Food-Label-Compliance.com - Food Labeling, Food Safety, and Food Science

March 26, 2023

Blog Articles

Charles Woodhouse Authors Book Chapter in ABA Practioner's Guide to Food Law ()
May 15, 2021 - Charles Woodhouse has completed his Book Chapter in the new American Bar Assocication Practitioner's Guide to Food Law. This treatise will be available for sale by the ABA in Fall ... [more]
Charles Woodhouse completes first year of studies at UFL in Soil Science ()
May 3, 2021. - Attorney Woodhouse has finished his first year of graduate studies in Soil Science at the University of Florida's Institute of Food and Agricultural Sciences. In his Spring 2021 ... [more]
Charles Woodhouse to Begin Graduate Studies in Soil Science at the University of Florida ()
June 14, 2020 - Soil Classification, Nutrient Management, Fertilization, and Biocide Application issues have become a routine part of Crop Insurance Litigation in recent years. Additionally, in the ... [more]
After finishing my second graduate degree in an important area of Food Science, we now return to regular posting of articles, documents, and comments ()
December 1, 2019 - In August of this year Attorney Woodhouse finished his second Food Science related Master of Science Degree at Michigan State University. I, of course, would never have been ... [more]
USDA / FSIS Releases New Draft Guidelines for Customer Complaints and Recalls ()
March 12, 2019 - New Draft Guidlines for FSIS procedures in Customer Complaint Documentation and Recall Management have been released. These Guidelines are regarded as a response to the many recent ... [more]
For Our Agricultural Producer Clients - Current Status of Buy-up Insurance Options in NAP Program ()
March 3, 2019 -For our Primary Agricultural Producer Clients participating in USDA/FSA Crop Insurance Programs. In view of the delayed updating of 7 USC Section 7333, as required by the 2018 Farm ... [more]
FDA Announces Changes in Food Import Monitoring Programs and Food Import Enforcement Priorities ()
March 1, 2019 - US Food Importers and Exporters to the US should review the newly published booklet on FDA Food Import Monitoring Policy. Additionally, we attach the most current (March 1, 2019) ... [more]
Safe Food for Canadians Act Major Provisions in Effect January 15, 2019 ()
January 11, 2019. - Reminder - The Safe Food for Canadians Act Major Provisions enter into effect January 15, 2019 - As a reminder to our clients in the Dairy, Produce, and Seafood Industries we note ... [more]
UK Food Standards Agency Issues Draft Guidance on Recalls and Traceability ()
January 9, 2019 - The UK Food Standards Agency has issued a Draft Guidance on Recalls and Traceability. This document will be of great interest to Food Safety legal practitioners as it contains ... [more]
USDA Issues Final Rule on Bioengineered Food Labeling ()
December 26, 2018 - The USDA Agricultural Marketing Service (AMS) has issued the Final Rule on Disclosure of Bioengineered Foods. The Federal Register Notice was published on December 21 and is ... [more]
President Trump Signs 2018 Farm Bill ()
December 21, 2018 - On December 20, President Trump signed the 2018 Farm Bill - properly titled "Agriculture Improvement Act of 2018" Public Law 115-334. Below we attach the Text of the Act, the ... [more]
Adding 7 New Books to Our Year-End Reading List ()
December 17, 2018 - This year we have added 7 new books of general interest to Food and Agricultural Scientists to our Reading List. Please see the full list on our Essays Page. Blum, Deborah, The ... [more]
Appologies to Readers ()
April 16, 2018 -- We are sorry for the need to reduce postings - Charles Woodhouse is in the final 2 semesters of his second Food Science related graduate degree and hard at work on his research ... [more]
Charles Woodhouse Article on US Food Policy ()
April 1, 2018. -- Charles Woodhouse co-authors article with Professor Barbara Bennett Woodhouse of Emory University. The article is titled - Children's Rights and the Politics of Food. The article ... [more]
Charles Woodhouse to Co-Edit Sci-Tech Lawyer Dedicated Food Law Issue ()
March 1, 2018 -- Charles Woodhouse, Editorial Board Member of Sci-Tech Lawyer Magazine - will co-edit the Winter 2019 issue of Sci-Tech Lawyer Magazine with expected publication daye of January ... [more]
Woodhouse Shanahan FSMA Compliance Services ()
December 12, 2017 - Woodhouse Shanahan has been engaged to provide Food Safety Modernization Act Compliance expertise to iRaiShimp SL, a leading consultancy to the international seafood industry, ... [more]
Charles Woodhouse to Present February 2018 CLE Class on Food Law ()
November 2, 2017 - Lorman Education Services will sponsor a National CLE (Continuing Legal Education) class given by Charles Woodhouse on Food Law, the Food Safety Modernization Act, and the Clean ... [more]
Charles Woodhouse Co-author of Food Policy Article for Hofstra University ()
November 1, 2017. - Charles Woodhouse is Co-author with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled The Politics of Food. This article is part of the Hofstra ... [more]
Woodhouse Shanahan Appointed as Counsel to International Design Group Rhythm, LLC ()
Woodhouse Shanahan serves as Counsel for technical Food Law and Food Science issues to Rhythm LLC a leading international design firm thatspecializes in the Consumer Packaged Goods industry. Rhythm ... [more]
Charles Woodhouse Appointed to Editorial Board of Sci-Tech Lawyer Magazine ()
September 4, 2017 - Charles Woodhouse has been appointed to the Editorial Board of Sci-Tech Lawyer Magazine. Sci-Tech Lawyer is the flagship quarterly publication of the American Bar Association ... [more]
New Woodhouse Shanahan Website at www.Food-Recall-Law.com ()
August 1, 2017. - Our new website is in development at www.food-recall-law.com and will feature our work on food industry Supply-Chain Risk-Management as developed in our recent articles in Sci-Tech ... [more]
CRISPR/Cas9 Advances Plant Breeding ()
June 13, 2017 - This week's c&en (Chemical & Engineering News - June 12) cover article is titled CRISPR: A new toolbox for better crops. The article is highly recommended for Food and ... [more]
Studies Cited by President Trump as Validating the Paris Agreement Withdrawal Decision ()
June 2, 2017 - In his June 1 announcement of the Administration's decision to withdraw from the Paris Climate Change Agreement, President Trump cited two studies. The popular press - notably the ... [more]
USDA Secretary Perdue Rolls-Back Sodium Reduction Targets for School Lunch Program ()
May 1, 2017. - With a press release titled Make School Lunches Great Again, USDA Secretary Purdue has delayed long-standing USDA Sodium Reduction Target I Goals by 3-years to 2020. Thus, American ... [more]
Charles Woodhouse and Prof. Barbara Woodhouse to Co-Present Paper for Hofstra University Symposium ()
April 28, 2017 - Charles Woodhouse will be Co-presenter with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled Children's Rights and the Politics of Food. This ... [more]
Charles Woodhouse Publishes Article on Supply-Chain Risk-Management ()
February 4, 2017 - Charles Woodhouse has published an article which orients Food Industry Attorneys and Food Executives to the important changes in Risk-Management practices which are necessitated ... [more]
FDA Issues Draft Guidance on Listeria Control in RTE Foods ()
January 17, 2017 - FDA has issued a January 2017 Draft Guidance on Listeria Control in RTE Foods. This extraordinarily important and long-awaited document belongs in the Tool Kit of all Food ... [more]
FDA Issues Draft Guidances on Nutrition Labels and RACCs ()
January 6, 2017 - With forthcoming implementation of changes in Nutrition Labeling and revisions to RACCs, practitioners should read the two new Draft Guidances against 81 FR 33742 and 81 FR 34000. ... [more]
Presentations and Charts Cited in Woodhouse In Press Article ()
January 1, 2017 - We post below the two Presentations and the two Supply-Chain conceptualizations cited in Charles Woodhouse's forthcoming article "Food Lawyers Face Challenges from 21st Century ... [more]
USDA/FSIS Issues Guidance on BEST IF USED BY Statements on Food Labels ()
December 14, 2016 - As our readers know, except for infant formula, Open Product Dating is not required by Federal Regulation. Nevertheless, a number of commonly used phrases appear on US food ... [more]
DOJ's Sally Yates and Benjamin Mizer Deliver Timely Remarks on Criminal Prosecution of Administrative Law Crimes ()
December 12, 2016 - Deputy AG Sally Yates and Assistant Deputy Benjamin Mizer have delivered important remarks in the past week on the prosecution of administrative crimes which include violations ... [more]
Third-Party Certification and Food Supply-Chain Liability Risk-Management ()
December 7, 2016 - We have updated our 2015 PowerPoint (previously posted) on Third-Party Certification and Food Supply-Chain Risk-Management. Our Reading List in the PDF posted below has been ... [more]
Comments on Potential Regulatory Rollback Following the 2016 Election ()
November 25, 2016 - An important article from the November 25 issue of Science, titled Republicans Ready a Regulatory Rollback, is must reading for food executives. Clearly, some provisions of ... [more]
Comments on a Paradigm for Food Safety Risk Management ()
November 15, 2016 - The greatest risk for the managers of an American food business may not be that FDA (or USDA, Meat & Poultry) will somehow intervene in the business and impose massive ... [more]
FDA Issues Guidance Document on Voluntary Qualified Importer Program ()
November 10, 2016 - FDA has now issued the Final Guidance Document on the VQIP (Voluntary Qualified Importer Plan). This document addresses one of the final important unresolved issues in FSMA ... [more]
Woodhouse Article on Supply Chain Structures: Guarantees, Waivers, and Indemnification ()
October 12, 2016 - We apologize to our readers for the reduced rate of postings during the Fall Semester. Now that I am back in Graduate School again (for my MS Packaging) and also busy with ... [more]
FDA Issues Industry Guidance for use of Healthy on Conventional Food Labels ()
September 25, 2016 - FDA has now issued an Industry Guidance document clarifying enforcement discretion with respect to the use of the word Healthy on Conventional Food labels. This Guidance ... [more]
FDA Issues Guidance on Structure / Function Claims for Conventional Foods ()
September 20, 2016 - The September 2016 Draft Guidance for Industry – Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling - represents USFDA’s first ... [more]
FDA Extends Compliance Dates on FSMA "Customer Assurances" and Releases Draft Guidance on RBPC Rule ()
AUGUST 24, 2016 - Today's Federal Register contains FDA's update of certain FSMA compliance dates related to the RBPC Final Rule. Of particular interest is the extension of the "Customer ... [more]
Review of Ed Yong's "I Contain Multitudes" a Timely and Important Discussion of the Microbiome ()
AUGUST 20, 2016 - We comment on an exciting new book, receiving great praise in Nature, that we have added to our “reading list” of important science books for both the broadly educated ... [more]
FDA Issues Revised DG for Dietary Supplement NDIs ()
August 18, 2016 - FDA has issued a new Revised Draft Guidance for Dietary Supplement NDIs (New Dietary Ingredients) to replace the 2011 Draft Guidance. This document should be studied carefully as ... [more]
Prepublication Copy - FDA Final Rule on GRAS ()
August 13, 2016 - The Final Rule on GRAS Notifications and new requirements for substantiation and the qualifications for GRAS Panels have been issued in prepublication form by FDA. Taking up the ... [more]
FDA Issues Amendments on Registration of Food Facilities ()
JULY 15, 2016 - FDA has released an updated Final Rule - Amendment to Registration of Food Facilities. We post the text of 81 FR 45912 July 14, 2016 below. Our readers should update their files ... [more]
S-762 National Bioengineered Food Disclosure Standard Finalized ()
July 14, 2016 - S-762 the National Bioengineered Food Disclosure Standard has now passed in both the House and the Senate and the Enrolled Bill has been sent to the President for signature. It is ... [more]
Reposting Our 2014 Article "Preparing for FSMA" ()
JULY 9, 2016 - We are now only 60-days from the most important compliance deadline under FSMA - the Risk-Based Preventative Controls Final Rule. To our great surprise, we are recording more ... [more]
Eighth Circuit Upholds DeCoster Prison Sentences ()
July 6, 2016 - The Eighth Circuit Court of Appeals has upheld the prison sentences for Austin (Jack) DeCoster and his son Peter. Our readers, as always, are cautioned against reading only "media" ... [more]
FDA Releases FSMA Final Rule on Intentional Adulteration and Food Defense ()
June 1, 2016 - On May 27, USFDA released the FSMA Final Rule on Intentional Adulteration. We post below the Federal Register Notice. The Intentional Adulteration (Food Defense) Rule cannot be ... [more]
American Bar Association Article by Woodhouse on FSMA Sanitary Transportation Rule ()
