FDA & USDA - Food Safety News
FDA & USDA - Food Safety News FDA & USDA - Food Safety News
BOOT CAMP DAY ONE • October 3, 20127:30 Registration and Continental Breakfast8:30 Co-Chairs’ Opening RemarksSarah RollerPartner & Chair, Food & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)Alana SharenowSenior Corporate CounselOcean Spray Cranberries, Inc. (Lakeville-Middleboro, MA)8:45 How Government Agencies Regulate the FoodIndustry: Deciphering the Jurisdiction, Functions,Organization and Operations of the FDA, USDA,FTC and Other Health Agencies, and How to Stayon Their Good SideAllyson WilcoxAssistant General CounselBeam Brands (Deerfield, IL)Edward ShinSenior Corporate CounselWelch Foods Inc. (Concord, MA)Jolyda O. SwaimPrincipalOlsson Frank Weeda Terman Matz PC (Washington, DC)• Understanding how FDA, USDA, FTC and other stateand federal health agencies intersect and overlap authorityover food products• Deciphering the organizational structure of each agency- FDA – CFSAN (Center for Food Safety and AppliedNutrition)- USDA – FSIS (Food Safety Inspection Service), AMS(Agriculture Marketing Service), APHIA (Animal PlantHealth Inspection Service)- FTC – Bureau of Consumer Protection- CDC, local/state health agencies- TTB (Alcohol and Tobacco Tax and Trade Bureau),Industry Self-Regulation (DISCUS, The Wine Institute,The Beer Institute) with FTC oversight• Defining the scope of each agency’s jurisdiction andauthority and how they intersect- production- importation and wholesale- labeling- marketing and advertising- product recalls• Examining how the agencies exercise their jurisdiction- rule making- product decisions- enforcement• How to work with the agencies and defining policiesand procedures• Recent developments at the FDA, USDA, FTC and TTB10:00 Inside the GRAS Program, Premarket Review andthe Approval Process for Food Additives: How theFDA Determines Food Ingredient ClassificationSarah RollerPartner & Chair, Food & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)• Distinguishing GRAS classification made through scientificprocedures vs. food additive safety determinations made bya sponsor• When circumstances may give rise to a pre-submissionmeeting with FDA to discuss issues relevant to thesubmission of the GRAS notice• How to outline a substance’s intended condition of usein the food product• Understanding when a GRAS determination can be madebased on “common use in food”• How to structure a response to an FDA response toa GRAS notice10:30 Morning Coffee Break10:45 What’s in a Label? Identifying the CoreComponents of a Compliant Package LabelFOOD LABELINGJeff CanavanDeputy Director, Labeling and Program DeliveryDivision, FSISU.S. Department of Agriculture (Washington, DC)Lynn SzybistSupervisor, Labeling Regulations Implementation TeamFood Labeling and Standards Staff, Office of Nutrition,Labeling & Dietary Supplements, CFSANFood and Drug Administration (College Park, MD)Amy NorrisChief Legal CounselClif Bar & Company (Emeryville, CA)Martin J. HahnPartnerHogan Lovells LLP (Washington, DC)• Understanding the regulatory landscape applicableto food labels- 21 CFR parts 100-199- FDCA Chapter IV- Fair Packaging and Labeling Act of 1966• Distinguishing the role of the FDA and USDA inapproving information listed on a product label- understanding the scope of authority of FSIS and AMSconcerning product labels- distinguishing labels approvable under the prior labelapproval system vs. under generic label approval• Defining the product “label”- front-of-pack, information panel, package insert- label requirements – contents, ingredients, allergens- how to list information posted on website and advertisements• How to avoid allegations of misrepresentation and misbranding• Update on the GMA “Facts up Front” Initiative• Examining FDA and FTC enforcement priorities in foodlabeling: knowing what the enforcement triggers are andhow to avoid themRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
