Food Waste – On September 20, 2023, USDA announced an additional $25 million in investments (funded under the American Rescue Plan Act (ARPA)) to expand efforts to prevent and reduce food loss and waste. This is a joint agency initiative between USDA’s National Institute of Food and Agriculture (NIFA) and USDA’s Office of the Chief
September Food and Agriculture Regulatory Recap Read More »
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
FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management Read More »
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
On August 30, 2023, The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) – an advisory committee originally established in 1988 by USDA – hosted a subcommittee Plenary Public Meeting. The 2021-2023 current NACMCF subcommittee work can be found here. During the meeting, NACMCF focused on two FDA subcommittee charges: Cyclospora cayetanensis in Produce
August Food and Agriculture Regulatory Recap Read More »
On July 5, 2023, FDA and the Federal Trade Commission (FTC) jointly sent six (6) cease and desist letters to companies marketing and selling edible products containing Delta-8 tetrahydrocannabinol (THC) in packaging similar to snacks and candy ordinarily eaten by children On July 27, 2023, the House Oversight and Accountability Subcommittee on Health Care and
July Food and Agriculture Regulatory Recap Read More »
On June 21, 2023, USDA issued Grants of Inspection (GOI) to two companies that intend to manufacture cell-cultured chicken products, Upside Foods and Good Meat Company (as well as a Good Meat co-packer, Joinn Biologics). Along with the GOI, FSIS released FSIS Directive 7800.1, “FSIS Responsibilities in Establishments Producing Cell-Cultured Meat and Poultry Food Products,”
June Food and Agriculture Regulatory Recap Read More »
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
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs Read More »
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 »
On April 25, 2023, the USDA’s Food Safety and Inspection Service (FSIS) released the anticipated “Salmonella in Not-Ready-To-Eat (NRTE) Breaded Stuffed Chicken Products; Proposed Determination and Request for Comments” (the Proposed Determination), todeclare Salmonella an adulterant in breaded, stuffed raw chicken products when the chicken component tests positive for Salmonella at 1 colony forming unit (CFU) per gram or greater
April Food and Agriculture Regulatory Recap Read More »
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 »
On March 17, 2023, FSIS announced it will make “Temporary Allowance for Use of Sodium Nitrite from Natural Sources, ”as a way to handle shortages of synthetic sodium nitrite used to cure meat and poultry products. Establishments interested in using the substitution may submit for temporary label approval under 9 C.F.R. § 412(1)(f). On March
March Food and Agriculture Regulatory Recap Read More »
2022 Achievements – On February 6, 2023, FSIS posted a list of the key achievements in 2022. These include the Agency’s efforts to reduce illnesses linked to Salmonella in poultry, support small and very small establishments, the result of the “Product of the USA” labeling survey, state inspection programs, collaboration, and fostering diversity, equity, and
February Food and Agriculture Regulatory Recap Read More »
On January 4, 2023, the Office of Management and Budget (OMB) released the Semiannual Regulatory Agendas for Fall 2022. All Federal Agency Regulatory Agendas can be found here. On December 20, 2023, the U.S. Federal Trade Commission (FTC) published a regulatory review; request for public comment on “Guides for the Use of Environmental Marketing Claims
January Food and Agriculture Regulatory Recap Read More »
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.
Frank Yiannas Announces Resignation from FDA Read More »
The building 2023 Farm Bill pressures coincide with FDA signaling that it will soon be taking significant action on cannabinoids. In addition to the November 2022 warning letters: In December 2022, FDA Chief Scientist Dr. Namandjé N. Bumpus said that “CBD science” is a top priority and that there are broad cross-agency initiatives underway, and
December Food and Agriculture Regulatory Recap Read More »
On November 29, 2022, USDA Agricultural Marketing Service (AMS) announced a forty-five (45) day extension for the submission of comments and information on “Inclusive Competition and Market Integrity Under the Packers and Stockyards Act.” Comments are now due on January 17, 2023. Other On November 18, 2022, USDA-FSIS published a Federal Register Notice, “Expansion
November Food and Agriculture Regulatory Recap Read More »
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,
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
FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD Read More »
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
FDA Warning Letters to Walmart and Amazon for Selling Drug Products Deemed Illegal Read More »
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
October Food and Agriculture Regulatory Recap Read More »
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
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 »
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
September Food and Agriculture Regulatory Recap Read More »
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
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 »
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 »
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
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
CAOA Filed in the Senate Read More »
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 »
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 »
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 »
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 »
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 »
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
