Regulatory Update: Food Safety and Nutrition
|
|
- Sharlene Dorsey
- 5 years ago
- Views:
Transcription
1 Regulatory Update: Food Safety and Nutrition Ricardo Carvajal Hyman, Phelps & McNamara, P.C. North American Millers Association March 2015
2 Today s Agenda FSMA Update Biological and chemical hazards Reportable foods Gluten-free labeling GMOs and FDA 2015 Dietary Guidelines Revamp of nutrition labeling 2
3 3 But first - musical chairs!
4 Who s out: Commissioner Margaret Hamburg Who s in: CFSAN Director Susan Mayne Chair, Chronic Disease Epidemiology, Yale School of Public Health CSPI Scientific Advisory Board Who s still in: Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine 4
5 Status of FSMA Rules 5 August 30, 2015 Preventive Controls for Human Food Preventive Controls for Animal Food October 31, 2015 Foreign Supplier Verification Program Produce Safety Standards Accreditation of Third Party Auditors March 31, 2016 Sanitary Transport of Food and Feed May 31, 2016 Intentional Contamination
6 Who s going to pay for this? In 2016 budget, FDA asks for $84M increase in budget authority $169M increase through proposed user fees (e.g., imports and facility registration) 20% of foods program budget would be paid by fees 6
7 Without the requested $$$ Delays in FSMA implementation Inadequate staffing Inadequate training of FDA and state inspectors Unable to provide guidance and technical assistance to industry Inadequate implementation of import safety system 7
8 The rules keep moving along On 9/29/14, FDA issued proposed supplemental rules for: Preventive controls (human and animal food) Foreign supplier verification program (FSVP) Some additional flexibility mostly additional obligations 8
9 Changes to Preventive Controls 9 Surprise! (not) product testing and environmental monitoring requirements have been added Product testing required to verify implementation and effectiveness of preventive controls, as appropriate Environmental monitoring required if contamination of an RTE food with an environmental pathogen is a significant hazard
10 Also in 10 supplier controls required if: hazard analysis identifies significant hazard for incoming ingredient hazard is controlled before receipt (in other words, by supplier) choice* of verification activities onsite audit sampling testing hazard analysis to include economic adulteration?
11 Small & very small businesses Small businesses: < 500 employees 2 years to comply VSBs: qualified facilities subject to modified requirements given 3 years to comply < $1M in total annual sales (human food) < $2.5M in total annual sales (animal food) 11
12 Changes to FSVP Hazard analysis: more comprehensive evaluation of risks combines hazard analysis with compliance status review Nature of hazard Entity applying controls Supplier s food safety SOPs Supplier s compliance with U.S. food safety regulations Food safety performance history 12
13 Supplier verification 13 Proposed rule included 2 options, one of which required on-site audits where there is a reasonable probability of SAHCODHA for hazard controlled by supplier Supplemental rule provides more flexibility Determine verification measures based on food and supplier risks On-site audits required if SAHCODHA, unless you can show something else will work If have supplier verification as manufacturer, no need to duplicate
14 And now back to our regularly scheduled programming 14
15 Biological hazards No news is good news FDA to designate high-risk foods additional recordkeeping requirements Not on most recent regulatory agenda 15
16 Chemical hazards Allergens cumin recall due to undeclared peanut Agricultural cross-contact? Economic adulteration? Is advisory labeling a fix? 16
17 Pesticides A food is adulterated if it bears or contains an unsafe pesticide residue Unsafe = unapproved Act prohibits residues, not use In import context, zero tolerance 17
18 Reportable foods Standard is reasonable probability of serious adverse health consequences or death 24 hours to report unless narrow exception applies Should determination be made in reference to hazard posed by finished food? 18
19 Gluten-free labeling claims Final rule published in August 2013 Compliance date of August 5, 2014 Noisy roll-out Total silence since then 19
20 20
21 Enforcement strategy? Misbranding results where gluten is > or = 20 ppm What is to be tested? Highly consequential decision, for commerce and public health 21
