Tag Archives: FSMA

FDA Publishes Findings from Investigation of Romaine Lettuce E. coli Outbreak

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As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, … Continue Reading

NGO Publishes Report on Food Safety

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The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies … Continue Reading

FDA Publishes Q&A Guidance on Mandatory Food Recalls

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The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to … Continue Reading

FDA Will Hold Public Meetings Throughout the U.S. in November and December for Discussion of the New Draft Guidance on Standards for Compliance with the Produce Safety Rule

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  As reported last week on The Daily Intake, FDA published two new draft guidance documents on October 19, 2018 to assist processors and farmers in complying with produce safety requirements under the Food Safety Modernization Act (FSMA).  The draft Guide to Minimize Food Safety Hazards of Fresh-cut Produce addresses compliance for fresh-cut produce with … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

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FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

VQIP Application Portal Will Open October 1st for the Fiscal Year 2020 Benefit Period

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The Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP).  VQIP is intended to expedite the review and import entry of human and animal foods into the United States.  To participate in VQIP, importers must meet eligibility criteria and pay a user fee.  Eligibility criteria include ensuring that the foreign supplier’s facility … Continue Reading

FDA Commissioner Discusses FDA’s Efforts to Prevent Foodborne Cyclospora Outbreaks

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FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce, highlighting the Agency’s efforts to prevent outbreaks of this foodborne illlness.  Cyclospora is an intestinal parasite that is spread through contamination of food with human waste. FDA has been surveying the food supply … Continue Reading

FSMA Update: FDA Issues Final Q&A Guidance and Attestation Forms for Qualified Facilities Under HARPC Rules

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On May 16, 2016 (81 FR 30219), FDA issued a draft guidance document intended to assist “qualified facilities” comply with modified requirements under the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).  A qualified facility is defined as: (1) a very small business (defined with respect to annual … Continue Reading

FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

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The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety … Continue Reading

FDA Recognizes a Fourth Accreditation Body Under FSMA’s VQIP

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  As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States.  Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP.  Under … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

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In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

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On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls … Continue Reading

FDA Issues First Warning Letter for Alleged HARPC Violations

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On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be … Continue Reading

FDA Issues First Draft Guidance Document on Intentional Adulteration

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As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food Safety Modernization Act (FSMA).  These rules are intended to guard against the deliberate adulteration of food by employees. The 94-page guidance provides an overview of … Continue Reading

FDA Issues Food Facility Registration Small Entity Compliance Guide

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FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to … Continue Reading

FDA Encourages Importer Preparation for Next VQIP Application Cycle

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As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program … Continue Reading

FDA Releases Small Entity Compliance Guide Reiterating January 2018 Guide on Extension of Certain Compliance Dates for Four FSMA Rules

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  As previously covered on this blog, on August 24, 2016, FDA published a final rule that extended and clarified the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  The implicated rules are (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for … Continue Reading

FDA Releases Intentional Adulteration Training Course

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In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration. The training … Continue Reading

FDA Issues First Ever Mandatory Recall Order for Kratom Products

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On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory … Continue Reading

FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

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In the March 28, 2018 FDA Voice blog  Dr. Gottlieb provided background and insight on the Intentional Adulteration rule. The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a … Continue Reading

FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

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As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered … Continue Reading
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