April 19, 2016 - Charles Woodhouse's article on the Sanitary Transportation FSMA Final Rule appears in the Spring 2016 issue of Food, Cosmetics & Nutraceuticals published by the American Bar ... [more]
OSHA Issues FSMA Whistleblower Complaint Final Rule ()
April 18, 2016 - Section 402 of FSMA provides Whistleblower Protection to employees who bring Food Safety violations to the attention of regulatory authorities. Attorneys familiar with Labor Law ... [more]
New Woodhouse Article - Food Packaging: Supply-Chain Compliance, Innovation, Food Safety ()
April 11, 2016 - Charles Woodhouse has published his article titled Food Packaging: Supply-Chain Compliance, Innovation, Food Safety in the Association of Food Industries 2016 Annual Report to the ... [more]
Sanitary Transportation Final Rule Issued by USFDA ()
April 6, 2016 -- FDA has issued the Final Rule on Sanitary Transportation of Human and Animal Foods. Charles Woodhouse is currently preparing an article on the Sanitary Transportation Rule for the ... [more]
Woodhouse Article on Food Packaging Compliance, Innovation, and Food Safety ()
March 14, 2016 - Charles Woodhouse has published an article titled "Food Packaging: Supply-Chain Compliance, Innovation, and Food Safety" in the Association of Food Industries 2016 Annual Report to ... [more]
Sampling by Attributes - Military Standard 105D and ANSI/ASQ Z1.4 ()
We have recently had several requests for information on statistical sampling protocols and note that it is very difficult to obtain copies of Military Standard 105D issued by the Department of ... [more]
Getting from HACCP to HARPC: The Risk-Based Preventative Controls Plan ()
February 23, 2016 - Perhaps the greatest challenge of 2016 for food industry executives is the preparation of the Risk-Based Preventative Controls Plan required by the Food Safety Modernization Act. ... [more]
FDA Releases Three Final Rules: Produce; FSVP; Third-Party Certification ()
November 27, 2015 - As discussed in our earlier posts, the Produce (215 pages), Foreign Supplier Verification (127 pages), and Third-Party Certification (98 pages) Final Rules were published in the ... [more]
FDA Releases Advance Copies of FSMA Final Rules: Produce, FSVP, and Third-Party Certification ()
November 13, 2015 - FDA has posted Advance Texts of three more FSMA Final Rules: (1) Third-Party Certification; (2) the Foreign Supplier Verification Program; and (3) the Produce Final Rule. ... [more]
FDA Publishes Restaurant Menu Labeling Guide ()
September 15, 2015 - FDA has now published the Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling ... [more]
DOJ Announces New Guidelines for Prosecution of Executives for Corporate Wrongdoing ()
September 12, 2015 -- We call our readers’ attention to Bill Marler’s excellent editorial in Food Safety News (September 9), “Why the CEO and Board Need to Pay Attention to ... [more]
Final Rules on FSMA Risk-Based Preventative Controls Released by FDA in Pre-Publication Format ()
September 10, 2015 - FDA has released the pre-publication texts in advance of the September 17 Federal Register Notices. Our professional regulatory-science readers will now be able to check the ... [more]
Dangers in Reliance upon Finished Product Food Safety Testing ()
August 1, 2015 -- We call our readers’ attention to a timely and important peer-reviewed article pointing out one of the most basic principles of Food Safety and Food Liability Management ... [more]
FDA Releases Supplemental PR on March 2014 Nutrition and Serving Size PRs ()
July 24, 2015 -- FDA has issued a Supplemental Proposed Rule that would: (1) require declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the ... [more]
FDA Issues Third-Party Auditor Standards and PR on FSVP User Fees ()
July 23, 2015 -- FDA has issued a Draft Guidance on Model Accreditation Standards for Certification Organizations as well as a Proposed Rule on User Fees for accreditation of auditors. We post ... [more]
Swiss Reinsurance - Annual Cost of US Food Recalls $15 Billion ()
July 20, 2015 - Swiss Reinsurance has issued two reports on the cost of US Food Recalls which topped $15 Billion in 2013. Among the key findings are: (1) the number of recalls per year in the US ... [more]
House Agriculture Committee Approves GMO Labeling Bill ()
July 16, 2015 - The House Agriculture Committee has approved and sent to the floor "The Safe and Accurate Food Labeling Act of 2015". This bill, if enacted, will accomplish four objectives: (1) ... [more]
FDA Issues Supplement to 2013 Food Code ()
July 1, 2015 - As our readers know, the FDA Food Code has been adopted into state law by all 50 states in one of its recent iterations. The Food Code is updated every four years by FDA with the ... [more]
FDA Removes PHOs from GRAS Status ()
June 17, 2015 - Readers should note today's Federal Register Notice announcing that FDA has removed PHOs from GRAS Status. Partially Hydrogenated Oils must be removed from all foods sold in the USA ... [more]
FDA Releases Draft Guidance on Voluntary Qualified Importer Program (VQIP) ()
June 15, 2015 - FDA has now released the Draft Guidance for Industry on the Voluntary Qualified Importer Program (VQIP). For background please read Charles Woodhouse's article from SciTech Lawyer ... [more]
USDA FSIS Releases Guidelines for Control of Listeria monocytogenes in Retail Deli Operations ()
June 10, 2015 - USDA FSIS has released Guidelines for Control of Listeria monocytogenes (Lm) in Retail Delicatessen Operations. Given the numerous recent Food Safety Incidents related to Lm in Deli ... [more]
Charles Woodhouse - Article on Preparing for FSMA ()
June 1, 2015 - With important new FSMA Final Rules beginning to issue in the next several months, we again post our article from the Summer 2014 issue of SciTech Lawyer Magazine. This is important ... [more]
Charles Woodhouse - Article on Importer Food Safety Vulnerability Review ()
May 15, 2015 - The Association of Food Industries has published an article written by Charles Woodhouse (principal author) on Importer Food Safety Vulnerability Review. This article discusses in ... [more]
FDA Issues Final Rules on Restaurant and Vending Machine Labeling ()
December 1, 2014 - FDA has now published, in the Federal Register, the Final Rules on Restaurant and Vending Machine Labeling. We post below the Federal Register files in PDF Format for the ... [more]
FDA Issues Four Revised Proposed FSMA Rules ()
September 29, 2014 - FDA has issued four revisions to FSMA Proposed Rules. The revised proposed rules are: Produce, FSVP, RBPCs for Human Food, and RBPCs for Animal Feeds. We post the Federal ... [more]
Charles Woodhouse Speaks at CAFC Federal Judges' Training Conference in DC ()
September, 21, 2014 - Charles Woodhouse, Food Law Attorney and Food Scientist, was an invited speaker at the annual Federal Judges' Training Conference at the Court of Appeals for the Federal Circuit ... [more]
Apology to Readers ()
September 1, 2014 - Please excuse our suspending regular postings for the Fall Semester. Charles Woodhouse is teaching his US Food Imports Regulation course this semester at Michigan State. Due to ... [more]
Charles Woodhouse to Brief Federal Judges on Food Safety Modernization Act and Customs Law ()
July 10, 2014 - Charles Woodhouse will speak at the Court of International Trade Judges' Tranining Conference in Washington in September. The topic will be the interaction of FSMA (Food Safety ... [more]
ABA "SciTech Lawyer" Publishes Article on FSMA Compliance by Charles Woodhouse ()
June 25, 2014 - SciTech Lawyer, published by the American Bar Association Section of Science & Technology Law has posted an advance copy of Charles Woodhouse's article from the Summer 2014 ... [more]
US Supreme Court Issues Decision in Pom Wonderful v. Coca-Cola ()
June 12, 2014 - The US Supreme Court has issued its decision in Pom Wonderful v. Coca-Cola. The full text of the decision is posted below. This important breaking-news in Food Law will be widely ... [more]
FDA Issues Clarification on Use of Wood Shelving in Artesanal Cheesemaking ()
June 11, 2014 - Many of us have been following the media-fuss over the FDA Warning Letter to an artesanal cheesmaker in New York State. The over-reaction of the US artesanal cheese industry has now ... [more]
CSPI Files Complaint Against USDA on AMR Salmonella as Adulterant ()
May 28, 2014 - The Center for Science in the Public Interest (CSPI) has filed a Complaint in Federal District Court (District of Columbia) seeking to compel USDA/FSIS to act on CSPI's May 25, 2011 ... [more]
FDA Files Motion to Dismiss in CFS v. Hamburg (GRAS Self-Affirmation) ()
May 14, 2014 - The FDA has filed a Motion to Dismiss in Center for Food Safety v. Hamburg. Please see our post of February 22 below (a copy of the original Complaint is posted there). Please also ... [more]
Senator Alexander Tasks FDA with Explanation for Use of Draft Guidances ()
May 6, 2014 - Senator Lamar Alexander (R-TN), the ranking Republican on the Senate HELP Committee (Health, Education, Labor, and Pensions) has written to FDA Commissioner Hamburg requesting ... [more]
FDA Approves Irradiation for Foodborne Pathogen Control in Crustaceans ()
April 11, 2014 - A Final Rule on use of Ionizing Radiation for pathogen control in crustaceans is scheduled to issue in the Federal Register on April 14. Absorbed doses of up to 6.0 kiloGray will be ... [more]
Journal of Animal Science Publishes Study on Bacteriophage Supression of E. Coli O157:H7 in Meat and Processed Foods ()
April 8, 2014 - We post below the abstract of the article published in the April 2014 issue of the Journal of Animal Science. Readers with access to academic journal services should, of course, ... [more]
NRDC Issues Report on GRAS Process ()
April 7, 2014 - The Natural Resources Defense Council has issued a report titled "GRAS: How the Loophole Swallowed the Law". As our readers know, we generally do not comment on the merits of such ... [more]
DC Circuit Orders Rehearing of American Meat Instutute v. USFDA ()
April 4, 2014 - The Court of Appeals for the DC Circuit has vacated the March 28 decision (see post below) and has ordered a rehearing en banc on May 19. Thus, the March 28 decision for USDA is ... [more]
DC Circuit Rules on American Meat Institute v. USDA ()
March 28, 2014 - The Court of Appeals for the District of Columbia Circuit has issued a decision in favor of USDA in the Country of Origin (COOL) meat labeling dispute. The 15-page opinion is ... [more]
EFSA Issues Scientific Opinion on Salmonella and Norovirus Risk in Leafy Greens ()
March 27, 2014 - The European Food Safety Authority has issued, in EFSA Journal, Part II of its series of Scientific Opinions on "risk posed by pathogens in food of non-animal origin" (Salmonella ... [more]
CPSI Sues to Compel FDA to Begin Rulemaking Process for Labeling for Methylmercury in Seafood ()
March 10, 2014 - On March 10, the Center for Science in the Public Interest filed a Complaint for Declaratory and Injunctive Relief in the US District Court for the District of Columbia. The ... [more]
Potentially Important Research on Acquired Microbial Resistance to Ionizing Radiation ()
March 4, 2014 - The Journal eLife (Editor, Randy Schekman, 2013 Nobel Prize, Physiology & Medicine) has published a potentially important article on acquired resistance to ionizing radiation in ... [more]
FDA Releases Pre-Publication Texts of New Labeling Rules for Nutrition Facts and Portion Size ()
February 27, 2014 - USFDA has today released the two pre-publication texts for the Proposed Rules on Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can ... [more]
FDA GRAS Self-Affirmation Process for Food Additives Challenged in Federal Court ()
February 22, 2014 - Under the 1997 Proposed Rule (never issued as a Final Rule), FDA has permitted the Self-Affirmation by Petitioners of GRAS Status for Food Additives for nearly 16 years. This ... [more]
FDA Settles with CFS - FSMA Final Rule Issuance Dates Set ()
February 21, 2014 - On February 20, FDA settled the Center for Food Safety lawsuit* with a Consent Decree agreeing to specific dates for the issuance of the "Big Seven" FSMA Final Rules. We post ... [more]
OSHA Issues Interim Final Rule on Section 402 FSMA - Employee Retaliation Protection ()
February 18, 2014 - OSHA has published its Interim Final Rule on Employee Retaliation Protection pursuant to Section 402 of the Food Safety Modernization Act. We have previously commented on this ... [more]
President Signs Farm Bill at Michigan State University ()
February 7, 2014 - President Obama traveled to Michigan State University today to sign the Agricultural Act of 2014 ("The Farm Bill"). Following the Conference Report on January 27, the House voted ... [more]
FDA Issues Draft Memorandum on Designation of High Risk Foods Under FSMA Section 204 ()
February 3, 2014 - FDA has issued its first statement on the criteria to be used in connection with the designation of "high risk foods" pursuant to the requirements of Section 204 of the Food ... [more]
FDA Issues Proposed Rule on Sanitary Transportation of Human and Animal Foods ()