22 GMOs and FDA Still no credible challenge to safety of GMO foods Some consumers claim right-to-know Why FDA is sitting it out Marketplace is moving on 22
23 2015 Dietary Guidelines Dietary Guidelines Advisory Committee (DGAC) issued Scientific Report on February 23 Public meeting on report is scheduled for March 24 Members of the Dietary Guidelines Advisory Committee greatly exceeded their scope in developing recommendations Agencies failed to keep the Committee focused on nutritional recommendations and away from areas such as sustainability and tax policy, which are outside of the Committee s purview. 23
24 Whole grains 24 The 2010 Dietary Guidelines for Americans recommended that half of all grain intake should come from whole grains. The 2015 DGAC brings forward this recommendation and here we give rationale and results to support this decision. The majority of the U.S. population has low intakes of key food groups that are important sources of the shortfall nutrients, including whole grains
25 Whole grains (cont d) The overall body of evidence examined by the 2015 DGAC identifies that a healthy dietary pattern is higher in whole grains and low in refined grains. Because the average intake levels of dietary fiber are half the recommended levels, achieving the recommendation requires selecting high-fiber cereals and whole grains [A] major shift from refined to whole grains is needed in order to meet recommendations. 25
26 Revamp of nutrition facts FDA harmonizing definition of dietary fiber with Institute of Medicine Certain isolated and synthetic carbohydrates would qualify as dietary fiber only if FDA approves petition demonstrating physiological effect beneficial to human health E.g., ß-glucan and barley ß-fiber Increase in DRV for fiber from 25g to 28g 26
27 Happy golfing, but remember Balls lost in the rough are not a deductible and you can t claim your caddy as a dependent. 27
28 28 QUESTIONS?
FSMA, FSVP, and FCS. Deborah Attwood May 12, 2016 Global Food Contact 2016
FSMA, FSVP, and FCS Deborah Attwood May 12, 2016 Global Food Contact 2016 Food Safety Modernization Act (FSMA) Became law in January 2011 Improves safety and security of food supply through prevention,
More informationFinal Rules Preventive Controls for Human Food Preventive Controls for Animal Food
Final Rules Preventive Controls for Human Food Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
More informationGROCERY MANUFACTURERS ASSOCIATION. Science Forum. Connecting Sound Science and Responsible Solutions
GROCERY MANUFACTURERS ASSOCIATION Science Forum Connecting Sound Science and Responsible Solutions FSMA Implementation Michael M. Landa Director, Center for Food Safety and Applied Nutrition Food and Drug
More informationFSMA & The Dietary Supplements Industry
FSMA & The Dietary Supplements Industry Overview FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) Foreign Supplier Verification Programs (FSVP) Produce Verification activities
More informationFood Safety Modernization Act - Impacts on the Grain and Feed Industry
Food Safety Modernization Act - Impacts on the Grain and Feed Industry NGFA 117th Annual Meeting and Convention March 17, 2013 San Francisco, California David Fairfield, NGFA Vice President of Feed Services
More informationFDA Food Safety Modernization Act (FSMA) January 4, 2011
FDA Food Safety Modernization Act (FSMA) January 4, 2011 FDA Food Safety Modernization Act (FSMA) The Most Sweeping Reform of the U.S. Food Safety Laws in More than 70 Years FDA Food Safety Modernization
More informationThe FDA Food Safety Modernization Act: The Key New Requirements
June 15, 2011 The FDA Food Safety Modernization Act: The Key New Requirements Executive Summary INSTITUTE FOR FOOD LAWS & REGULATIONS Michigan State University 140 G.M. Trout Building East Lansing, MI
More informationFinal Rule for Preventive Controls for Animal Food
Final Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Background Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
More informationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Docket No. FDA-2011-N-0143 Reference 2: FDA, Proposed 21 Code of Federal Regulations, Part 1, Subpart L Foreign Supplier
More informationUpdate FDA/Center for Food Safety and Applied Nutrition
Update FDA/Center for Food Safety and Applied Nutrition Comments by Susan Mayne, Ph.D. Director Center for Food Safety and Applied Nutrition FDLI Annual Conference May 3, 2018 Food Safety, Nutrition and
