All Matters FDA - Delawarelaw.widener.edu

HOOMAN NOORCHASHM, M.D.Cardiac Surgeon, Philadelphia, PADr. Hooman Noorchashm is a cardiothoracic surgeon in Philadelphia, Pennsylvania. He trainedat Hospital of University of Pennsylvania and Harvard Medical School’s Brigham and Women’sHospital. Dr. Noorchashm is a devoted patient advocate, author, speaker and father of six children.Dr. Noorchashm met his wife, Amy Reed, in Medical School at the University of Pennsylvania.Amy was an anesthesiologist and surgical intensive care physician.In October, 2013, Amy, underwent surgery to remove uterine fibroids through a laparoscopicprocedure. The surgery involved the use of a medical device known as the Power Morcellator.Shortly thereafter it was discovered that Amy’s fibroid was, in fact cancerous. The morcellationof the fibroid caused the cancer to spread throughout her abdomen, leading to Amy’s untimelydeath in May of 2017.Amy’s diagnosis of leiomyosarcoma served as the beginning of Amy and Hooman’s extensiveresearch on power morcellation. As a result of their research, Hooman and Amy began a quest toeducate companies, lawmakers, the medical community and the public about the dangers of powermorcellation. They also lead, and Hooman continues to pursue regulatory reform efforts relatingto FDA approved medical devices.Hooman and I will present to you today in an interview/conversational format. We welcomeinterjection of questions throughout the presentation, so please feel free to raise your hand at anytime and we will address your questions.********KEVIN SPRADLINIntelligence Analyst, FBI, Washington, D.C.Kevin Spradlin is an intelligence analyst in the FBI’s Weapons of Mass Destruction Directorate(WMDD) in Washington, DC. As an analyst in the Critical Infrastructure Fusion Cell (CIFC), heidentifies WMD threats and vulnerabilities associated with the food, water, energy, andtransportation sectors. He joined the FBI in 2004 and was assigned to the Oklahoma City FieldOffice where he worked gang and violent crime matters, served on the Joint Terrorism Task Force,and was the WMD analyst. In 2010 Mr. Spradlin transferred to the FBI Academy at Quantico,Virginia as an instructor for newly hired analysts. He joined the CIFC in 2016.********

ROSEANN B. TERMINI, ESQUIREFood and Drug Law Legal Scholar; National Speaker, Online FDA Law Courses,Widener University Delaware Law SchoolRoseann B. Termini, B.S., Ed. M., J.D. has extensive experience in food, drug, medical devices,personal care, dietary supplement, tobacco and veterinary products regulation. Ms. Terminirecently published a new comprehensive edition both in print and E-book formats of Food andDrug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, DietarySupplements, Personal Care, Veterinary and Tobacco Products (2017). She published the newedition because of evolving law, novel cases and latest regulations and an E-book that mirrors theprint book as well as 12 stand-alone separate subject specific E-books. Professionalconsiderations, ethical issues, enforcement, criminal corporate liability and politics are covered.See: www.fortipublications.comFrequently, Ms. Termini is a featured speaker at international and national conferences andwebinars including the Central Atlantic Association of Food and Drug Law Officials, thePennsylvania Bar Institute, FDANews and the Food and Drug Law Institute. Recently, she wasselected to present at the Center for Ethics and Rule of Law Opioid Conference, was the solespeaker at a national opioid webinar and has been interviewed about this crisis. Ms. Termini is thefaculty conference head of the annual “All Matters FDA” conference at Delaware Law, WidenerUniversity that addresses “hot topics” such as the Opioid Crisis, Foreign Corrupt Practices Act,Biosimilars, Intended Use, Tobacco Products Regulation, e-cigarettes, Dietary Supplements, andCorporate Accountability. Presentations have included: Opioids, Botox, Personal Care ProductClassification, Medical Marijuana, Right-to-Ask, Criminal Enforcement, Who Really RegulatesYour Pizza, Are “Smart Labels” Really Smart, Terminology such as Healthy and Natural, andregulations under the Food Safety and Modernization Act. Other publications span a broad arrayof topics such as: corporate criminal liability and accountability, the Foreign Corrupt PracticesAct, health claims, supplements, product classification, personal care products safety, duty towarn, preemption, promotion, tobacco, stem cells, risk assessment and globalization.Her writing expertise led her to an appellate clerkship, position as sole corporate pharmaceuticalcounsel, regulatory affairs attorney and senior deputy attorney general at the Pennsylvania Officeof Attorney General (OAG) where she prosecuted cases at the trial and appellate levels andspearheaded the implementation procedures for the Pennsylvania Plain Language Act. She was thefirst recipient of the “Plain English” Award by the Pennsylvania Bar Association. Who’s Whorecognized Ms. Termini’s excellence in the field with the Lifetime Achievement Award in 2017.Ms. Termini has been actively involved in committees of several professional associations formany years, including her service as Chair of a Food and Drug Law Institute Committee. She isVice Chair of the Pennsylvania Bar Association Disability Rights and Health Law Committees.She served on the President’s Council at Immaculata University and as Vice Chair of the JustinianAssociation. Ms. Termini was appointed to the Board membership of the St. Thomas More LawSociety and is a member of the Central Atlantic Association of Food and Drug Law Officials. Herpublications are available for download on the SSRN Author page link below.Contact Detailsrbtermini@widener.edu www.fortipublications.comSSRN Author page: http://ssrn.com/author 944614http://fortipublications.com/blog/ (All Topics Food and Drug Law n.com/in/roseanntermini/

