Kyla S. Kaplan

FDA and FTC Issue Warning Letters to Companies Selling Copycat Delta-8 THC Food Products

On July 16, 2024, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to six companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (THC) and introducing them into the marketplace, violating the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA highlighted two primary concerns: the

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Loper Bright + Corner Post = Supreme Court Opinions and Their Impact on FDA- and USDA-Regulated Industries 

The U.S. Supreme Court recently issued two important opinions for any entity regulated by a federal agency, such as FDA and USDA.  1. Loper Bright Enterprises v. Raimondo, slip op. 22-451, (June 28, 2024) (Loper Bright): For 40 years, Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) required courts to defer

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USDA-AMS Announces Proposed Revision to the Packers and Stockyards Regulations

On June 3, 2024, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced a pre-published version of the proposed rule, “Poultry Grower Payment System and Capital Improvement Systems.” The Proposed Rule is part of the agency’s broader effort to increase transparency and address potential deception and unfairness in contracting arrangements. The Proposed Rule

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November 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 November that should be highlighted. If you have any questions or would like more information, please do

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PFAS in Food Packaging – State Compliance Deadlines and Requirements (2026 Update)

PFAS in food packaging is now regulated by law in a growing number of states, and several of the compliance dates that once looked distant have already arrived. Food manufacturers, distributors, and retailers who have not revisited their packaging since these laws passed may be out of step with rules already in force in California,

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Arkansas Becomes the First State to Enforce Foreign-Ownership Land Restrictions

On October 17, 2023, Arkansas became the first state to enforce a state law banning certain foreign entities from owning agricultural land (doing so under Act 636, which blocks “prohibited foreign-party-controlled business” from owning public or private land directly or through affiliation). Arkansas Attorney General, Tim Griffin ordered Syngenta Seeds LLC. to sell 160 acres

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Comment Period on First Congressional Bipartisan and Bicameral Request for Information on Cannabidiol Closes

On August 18, 2023, comments were due to Congress on the bipartisan and bicameral request for information (RFI), which sought written stakeholder comments and analysis to “asses[s] the potential for a regulatory pathway for hemp-derived [cannabidiol (CBD)] products that prioritizes consumer safety and provides certainty to the U.S. market.”   By way of background on

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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 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

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

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

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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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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 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

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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