More informationU.S. FDA Regulations for Exporting Food to the United States. Presented by: David Lennarz President, Business Development & Operations
U.S. FDA Regulations for Exporting Food to the United States Presented by: David Lennarz President, Business Development & Operations Overview FDA Overview Food Facility Registration Prior Notice Food
More informationAKA Good Manufacturing Practice (GMP) Certification Program
AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements
More informationThe Food Safety Modernization Act A Series on What is Essential for a Food Professional to Know
SPECIAL INTEREST PAPER The Food Safety Modernization Act A Series on What is Essential for a Food Professional to Know [ Article 2. Hazard Analysis and Risk Based Preventive Controls [ Theodora Morille-Hinds*
More informationTECHNICAL & REGULATORY AFFAIRS REPORT. 77th Annual CSA Convention May 11, 2018 Presented by: Anthony Gene
TECHNICAL & REGULATORY AFFAIRS REPORT 77th Annual CSA Convention May 11, 2018 Presented by: Anthony Gene 1 CSA Meeting Agenda Food Industry Overview CSA Strategic Updates Safe Foods For Canadians Regulations
More informationShawn Stevens Food Industry Consultant and Lawyer
Shawn Stevens Food Industry Consultant and Lawyer stevens@foodindustrycounsel.com 920.698.2561 COMPLYING WITH FSMA S PREVENTIVE CONTROL RULE AS A SMALL BUSINESS COMPLYING WITH FSMA S PREVENTIVE CONTROL
More informationEffective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products
Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Quick Facts Retailers that mix and prepare e-liquids or create or modify vaporizers
More informationFood Commissaries under FSMA and the US FDA model Food Code
Food Commissaries under FSMA and the US FDA model Food Code Introduction A food commissary is a facility or operation that procures and/or produces foods intended for distribution. A retail or foodservice
More informationFDA Food Contact Fundamentals
FDA Food Contact Fundamentals Deborah Attwood 2017 SPE International Polyolefins Conference March 1, 2017 Legal Highlights for Food 1906: Pure Food and Drug Act 1938: Federal Food, Drug and Cosmetic Act
More informationProposed FDA Food Safety Modernization Act:
Proposed FDA Food Safety Modernization Act: Its impact on distillers production and sales Paula Emberland Business Analyst History of the FDA 1862 Beginning of Bureau of Chemistry 1927 Bureau of Chemistry
More informationWhy all the Attention to Food Safety?
Why all the Attention to Food Safety? IFST London April 23, 2015 By Gale Prince, CFS SAGE Food Safety LLC Presentation Agenda Historical Trends in food safety issues Detecting food safety issues Consumer
More informationFDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination
Food Law and Regulation Boot Camp November 15-16, 2016 FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination Justin J. Prochnow Shareholder, Greenberg Traurig Mollie Kober
More informationFood Safety Modernization Act (FSMA) Overview
Food Safety Modernization Act (FSMA) Overview Achyut Adhikari Assistant Professor & Extension Food Safety Specialist School of Nutrition and Food Sciences Louisiana State University AgCenter Why Food Safety?
More informationFoodDrinkEurope Position on GLP studies
FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?
More informationCFSAN Update Michael M. Landa
CFSAN Update Comments by Michael M. Landa Director, Center for Food Safety and Applied Nutrition JIFSAN Fall Advisory Council Meeting November 14, 2013 1 CFSAN Plan for Program Priorities (2013 2014) Reduce
More informationDistillers Grains Symposium
Distillers Grains Symposium REGULATORY ISSUES/FSMA IMPACTS ON PRODUCTION & SALE OF DDGS Leah Wilkinson American Feed Industry Association lwilkinson@afia.org Dallas, TX May 15, 2014 Topics to be Presented
More informationARE YOU READY FOR RETAIL?
ARE YOU READY FOR RETAIL? JAY SHIRODKER AGENDA Current landscape of food safety oversight What is changing for Manufacturers, Retail, Consumers Drivers of changes How is retail industry impacted Food Safety
More informationApril 30, By Electronic Mail
April 30, 2018 By Electronic Mail Dr. Scott Gottlieb, Commissioner Office of the Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 CommissionerFDA@fda.hhs.gov
More informationOctober 9-11, Are you ready to export your food products to North America?