February 1, 2014 - FDA has now issued the last of the "Big Seven" proposed rules pursuant to the Food Safety Modernization Act. The Sanitary Transportation Rule is estimated by FDA to affect some ... [more]
USDA RMA Food Recall Insurance Study Remains in Farm Bill ()
January 28, 2014 - As the Agriculture Act of 2014 ("The Farm Bill") moves to a final vote in the House, the Food Safety Insurance Study remains in the Bill. This provision instructs the FCIC ... [more]
Farm Bill Expected Not to Modify Produce Food Safety Proposed Rule ()
January 28, 2014 - Despite extensive discussions between FDA and produce growers, dealers, and retailers, Section 12311 of the Agricultural Act of 2014 ("Farm Bill") does not appear to require any ... [more]
FDA Issues Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages ()
January 15, 2014 -- FDA has issued a Draft Guidance for Industry document on Distinguishing Liquid Dietary Supplements from Beverages. A PDF of the Draft Guidance is posted below: [more]
FDA Issues FSMA Intentional Adulteration Proposed Rule ()
December 24, 2013 - FDA has Issued the FSMA Intentional Adulteration Proposed Rule. We post below three documents: (1) the Federal Register Notice; (2) the Fact Sheet; and (3) the explanatory ... [more]
FDA Updates GFI 209, 213 with New Guidance on Antimicrobial Use in Food Animal Production ()
FDA has updated GFI 209, 213 with New Guidance on Antimicrobial Use in Food Animal Production. As has been FDA's practice thusfar, reliance is placed upon voluntary guidelines. A PDF of the Draft ... [more]
FDA Issues 2013 Quadrennial Update of Food Code ()
We thank our readers for their patience during our first semester of teaching US Food Import Regulation. We will now reaume our normal pace of postings on important developments in food regulation ... [more]
American Bar Association Publishes First Issue of FOOD, COSMETICS AND NUTRACEUTICALS NEWS ()
We are pleased to post the first issue of the American Bar Association's FOOD, COSMETICS AND NUTRACEUTICALS NEWS in which our article "Preparing for the Food Safety Modernization Act" appears. [more]
We Apologize for the Temporary Suspension of Postings ()
I apologize for the temporary suspension. This semester I am teaching a new graduate (LLM) course at MSU College of Law - US Food Imports: Process, Regulation, and Food Safety. This topic is very ... [more]
FDA Issues Gluten Free Labeling Rule ()
August 2, 2013 - FDA has issued the long-awaited Final Rule on Gluten Free Labeling. Please see posted below the Final Rule, the Q&A, and the Press Release. [more]
FDA Releases Foreign Supplier Verification Program and Third-Party Audit Proposed Rules ()
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Updated Essay by Charles Woodhouse on Preparing for the Food Safety Modernization Act ()
July 1, 2013 We post an updated essay "Preparing for the Food Safety Modernization Act" as we wait for the release, by USFDA, of the Proposed Rules on the Voluntary Qualified Importer Program ... [more]
FDA Issues Advance Copy of Prior Notice Final Rule Under FSMA ()
May 30, 2013 - This week FDA, pursuant to the requirements of the FSMA, issued a advanced copy of the Final Prior Notice Rule. When the official Federal Register Notice issues (in a few days) we will ... [more]
USDOC Issues Initial Rates for Shrimp Countervailing Duties ()
May 29, 2013 - As we wait for the Federal Register Notice, we post the Shrimp Countervailing Duties Fact Sheet released on May 29 by DOC. When the FR Notice issues, it will be posted here. [more]
Preparing for the Food Safety Modernization Act - An Essay by Charles Woodhouse - Posted May 15, 2013 - We apologize for software error which adds line below. Please continue reading on link. ()
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US Supreme Court Backs Monsanto on Gene Patent Case ()
May 14, 2013 In a unanimous decision written by Associate Justice Elena Kagan, the US Supreme Court has affirmed that the doctrine of patent-exhaustion does not apply recombinant DNA technology. ... [more]
USDA & USFDA Issue Listeria Risk Assessment for RTE Deli Foods ()
May 3, 2013 The interagency FDA and USDA working group has issued a Risk Assessment for Listeria at the retail deli level. All Food Safety professionals working on RTE Foods need to review this ... [more]
Congressman Peter DeFazio Sponsors Genetically Engineered Food Right-to-Know Act ()
May 2, 2013 Responding to widespread demand from Consumer and Environmental Groups, Congressman Peter DeFazio (D-OR) has sponsored the Genetically Modified Food Right-to-Know Act (HR-1699). The ... [more]
Defying the "Common Wisdom" of DSHEA, an Energy Drink Manufacturer Moves to the Grocery Aisle ()
In the New York Times of March 20, we were most interested in a provocative article titled, “In a New Aisle, Energy Drinks Sidestep Some Rules”. As food labeling practitioners, we are ... [more]
Congressman Markey Introduces SAFE Seafood Act in Response to Oceana Labeling Fraud Investigation. ()
Post 3/13/13: To address the widespread problem of seafood labeling fraud, Representative Ed Markey (D-MA) has introduced the Safety and Fraud Enforcement for Seafood Act (“SAFE Seafood ... [more]
USDA Issues Proposed Rule on COOL in Response to WTO Ruling ()
Post 3/12/13: With reference to our Post of November 18, 2011, students and practitioners of food labeling will want to study the USDA’s response to the WTO Panel’s decision on the ... [more]
Recent Developments in Cantaloupe Food Safety ()
On March 1, FDA released its Environmental Factors Analysis of the 2011 Chamberlain Farms Salmonellosis outbreak. This report closely followed the February 25 letter to United Fresh Produce ... [more]
CDC Releases Commodity-Specific Food Safety Data ()
The March 3 issue of Emerging Infectious Diseases contains a major study tabulating 1998-2008 United States data for hospitalizations and deaths attributed to some 17 food commodities. During this ... [more]
PLOS ONE Publishes Study on Linkage between Sugar Consumption and Type-2 Diabetes ()
PLOS ONE HAS PUBLISHED (Feb. 27) a major study on the linkage between dietary-intake of sugar and the development of type 2 diabetes. The Relationship of Sugar to Population-Level Diabetes ... [more]
NEJM Publishes Major Study on Mediterranean Diet and Cardiovascular Disease ()
We post below the link to the major research study on the Mediterranean Diet and Cardiovascular Disease published in the New England Journal of Medicine on Feb. 25, 2013. You may access the full ... [more]
Criminal Prosecution of Companies and Individuals in Honey-Laundering Cases ()
Groeb Farms of Onsted, MI and Honey Holdings of Baytown, TX have signed Deferred Prosecution Agreements (DPAs) with the Justice Department in one of the largest cases of Antidumping Duty evasion in ... [more]
USDOJ Announces Peanut Corporation of America Criminal Prosecutions of Individual Executives ()
On February 21, the US Department of Justice announced the criminal prosecution of individual corporate officers and employees related to the 2009 peanut products related Salmonella outbreak. This ... [more]
Oceana Releases New Study on Seafood Species Substiutution ()
Although advanced copies have been widely circulated to seafood industry insiders, Oceana has now permitted release of its new (Feb. 21, 2013) survey on seafood species substitution at the retail and ... [more]
Mandatory GMO Labeling Legislation to be Introduced in US Congress ()
Representatives Peter DeFazio (D-OR) and Jared Polis (D-CO) have announced that they will introduce national legislation to require GMO labeling on human food products. The text of the bill is not ... [more]
FDA and CDC Issue Reports on Antimicrobial Use in Food Production Animals and Antimicrobial Resistance ()
As required by Congress, FDA has issued its Summary Report - Antimicrobials Sold or Distributed for Use in Food-Producing Animals – 2011. This release was accompanied by the release by CDC of ... [more]
FDA Issues Final Rule on Administrative Detention of Human and Animal Foods ()
As expected, on February 5, FDA issued as a Final Rule "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption". The Final Rule issued without change from the text ... [more]
FDA Releases 2011 Report on Antimicrobial Use in Food-Producing Animals ()
As provided in FDCA section 512, the FDA has released its 2011 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Production Animals. We post the report below: [more]
CDC Releases Foodborne Disease Outbreak Surveillance Data for 2009-2010 ()
The January 25, 2013 issue of MMWR (Vol. 62, No. 3) includes the report on Foodborne Disease Outbreak Surveillance Data for 2009-2010. For the convenience of our readers we have posted pages 41-47 ... [more]
CDC Publishes 2009-2010 Data on Foodborne Illness ()
In the January 25 issue of MMWR (Mortality and Morbidity Weekly Report) the CDC has published the "Surveillance for Foodborne Disease Outbreaks 2009-2010" data analysis. We post the report below: [more]
FDA Issues FSMA Proposed Rules on Produce and Risk-Based Preventative Controls ()
On January 4, FDA released the Proposed Rules under the FSMA for both Produce Safety and for Risk-Based Preventative Controls. We will be preparing reviews of both documents for submission to the ... [more]
FDA Quietly Announces FONSI for GE Salmon on Holiday Weekend ()
Slipping a major and highly controversial announcement into the long Holiday Weekend, FDA has issued a "Finding of No Significant Impact" (FONSI) on Genetically Engineered Salmon. This ... [more]
Healthy Hunger Free Kids Act School Lunch Nutrition Rules Relaxed by USDA ()
Apparently, bowing to congressional pressure (see our Post of Sept. 19, 2012), USDA has relaxed serving size maximums for meat and grain products. The Healthy Hunger Free Kinds Act, signed by ... [more]
FDA Responds with Motion to Dismiss CFS Suit to Compel Action on FSMA Rules ()
Industry observers are becoming increasingly critical of FDA's protracted delay in issuance of important FSMA (Food Safety Modernization Act) Proposed Rules, some of which have been held at OMB ... [more]
Controversial CFIA Memo Surfaces in XL Foods Investigations ()
The extraordinary controversy caused by the revelation of CFIA (Canadian Food Inspection Agency) memos dating back as far as 2008 is raising serious questions about Food Safety both in Canada and ... [more]
FDA's First Use of FSMA Authority to Suspend Registration of Food Facility ()
Regulatory Food Science professionals must read the full text of FDA Commissioner Margaret Hamburg's "Suspension Letter" issued to Sunland Inc. in connection with the latest peanut product ... [more]
The Safe Food for Canadians Act Now Appears Assured of Passage ()
The Safe Food for Canadians Act had its Senate Third Reading on October 17 and its House of Commons Second Reading October 23. Following the approval of the Standing Committee on Agriculture and ... [more]
Congressional Grilling of Hamburg over Compounding Pharmacy Regulatory Failures Prompts FDA Action on Energy Drinks ()
It came as no surprise that, on Friday November 16, the FDA made clear to the public its plan to get “in front” of the current controversy over the discontinuity in the regulation of ... [more]
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Congressman Ed Markey Issues Report on Compounding Pharmacy Regulatory Debacle ()
While we generally confine our comments on FDA matters to Food and Dietary Supplements, the lessons of the ongoing regulatory failure in the compounding pharmacy scandal should prove valuable to ... [more]
Congressman Waxman to Introduce Legislation to Monitor Antimicrobial Use in Food Animal Production ()
House Energy and Commerce Committee Ranking Member Henry A. Waxman (D-CA) will introduce the Delivering Antibiotic Transparency in Animals Act of 2012 (the DATA Act). DATA will require antimicrobial ... [more]
Senator Barbara Boxer Urges FDA Commissioner Hamburg to Act to Curb Seafood Labeling Fraud ()
Senator Barbara Boxer (D-CA) has written to FDA Commissioner Margaret Hamburg to urge FDA action to curb seafood labeling fraud. Citing the recent Oceana study, Senator Boxer asks, in the attachment ... [more]
EFSA and BfR Publish Scientific Opinions Critical of Seralini GMO Maize Study ()
Because of the extraordinary potential impact of Proposition 37 on US Food labeling, we follow this controversy closely. Both the EU's EFSA (Oct 4) and Germany's BfR (Oct 1) have published reviews ... [more]
Food and Chemical Toxicology Article in Press Links GMO-maize to Carcinogenicity Effects ()
In view of Proposition 37 being on the ballot in California six weeks from now (see our June 15, 2012 post), we call our readers’ attention to a Food and Chemical Toxicology journal article in ... [more]
House Republicans Seek Repeal of School Lunch Program Nutrition Standards ()
Congressmen Steve King (R-IA) and Tim Huelskamp (R-KS) have introduced the "No Hungry Kids Act" which seeks to overturn School Lunch Program Nutrition Standards issued by the USDA in January ... [more]
