the Term ‘Healthy’” nutrient content claims. FDA updated its Nutrition Initiatives, and issued the proposed rule, to more closely align with the HHS and USDA’s 2020-2025 Dietary Guidelines for Americans, nutrition facts labels,

FDA’s Nutrition Initiatives: FDA’s Proposed Rule to Update the Definition of “Healthy” 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 »

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 »

Summary of Senate’s Hearing “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms”

FDA, Cannabis, Food Manufacturing, Processing, and Marketing, Government Relations, Miscellaneous, Public Policy /

On July 26, 2022, the Senate Judiciary Committee’s Subcommittee on Criminal Justice and Terrorism held a hearing on “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms.” The hearing largely addressed the recently introduced S. 4591, “Cannabis Administration and Opportunity Act” (the “CAOA”). The witnesses included: Malik Burnett, Medical Director, Maryland Department

Summary of Senate’s Hearing “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms” Read More »

CAOA Filed in the Senate

Miscellaneous, Cannabis, FDA, Food Manufacturing, Processing, and Marketing, Public Policy /

On Thursday, July 21, 2022, Senators Chuck Schumer (D-NY) Cory Booker (D-NJ), and more officially filed the Cannabis Administration and Opportunity Act (CAOA) (S.4591) to legalize cannabis nationwide. OFW has prepared material on this bill and will be monitoring supplementary announcements and hearings for more information. Please note that OFW has provided other posts on key areas of interest in

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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 »

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

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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 »

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 »

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 »

“Top Legal and Regulatory Issues for Food and Beverage Companies in 2022” Online Seminar Hosted by OFW Law and the Food Institute

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

OFW Law and the Food Institute will host a special four-part virtual seminar Feb. 16-17, 2022 on some of the top legal and regulatory issues facing food and beverage companies. Click to Register  Early Bird and Group Discounts Available! Day 1 – The Agenda: Session 1: Latest FDA Developments on “Healthy” Claims on Food Labels.

“Top Legal and Regulatory Issues for Food and Beverage Companies in 2022” Online Seminar Hosted by OFW Law and the Food Institute Read More »

Modernization of Principles for Food Standards of Identity (SOI) – In a Long-Line of What Needs to be Done, “French Dressing” SOI Revoked

FDA, Food Manufacturing, Processing, and Marketing /

Modernizing Food Standards of Identity (SOI) has been on United States Food and Drug Administration’s (FDA) radar for the last 20 years, but there has been very little movement on the subject until this past year.  On Wednesday, FDA announced that it is revoking the Standard of Identity (SOI) for French Dressing, which is the

Modernization of Principles for Food Standards of Identity (SOI) – In a Long-Line of What Needs to be Done, “French Dressing” SOI Revoked Read More »

The National Bioengineered Food Disclosure Standard Is Now in Effect

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

As of January 1, 2022, foods that are deemed “bioengineered” must be accompanied by labels disclosing that the food is bioengineered or contains a bioengineered ingredient. This disclosure requirement is the culmination of a decades-long battle and a legislative compromise over what has been commonly known as “GMO labeling.” After multiple unsuccessful West Coast ballot

The National Bioengineered Food Disclosure Standard Is Now in Effect 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 »

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