U.S. and Canadian Regulations Overview for Exporters: Food Labelling, FSMA Foreign Supplier Verification Program and the Safe Foods for Canadians Regulations October 9-11, 2018 Are you ready to export
More informationAlignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference
Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference Donald Kautter US Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food
More informationPreventive Controls for Human Foods & Preventive Controls Qualified Individuals
Preventive Controls for Human Foods & Preventive Controls Qualified Individuals MATTHEW TAYLOR TEXAS A&M UNIVERSITY USDA NIFA AWARD NUMBER 2015-70020-24397 Food Safety Modernization Act I thank the President
More informationCurrent Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Lillian Hsu, Ph. D. 2018 American Hop Convention January 25, 2018 2 Who is Covered by Part 117? In
More informationEdible Fats and Oils Regulatory Update. National Institute of Oilseed Products March 16-18, 2014 San Antonio, TX
Edible Fats and Oils Regulatory Update National Institute of Oilseed Products March 16-18, 2014 San Antonio, TX The Institute of Shortening and Edible Oils (ISEO) is a trade association representing the
More informationFSMA: Implementation and Impact on Global food Industry and role of FSPCA in Preventive Controls Education and Outreach
FSMA: Implementation and Impact on Global food Industry and role of FSPCA in Preventive Controls Education and Outreach 56th Annual Tanner Lecture Chicago section IFT Purnendu C. Vasavada Professor Emeritus,
More informationLIVE INTERACTIVE YOUR DESKTOP. Food Recall Process. Cecilia M. Wolyniak Food and Drug Administration Office of Enforcement
LIVE INTERACTIVE LEARNING @ YOUR DESKTOP Food Recall Process Cecilia M. Wolyniak Food and Drug Administration Office of Enforcement Wednesday, December 9, 2009 LEGAL ISSUES Code of Federal Regulations
More informationJuly 27-30, th Annual Meeting of the Poultry Science Association Louisville, Kentucky. Presented at:
July 27-30, 2015 104 th Annual Meeting of the Poultry Science Association Louisville, Kentucky Presented at: From Egg to Plate The Influence of Gut Health Symposium Presentations distributed by DuPont
More information2017 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.
Trading Food with Canada: Regulatory Requirements for Food Canada s Food Regulatory Regime and Import Framework Daniel Burgoyne National manager, Food Imports May 2018 2017 Her Majesty the Queen in Right
More informationFDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS
FDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS Presented by W. Patrick Noonan And Chris Noonan For NUTRITION INDUSTRY ASSOCIATION W. Patrick Noonan, P.C. 21800 Oxnard Street, Suite 840 Woodland Hills,
More informationNDI: LOOKING BACK & AHEAD
NDI: LOOKING BACK & AHEAD Chi Hee Kim D i r e c t o r, W o r l d w i d e R e g u l a t o r y, G o v e r n m e n t a n d I n d u s t r y A f f a i r s H e r b a l i f e I n t e r n a t i o n a l o f A m
More informationPublic Hearing Before U.S. Food and Drug Administration
Substances in Food and Labeling; Regulatory Framework for Foods that Companies are Marketing as Functional Foods Public Hearing Before U.S. Food and Drug Administration Ilene Ringel Heller Senior Staff
More informationRoseann B. Termini, Esq.
Food Labeling and Food Safety Kind, Naked and Legal Issues... Do you Know who Really regulates Your Pizza and Where Your Beef is From? What is Smart About FOP Labelling? Roseann B. Termini, Esq. www.fortipublications.com
More informationCenter for Food Safety & Applied Nutrition: Update
Center for Food Safety & Applied Nutrition: Update Comments by Ted Elkin Deputy Director for Regulatory Affairs FDA/Center for Food Safety and Applied Nutrition AFDO 2017 Annual Meeting June 20, 2017 Foods
More informationWhy Should the Malting and Brewing Industry Be Concerned About Food Safety? Part 1
MBAA TQ vol. 53, no. 1 2016 pp. 34 38 Why Should the Malting and Brewing Industry Be Concerned About Food Safety? Part 1 Tatiana A. Lorca Ecolab, Inc., St. Paul, MN, U.S.A. How many of those reading remember
More informationSpecific Accreditation Guidance OECD GLP
Specific Accreditation Guidance OECD GLP Information for GLP Study Sponsors January 2018 Copyright National Association of Testing Authorities, Australia 2013 This publication is protected by copyright
