EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Dean Cirotta Featured in Tobacco Reporter on FDA’s Proposed Foreign Tobacco Manufacturer Registration Rule
Dean R. Cirotta, President of EAS Consulting Group, recently contributed an article to Tobacco Reporter examining FDA's newly proposed rule, Establishment Registration and Product Listing for Tobacco Products. The proposed rule would require foreign tobacco product manufacturers to register their...
CFIA Food Fraud Report Highlights Ongoing Food Authenticity Challenges
CFIA Releases 2024-2025 Food Fraud Annual Report The Canadian Food Inspection Agency (CFIA) has released its Food Fraud Annual Report 2024-2025, summarizing the agency's efforts to prevent, detect, and deter food fraud in the Canadian marketplace between April 1, 2024 and March 31, 2025. The...
California Food Date Labeling Requirements Take Effect July 1
California Standardizes Food Date Labels Beginning July 1 Beginning July 1, 2026, food manufacturers, processors, and retailers selling products in California must comply with California's food date labeling law, Assembly Bill 660 (AB 660). The law establishes standardized terminology for food...
USDA Food Safety and Inspection Service (FSIS) Label “Approval Process”
USDA Food Safety and Inspection Service (FSIS) labels play a critical role in product compliance and market access. This article explores the FSIS label approval process, including generic, sketch, and temporary approvals, while highlighting common compliance challenges and the recordkeeping requirements establishments must maintain to support approved labeling claims.
FDA Updates 2026 Human Foods Program Guidance Agenda
FDA Releases Updated 2026 Human Foods Program Guidance Agenda The U.S. Food and Drug Administration has released an updated version of its 2026 Human Foods Program (HFP) Guidance Agenda, adding three new guidance topics for industry consideration. The Human Foods Program Guidance Agenda provides...
When AI Isn’t Enough: Human Expertise Remains Essential in Regulatory Affairs
Artificial intelligence is rapidly transforming how companies gather information, analyze data, and support decision-making. However, in highly regulated industries, technology alone cannot replace the experience, judgment, and practical understanding required to navigate complex regulatory...
Drug and Device Corner 2026 June
EAS has become aware of the agency’s increased enforcement policy described in their Guidance Document Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. For extension requests that identify the same reason for the request multiple times, FDA is beginning to...
FDA Proposes Rule to Strengthen Accountability for Foreign Tobacco Product Manufacturers
FDA Announces Proposed Rule Affecting Foreign Tobacco Product Manufacturers The U.S. Food and Drug Administration has issued a proposed rule designed to strengthen oversight of foreign tobacco product manufacturers and improve accountability for tobacco products entering the U.S. marketplace....
USDA Opens Food Safety Outreach Grant Competitions
The USDA's National Institute of Food and Agriculture has opened applications for its 2026 Food Safety Outreach Grant Program, which will provide nearly $10 million in funding for food safety education, training, outreach, and technical assistance projects. Applications are due July 20. According...
FDA Updates Pesticide Monitoring Program for Domestic and Imported Foods
FDA Modernizes Pesticide Monitoring Compliance Program The U.S. Food and Drug Administration has announced several updates to its pesticide monitoring compliance program designed to strengthen oversight of pesticide residues in domestic and imported foods. The revisions update Compliance Program...
Import Seafood HACCP: Understanding FDA Requirements for U.S. Seafood Importers
Importing seafood into the United States carries specific responsibilities under FDA’s Seafood HACCP regulations. Firms importing fish and fishery products must comply with 21 CFR 123.12 and establish appropriate verification procedures to demonstrate seafood import compliance.
Animal Food GRAS: Unpacking the Essentials
This webinar explores the history and legal basis of GRAS, compares GRAS to alternative regulatory pathways, and reviews FDA notification and self-determined GRAS approaches. The presentation also discusses the role of qualified experts in establishing GRAS conclusions, species-specific safety considerations, and regulatory challenges associated with novel animal food ingredients.
USDA Launches Small Processors Action Plan to Support Meat and Poultry Industry Growth
USDA Announces New Support Initiatives for Small Processors The U.S. Department of Agriculture has released a Small Processors Action Plan aimed at strengthening the nation’s meat and poultry processing sector through technical assistance, workforce development, regulatory support, and targeted...
FDA Updates Food Traceability Rule FAQs with Six New Clarifications
FDA Adds New Frequently Asked Questions on the Food Traceability Rule The U.S. Food and Drug Administration has updated its Frequently Asked Questions (FAQ) resource for the Food Traceability Rule, adding six new questions and answers that address common implementation scenarios. The Food...
