FDA

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

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

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

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 

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”

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, …

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

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 …

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CAOA Filed in the Senate

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

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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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 …

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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, …

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

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” …

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

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

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 …

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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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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 …

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Biden to Nominate Dr. Robert Califf as FDA Commissioner

On Friday November 12, 2021, President Biden nominated former United States Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, a cardiologist by training, to again be FDA Commissioner, replacing acting Commissioner Dr. Janet Woodcock. Califf, 70, was the FDA Commissioner for a year at the end of the Obama Administration. He garnered broad support …

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The Potential Time Bomb of African Swine Fever

OFW Law’s John Dillard is a frequent contributor to Farm Journal, the premiere U.S. farm magazine. His latest contribution covers African Swine Fever. African swine fever (ASF) is a nasty bug and it’s getting closer to the U.S. The highly contagious viral infection doesn’t infect humans, but it is 100% fatal to hogs.  Countries where …

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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.   …

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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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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 we took note of. If you have any questions or would like more information, please …

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FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020).    The GGP Rule required: Each guidance document issued by HHS …

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FDA Announces a DSCSA Public Meeting and Requests Comments

The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation.  The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions …

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OFW Law to co-host the 2021 Food Labeling Summit with the Food Institute next month

Next month, The Food Institute kicks off its 3-day virtual training seminar on Food Labeling and Olsson Frank Weeda Terman Matz PC will be co-hosting the event. Each day has its own unique theme. On day one, attendees may expect to first learn the basics of the Food and Drug Administration’s (FDA) and the U.S. …

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