BPI v. ABC Complaint Partially Based Upon South Dakota Food Disparagement Law ()
Because of our interest in the so-called “Food Disparagement Laws” which have now been enacted in 13 states, we note with some interest the filing of the BPI v. ABC complaint in South ... [more]
Final Rules on FSMA Risk-Based Preventative Controls Released by FDA in Pre-Publication Format ()
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Annals of Internal Medicine Publishes Metadata Review on Evaluation of Possible Health Benefits of Organic Foods ()
The search for statistically significant evidence as to the possible association of health benefits with consumption of organic foods continues. Please see our posts on the UK’s FSA study (July ... [more]
Advocacy Groups File Lawsuit to Compel FDA to Issue FSMA Rules ()
Two non-profit advocacy groups - the Center for Food Safety and the Center for Environmental Health – have filed a complaint for declaratory and injunctive relief against FDA. The complaint, ... [more]
Safe Food Coalition Again Urges USDA to Act on Labeling for Mechanically Tenderized Non-intact Beef Products ()
The Safe Food Coalition has again written to USDA Secretary Tom Vilsack urging action on required labeling for mechanically tenderized non-intact beef products. Here are two statements from the USDA ... [more]
US Senators Ask FDA for Stronger Action on Antimicrobials in Food-Animal Production ()
Thirteen US Senators have addressed a letter to FDA Commissioner Margaret Hamburg asking for stronger restrictions on antimicrobial use in food-animal production. The request focuses upon the two, ... [more]
FDA Publishes Second Annual Report on FSMA ()
The FDA has released its second Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. Although the Report contains relatively little new information, some instructive statistics ... [more]
CFIA Releases Unified Food Safety System Draft for Comment Period ()
The Canadian Food Inspection Agency (CFIA) has released its draft proposal for the Canadian Unified Food Safety System for a comment period which will remain open until October 31. Regulatory Food ... [more]
GAO Issues Report on FDA Food Advisory and Food Recall Process ()
An in-depth study of FDA Food Advisory and Food Recall Procedures has been issued by the Government Accountability Office (GAO). This is timely information since Congress is considering adding a ... [more]
Consumers Union and USDA Exchange Letters on Antibiotic Free Meat Labels ()
In a June 18 letter to Agriculture Secretary Thomas Vilsack, Dr. Urvashi Rangan, Safety and Sustainability Director of Consumers Union has expressed concerns regarding USDA standards of review for ... [more]
Food Recall Insurance Amendment to Farm Bill Introduced in House ()
Congressman Dennis Cardoza (D-CA) has introduced in the House, a parallel to the Senate Feinstein-Chambliss amendment to the 2012 Farm Bill. Cardoza's amendment would require USDA-RMA to study the ... [more]
JFP Publishes Two Articles on the Societal Costs of Foodborne Illness ()
In two articles in its July 2012 issue, the Journal of Food Protection presents one possible approach to the assessment of the societal “costs” of foodborne illness. While these attempts ... [more]
Farm Bill - Passed in Senate - Moves to House ()
There are a number of provisions in the current Senate and House versions of the 2012 Farm Bill that are of major importance to the Produce Industry. To facilitate our ongoing discussion, we post the ... [more]
Organic Standards Protection Act Introduced in Congress ()
Congresswoman Lois Capps (D-CA) and Congressman Richard Hanna (R-NY) have introduced the Organic Standards Protection Act (HR 5962), to ensure that products bearing the USDA organic seal comply with ... [more]
California Certifies GMO Labeling Ballot Initiative ()
California Secretary of State Debra Bowen has certified "The California Right to Know Genetically Engineered Food Act" for the November 2012 General Election ballot. The popular press has, as usual, ... [more]
Canadian Government Proposes Comprehensive Food Safety Legislation ()
On June 7, the Harper Government introduced legislation to reform and unify the Canadian Food Safety system. We post below a complete text of The Safe Food for Canadians Act (S-11, 1st Session, 41st ... [more]
Federal Court Again Orders FDA to Re-examine Rejection of NRDC Petitions on Antimicrobial Use in Food Production Animals ()
With reference to our posts of April 17, 2012, March 23, 2012 and May 27, 2011, United States Magistrate Judge Theodore H. Katz has once again issued an Order in favor of the National Resources ... [more]
Corn Refiners Association Petition Denied by FDA ()
Food Labeling and Food Science professionals have been awaiting the decision of FDA on the Petition of the Corn Refiners Association to permit HFCS to be labeled as "Corn Sugar". The FDA decision, ... [more]
USDA/FSIS Issues Food Safety Notification Rule Conflicting with FDA Reportable Food Registry Rules ()
Food Safety professionals will need to carefully review the Final Rule published by USDA’s Food Safety Inspection Service on in the May 8 Federal Register. The Rule presents alternative and ... [more]
Harvard's Daniel Carpenter Publishes Opinion Piece on FDA Reform in Nature ()
Regulatory Food Science professionals should read the opinion piece published in this week’s issue of Nature by Harvard University Government Professor Daniel Carpenter. Science professionals ... [more]
Representatives Slaughter and Markey Question FDA on Antimicrobial Residues in DGS ()
Congresswoman Louise M. Slaughter (D-NY) and Congressman Edward J. Markey (D-NY) have issued a joint-demand for information to FDA Commissioner Margaret Hamburg regarding recent reports and prior FDA ... [more]
California State Senator Ted Lieu Asks USDA/FSIS to Regulate Transgluaminase ()
California State Senator Ted Lieu, one of the country's most active state legislators in the area of Food Safety, has asked USDA/FSIS to regulate the use of transglutaminase (referred to in the ... [more]
FDA Issues Draft Guidances for Nanotechnology Applications in Food Ingredients and Food Contact Materials ()
As our readers know, we follow nanotechnology developments in the areas of food additives and food contact materials with great interest. Both in the European Union and in the US, regulators are ... [more]
Lt Col Bill Shanahan Awarded Bronze Star for Afghanistan Service ()
Lieutenant Colonel William C. Shanahan, founding principal of Woodhouse Shanahan, has returned from his tour of duty with the US Army in support of Operation Enduring Freedom in the Afghanistan ... [more]
FDA Faces Continuing Pressure on BPA Decision ()
Please see our March 30 post discussing FDA’s rejection of the appeal by the Natural Resources Defense Council (NRDC) and other environmental groups to ban bisphenol-A (BPA). This week’s ... [more]
Charles Woodhouse to Speak on Produce Safety and Food Recalls at July Seminar ()
Charles Woodhouse will be a featured speaker on Produce Food Safety Compliance and Food Recall Management at the July 2012 Food Regulation Current Issues Seminar at Michigan State University in East ... [more]
FDA Issues Additional Nonbinding Guidance on Antimicrobial Use in Food Animal Production ()
This document, released on April 13, is a valuable resource for industry professionals primarily because of its excellent and detailed summary of reports, reviews, and peer-reviewed articles on this ... [more]
FDA Issues Second Edition of the Foodborne Pathogenic Microorganisms and Natural Toxins Handbook ()
On April 3, the FDA issued the Second edition of the Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (known as the “Bad Bug Book”). The Handbook is now available for ... [more]
FDA Rejects NRDC Petition to Regulate BPA ()
On March 30, USFDA rejected a petition by the Natural Resources Defense Council (NRDC) and other environmental groups to ban bisphenol-A (BPA), saying there was not enough scientific evidence to ... [more]
ECDC Issues Report on Climate Change and Food and Waterborne Disease ()
The European Centre for Disease Prevention and Control (ECDC) has published a literature review titled “Assessing the potential impacts of climate change on food- and waterborne diseases in ... [more]
NRDC Prevails in Lawsuit Against FDA Regarding Antimicrobial Use in Food Animal Production ()
With reference to our post of May 27, 2011, United States Magistrate Judge Theodore H. Katz has issued an Order in favor of the National Resources Defense Council (NRDC) The National Resources ... [more]
Scientific American Publishes Article on Long-Term Sequelae of Foodborne Illness ()
An article which is likely to receive considerable attention will appear in the April issue of Scientific American. The article, entitled Food Poisoning’s Hidden Legacy is written by science ... [more]
CSPI Issues White Paper on Antimicrobial Resistance in Foodborne Pathogens ()
The Center for Science in the Public Interest has issued a White Paper titled "Antibiotic Resistance in Foodborne Pathogens: Evidence of the Need for a Risk Management Strategy". The documents is an ... [more]
CDC Presents Data on Possible Increase in Foodborne Disease Attributed to Imports ()
At the current International Conference on Emerging Infectious Diseases in Atlanta, CDC researcher Hannah Gould has presented data which may indicate an increase in the prevalence of foodborne ... [more]
55 Members of Congress Back GE Food Labeling Petition ()
Led by Senator Barbara Boxer (D-CA) and Congressman Peter DeFazio (D-OR), fifty-five Members of Congress have written to FDA Commissioner Margaret Hamburg urging her to require labeling of GE ... [more]
FDA Commissioner Hamburg Testifies Before House Agriculture Subcommittee on FSMA User Fees ()
On February 29, FDA Commissioner Margaret Hamburg testified before the House Subcommittee on Agriculture and detailed FDA's proposed $220 million in Food Establishment Registration Fees. Our readers, ... [more]
FDA Issues Interim Final Rule on Records Access Under FSMA ()
On February 23, 2012, FDA issued an Interim Final Rule, effective March 1, 2012, Amending 21 CFR Part 1, Subpart J, § 1.361 to incorporate language conforming to changes made to Sections 414 and ... [more]
Dartmouth Research Team Documents Inorganic Arsenic Levels in Organic Brown Rice Syrup ()
A research team led by Brian Jackson of the Dartmouth Toxic Metals Superfund Research Project has documented high levels of inorganic arsenic in brown rice syrup used as a sweetener in many ... [more]
EU and US Sign Organic Equivalency Agreement ()
On February 15, the European Commission and USDA signed an Equivalency Agreement granting mutual recognition of US and EU organic standards for most food products. We post the Letter from USDA and ... [more]
Obama Administration Fiscal 2013 Budget Includes 48.5% Increase in FDA User Fees ()
The Fiscal year 2013 Budget of the U. S. Government was released by the Office of Management and Budget on February 13. As we are dissatisfied by simplistic journalistic reviews of the Budget in the ... [more]
Legislation Introduced to Require FDA to Establish Arsenic and Lead MCLs for Beverages Containing Fruit Juices ()
Members of Congress Rosa DeLauro (D-CT) and Frank Pallone (D-NJ) have introduced the “Arsenic Prevention and Protection from Lead Exposure Act of 2012”. From its acronym APPLE, the Act is ... [more]
USDA/FSIS Extends non-O157:H7 E. coli Sampling Implementation ()
Posted below is the February 7 FSIS Constituent Update Special Edition. FSIS has extended from March 5, 2012 to June 4 2012, the implementation of routine sampling of ground-beef and its precursor ... [more]
Three Consumer and Environmental Advocacy Groups File Petition to Regulate GE Salmon as Food Additive ()
Food & Water Watch, Consumers Union, and the Center for Food Safety have filed a Food Additive Petition with FDA’s Office of Food Additive Safety. The petitioners request that FDA evaluate ... [more]
Congressman DesJarlais Introduces Federal Food Disparagement Legislation ()
U.S. Representative Scott DesJarlais (R-TN) has introduced H.R. 3848 the "Protecting Foods and Beverages from Government Attack Act of 2012". This legislation would prohibit the use of federal money ... [more]
USDA/AMS Issues Proposed Rule for Sampling and Inspection of Food Containers ()
The first revisions since 1983 for statistical sampling and inspection of food containers - Standards for Condition of Food Containers – have been issued for comment by the USDA Agricultural ... [more]
University of Iowa Researchers Find Equivalent MSSA and MRSA Levels in Organic and Conventional Pork Products ()
Readers interested in the ongoing debate about the relative food safety attributes of conventional and organic food animal products will want to review a recent publication in PLos ONE. O’Brien ... [more]
NEJM Article Strongly Critical of FDA Dietary Supplement Notification Proposal ()
The New England Journal of Medicine has published an opinion piece written by Pieter Cohen of Harvard Medical School which is strongly critical of FDA’s approach to Dietary Supplement New ... [more]
