Your production schedule just got derailed by an FDA inspection observation. Your quality team is scrambling to understand why procedures you’ve followed for years suddenly don’t meet current Good Manufacturing Practice requirements. And now you’re facing questions from executives about potential warning letters and what they mean for your business. I’ve seen this pattern repeatedly […]
Meat and poultry processors face labeling rejections from FSIS that delay product launches and waste printing costs. Label approval specialists cite obscure policy memos and technical violations that weren’t apparent from reading the core regulations. I know this because USDA labeling laws and requirements represent one of the most detailed regulatory frameworks in food production
Meat, Poultry & Egg Labeling Laws: USDA Labeling Requirements Read More »
Agricultural businesses operating under USDA regulations face policy shifts every five years when Congress passes the Farm Bill. These massive legislative packages – sometimes exceeding 1,000 pages – reshape USDA programs, enforcement priorities, and compliance requirements across every regulated sector. I know this because the Farm Bill determines which USDA programs receive funding and enforcement
The Farm Bill and What It Means for USDA-Regulated Industries Read More »
The robust science-based framework established by Congress for regulating food and color additives is encountering significant challenges. Concerns about these additives, first raised by advocacy groups, have been picked up by state legislatures. These concerns have been further amplified by the Make America Healthy Again (MAHA) movement and U.S. Health and Human Services (HHS) Secretary
As generative artificial intelligence (AI) systems become increasingly powerful and widespread, the United States Patent and Trademark Office (USPTO) is beginning to evaluate the legal implications for intellectual property rights and protection. On March 27th, the USPTO and the U.S. Copyright Office jointly held a public symposium to explore the emerging challenges AI presents across
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
Upcoming State Effective Dates for PFAS in Food Packaging 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
OFW Law’s Ken Ackerman was featured in an Agri-Pulse article discussing the Agricultural Foreign Investment Disclosure Act (AFIDA). In the article, “While Foreign Purchases of US Land Surge, USDA’s Reporting Penalties Plunge,” Mr. Ackerman discussed his experience in representing clients on AFIDA matters. AFIDA is a law administered by USDA’s Farm Service Agency (FSA). Under
OFW Law’s Ackerman Discusses AFIDA in Agri-Pulse Read More »
In October, the United States Securities and Exchange Commission (SEC) announced that it would be charging two (2) cannabis companies, Emerald Health and HighTimes, and six (6) associated individuals who worked with the companies, for their involvement in “stock promotion schemes.” Stock promotion schemes are “fraudulent schemes to promote the securities of issuers that were
SEC Stock Promotion Scheme Charges Against the Cannabis Industry Read More »
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 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 »
The State of Massachusetts will delay enforcement of its Question 3 regulations that would restrict pork sales in the state
Massachusetts Delays Enforcement of Question 3 Pork Restrictions 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 »
As of July 2022, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS or the agency) has made publicly available the agency’s annual summary of foodborne illness outbreaks investigated last year (i.e., FY2021). The summary reports on all outbreaks that were investigated by FSIS during FY2021 and includes the following key
USDA Publishes Annual Summary of Foodborne Illness Outbreaks Investigated During FY2021 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 »
The “Uyghur Forced Labor Prevention Act” (the UFLPA) went into effect this past Tuesday, June 21, 2022. The UFLPA creates a rebuttable presumption that “any goods, wares, articles, and merchandise mined, produced, manufactured wholly or in part” in the Xinjiang Uyghur Autonomous Region (Uyghur Region) of China are produced with forced labor and therefore are
As Operational Guidance Becomes Available; The Uyghur Forced Labor Act Goes Into Effect 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 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
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
March 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 February that we took note of. If you have any questions or would like more information, please
February Food and Agriculture Regulatory Recap Read More »
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,
On February 17, 2022, following consumer complaints relating to the presence of pathogens in Similac, Alimentu, and EleCare, Abbott issued a voluntary recall for certain lots of those powdered infant formula products. Abbott’s recall is broad, applies to all distribution levels (domestic and international), and includes all lots manufactured in its Sturgis, Michigan facility with
Infant Formula Recall Triggers Concerns for WIC Beneficiaries Read More »
On Monday, February 7, 2022, United States Department of Agriculture (USDA) Secretary Tom Vilsack delivered an announcement that USDA would invest“$1 billion in Climate Smart Commodities, Expanding Markets, Strengthening Rural America.” Titled “Partnerships for Climate-Smart Commodities,” USDA has committed to finance projects that expand the market for U.S. agricultural and forestry products that use “climate-smart
USDA Announces Funding for Climate-Smart Agriculture Projects Read More »
Today, the U.S. Department of Agriculture (USDA) and U.S. Department of Justice (DOJ) launched an online reporting portal, located at USDA’s Farmer Fairness website, to advance the goals of the “Biden-Harris Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain” (the Action Plan). By way of review,
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
January Food and Agriculture Regulatory Recap Read More »
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”
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
On December 18, 2021, regulations implementing the Trademark Modernization Act of 2020 (“TMA”) went into effect. By amending the Trademark Act of 1946 (Lanham Act), individuals, businesses, and the United States Patent and Trademark Office (USPTO) now have new tools at their disposal to clear unused trademarks and service marks (hereinafter “marks”) from the Principal/Supplemental
Trademark Modernization Act Took Effect December 18, 2021 Read More »
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
The National Bioengineered Food Disclosure Standard Is Now in Effect 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 December that we took note of. If you have any questions or would like more information, please
December Food and Agriculture Regulatory Recap Read More »
On November 29, 2021, the Federal Trade Commission (FTC) ordered nine large retailers, wholesalers, and consumer good suppliers to provide “detailed information” to the FTC. The FTC explains that it is seeking this information to “shed light on the causes behind ongoing supply chain disruptions and how these disruptions are causing serious and ongoing hardships
On Tuesday, November 16th, 2021, the United States Trade Representative (USTR) and the United States Department of Agriculture (USDA) held an informal informational meeting on the General Administration of Customs of the People’s Republic of China’s (GACC) Decrees 248 and 249 affecting U.S. agricultural exports. The Decrees, which were published in 2019, set out new
USTR/USDA Holds Open Meeting to Discuss China Decrees 248 and 249 Read More »
