FDA

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

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 […]

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March Food and Agriculture Regulatory Recap

Cannabis, FDA, USDA / Kyla S. Kaplan

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

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February Food and Agriculture Regulatory Recap

Cannabis, FDA, USDA / Kyla S. Kaplan

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

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January Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, Cannabis, FDA / Kyla S. Kaplan

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

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The FDA Concludes “Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate” for CBD

FDA, Cannabis / Kyla S. Kaplan

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

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Frank Yiannas Announces Resignation from FDA

FDA / Kyla S. Kaplan

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

Cannabis, FDA, USDA / Kyla S. Kaplan

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

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November Food and Agriculture Regulatory Recap

FDA, USDA / Kyla S. Kaplan

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

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

Medical Devices / Mark Mansour

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,

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

FDA, Agriculture & Agribusiness, Cannabis, Government Relations / Elisa Bayoumi

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 / Kyla S. Kaplan

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

FDA, USDA / Kyla S. Kaplan

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

Cannabis, FDA, Government Relations / Kyla S. Kaplan

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

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

FDA, Food Manufacturing, Processing, and Marketing / Lauren R. Aguilar

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 »

September Food and Agriculture Regulatory Recap

FDA, USDA / Kyla S. Kaplan

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

FDA, Food Distribution & International Trade, USDA / Kyla S. Kaplan

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

ESG Disclosure/Reporting Continues to Trend Across Food, Agriculture, and Medical Device Sectors Read More »

August Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing / Kyla S. Kaplan

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 / Kyla S. Kaplan

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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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 / Elisa Bayoumi

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 / Elisa Bayoumi

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan & Lauren R. Aguilar

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Tish Eggleston Pahl and Kyla S. Kaplan

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 / Kyla S. Kaplan

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 / Bruce Silverglade

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”

“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 / Mason J. Weeda and Kyla S. Kaplan

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 / Kyla S. Kaplan and John G. Dillard

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 / Kyla S. Kaplan

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 »

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 / Kyla S. Kaplan

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 »

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