Two Complaints Filed in Federal Courts Challenging "Natural" Advertising for Orange Juice ()
Please see our December 12, 2012 comments (on our “Essays” page) on FDA’s refusal to define “Natural”. Across the country, consumer rights attorneys are filing false ... [more]
House Energy and Commerce Committee Issues Report on Listeria Outbreak Associated With Cantaloupe ()
The House Energy and Commerce Committee has issued a Report on the 2011 Listeria monocytogenes Outbreak associated with Cantaloupe. The Report is highly critical of the role of third-party auditors ... [more]
FDA Issues Order Restricting Extra-Label Cephalosporin Use in Food-Producing Animals ()
On January 4, FDA issued a Press Release and Q&A on the Order of Prohibition that will issue in the next several days. The extra-label use of cephalosporin drugs in major food-producing animals ... [more]
McGill University Study Suggests Link Between Food Allergy Prevalence and Family SES ()
A McGill University research team has published an intriguing comment on the so-called “hygiene hypothesis” relating the prevalence of food allergies to family SES (Socio-economic ... [more]
Environmental Groups File Complaint to Compel FDA to Regulate Nanotechnology ()
A group of environmental and consumer organizations, led by the International Center for Technology Assessment, has filed a complaint in the US District Court for the Northern District of California ... [more]
USDA/FSIS Extends to March 1, 2012 Effective Date for Meat and Poultry Nutrition Labeling Changes ()
On December 28, USDA/FSIS announced the extension of the effective date for implementation of the Final Rule “Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and ... [more]
FDA issues Guidance for Industry on Prevention of Salmonella Enteritidis in Shell Eggs ()
On December 27, FDA issued “Guidance for Industry on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation”. The purpose of this document is to ... [more]
FDA Withdraws 1977 NOOHs on Antimicrobial Use in Food Animal Production ()
On December 22, and without announcement on its website, the FDA published in the Federal Register the “Withdrawal of Notice and Opportunity for Hearing; Penicillin and Tetracycline Used in ... [more]
White House Issues Federal Food Safety Working Group 2011 Progress Report ()
The December 2011 Progress Report of the Federal Food Safety Working Group is posted below. This document is a useful summary of progress to date on the implementation of the Food Safety ... [more]
CDC Issues Report on State Level Food Safety Epidemiology Capacity ()
In the December 23 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC has published a report which evaluates the challenges facing state Food Safety Epidemiology systems in an era of ... [more]
Health Canada Issues Final Weatherill Report on 2008 Listeriosis Outbreak ()
The Final Weatherill Report on the 2008 Toronto Listeriosis outbreak is posted below. Our readers who are Regulatory Food Science professionals are not well served by summaries prepared by ... [more]
USDA/FSIS Announces Proposed Rule to Streamline Generic Labeling Approval ()
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing a new rule that will allow establishments to label a broader range of products without first ... [more]
European Commission Issues Guidance on Use of Active and Intelligent Materials in Food Packaging ()
On November 23, 2011, the European Commission Health and Consumers Directorate-General (DG-SANCO) issued EU Guidance to the Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and ... [more]
Cornell Team Develops Whole-Genome SNP Techniques to Pinpoint Etiology of Foodborne Illness ()
As molecular biology techniques improve, the ability to rapidly, and at comparative low-cost, establish etiologies of foodborne illness may soon reduce the importance of traditional PFGE ... [more]
European Commission Publishes Definition of Nanomaterials ()
The long-awaited EU recommended definition of Nanomaterials was published on October 20 in the Official Journal (OJ L 275/38-40). The definition reads (in part): Nanomaterial means a natural, ... [more]
USDA to Begin Testing in March 2012 for Shiga Toxin-Producing E. coli in Raw Beef Products ()
In September, USDA / FSIS announced that it intends to carry out verification procedures, including sampling and testing of manufacturing trim and other raw ground beef components, to ensure control ... [more]
UK Health Protection Agency Issues Guidelines for the Management of Norovirus Outbreaks ()
On November 25, the UK’s Health Protection Agency (HPA), together with other professional bodies from the Norovirus Working Party, issued an updated set of Guidelines for the Management of ... [more]
European Union Food Information Regulation (FIR) Published on 22 November in OJ(L) ()
The long awaited Food Information Regulation was published in the Official Journal (L) of the European Union on November 22. The citation is Reg. (EU) 1169/2011. OJ(L) 304/18, 22 Nov 2011. The full ... [more]
Review of Current Scientific Evidence - Antimicrobial Use in Food Animal Production ()
The American Society for Microbiology’s journal, Clinical Microbiology Reviews has published a major review article on the current state of the “science” on antimicrobial use in the ... [more]
WTO Panel Decides Against US in COOL Complaints of Canada and Mexico ()
In the weeks ahead, students and practitioners of food labeling will be studying the WTO Panel’s decision on the consolidated cases WT/DS 384 (Canada) and WT/DS 386 (Mexico). In 2008, Canada ... [more]
FSIS to Delay Nutrition Labeling Rule to March 1, 2012 ()
FSIS is delaying the effective date of the final rule that will require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry ... [more]
Johns Hopkins Study Highlights Veterinary Drug Residues in Seafood ()
A study at Johns Hopkins University details findings regarding veterinary drug residues in seafood products. Copyright restrictions prevent us from posting the study. However, we post the abstract ... [more]
Charles Woodhouse on the Imported Food Provisions of the Food Safety Modernization Act ()
Charles Woodhouse has published a White Paper on the imported food provisions of the Food Safety Modernization Act. This paper is a version of materials prepared by Mr. Woodhouse as Guest Instructor ... [more]
CDC Issues Update on Listeriosis Outbreak Associated with Cantaloupes ()
The CDC has announced that, as of November 1, 2011, a total of 139 persons have been infected with one of the four outbreak-associated strains of Listeria monocytogenes. Twenty-nine deaths and ... [more]
FDA to Focus Testing Resources on Salmonella in Pet Foods ()
FDA has announced a national testing program to assess risk of Salmonella transmission to humans through pet food, pet treats, and pet supplements. Details of the announcement are posted below: [more]
IOM Issues Report Advocating FOP Nutrition Labeling ()
The Institute of Medicine (IOM) of the National Academies has issued a report entitled "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices". The report supports a ... [more]
Brustle Decision Offers Insight into ECJ's Approach to Scientific Issues ()
We have previously posted (October 8) the Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern noting that it has created considerable confusion and controversy among ... [more]
GAO Issues Report Critical of both FDA and ISSC on V. vulnificus Reduction in Raw Oysters ()
The Government Accountability Office (GAO), the investigative arm of Congress, has issued a report which highlights the need for FDA and the ISSC (Interstate Shellfish Sanitation Conference) to ... [more]
CSPI Files Class Action Against General Mills for Allegedly Deceptive Labeling Practices ()
The Center for Science in the Public Interest (CSPI) has filed a class action suit against General Mills for allegedly deceptive advertising of "Fruit Roll-ups". The action was filed today in the US ... [more]
ECJ Decision on GMO Regulation in Bablok v. Freistaat Bayern ()
The Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern has created considerable confusion and controversy among students and practitioners who follow European GMO ... [more]
Food Safety Advocacy Group Files Petition with FDA to Require GE Labeling ()
The Center for Food Safety, a Washington based advocacy group, has filed a Petition with USFDA to require the labeling of all foods produced with Genetic Engineering technology. We express no opinion ... [more]
European Council Adopts FIR (Food Information Regulation) ()
The Food Information Regulation (FIR) will be the most significant change in European Food Labeling in 30 years. The vote by the European Council now clears the way for publication in the Official ... [more]
FDA Releases 2009 Food Code Supplement and Retail Food Safety Action Plan ()
FDA has released the first 2009 Food Code Supplement and has also announced its Retail Food Safety Action Plan. The Food Code Supplement is posted below as is the Press Release for the Retail Food ... [more]
Produce Safety and the Food Safety Modernization Act ()
Charles Woodhouse comments on Produce Safety and the Food Safety Modernization Act. The attached essay provides an advanced look at the probable shape of the forthcoming Produce Safety Rule by ... [more]
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Law Professors Address 1st Amendment Issues in IWG Food Advertising to Children Proposal ()
Thirty-six prominent American law professors have written to the heads of the FTC, the FDA, the USDA, and the CDC to express their collective judgment that the Preliminary Proposed Nutrition ... [more]
GAO Report Critical of FDA and USDA on Antimicrobial Use in Food Animal Production ()
A GAO Report issued this week is sharply critical of the apparent lack of diligence of USFDA and USDA in addressing the problems of antimicrobial use in food animal production and the development of ... [more]
Senator Gillibrand Sponsors Foodborne Illness Reduction Act ()
Senator Kirsten Gillibrand has introduced the Foodborne Illness Reduction Act to reform USDA and FSIS Food Safety Programs. This Bill addresses issues not reached in the FSMA. As a service to our ... [more]
USDA Classes Six Non-O157 STEC Serogroups as Adulterants ()
USDA/FSIS (Food Safety Inspection Service) announced today that in addition to E. coli O157:H7, six additional serogroups of pathogenic E. coli will be declared adulterants in non-intact raw beef ... [more]
New Data on Contamination Levels and Infective Doses of Foodborne Pathogens ()
Researchers at the National Institute of Health Sciences in Japan have published a paper in the current issue of Epidemiology and Infection which provides guidance for the relative risk-assessment of ... [more]
Ireland Issues Guidelines for RTE Sprouted Seeds ()
Ireland Issues Guidelines for Ready-to-Eat (RTE) Sprouted Seeds The Food Safety Authority of Ireland (FSAI) has published guidelines for the safe production of sprouted seeds to be consumed raw, ... [more]
Anti-Regulatory Lawsuit Filed Against FDA on Cantaloupe Recall ()
We express no opinion with respect to the merits of the present matter before the US District Court for the District of Maryland in the matter of Del Monte Fresh v. USFDA. However, we post below the ... [more]
FDA Publishes Agenda for Advancing Regulatory Science ()
USFDA has issued a new "White Paper" titled "Advancing Regulatory Science at FDA". As used by FDA Commissioner Margaret Hamburg, the term "Regulatory Science" means the use of evidence-based science ... [more]
USFDA Announces FSMA User Fees for Reinspections and Recalls ()
USFDA has announced in the Federal Register its first User Fee Schedules in connection with implementation of the Food Safety Modernization Act. The schedules cover fees for domestic and foreign ... [more]
European Union Approves 2nd Article 13 Health Claim ()
Under the ongoing Article 13 process, the EU's EFSA (European Food Safety Authority) has approved its second qualified health claim. The claim related to glycaemic response effects of slowly ... [more]
USFDA Reopens Comment Period on Gluten Free Labeling ()
USFDA has reopened the Comment Period on the "Gluten Free" Labeling Proposed Rule that was initially published in 2007 (see 72 FR 2795). We post the Federal Register Notice (76 FR 46671) regarding ... [more]
USDA Proposes New Rule on Labeling of Meat and Poultry Containing Injections, Marinades, and other Added Solutions ()
The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) has issued a proposed rule on labeling of meat and poultry containing injections, marinades, and other added ... [more]
EFSA Publishes Scientific Opinion Update on Viral Foodborne Illness Etiology ()
EFSA has released a Scientific Opinion updating its assessment of the state of present knowledge of the etiology and control of viral foodborne illness. The text of the 91 page document is posted ... [more]
EU Parliament Votes on Changes in Food Information Regulation ()