More informationCommercial Feed Mill Verification Task Procedures
Introduction The Canadian Food Inspection Agency (CFIA) is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada s people, environment and economy. As part
More informationThe Food Safety Modernization Act of 2011 Final Rule for Preventive Controls for Human Food 1
FSHN17-6 The Food Safety Modernization Act of 2011 Final Rule for Preventive Controls for Human Food 1 Jessica Lepper, Soohyoun Ahn, Keith R. Schneider, Michelle D. Danyluk, and Renée Goodrich-Schneider
More informationFDA Foods Program Update
FDA Foods Program Update Comments by Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Food Safety and Applied Nutrition JIFSAN Annual Meeting, College Park, MD March 25, 2010 The Food Safety Working
More informationAllergen Management The View and Experiences of DFSV
Allergen Management The View and Experiences of DFSV FAMS2017 Rob Antonic Food Safety Manager Overview DFSV and our Key Functions. Regulatory obligations of manufacturers. What is an allergen management
More informationThe Food and Drug Administration Globalization Act of 2008
Covington & Burling llp Brussels London New York San Francisco Washington Food & Drug E-Alert The Food and Drug Administration Globalization Act of 2008 April 24, 2008 On April 17, 2008, Representative
More informationRaritan Pharmaceuticals, Inc. 6/20/17
Raritan Pharmaceuticals, Inc. 6/20/17 U.S. Food & Drug Administration Division of Pharmaceutical Quality Operations I New Jersey District 10 Waterview Boulevard, 3rd Floor Parsippany, NJ 07054 June 20,
More informationFood Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of
This document is scheduled to be published in the Federal Register on 10/02/2017 and available online at https://federalregister.gov/d/2017-21019, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationManaging Allergens within a manufacturing context. Helen Brown CampdenBRI Chipping Campden
Managing Allergens within a manufacturing context Helen Brown CampdenBRI Chipping Campden Food Allergens An unusual food safety issue Harmless natural substances however In allergic individuals cause reactions,
More informationFDA s Nutrition Facts Panel and the Labeling of Added Sugars September 8, 2016 Bruce Silverglade Principal, OFW Law
FDA s Nutrition Facts Panel and the Labeling of Added Sugars September 8, 2016 Bruce Silverglade Principal, OFW Law November 7, 2017 Sweetener Systems Conference bsilverglade@ofwlaw.com (1) 202 518 6316
More informationThe Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j))
The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j)) January 12, 2011 Cristi Stark, MS Senior Regulatory Health Project Manager Office
More informationFrequently Asked Questions by HPs to NCs
Frequently Asked Questions by HPs to NCs 1. What is the advantage of working with a distribution company instead of the manufacturer? As a distribution company, we are able to choose different manufacturers
More informationCONDUCTING AN EFFECTIVE ANIMAL FEED HAZARD EVALUATION
CONDUCTING AN EFFECTIVE ANIMAL FEED HAZARD EVALUATION How ready are you for compliance with Subpart C of the Preventive Controls for Animal Food rule (food safety plan requirement of FSMA)? A. I am exempt
More informationRE: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability: Docket No.
1400 Crystal Drive, Suite 260 Arlington, VA 22202 P: (202) 289-0873 F: (202) 289-5388 July 23, 2018 Dockets Management Staff (HFA 305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville,
More informationRESULTS AT A GLANCE. FDA Oversight of Tobacco Manufacturing Establishments. HHS OIG Data Brief August 2017 OEI
HHS OIG Data Brief August 2017 OEI-01-15-00300 FDA Oversight of Tobacco Manufacturing Establishments RESULTS AT A GLANCE The Tobacco Control Act authorized FDA to regulate domestic tobacco manufacturers
More informationFDA Regulation of Claims on Dietary Supplement and Food Products
FDA Regulation of Claims on Dietary Supplement and Food Products Patricia Kaeding August 2004 Topics FDA Overview What are claims Why claims matter Categories of claims Regulatory requirements for types
More informationOverview of Dietary Supplement GMP Inspection Trends Quality Session 6
Overview of Dietary Supplement GMP Inspection Trends Quality Session 6 Presented by: Dean R. Cirotta, MBA President & Chief Operating Officer EAS Consulting Group, LLC 1700 Diagonal Road, Suite 750 Alexandria,