12:00 Networking Luncheon for Attendees and Speakers1:15 Marketing and Advertising: What Can and CannotBe Said When Crafting Health, Nutrition, Benefit,Function and Mental Performance ClaimsNUTRITION AND HEALTH CLAIMSC. Steven BakerDirector, Midwest RegionFederal Trade Commission (Chicago, IL)Allyson WilcoxAssistant General CounselBeam Brands (Deerfield, IL)Jennifer B. SoussaCounsel, Advertising, Marketing & PromotionsPractice Group, Davis & Gilbert LLP (New York, NY)Product Claims• Delineating the various types of food and beverage productclaims and the regulatory requirements for making each:- nutrient and health – distinguishing NLEA authorizedvs. claims based on an authoritative statement vs.qualified health claims- structure/function – dietary supplements vs. conventionalfoods- mental performance and focus- disease- comparative- calories/ingredients- distinguishing when information provided on a foodproduct label can be classified as “optional information”under 21 CFR 101.81 (d) when making specific healthand disease benefit claims• Distinguishing under what circumstances a health claimthat has been cleared through FDA’s pre-market clearanceprocedures can be deemed:- unauthorized under the FDCA- an unapproved new drug specifically in the contextof disease prevention claimsClaim Substantiation• Identifying what type and quantity of evidence is sufficientto meet FDA and FTC expectations for product claims- scientific evidence and testing required- consumer surveys- taste and internal expert panels- market research firms- clinical studies• Evaluating the evolution of the standard used by FTCto assess claim substantiation• Update on the status of joint enforcement activity in foodand beverage marketing and advertising2:30 Preemption Fundamentals: Overview of RecentCase Decisions and How to Successfully AssertFederal PreemptionMadeleine M. McDonoughPartner & Co-Chair, Agribusiness & Food Safety PracticeShook, Hardy & Bacon L.L.P. (Washington, DC)• Defining express and implied preemption• Understanding the basis for asserting preemption• Recognizing the interplay between preemption and theFDA regulatory process• Examining recent cases where preemption has succeededas a theory – lead, mercury3:00 Afternoon Refreshment Break3:15 Food Safety Modernization Act: Implementation,Timelines & New RequirementsMark CollinsSenior Manager – Regulatory and Consumer AffairsMcCain Foods USA, Inc. (Lisle, IL)Michael MullicanVice President, Assistant General CounselMeijer, Inc. (Grand Rapids, MI)During this practical session, attendees will be brought up tospeed on new and revised requirements under the Food SafetyModernization Act as well as effective and proposed dates forimplementation of key provisions. Learn who will be impactedand when as well as what you need to do now in order to becompliant under:• Title I – prevention of food safety problems• Title II – detection and response to food safety problems• Title III – imported food4:15 MOCK SCENARIO:How to Bring a New Food Product to Market:Best Practices for Ensuring Your Product Complieswith Regulatory Requirements Across all FrontsEdward ShinSenior Corporate CounselWelch Foods Inc. (Concord, MA)Alana SharenowSenior Corporate CounselOcean Spray Cranberries, Inc. (Lakeville-Middleboro, MA)Janet RaddatzVice President – Quality & Food Safety SystemsSargento Foods Inc. (Plymouth, WI)During this session be led through a comprehensive, A to Zdiscussion of the relevant legal, regulatory and complianceconsiderations for bringing a new food or beverage product tomarket. Illustrated through the reference of a brief mock factpattern that will be distributed to attendees on-site, take noteduring this panel as the session leaders guide you through apractical discussion of what boxes to check and in which order.Topics of discussion during this panel will include:• Understanding the regulatory landscape applicable to your“new” product – how requirements vary for food (includingmeat, poultry and egg products) vs. beverage products• Marketing considerations – how to maintain an open lineof communication between marketing and legal whenscreening and developing promotional marketing• How to develop and distinguish your product against:- previous versions of the same product- competitor’s products and claims5:30 Boot Camp Adjourns to Day TwoRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