COURSEMATERIALS

An Overview of FDA’s Regulationof Dietary SupplementsBob Durkin, Deputy Director, CFSAN/ODSP“All Matters FDA”Widener University Delaware Law SchoolApril 4, 2018

Dietary Supplement Authority Federal Food, Drug, and Cosmetic Act (21 U.S.C.§ 301 et. seq.)– Dietary Supplement Health and Education Act Laid out the major framework for dietary supplements– Public Health Security and BioterrorismPreparedness and Response Act Requirement for facilities to register with FDA– Food Allergen Labeling and Consumer ProtectionAct Allergen labeling requirementwww.fda.gov2

Dietary Supplement Authority Federal Food, Drug, and Cosmetic Act (21 U.S.C.§ 301 et. seq.)– Dietary Supplement and Nonprescription DrugConsumer Protection Act Requirement for dietary supplement firms to submitserious adverse events to FDA– FDA Food Safety Modernization Act Major overhaul of framework for food facilitieswww.fda.gov3

Dietary Supplement Authority Dietary Supplement Health and Education Actof 1994– Defined the term dietary supplement– Established requirements for new dietary ingredientpremarket review– Established requirements for current goodmanufacturing practices– Included dietary supplements under theadulteration provisionswww.fda.gov4

Definition of Dietary Supplement Product (other than tobacco) that is intended tosupplement the diet Product that is intended for ingestion Contains one or more dietary ingredients––––VitaminMineralHerb or other botanicalAmino acidwww.fda.gov– Dietary substance for use by man tosupplement the diet by increasing thetotal dietary intake– A concentrate, metabolite, constituent,extract, or combination of any of theabove dietary ingredients5

Definition of Dietary Supplement It does not include– an article that is approved as a new drug, certifiedas an antibiotic, or licensed as a biologic– an article authorized for investigation as a new drug,antibiotic, or biological for which substantial clinicalinvestigations have been instituted and for whichthe existence of such investigations has been madepublic(unless such article was first marketed as a dietarysupplement or food)www.fda.gov6

Regulatory Responsibilities Facility RegistrationNew Dietary Ingredient NotificationGood Manufacturing PracticesDietary Supplement LabelingStructure/Function Claim NotificationAdverse Event Reportingwww.fda.gov7

Facility Registration All food facilities must register with FDA– Domestic and foreign– Basic information: name, address, type of activityconducted at the facility for each food productcategory, responsible party– FDA inspection acknowledgement Renewal of information every even numberedyearwww.fda.gov8

