FDA

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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FTC to Issue Final Rule to Combat “Made in USA” Fraud

On July 1st, the Federal Trade Commission voted 3-2 to publish the final Made in USA Labeling Rule in the Federal Register.  The rule is consistent with – and essentially codifies – its prior 1997 Enforcement Policy Statement on U.S. Origin Claims, and provides the agency with enforcement tools to combat fraudulent claims.   The rule …

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Long-Awaited DSCSA Guidances Published

On June 3, the Food and Drug Administration (FDA) released four  guidances implementing the Drug Supply Chain Security Act (DSCSA). Final Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification  (Suspect Product Final Guidance) Final Guidance for Industry: Product Identifiers under the Drug Supply Chain Security Act – Questions …

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FDA Reverses Trump Administration’s Unapproved Drugs Policy

On May 26, the Food and Drug Administration (FDA) reversed a Trump Administration policy that revoked the agency’s longstanding Unapproved Drugs Initiative (UDI).  On November 15, 2020, then HHS Secretary Alex Azar issued a notice and a request for information entitled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding …

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FDA Reverses a Trump Administration Drug Review Transparency Policy

On April 30, the Food and Drug Administration (FDA) reversed a  Policy issued by the Department of Health and Human Services (HHS) near the end of the Trump Administration that was purportedly intended to increase drug review timeline transparency.  The Policy was announced in the Federal Register on January 15 and would have required FDA …

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The American Rescue Plan Act of 2021—What’s in It for CDC and FDA?

On March 10, the House passed the Senate-amended version of the American Rescue Plan Act of 2021 (H.R. 1319), a $1.9 trillion COVID-19 relief package intended to address the impact of the pandemic on the economy, state and local governments, and individuals.  The package contains public health provisions intended to boost COVID testing and contact …

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CDRH Cracks Down on Misleading “Registration Certificates”

On March 3, Rear Admiral Sean Boyd, Director of the Office of Regulatory Programs at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced an uptick in firms selling and issuing fraudulent “FDA registration certificates” which indicate that a medical device has been authorized, approved, cleared, or reviewed by the …

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A big pile of bulk blue medical masks

FDA Issues Warning Letters Targeting COVID-19 (and other) Products

Since the COVID-19 pandemic began to intensify in March 2020, the Food and Drug Administration (FDA) has sent warning letters to 146 manufacturers of products claiming to prevent, treat, mitigate, diagnose or cure coronavirus.  These products range from teas, tinctures, test kits, soaps, supplements, and CBD products.  In January, the FDA’s Office of Criminal Investigations …

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Xavier Becerra’s Nomination Hearing Set

The Senate Committee on Health, Education, Labor and Pensions (HELP) announced that it will hold a hearing on Tuesday, February 23 to consider Xavier Becerra’s nomination to serve as Secretary of Health and Human Services (HHS).  The Senate Finance Committee will hold a hearing on Wednesday, February 24.   Becerra has served as Attorney General of California …

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Candidates Emerge to Lead FDA

As the Biden Administration settles into Washington and works to address the COVID-19 pandemic, many medical products and food safety stakeholders wonder who will lead the Food and Drug Administration.  Janet Woodcock, M.D. who long led the Center for Drug Evaluation and Research (CDER) and advised “Operation Warp Speed” on COVID-19 therapeutics currently serves as …

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Food and Drug Administration building

FDA Funding in the Energy & Commerce Reconciliation Bill

House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) announced that the committee will hold a markup on Thursday at 11:00 AM ET to consider legislative recommendations for its budget reconciliation instructions.  Section 3004 of the bill provides $500 million to the Food and Drug Administration to combat the COVID-19 pandemic by: Supporting the review …

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Carbon Labeling: Who is Ahead of the Game?

With climate change discussions being elevated on a local, regional, and global scale, many individuals are considering how their personal choices, including foods they consume, impact the environment. This has translated to a resurgence of interest in carbon labeling food products. Now that we understand the basics of carbon labeling and what it means for …

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