As discussed in our earlier post, the text of the July 6 Resolution of the European Parliament provides significant insight into the final amendments to the Food Information Regulation (FIR) that ... [more]
European Parliament to Vote on Food Label Changes ()
On July 5, the European Parliament will vote on a wide range of proposed changes in food labeling. The full text has remained unpublished, but a preview of the changes was released on July 29 and is ... [more]
EFSA and ECDC Release E-coli 0104:H4 Updates ()
EFSA (the European Food Safety Authority) has released an updated Risk Assessment in consideration of the HUS (Haemolytic Uremic Syndrome) cases in France. Additionally Eurosurveillance, published by ... [more]
Senator Feinstein Reintroduces PAMTA in 112th Congress ()
Senator Dianne Feinstein (D-CA), has reintroduced (June 15) the “Preservation of Antibiotics for Medical Treatment Act of 2011” (PAMTA) in the 112th Congress. Senators Susan Collins ... [more]
HHS Inspector General Finds FDA Imported Food Recall Management Seriously Flawed ()
The Inspector General (IG) of HHS (Health and Human Services) has issued an investigative report which points to serious flaws in USFDA's administration of recalls of imported foods. The IG surveyed ... [more]
FDA Issues Policy Report on Import Regulation in the Global Era ()
The U.S. Food and Drug Administration (USFDA) has issued a new Policy Report entitled, "Pathway to Global Product Safety and Quality". The Policy Report discusses the challenges facing USFDA in the ... [more]
Major Epidemiological Food Allergy Study Finds 8% Prevalence in US Children ()
A research team, headed by Dr. Ruchi Gupta of Northwestern University, has published its findings in the July issue of Pediatrics. The report titled, “The Prevalence, Severity, and Distribution ... [more]
FDA Issues Draft Guidance for Nanotechnology and Nanomaterials ()
The Food and Drug Administration (FDA) has issued a Draft Guidance for Industry document which gives nanotechnology stakeholders their first insight into FDA’s thinking about the probable scope ... [more]
Senator Gillibrand Introduces Legislation to Mandate STEC/VTEC Testing of America's Beef Supply ()
Senator Kirsten Gillibrand, the only trained microbiologist in Congress, has introduced strengthened meat safety legislation that targets high-risk pathogens and currently unregulated strains of E. ... [more]
EFSA and ECDC Issue Technical Report on German STEC/VTEC Outbreak ()
The European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) have issued a Technical Report on the recent STEC/VTEC outbreak in Germany. Citation: Shiga ... [more]
Conservation International and WorldFish Issue Major Aquaculture Report ()
Conservation International and the WorldFish Center have issued a major report based upon Life Cycle Analysis (LCA) of Aquaculture as compared with other Center-of-the Plate animal protein production ... [more]
CDC Releases 2010 Foodborne Illness Surveillance Data ()
In the June 10 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC (Centers for Disease Control) has released the 2010 data from the Foodborne Illness Active Surveillance System. This is ... [more]
Review Article on EU Restrictions on AGP Use in Food Animal Production ()
The American Society for Microbiology (ASM) has published an important review of the European experience in efforts to control the use of AGPs (Antibiotic Growth Promoters) in food animal ... [more]
NOAA Announces National Marine Aquaculture Policy ()
As background to this announcement, NOAA (National Oceanic and Atmospheric Administration) calls attention to the poor performance of US policy makers with respect to job-creation in this industry ... [more]
NRDC, CSPI, and other Environmental Groups Challenge FDA Approvals of Antibiotic Use in Animal Feeds ()
The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have ... [more]
Update on USDA National Organic Apiculture Standard ()
In response to recent communications from readers, we are providing an update on the status of NOP (National Organic Program) progress towards the implementation of the Organic Apiculture Standard. ... [more]
GAO Issues Report on Seafood Safety which is Sharply Critical of USFDA ()
The GAO (Government Accountability Office), the investigative arm of the US Congress, has issued another report in its series of analyses of the performance of USFDA and USDA in the protection of US ... [more]
USFDA Issues First Rules Under the Food Safety Modernization Act ()
The first issuance of rules under the Food Safety Modernization Act (FSMA) were released by USFDA on May 5. The Press Release is attached as well as the two Federal Register Notices. Effective July ... [more]
Health Canada Releases Updated Rules for Listeria monocytogenes in Ready-to-Eat Foods ()
Following up on our October 2010 posting, Health Canada has released updated Rules for Control of Listeria monocytogenes in Ready-to-Eat foods. We post the new Guidelines below: [more]
Federal Agencies Release Recommendations on Marketing Food to Children ()
On April 28, the Interagency Working Group on Food Marketed to Children - consisting of the Federal Trade Commission (FTC), the Centers for Disease Control (CDC), the Food and Drug Administration ... [more]
FDA Issues Updated Fish and Fisheries Products Hazards and Controls Guidance ()
On April 28, USFDA issued the 4th edition of "Fish and Fishery Products Hazards and Controls Guidance” as required by the Food Safety Modernization Act (FSMA), which President Obama signed into ... [more]
FDA Releases "Strategic Priorities 2011-2015" ()
Food industry readers will want to review the FDA's newly released "Strategic Priorities 2011-2015" document. 2011 and 2012 will be the critical years for the most sweeping changes in food regulation ... [more]
FDA to Fund Study of Consumer and Industry Post-Recall Economic Behavior ()
USFDA will fund a research study to evaluate market disruptions after major food recall-events in order to better understand the complex behavior of consumers, grocery retailers, and producers ... [more]
FDA Updates RPM Chapter 7 - Recalls ()
FDA has updated Chapter 7 (Recalls) of the Regulatory Procedures Manual. We attach a PDF of the revised Chapter 7 below as well as updated copies of Industry Guidance on Recalls and 21 CFR Part 7. We ... [more]
Comment Period Opens April 6 on FDA's Restaurant and Vending Machine Nutrition Labeling Rules ()
We have posted below advance copies of proposed FDA rules on Restaurant and Vending Machine nutrition labeling rules as mandated by the Affordable Care Act of 2010. The final text will be published ... [more]
USFDA Releases Background Memo on Labeling and Safety Issues for Color Additives ()
On March 30, USFDA released a "Background Document" reviewing health and labeling issues related to Certified Color Additives. The document reviews the "Southampton Study" commissioned by the United ... [more]
GAO Issues Report Critical of Food Safety Interagency Coordination ()
The Governmental Accountability Office (GAO), the investigative arm of Congress, has issued a report on "Federal Food Safety Oversight" which is critical of the continuing fragmentation of agency ... [more]
USDA Issues New Performance Standards for Control of Salmonella and Campylobacter in Poultry ()
The USDA's Food Safety Inspection Service ("FSIS") has issued new standards for control of Salmonella and Campylobacter in poultry. Attached below is the March 16 Press Release as well as an Advance ... [more]
FDA Takes First Steps in Implementation of the Food Safety Modernization Act ()
With the publication of two Federal Register Notices today, the FDA has taken the first administrative steps in the implementation process for the Food Safety Modernization Act ("FSMA"). Today's ... [more]
Congresswoman Louise Slaughter Introduces Legislation to Restrict Antibiotic Use in Animal Production ()
Congresswoman Louise Slaughter has introduced H.R. 965, the Preservation of Antibiotics for Medical Treatment Act (“PAMTA”). Her legislation would limit the use of seven classes of ... [more]
GAO Study on Governmental Program Duplication Highlights Food Safety Issues ()
On March 3, the Government Accountability Office issued a new Report titled “Opportunities to Reduce Potential Duplication in Government Programs” highlighting Food Safety programs among ... [more]
Bipartisan Senate Group Introduces Bill to Prevent FDA Approval of GE Salmon ()
Senators Begich, Murkowski, Murray, and Wyden have introduced two bills in the opening days of the 112th Congress. S-230 would prohibit USFDA from approving the marketing of genetically-engineered ... [more]
USDA Issues "Dietary Guidelines fo Americans - 2010" ()
On January 31, USDA released the 2010 update of "Dietary Guidelines for Americans", 7th Edition. This document, issued every 5-years, and from an inherently cautious governmental agency, remains an ... [more]
FDA Issues First Annual Report on Reportable Food Registry ()
FDA has issued the first Annual Report on the initial 12-months of operation of the Reportable Food Registry (September 2009 to September 2010). Participants in the farm-to-market value chain filed ... [more]
Grocery Manufacturers Association - Second Initiative on FOP Labels ()
The GMA (Grocery Manufacturers Association) has made public a second FOP (Front of Package) labeling scheme which is called "Nutrition Keys". In 2010 the previous "Smart Choices" GMA initiative was ... [more]
GAO Issues Report on Food Label Health, Qualified Health, and Structure / Function Claims ()
The Government Accountability Office (the "investigative arm" of the US Congress) has issued another of its series of reports on Food Labeling issues. The report is titled "Food Labeling: FDA Needs ... [more]
Essay #1 - Food Safety Modernization Act ()
THIS IS THE FIRST OF A SERIES OF ESSAYS ON THE FSMA WRITTEN BY CHARLES WOODHOUSE THESE ESSAYS ARE DRAWN FROM THE MONTHLY FOOD SAFETY COLUMN WRITTEN BY CHARLES WOODHOUSE IN THE AMERICAN AGRICULTURAL ... [more]
USDA to Require Nutrition Fact Panels on Meat and Poultry ()
The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced on December 29 that, effective January 1, 2012, it will require nutritional information panels for 40 of the ... [more]
Provisional Text of Food Safety Modernization Act ()
The Food Safety Modernization Act has now passed both the House and Senate in the final days of the 111th Congress and heads for the desk of President Obama. Posted below is the latest available GPO ... [more]
CDC Issues New Data on Public Health Impact of Foodborne Pathogens ()
In three new documents released (pre-publication) to support testimony before Congress, the CDC estimates that each year 1 out of 6 Americans (or 48 million people) experiences a foodborne illness, ... [more]
FDA Issues "Dear Manufacturer Letter" on Dietary Supplements ()
On December 15, as part of its ongoing enforcement offensive to police the dietary supplements industry, the FDA issued a broad new warning about some dietary supplements, body-building products, and ... [more]
President Obama Signs the Healthy, Hunger Free Kids Act ()
On December 13, President Obama signed the Healthy, Hunger Free Kids Act of 2010. The Act includes significant Food Safety program requirements for School Lunch Programs, recall provisions, and ... [more]
House and Senate Action on Food Safety Modernization Act S-510 ()
The Enrolled Senate version of the Food Safety Modernization Act (S-510 ES) is back in play. Please see our post of December 7 for a discussion of the constitutional error made in the Senate on ... [more]
Enrolled Senate Version of S-510 Released by GPO ()
The final Enrolled Senate (ES) version of S-510 (the Food Safety Modernization Act) has now been released by the Government Printing Office. Readers are referred to our previous post on the ... [more]
US Senate Passes S-510 and Food Safety Legislation Moves to House ()
On November 30, with a vote of 73 to 25, the US Senate passed an amended version of S-510, the Food Safety Modernization Act. The action now moves to the House of Representatives in the final days of ... [more]
EFSA Publishes Survey of EU Consumer Perceptions of Food Related Risks ()
The European Food Safety Authority (EFSA) has published its 2010 Eurobarometer Survey Report on consumer perceptions of food related risks. Contamination of food with industrial chemicals is ... [more]
Duke Researchers Criticize FDA Methodology on GE Salmon Risk Assessment ()
A team of researchers at Duke University has published an article criticizing the FDA methodology for the approval of GE (Genetically Engineered) Atlantic Salmon. The article was published in the ... [more]
Australian Parliament Joins Debate Over GE Foods Labeling ()
Students of Food Labeling will wish to note that the debate on labeling of GE (Genetically Engineered) Foods has now reached Australia and New Zealand. Australian Senator Nick Xenophon has introduced ... [more]
Health Canada Issues New Policy on Listeria monocytogenes in RTF Foods ()
The 2008 Listeria monocytogenes outbreak in Canada claimed 22 lives and caused a major review of the 2004 Health Canada guidelines for contorl of L. monocytogenes in Ready-to-Eat (RTE) foods. Readers ... [more]