New Dietary Ingredients Dietary ingredients not marketed in a dietarysupplement prior to October 15, 1994 Manufacturers must submit a safety notificationto FDA at least 75 days prior to marketing FDA has 75 days to respond– Acknowledgement – not approval– Objection (generally based on identity or safety) Notification is made public after 90 dayswww.fda.gov9

New Dietary Ingredients Notification must include– Name and address– Signature of responsible party– Name of the ingredient– Description of the product(s) containing the NDI– Amount of the NDI in product(s)– Conditions of use– History of use or other evidence of safety establishingthe NDI “will reasonably be expected to be safe”www.fda.gov10

New Dietary Ingredients While the requirement has been in place for 20 years, FDA has only received 1000 NDINs Important that firms know:– When to submit a premarket notification– How to prepare a premarket notificationwww.fda.gov11

Current Good Manufacturing Practices FDA published the CGMP Rule in 2007– 21 CFR 111 To help ensure dietary supplement productquality, purity, consistency, and safety– Production and process controls– Testing requirements for raw materials and finishedproductswww.fda.gov12

Current Good Manufacturing Practices Applies to all firms who manufacture, package,label or hold dietary supplements– Domestic and foreign Compliance confirmed by periodic inspections– ORA investigatorswww.fda.gov13

Dietary Supplement Labeling Dietary supplements must follow food labelingrequirements (21 CFR 101)– Must be labeled as a “dietary supplement”– Must list all ingredients Properly formatted Supplement Fact label– Name/location of manufacturer– Domestic contact information for submission ofadverse eventswww.fda.gov14

Dietary Supplement Labeling Allowed claims– Nutrient content claims Characterizes the level of a nutrient– Structure/function claims Describes the role of a nutrient or dietary ingredientintended to affect the structure or function in humans– Health claims/qualified health claims Characterizes the relationship of any substance toreducing risk of a diseasewww.fda.gov15

Structure/Function Claims Claims made in accordance with section403(r)(6) of the FD&C Act– nutrient deficiency disease claim– general well-being claim– structure/function claim Cannot claim to treat, cure, prevent disease– Disease damage to an organ, part, structure, orsystem of the body such that it does not functionproperly, or a state of health leading to suchdysfunctionwww.fda.gov16

Structure/Function Notification Firms need to– have substantiation that the claim is truthful and notmisleading– notify FDA of the text of the claim no later than 30 daysafter marketing the product containing the claim– include the FDA disclaimer language Firms do not need to– provide the entire label/labeling with their notification– provide the substantiation17

Disease Claims Context is CRITICAL– Not always possible to draw a clear line– Need to consider all information in labeling andelsewhere– No claim is likely to be always or never appropriate Factors to take into account– Guidance for Industry: Structure/Function Claims,Small Entity Compliance Guidewww.fda.gov18

Adverse Event Reporting FDA’s MedWatch program receives dietarysupplement adverse events– Electronic portal, email, phone calls, letters Consumers and health care providers areencouraged to submit adverse events Manufacturers are required by law to submitserious adverse events to FDA within 15business dayswww.fda.gov19

Adverse Event Reporting All dietary supplement adverse events areentered into the CFSAN Adverse EventReporting System (CAERS) database Reviewer will evaluate cases– Identify any triggers with firms, products,ingredients– Determine if any follow-up information is necessary Inspection, consumer warning, product recallwww.fda.gov20

Regulatory Recap Facility (not product) Registration New Dietary Ingredient Notification (notapproval) Good Manufacturing Practices Dietary Supplement Labeling Structure/Function Claim Notification (notapproval) (Serious) Adverse Event Reportingwww.fda.gov21

Dietary Supplements in FDA22

FDA Organizationwww.fda.gov23

CFSAN Organizationwww.fda.gov24

CFSAN’s ODSP 26 FTE’s Program priorities– Protect consumers Identifying and removing dangerous products– Ensure product integrity Ensure products contain what they’re supposed tocontain– Promote informed decision-makingwww.fda.gov25