More informationSTATEMENT OF JOSHUA M. SHARFSTEIN, M.D. PRINCIPAL DEPUTY COMMISSIONER U.S. FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 STATEMENT OF JOSHUA M. SHARFSTEIN, M.D. PRINCIPAL DEPUTY COMMISSIONER U.S. FOOD AND DRUG
More informationThis whitepaper will cover the suggested methodology to be employed when developing a PCP plan. This includes how to develop your plan in accordance
This whitepaper will cover the suggested methodology to be employed when developing a PCP plan. This includes how to develop your plan in accordance with FSMA s Final Rule for Preventive Controls for Human
More informationProduct Information Sheet REZISTA DF
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationImporting pre-packaged foods
Importing pre-packaged foods Information for those who wish to import pre-packa Starting your business This brochure provides important information for those who wish to import and sell pre-packaged foods
More informationInter-Agency Overlap and Jurisdictional Boundaries
Inter-Agency Overlap and Jurisdictional Boundaries FDLI Food Advertising, Labeling, and Litigation Conference September 14, 2017 Jessica P. O Connell Covington & Burling LLP jpoconnell@cov.com 1 FDA Approach/Perspective
More informationDivision of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
October 31, 2017 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket Nos. FDA 2012 N 1210 & FDA 2004 N 0258 Dear Sir or Madam: The (AHA)
More informationAgency Information Collection Activities; Submission for Office of Management and
This document is scheduled to be published in the Federal Register on 03/04/2019 and available online at https://federalregister.gov/d/2019-03824, and on govinfo.gov 4164-01-P DEPARTMENT OF HEALTH AND
More information2014 FDA/JIFSAN Food & Nutrition Webinar
2014 FDA/JIFSAN Food & Nutrition Webinar Medical Foods Shawne Suggs-Anderson, MMSc, _ RD Infant Formula and Medical Foods Staff ONLDS/CFSAN/FDA September 23, 2014 53 Main Objectives History What is a Medical
More informationSUPPLIER INGREDIENT INFORMATION. 50 lb bag
SUPPLIER INGREDIENT INFORMATION CHOLMONDLEY'S ENGLISH MUFFIN LOAF BASE BRAND: ORTH 3206354-00 Cholmondley's English Muffin Loaf Base is a pre-blended, fully prepared, dry mix base for using in bread applications.
More informationResponding to a Food Recall
Responding to a Food Recall Time: 4 hours National Food Service Management Institute The University of Mississippi 2013 Table of Contents Objectives... ii Lesson 1: Introduction to the Food Recall Process...
More informationCOMMISSION DELEGATED REGULATION (EU).../... of XXX
EUROPEAN COMMISSION Brussels, XXX SANTE/10355/2015 (POOL/E4/2015/10355/10355-EN. doc) [...1(2015) XXX draft COMMISSION DELEGATED REGULATION (EU).../... of XXX supplementmg Regulation (EU) No 609/2013 of
More informationBEFORE THE UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION COMMENTS OF THE AMERICAN HERBAL PRODUCTS ASSOCIATION
DOCKET NO. FDA 2017 N 5094 BEFORE THE UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION COMMENTS OF THE AMERICAN HERBAL PRODUCTS ASSOCIATION ON FDA s Request for Comments on Evaluation of Existing
More informationRegulatory Update Jennifer McEntire. PMA & United Fresh Joint Listeria Workshop
Regulatory Update Jennifer McEntire Key Points FSMA Preventive Controls: focus on env. pathogens inc Listeria Preventive Controls draft guidance chapters Draft guidance on Listeria Pay attention to this!!!
More informationFDA RELEASES FOOD CURRENT GOOD MANUFACTURING PRACTICE MODERNIZATION REPORT
November 17, 2005 FDA RELEASES FOOD CURRENT GOOD MANUFACTURING PRACTICE MODERNIZATION REPORT Executive Summary On November 2, 2005, FDA issued the Food CGMP Modernization - A Focus on Food Safety report.
More informationReishi D. International, Inc. 2/6/18
Reishi D. International, Inc. 2/6/18 San Francisco District Office 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Via UPS Overnight February 7, 2018 Mr. Zheng Xiong Li, CEO Reishi D. International, Inc.
More informationProposition 65 and Supplements
Proposition 65 and Supplements Nutrition Industry Association John Venardos Senior Vice President Worldwide Regulatory & Government Affairs Herbalife International of America, Inc. 5/23/2011 SYNOPSIS Now
More informationRe: National Bioengineered Food Disclosure Standard; Proposed Rule; Request for Comments, 83 Fed. Reg (May 4, 2018), Docket No.
