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Upcoming State Effective Dates for PFAS in Food Packaging

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

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 […]

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FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Medical Devices, FDA, Uncategorized /

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

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How will FDA and USDA operate during a Government Shutdown?

FDA, USDA /

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 »

OFW and AFI Invite You to a Food Industry Update: Trends in Customs and Trade and Litigation

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

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

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June Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Government Relations /

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

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FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Agriculture & Agribusiness, Cannabis, FDA, Government Relations /

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

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Tattoo Ink Safety – A Reinvigorated Agency Concern

FDA /

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 »

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 »

January Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, Cannabis, FDA /

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 »

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

FDA, Cannabis /

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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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

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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

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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 »

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