Yale's Rudd Center Releases Report on Fast Food Marketing to Youth ()
The Yale University Rudd Center on Food Policy & Obesity has issued a major report entitled Evaluating Fast Food Nutrition and Marketing to Youth. Our readers with interests in Food Labeling and ... [more]
US Justice Department files amicus brief in Gene Patent Case ()
The US Department of Justice has filed an amicus brief in a case before the US Court of Appeals for the Federal Circuit (“CAFC”) opposing the issuance of gene patents to naturally ... [more]
USFDA Releases Retail, Restaurant, and Food Service Survey of Foodborne Illness Risk Factors ()
On October 22, USFDA released a new 10-year Survey tracking food retail, restaurant, and food service industry efforts to control and reduce key food safety risk factors. In addition, USFDA has ... [more]
USDA Foreign Agricultural Service Issues Export Programs Review ()
The US Department of Agriculture Foreign Agricultural Service has issued a review of FY 2010 agricultural export programs. This document is a valuable reference and review and is posted ... [more]
Johns Hopkins / NIH Study Finds 7.5 Million Americans with Clinical Level Food Allergies ()
Funded by a grant from the National Institutes of Health (National Institute of Environmental Health Sciences), researchers at Johns Hopkins University have completed the largest study ever conducted ... [more]
UK Food Standards Agency Issues Warnings on Morpholine as Carrier for Produce Glazes ()
The UK Food Standards Agency has issued warnings to importers on produce coated with wax containing morpholine as a carrier for glazing agents. The warning is primarily directed at apples since ... [more]
Canada Lists BPA (bisphenol A) as Schedule-1 Toxic Substance ()
On October 13, the Canada Gazette published an Official Notice listing bisphenol A as a Schedule-1 Toxic Substance under the Canadian Environmental Protection Act, 1999. This Notice will pave the way ... [more]
Congresswoman Rosa DeLauro Introduces Consumer Right to Know Food Labeling Act ()
Congresswoman Rosa DeLauro (D-CT), Chair of the Appropriations Agriculture Subcommittee (controlling the budget of USFDA and USDA) has issued what some may view as a direct challenge to USFDA ... [more]
Institute of Medicine of National Academies of Sciences issues first report on Front-of-Package Food Labeling ()
The Institute of Medicine of the National Academies of Sciences has issued the first of two reports on Front-of-Package (FOP) Food Labeling Examination of Front-of-Package Nutrition Rating Systems ... [more]
Federal Trade Commission Opens Comment Period on Green Guides Revisions / Updates ()
With an increasingly activist Federal Trade Commission (FTC) taking a more aggressive posture with regard to food label claims of an environmental nature, readers should note the first update of the ... [more]
FDA Issues Agenda for Development of Regulatory Science ()
Lawyers who are also trained and credentialed in the biological sciences will play a vital role in the development of the new field of Regulatory Food Science. In an important report, issued today, ... [more]
GHG Emissions Embedded in Food Waste ()
An important study on GHG Emissions and Food Waste has been published in Environmental Science and Technology. The authors include the noted agricultural efficiency researcher, Michael D. Webber of ... [more]
Eleven US Senators Urge FDA Commisioner Hamburg to Delay GE Salmon Approval ()
In an action which casts serious doubt upon the prompt approval of the first Genetically Engineered (GE) Animal by USFDA, eleven US Senators have written to FDA Commissioner Hamburg urging that the ... [more]
Research Indicates Possible Relationship Between Salmonella enterica and Tomato Variety and Ripeness ()
Using recombinant-based in vivo expression technology (RIVET), University of Florida researchers have discovered that tomato variety and maturity may influence the growth and prevalence of Salmonella ... [more]
EU Agriculture Ministers Strongly Oppose Decentralization of Approval of GE Crops ()
On September 27, European Union agricultural ministers representing Germany, France, Italy and Spain reportedly expressed strong opposition to a proposal that would decentralize Genetically ... [more]
US Senators Introduce Bill to Increase Food Safety Criminal Sanctions ()
United States Senators Patrick Leahy, Amy Klobuchar, and Al Franken have introduced S-3767 the FOOD SAFETY ACCOUNTABILITY ACT OF 2010. This proposed legislation would dramatically increases prison ... [more]
NIH Funds Research on Dietary Supplements ()
On September 14, the Wall Street Journal published an important review article detailing the National Institutes of Health (NIH) research program that may lead to greater restrictions on structure / ... [more]
Consumer Recall Notification Act and Food Safety Legislative Update ()
As Food Safety legislation moves forward in Congress, Senator Kirsten Gillibrand (D-NY) has emerged as one of the foremost Food Safety advocates in Congress. In March she introduced S-3114, a bill ... [more]
USFDA Publishes Favorable Position on Possible Approval of GE AquAdvantage Salmon ()
BRIEFING PACKET The USFDA Veterinary Medicine Advisory Committee has released its Briefing Packet for the September 20 meeting to review the possible approval of Genetically Engineered (GE) ... [more]
USFDA Releases Background Document on Labeling of Foods Made from GE Salmon ()
On August 26, FDA released a Background Document discussing its current thinking on the labeling of foods derrived from Genetically Engineered Salmon. This document is of significant interest in that ... [more]
FDA Issues Updated Industry Guidance on Restaurant Nutrition Food Labeling ()
On August 24, USFDA released a new Industry Guidance document on Restaurant Nutrition Food Labeling. We attach below the two Federal Register Notices and the updated Guidance Document. [more]
FDA Issues New Draft Guidance for Control of Salmonella Enteritidis in Shell-Eggs ()
Please see our July 12 posting for discussion of the new Shell-Egg Rule (74 FR 33030) which entered into effect on July 9, 2010 for producers with 50,000 or more layers at one farm. Below we have ... [more]
EFSA Advisory Forum Holds Discussions on the Role of Science in Food-Safety Policy ()
In coordination with the EFSA Advisory Forum, the Belgian Federal Public Service for Health, Food Chain Safety and the Environment is hosting a series of round tables on the role of science in the ... [more]
CDC Releases 2007 Foodborne Illness Data Analysis ()
The August 13 issue of MMWR (Morbidity and Mortality Weekly Report) includes the release of 2007 data on Foodborne Illiness in the United States. We attach the relevant pages below. [more]
Senate Passes Child Nutrition Act S-3307 ()
On August 9, the US Senate passed the "Healthy, Hunger-Free Kids Act" (Child Nutrition Act S-3307). This legislation now will move to the House in September (after recess) where passage is also ... [more]
USFDA Issues First Review of Reportable Food Registry Operations ()
USFDA has issued its Review Report on the first six-months of operations of the Reportable Food Registry (RFR). We have also included below the most recent Compliance Guide for the RFR updated to ... [more]
UK Food Agencies Announce Campylobacter Research Program ()
The UK’s Food Standards Agency (FSA), Biotechnology and Biological Sciences Research Council (BBSRC), and the Department for Environment, Food and Rural Affairs (Defra) have announced a new ... [more]
FDA Issues Opt-in Nutrition Disclosure Rules for Small Restaurant Operators ()
July 21, 2010 - USFDA today issued a Federal Register notice that explains how restaurants and similar retail food establishments not covered by the new federal menu labeling requirements, such as ... [more]
EFSA Issues Guidance Document on Risk-Benefit Assessment of Foods ()
The European Food Safety Authority (EFSA) has issued a Scientific Opinion of its Scientific Committee - "Guidance on human health risk-benefit assessment of foods" The document develops the EFSA ... [more]
New FDA Regulations for Prevention of Salmonella in Shell Eggs in Effect Today ()
The new FDA regulation for prevention of Salmonella in Shell Eggs take effect this week. We attach the Guidance document as well as the Federal Register Notice of the Final Rule. [more]
FDA Proposed Restaurant Nutrition Information Rule ()
On July 7, the Proposed Rule on Restaurant and Food Service Nutrition Information was published in the Federal Register. The Notice is attached below. We also attach Section 2572 of the Health Care ... [more]
University of London Study on Health-Related Benefits of Organic Foods ()
Scientists at the University of London’s School of Hygiene and Tropical Medicine have published a review of the nutrition-related benefits to health of consuming organic foods in the American ... [more]
USDA-ERS Releases Report on Local Food Supply Chains ()
The USDA Economic Research Service has released a report on Local and Mainstream Food Supply Chains. Local, so called "Low Food Miles", food products have been rapidly gaining popularity with ... [more]
EU Organic Production and Labelling Rules (Including Organic Aquaculture) Now In Full Effect as of July 1 ()
European Union Council Regulation (EC) No 834-2007 covering the production and labelling of organic products is now in full effect. We attach the complete text below. Readers should also understand ... [more]
FDA Issues Letter to Industry and Analytic Protocol on Gulf Seafood Contamination ()
In connection with potential contamination concerns raised by the Gulf Oil Spill, USFDA has issued a Letter to Industry reviewing regulations and requirements applicable to molluscan shellfish and ... [more]
Stanford University Researchers Document GHG Emissions Mitigation form Agricultural Intensification ()
Stanford University researchers have published a study in PNAS, the Proceedings of the National Academy of Sciences, documenting cumulative GHG (Greenhouse Gas) mitigation provided by agricultural ... [more]
FDA Issues Draft Guidance on Antimicrobial Use in Food-Producing Animals ()
On June 28, FDA issued a Draft Guidance Letter to Industry on Use of Antimicrobials in Food-Production Animals. We attach the Letter, the Press-Release, and the Q&A below. This Letter has ... [more]
EFSA Annual Report for 2009 Issued ()
The European Food Safety Authority has issued its 2009 Annual Report. This author believes that USFDA CFSAN should also issue a similar Annual Report to its "stakeholders". [more]
USDA Proposal to Modify PACA Trust Protection of Post-Default Agreements ()
USDA has published a proposed modification of PACA Trust provisions which may protect post-default agreements. The Federal Register Notice is attached below. [more]
US Supreme Court Issues Monsanto Genetically Engineered Alfalfa Decision ()
On June 21, the US Supreme Court issued its long-awaited decision in Monsanto Company v. Geertson Seed Farms, 561 U.S. ___ (2010). In this important decision, the Supreme Court has lifted the ... [more]
Anticipated Changes in European Union Food Labeling ()
As the European Union prepares for adoptions of major revisions in Food Labeling Regulations we post both the current law (Directive 2000 13 EC) and the Proposed Revisions. When the final text is ... [more]
Health Canada Issues Study of Bisphenol A Residual Levels in Canned Foods ()
Health Canada has issued a survey of BPA residual levels in common canned foods. The attached report summarizes the methodology of the survey and reports results. Health Canada has previously ... [more]
Institute of Medicine Releases Study of the USFDA Food Safety System ()
While food safety is also regulated by the USDA, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce and seafood. Food safety experts and the public have ... [more]
USDA Issues Update on Organic Farming Status and Opportunities ()
The June issue of the USDA magazine "Amber Waves" presents a valuable update on the current status of organic farming in the USA and discusses challenges and opportunities for the future. We also ... [more]
FDA Files Motion to Dismiss in CFS v. Hamburg ()
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GAO Releases Report to Congress Highlighting Gaps in FDA Food Safety Programs ()
On May 24, the Government Accountability Office released the text of its April 23 letter to USFDA highlightings GAO findings that show significant gaps in FDA Food Safety Research and Programs. The ... [more]
Produce Safety Project Report on European Food Safety Systems ()
The Produce Safety Project has issued another excellent report in its series. The report issued this week focuses on lessons that can be learned from the European Union’s Food Safety Policy. ... [more]
Presidential Cancer Panel Endorses Organic Food Choices ()
HHS, NIH, and the National Cancer Institute have issued the 2008-2009 report titled “Reducing Environmental Cancer Risk”. This report, see link below, contains numerous Food Safety ... [more]