VIA ELECTRONIC SUBMISSION July 3, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: National Bioengineered Food Disclosure Standard;
More informationII. History and importance of defining Healthy : Government/regulatory science perspective
II. History and importance of defining Healthy : Government/regulatory science perspective Barbara Schneeman, Ph.D. Professor Emerita of Nutrition University of California, Davis Main Question What are
More informationWHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS
WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS SEPTEMBER 23, 2009 COUNCIL OF THE CONVENTION SECTION ON THE QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS INTRODUCTION The 1994 Dietary Supplement
More information- Notification to specify uniform limit (Ministry of Health, Labour and Welfare Notification No. 497, 2005)
Syoku-An No.1129001 November 29, 2005 *1 Director Notice *2 Department of Food Safety Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Establishment of Applicable Laws and Ordinances
More informationProduct Information Sheet
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet MALTOSWEET
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet RESISTAMYL
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationProduct Information Sheet CLARIA Elite
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationPutting the Nutritional Supplement Industry to the Test: Looking for Transparency
Putting the Nutritional Supplement Industry to the Test: Looking for Transparency Frederick H. Fern @RickFern_HB ffern@harrisbeach.com Marina Plotkin @MarinaPlotkin_HB mplotkin@harrisbeach.com Putting
More informationProduct Information Sheet REZISTA HV
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationsee FFI Report Review: Final Rule for FSMA Intentional Adulteration (Food Defense) Regarding Food Fraud and EMA
see FFI Report Review: Final Rule for FSMA Intentional Adulteration (Food Defense) Regarding Food Fraud and EMA By John Spink 1, Douglas C Moyer 1, Andrew Huff 2 & Bradley Evans 3 1 Michigan State University,
More informationProduct Information Sheet
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationRe: Docket No. FDA-2011-N-0922; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Via electronic submission March 31, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2011-N-0922; Current Good
More informationEXPORTING TO THE USA. Andy Kerridge Primority Ltd
EXPORTING TO THE USA Andy Kerridge Primority Ltd ak@primority.com F.S.M.A. The US FDA's Food Safety Modernization Act is the most exhaustive reform of US food safety laws in >70 years. Signed into law
More informationAgency Information Collection Activities; Submission for Office of Management and Budget
This document is scheduled to be published in the Federal Register on 01/28/2016 and available online at http://federalregister.gov/a/2016-01690, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationCleaning and Allergens
Introduction The prevalence of people with life-threatening food allergies is increasing. It is now believed as many as 1-2% of adults and 5-8% of children are affected. Avoidance of allergen-containing
More informationRegulations Amending the Food and Drug Regulations (1288
CANADA GAZETTE, PART II FOOD AND DRUG REGULATIONS - AMENDMENTS WILL BE PUBLISHED IN CANADA GAZETTE, PART II OF DECEMBER 5, 2001 SCHEDULE NO. 1288 (FOMESAFEN) P.C. 2001-2143 OF NOVEMBER 21, 2001 SOR/2001-514
More informationAn FDA Update: Sugary Ingredients' Impact on Added Sugar Labeling
An FDA Update: Sugary Ingredients' Impact on Added Sugar Labeling October 23, 2018 Lauren Swann, MS, RD, LDN Concept Nutrition, Inc. Sugars Labeling Total Sugars Nutrition Labeling & Education Act of 1990
More informationProduct Information Sheet MERIZET
Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide
More informationRegulation of Dietary Supplements
(name redacted) Analyst in Health Policy December 16, 2014 Congressional Research Service 7-... www.crs.gov R43062 Summary Many Americans take dietary supplements (e.g., vitamins, herbs, sports nutrition
More informationAppendix N Pilot Program Question and Answer Version 5.0 6/23/2017
Appendix N Pilot Program Question and Answer Version 5.0 6/23/2017 This Q&A document answers questions that have been submitted to the NCIMS Appendix N Modification Study Committee. The start date for
More informationComparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome
Comparability and quality of experimental data under different quality systems S. Caroli Istituto Superiore di Sanità Rome Programme of this presentation Part I. Background information Part II. Key aspects
More informationAppendix N Pilot Program Question and Answer Version 7.0 6/13/2018
Appendix N Pilot Program Question and Answer Version 7.0 6/13/2018 This Q&A document answers questions that have been submitted to the NCIMS Appendix N Modification Study Committee. The start date for
More informationFood Safety and Inspection Service:
1 Overview and Update on Current FSIS Labeling Activities Jeff Canavan, Deputy Director Labeling and Program Delivery Staff, FSIS February 5, 2018 2 Mission in Action We are the public health agency in
More information