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BOOT CAMP DAY ONE • October 3, 20127:30 Registration and Continental Breakfast8:30 Co-Chairs’ Opening RemarksSarah RollerPartner & Chair, <strong>Food</strong> & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)Alana SharenowSenior Corporate CounselOcean Spray Cranberries, Inc. (Lakeville-Middleboro, MA)8:45 How Government Agencies Regulate the <strong>Food</strong>Industry: Deciphering the Jurisdiction, Functions,Organization and Operations of the <strong>FDA</strong>, <strong>USDA</strong>,FTC and Other Health Agencies, and How to Stayon Their Good SideAllyson WilcoxAssistant General CounselBeam Brands (Deerfield, IL)Edward ShinSenior Corporate CounselWelch <strong>Food</strong>s Inc. (Concord, MA)Jolyda O. SwaimPrincipalOlsson Frank Weeda Terman Matz PC (Washington, DC)• Understanding how <strong>FDA</strong>, <strong>USDA</strong>, FTC and other stateand federal health agencies intersect and overlap authorityover food products• Deciphering the organizational structure of each agency- <strong>FDA</strong> – CFSAN (Center for <strong>Food</strong> <strong>Safety</strong> and AppliedNutrition)- <strong>USDA</strong> – FSIS (<strong>Food</strong> <strong>Safety</strong> Inspection Service), AMS(Agriculture Marketing Service), APHIA (Animal PlantHealth Inspection Service)- FTC – Bureau of Consumer Protection- CDC, local/state health agencies- TTB (Alcohol and Tobacco Tax and Trade Bureau),Industry Self-Regulation (DISCUS, The Wine Institute,The Beer Institute) with FTC oversight• Defining the scope of each agency’s jurisdiction andauthority and how they intersect- production- importation and wholesale- labeling- marketing and advertising- product recalls• Examining how the agencies exercise their jurisdiction- rule making- product decisions- enforcement• How to work with the agencies and defining policiesand procedures• Recent developments at the <strong>FDA</strong>, <strong>USDA</strong>, FTC and TTB10:00 Inside the GRAS Program, Premarket Review andthe Approval Process for <strong>Food</strong> Additives: How the<strong>FDA</strong> Determines <strong>Food</strong> Ingredient ClassificationSarah RollerPartner & Chair, <strong>Food</strong> & Drug Law PracticeKelley Drye & Warren LLP (Washington, DC)• Distinguishing GRAS classification made through scientificprocedures vs. food additive safety determinations made bya sponsor• When circumstances may give rise to a pre-submissionmeeting with <strong>FDA</strong> to discuss issues relevant to thesubmission of the GRAS notice• How to outline a substance’s intended condition of usein the food product• Understanding when a GRAS determination can be madebased on “common use in food”• How to structure a response to an <strong>FDA</strong> response toa GRAS notice10:30 Morning Coffee Break10:45 What’s in a Label? Identifying the CoreComponents of a Compliant Package LabelFOOD LABELINGJeff CanavanDeputy Director, Labeling and Program DeliveryDivision, FSISU.S. Department of Agriculture (Washington, DC)Lynn SzybistSupervisor, Labeling Regulations Implementation Team<strong>Food</strong> Labeling and Standards Staff, Office of Nutrition,Labeling & Dietary Supplements, CFSAN<strong>Food</strong> and Drug Administration (College Park, MD)Amy NorrisChief Legal CounselClif Bar & Company (Emeryville, CA)Martin J. HahnPartnerHogan Lovells LLP (Washington, DC)• Understanding the regulatory landscape applicableto food labels- 21 CFR parts 100-199- FDCA Chapter IV- Fair Packaging and Labeling Act of 1966• Distinguishing the role of the <strong>FDA</strong> and <strong>USDA</strong> inapproving information listed on a product label- understanding the scope of authority of FSIS and AMSconcerning product labels- distinguishing labels approvable under the prior labelapproval system vs. under generic label approval• Defining the product “label”- front-of-pack, information panel, package insert- label requirements – contents, ingredients, allergens- how to list information posted on website and advertisements• How to avoid allegations of misrepresentation and misbranding• Update on the GMA “Facts up Front” Initiative• Examining <strong>FDA</strong> and FTC enforcement priorities in foodlabeling: knowing what the enforcement triggers are andhow to avoid themRegister now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/foodbootcamp
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