National Academy of Sciences Committee Reports on Scientific Evaluation Standards for Health and Function Claims ()
In “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease” an Institute of Medicine (National Academy of Sciences) panel has recommended that FDA adopt a consistent ... [more]
Reviewing HR 2749 as the Probable Shape of Forthcoming Food Safety Legislation ()
It is increasingly clear that the final Food Safety legislation which will emerge from the 111th Congress will be very close to the provisions of HR 2749 which passed the House and moved to ... [more]
GAO Issues Updated Report on Food Import Oversight by USFDA ()
On May 6, the Government Accountability Office (GAO) issued an important update of the September 2009 Import Food Safety Report (GAO-09-873) previously posted on this Weblog. For our reader's ... [more]
Senator Alexander Tasks FDA for Explanation of Use of Draft Guidances ()
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USFDA Initiates Request for Comments on Proposed FOP Labeling ()
USFDA has opened a comment period for FOP (Front of Pack) food labeling. We have attached below the Federal Register Notice (75 FR 22602). This document contains an excellent discussion of FOP ... [more]
USDA IG Issues Report Critical of National Residue Program Monitoring for Cattle ()
The USDA Inspector General released today a highly critical report on National Residue Program monitoring for pesticide, heavy metal, and antibiotic residues in the national meat supply. The report ... [more]
USDA Economic Research Service Releases New Organic Agriculture Data Sets ()
On March 30, the US Department of Agriculture Economic Research Service released data updated through 2008 on organic agriculture. A remarkable 15% annual growth of acreage dedicated to organic ... [more]
HHS IG Issues Report on FDA Domestic Food Plant Inspections ()
The Department of Health and Human Services Inspector General has issued a report on USFDA's inspection program for domestic food plants. The report documents an underfunded and under-resourced ... [more]
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Health Care Bill Includes Restaurant Labeling Provisions ()
The Affordable Healthcare for America Act signed by President Obama on March 23 contains the Restaurant Labeling provisions that we discussed in our posting of 11/3/2010. To assist our readers we ... [more]
USDA Inspector General Faults Agency on Organic Standard Oversight ()
The Office of Inspector General of the USDA has issued a report that is sharply critical of USDA enforcement of the National Organic Program (NOP). The OIG Report highlights lax enforcement by USDA ... [more]
GAO Report Critical of USFDA's Handling of Food Irradiation Petitions ()
In a report released on March 18, the Government Accountability Office (GAO) was sharply critical of FDA in its handling of Food Irradiation Petitions on a timely basis. The report faults FDA for ... [more]
Review of COOL Program Labeling Requirements ()
We are posting again (a year later) a review of COOL Labeling requirements in response to continuing questions that arise in connection with COOL implementation. Country of Origin Labeling is a ... [more]
GAO Report on FDA Oversight of GRAS Food Ingredients ()
A February 2010 Report released by the Government Accountability Office finds significant shortcomings in USFDA's oversight of the GRAS determination process. The Report highlights significant ... [more]
FDA Commissioner Hamburg issues major statement on Food Labeling ()
On March 3, FDA Commissioner Hamburg issued the attached Open Letter to Industry on Food Labeling issues. Also attached is the list of Warning Letters issued in connection with this Open Letter. You ... [more]
EFSA launches cooperation project on non-plastic food contact materials ()
The European Food Safety Authority has set up an EFSA scientific cooperation (ESCO) working group to collect and analyze information on the safety of substances used in non-plastic materials which ... [more]
USDA Releases 2008 Organic Production Survey ()
The 2008 Organic Production Survey (OPS) is a follow-on survey to the 2007 Census of Agriculture. It is the first organic production and practices survey conducted on the national level by the U.S. ... [more]
EFSA Issues 2008 Zoonoses & Foodborne Illness Report ()
The European Food Safety Authority (EFSA) has issued its 2008 Statistical Report on Zoonoses and Foodborne Human Illness within the European Union. Release date 1/28/2010. Please see attached file. [more]
USCBP to Enforce ISF 10+2 Rules Starting January 26 ()
For the past year, Customs Brokers have been preparing their customers - international seafood and produce shippers should be prepared for a new phase of regulatory enforcement that will soon take ... [more]
National Salt Reduction Initiative Announced by New York City Health Department ()
The New York City Health Department announces the Natiuonal Salt Reduction Initiative on Ja. 11, 2010. The Press Release and additional background information is attached below. This program is ... [more]
UK Introduces Voluntary GHG Carbon Footprint Food Labels ()
As part of a UK Government strategy to reduce Greenhouse Gasses, Hilary Benn, the UK’s Environment Secretary has introduced the new “Carbon Footprint” labeling strategy and several ... [more]
UK Parliamentary Committee Urges Research on Safety of Food Nanotechnology ()
The science and technology committee of Britain's upper house of parliament said, in a report issued on January 8, that use of nanoparticles in food and food packaging is likely to grow dramatically ... [more]
Nutritional Value of Organic Foods - France's AFSSA study contradicts UK FSA Study ()
A new review from France has concluded that there are nutritional benefits to organic produce, on the basis of data compiled for the French food agency AFSSA. The conclusion opposes that of a UK ... [more]
HHS Inspector General Finds Low Compliance Rate for FDA's Food Facility Registry ()
The lack of Food Industry compliance with the Bioterrorism Preparedness and Response Act of 2002 is again in the news (See our Weblog posting of March 31, 2009). Compliance with the Food Facility ... [more]
FDA Announces Plan for Enforceable Produce Safety Regulations ()
In the Fall 2009 Federal Unified Agenda, FDA announced its intent to issue enforceable regulations in line with the August 2009 commodity specific guidance documents on leafy greens, tomatoes, and ... [more]
EFSA Issues Guidance Document on Article 13.1 Health Claims ()
General function claims under Article 13.1 of Regulation (EC) No. 1924/2006 refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioral ... [more]
USFDA Releases Food Traceability Study ()
On November13, the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) released a report from the Institute of Food Technologists (IFT), which recommends clear ... [more]
The Food Safety Modernization Act of 2009 moves to Senate Debate ()
The Food Safety Modernization Act of 2009 will now move to Senate debate. On November 18, the Senate Committee on Health, Education, Labor, and Pensions ordered S-510 to be reported with ... [more]
USFDA Releases Updated 2009 FOOD CODE ()
Last updated in 2005, the USFDA today released the 2009 Food Code. There are important changes for produce food safety with newly updated instructions for handling leafy greens. [more]
FDA/FSIS Traceability Meeting Notice - Dec 9 ()
The Federal Register Notice (FR-74-211-56843-110309) on the forthcoming FDA / FSIS meeting has been posted below. There is a good deal of useful background information in the notice so it is well ... [more]
Healthcare Legislation May Include Restaurant Nutrition Labeling Provision ()
HR 3962, entitled the "Affordable Health Care for America Act" was introduced by Representative John Dingell (D-MI) on October 29, 2009. Section 2572, entitled "Nutrition Labeling of Standard Menue ... [more]
USFDA Industry Guidance on Front of Package (FOP) Labeling ()
In a letter to Congresswoman Rosa DeLauro, important new conceptual guidance on USFDA's approach to FOP Labeling has been provided by Commissioner Margaret Hamburg. The Release, the Backgrounder, and ... [more]
USFDA Announces New Shellfish Food Safety Requirements ()
In a major policy speech on October 17, USFDA's Michael Taylor announced new food safety requirements for fresh shellfish. The attached PDF file includes the policy speech text, a Backgrounder, a ... [more]
USDA National Nutrient Database for Standard Reference, Release 22 ()
An updated version of the Agricultural Research Service's (ARS) flagship nutrient database has been launched by ARS, the principal intramural scientific research agency of the U.S. Department of ... [more]
EFSA Delivers First Opinions on General Function Health Claims ()
The European Food Safety Authority - EFSA - has published its first series of opinions on the list of ‘general function’ health claims compiled by Member States and the European ... [more]
Center for Science in the Public Intrest Releases Report on Ten Riskiest Foods Regulated by USFDA ()
On October 6, the Center for Science in the Public Interest issued its Report "The Ten Riskiest Foods Regulated by USFDA". Because of copyright restrictions we refer readers to the web site ... [more]
Agriculture Secretary Vilsak Responds to Food Safety Investigative Journalism Artilce in October 4 New York Times ()
The NY Times article presents strong criticism of USFDA's Food Safety policy and enforcement of the Federal Meat Inspection Act. The link to the article is posted ... [more]
Vitter Amendment to Food Safety Enhancement Act ()
The Food Safety Enhancement Act of 2009 (HR 2749) went to House Senate Conference on August 3. The amendment process is underway and we note an amendment introduced by Senator David Vitter (R, LA) ... [more]
UK Food Standards Agency issues 2008 Pesticide Residues Report for Produce ()
The Pesticide Residues Committee of the UK's Food Standards Agency has released its controversial 2008 Pesticide Residues Annual Report. As was the case with the July report on Organic Foods, this ... [more]
European Union - RASFF Annual Report 2008 ()
The EU's Rapid Alert System for Food and Feed ("RASFF") has released its 2008 Annual Report on Border Refusals during 2008. For comparison purposes we also attach the September 2008 USDA-ERS EIB ... [more]
USDOC-ITA Finalizes Period of Review #3 Antidumping Margins for Shrimp from Thailand, Vietnam, India, and Ecuador ()
The Third Period of Review (POR#3) runs from 2/1/07 to 1/31/08 [more]
Canada's Health and Agriculture Ministers will implement all 57 recommendations in the Weatherill Report ()
In 2008, listeriosis associated with processed meat products killed 22 Canadians. We have attached both the full Investigative Report as well as the Executive Summary. [more]
Department of Labor releases 2009 Report on Child Labor ()
The US Department of Labor has released its 2009 Report on Child Labor and Forced Labor. This report singles out possible abuses related to certain seafood products and producing countries. [more]
USFDA Initiates REPORTABLE FOOD REGISTRY ()
On September 8, USFDA initiated the active phase of the REPORTABLE FOOD REGISTRY. Industry personnel at all levels of the food industry value-chain must be familiar with the 24-hour reporting mandate ... [more]
Important Traceability Status Review published in Food Technology ()
Institute of Food Technologists (IFT) members should read the August 2009 Traceability Review in Food Technology. This material cannot be linked or posted here since it is copyrighted material on an ... [more]
Judge Stanceu of US Court of International Trade Rules on Shrimp Bonding Case ()
Five years later, after great financial hardship imposed upon shrimp importers, the US Court of International Trade rules in favor of the industy and against USCBP on antidumping bonds placed to ... [more]
USFDA Issues Updated Industry Guidance on Seafood Glaze ()
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USFDA Guidance - Microbial Contamination of Leafy Greens ()
July 25 release of FDA Guidance on Food Safety Requirements for Leafy Greens [more]
USFDA Guidance - Microbial Contamination of Tomatoes ()
On July 25 USFDA released Food Safety Guidance for Tomatoes [more]
USFDA Guidance - Microbial Contamination of Melons ()
On July 25, USFDA released Guidance for Food Safety requirements for Melon production. [more]
United Kingdom - Food Standards Agency - Organic Foods Health Effects Report ()
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Charles Woodhouse - Article on Preparing for FSMA

Charles Woodhouse

Published: Monday, June 1, 2015

June 1, 2015 - With important new FSMA Final Rules beginning to issue in the next several months, we again post our article from the Summer 2014 issue of SciTech Lawyer Magazine. This is important background for understanding the forthcoming Final Rules. Particularly important is the Final Rule on Risk-Based preventative Controls that FDA plans to issue in July 2015.

Attachments

SCI-TECH-LAWYER-MAGAZINE-Summer-2014-PREPARING-FOR-FOOD-SAFETY-MODERNIZATION-ACT-Charles-F-Woodhouse.pdf