ODSP Priorities Protect consumers– Identifying and removing dangerous products Ensure product integrity– Enhance CGMP and NDIN compliance througheducation and enforcement Promote informed decision-makingwww.fda.gov26

Dietary Supplement Market Size1994– 600 manufacturersToday– 4,000 products– 7,000 registeredfacilities– 75,000 products*– 4 billion– 40 billion*www.fda.gov*based on external data27

Thank you!Office of Dietary Supplement ProgramsCenter for Food Safety and Applied NutritionBob Durkin, Deputy Directorrobert.durkin@fda.hhs.gov

UNCLASSIFIED//FOR OFFICIAL USE ONLYFOOD DEFENSE THREAT OVERVIEW4 April 2018All Matters FDA ConferenceWilmington, DEFederal Bureau of InvestigationBaltimore Field OfficePhiladelphia Field OfficeWMD DirectorateUNCLASSIFIED//FOR OFFICIAL USE ONLY

UNCLASSIFIEDProtecting the Food ionunintentionalcontaminationUNCLASSIFIED2

UNCLASSIFIED//FOR OFFICIAL USE ONLYFood Sector Threat Overview No known, imminentthreat to the US foodsector. Insider threats are aconcern. Terrorist groups haveexpressed interest inattacking the food sectorwith biological andchemical agents.UNCLASSIFIED//FOR OFFICIAL USE ONLY3

UNCLASSIFIED//FOR OFFICIAL USE ONLYWhy Target Food? Everyone eatsWidespread publicityShort and long term impactsDifficult to distinguish deliberate,accidental, or natural outbreak Low cost to attack Little technical expertise required4UNCLASSIFIED//FOR OFFICIAL USE ONLY

UNCLASSIFIEDPotential Targets: From Farm to ForkUNCLASSIFIED5

UNCLASSIFIED//FOR OFFICIAL USE ONLYPotential Threat Actors Wide range of potential threat actors- Disgruntled employees- Foreign terrorist organizations- Homegrown violent extremists- Dissatisfied customers- Domestic extremist groups- Unaffiliated lone offendersUNCLASSIFIED//FOR OFFICIAL USE ONLY6

UNCLASSIFIED//FOR OFFICIAL USE ONLYAssessing Threat Actors Intent Capability AccessUNCLASSIFIED//FOR OFFICIAL USE ONLY7

UNCLASSIFIED//FOR OFFICIAL USE ONLYInsider Threat What is the “Insider Threat”? Individual who exploits his/her position toaccess a target in order to carry out aterrorist or criminal action. Difficult to protect against Difficult to detectUNCLASSIFIED//FOR OFFICIAL USE ONLY8

UNCLASSIFIEDDisgruntled Employee: Oizumi, Japan January 2014 - Toshiki Abearrested for lacing frozenfoods with malathion. Contract worker for seafoodcompany Maruha NichiroHoldings Inc. Sickened more than 2,800peopleUNCLASSIFIED9

UNCLASSIFIEDDisgruntled Employee: Cold Spring, MN June 2016- Anemployee addssand and dirt fromfacility parking lotto vat in a poultryprocessing plant. Results in recall of27 tons of chicken.UNCLASSIFIED10

UNCLASSIFIED//FOR OFFICIAL USE ONLYIslamic State of Iraq and ash-Sham (ISIS)UNCLASSIFIED//FOR OFFICIAL USE ONLY11

UNCLASSIFIED//FOR OFFICIAL USE ONLYPro-ISIS Social Media, Knights of Lone JihadUNCLASSIFIED//FOR OFFICIAL USE ONLY12

UNCLASSIFIEDISIS Supporters: Derby, United Kingdom December 2016 –Munir Mohammed andRowaida el-Hassanarrested for bomb plotin the UK. Mohammed wasemployed at a foodplant that made readyto-eat meals forgrocery stores.UNCLASSIFIED13