FSIS Launches Pilot Program to Expand Listeria Verification Sampling in Ready-to-Eat Meat and Poultry Establishments
FSIS Expands Environmental Sampling Activities Through New Pilot Program The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced a pilot program designed to strengthen oversight of ready-to-eat (RTE) post-lethality exposed meat and poultry establishments. The...
FDA Expands Sunscreen Options for the First Time in 20 Years
FDA Takes Action to Expand Available Sunscreen Ingredients The U.S. Food and Drug Administration has announced a significant milestone in sunscreen regulation by expanding the list of permitted sunscreen active ingredients for the first time in more than 20 years. The action adds bemotrizinol as...
FDA is Hosting a Public Meeting on Implementation of the Food Traceability Rule
FDA is hosting a virtual public meeting on June 15, 2026, to give the public an opportunity to share information on implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and flexibilities for compliance. To register, please...
House Lawmakers Introduce Gluten Allergen Bill
Reps. Emanuel Cleaver (MO) and Betty McCollum (MN) have introduced the Celiac Safety Act of 2026, legislation that would require foods containing wheat, barley or rye to identify “gluten-containing grain” as a major food allergen under federal food labeling law. According to the bill sponsors, the...
Importing Meat, Poultry and Egg Products to the United States
Understanding FSIS requirements from country eligibility through import reinspection.By Robert J. Berczik, Jr., EAS Consulting Group Independent ConsultantThe U.S. Department of Agriculture’s (USDA), Food Safety and Inspection Service (FSIS) is the public health agency responsible for ensuring...
Drug and Device Corner 2026 May
Reminder that OMUFA user fee payments are due 1 June 2026. The agency allows a 20-day grace period before publishing facilities on the arrears list. Keep in mind, per regulation, drugs manufactured at facilities identified on the arrears list are considered misbranded. You can check both the Paid...
FDA Issues Foreign Supplier Verification Program (FSVP) Warning Letters
The FDA recently issued a series of warning letters citing companies for failure to comply with Foreign Supplier Verification Program requirements. In these cases, the FDA said the companies “did not develop, maintain, and follow an FSVP” for several imported food products sourced from foreign...
New FDA Guidance on Infant Formula Protein Efficiency Ratio (PER) Studies
The FDA has issued final guidance for industry on Protein Efficiency Ratio rat bioassay studies used to demonstrate that new infant formulas meet the required “quality factor of sufficient biological quality of protein.” The guidance outlines the agency’s current recommendations for infant formula...
Publication of Final Rule: Visual Post-Mortem Inspection in Swine Slaughter Establishments
On May 21, 2026, the Food Safety and Inspection Service (FSIS or agency) published a final rule (Federal Register :: Visual Post-Mortem Inspection in Swine Slaughter Establishments) amending its regulations to end mandatory mandibular lymph node incision and viscera palpation of swine carcasses in...
Responding to Food and Seafood FDA 483s
When the FDA issues a Form 483 or Warning Letter, your response is critical—and time-sensitive. How you respond can directly impact regulatory outcomes, enforcement risk, and your firm’s credibility.
This webinar will walk through FDA expectations for responding to inspectional observations, along with proven strategies for developing clear, complete, and effective responses. Attendees will gain practical guidance on crafting responses that not only address findings, but also demonstrate control, accountability, and a path to sustained compliance.
Marty Makary Resigns as FDA Commissioner
Marty Makary Steps Down as FDA Commissioner Multiple news outlets are reporting that Dr. Marty Makary has resigned as Commissioner of the U.S. Food and Drug Administration after serving in the role for just over one year. Makary, a surgeon and public health researcher, became FDA Commissioner in...
FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products
FDA Updates Enforcement Priorities for Unauthorized Tobacco Products FDA’s Center for Tobacco Products (CTP) has issued guidance titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” The guidance outlines FDA’s current enforcement priorities for...
FDA Launches One-Day Inspectional Assessments to Expand Regulatory Oversight
FDA Introduces One-Day Inspectional Assessments The U.S. Food and Drug Administration has announced a new initiative called One-Day Inspectional Assessments, designed to expand oversight activities and improve the agency’s ability to evaluate regulated facilities more efficiently. According to...
FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination
USDA Establishes Office of Seafood The U.S. Department of Agriculture has announced the creation of a new Office of Seafood, aimed at strengthening coordination, policy development, and support for the U.S. seafood industry. According to USDA, the new office will focus on improving collaboration...
Drug and Device Corner 2026 April
Reminder that the annual GDUFA self-ID submission period begins 1 May 2026. Submissions must be filed during the month of May. EAS can assist with this submission if needed. The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is...