UNCLASSIFIEDContamination for a Cause: Athens, Greece December 2017 – An anarchistgroup in Greece announced ithad obtained products fromgrocery stores near Athens,contaminated the products withchlorine and hydrochloric acid,and returned the taintedmerchandise to store shelves. Intended to cause economicdamage to major foodcompanies.UNCLASSIFIED14

UNCLASSIFIEDExtortion Attempt: Friedrichshafen, Germany September 2017– Anindividual in Germanythreatened to poison 20different kinds ofproducts if he did notreceive 12 million. Police found five jars ofbaby food tainted withethylene glycol in grocerystore.UNCLASSIFIED15

UNCLASSIFIEDSupermarket Salad Bar: Ann Arbor, MI April 2016 – Kyle Bessemercontaminated grocery storefood bars with a mixture of ratpoison and hand sanitizer Charged with two counts ofpoisoning food, drink,medicine, or water supplycausing property damageUNCLASSIFIED16

UNCLASSIFIEDWMD Coordinators Special agents At least one in each fieldoffice Conduct outreach Implement countermeasures Investigate WMD crimes andacts of terrorism Provide WMD training Coordinate FBI response toWMD incidentsUNCLASSIFIED17

UNCLASSIFIED//FOR OFFICIAL USE ONLYWeapons of Mass Destruction DirectorateVision: An enduring, integrated, and agile USG capability to prevent and neutralize all WMDthreatsR E S P O N S E C O O R D I N AT I O N Lead and managethe ThreatCredibilityEvaluation (TCE) Recognized USGprocess to assessWMD ionalPracticalityUNCLASSIFIED//FOR OFFICIAL USE ONLY WMDCs reachback into WMDD toget real-timefeedback frominteragency WMDStrategic Group As the threatbecomes relevant,teams deployedfrom HQ to supportinvestigations18

UNCLASSIFIEDKey Takeaways Intentional contamination is a real threat to the foodsupply Possible to have significant public health andeconomic impact from intentional contamination Collaboration is required to implement food defensebecause the scale of the food sector means noagency can address the issue singlehandedly19UNCLASSIFIED

UNCLASSIFIEDques tions?SA Erik NegronFBI PhiladelphiaEmail: ernegron@fbi.govIA Kevin SpradlinFBI WMDD RNCIUEmail: kspradlin@fbi.govUNCLASSIFIED

Opioids, WhistleblowerActions, Medical Device Safety,Food Defense, Personal CareProducts, Dietary SupplementRegulation, Top Notables andOther Matters FDA .Roseann B. Terminic. Roseann B. Termini, Esq. Food and Drug Law: Federal Regulation ofDrugs, Biologics, Medical Devices, Foods, Dietary Supplements, PersonalCare, Veterinary and Tobacco Products www.fortipublications.com

Rules of Professional ConductKey Focus Communication Competence Diligence Expediting Litigation Zealous Advocacyc. 2018 Roseann B. Termini, Esq., All rights reserved.Unauthorized use strictly prohibited by law.

Federal Court OrderAltria, R.J. Reynolds Tobacco, Lorillard andPhilip Morris USA Corrective Statements RemedyNewspapers and Television c. 2018 Roseann B. Termini, Esq., All rightsreserved. Unauthorized use strictly prohibited bylaw.

United States v. Tobacco-FreeKids Action Fund v. Philip MorrisUSA Inc. and ITG Brands, LLC Corrective statements remedy Order #1015 (Dkt. No.5733; Aug. 17, 2006), United States v. Philip Morris USAInc., 449 F. Supp. 2d I, 938-41 (D.D.C. 2006), aff'd inpart & vacated in part, 566 F.3d 1095 (D.C. Cir. 2009)(per curiam), Cert. Denied, 561 U.S. 1025 (2010), ishereby MODIFIED by Order Dated Oct. 5, 2017Example N.Y. Times 9 (Jan. 7, 2018).c. 2018 Roseann B. Termini, Esq., All rights reserved.Unauthorized use strictly prohibited by law.

Federal Court Order A. Adverse Health Effects of Smokingc. 2018 Roseann B. Termini, Esq., All rightsreserve

All Matters FDA: Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation, Top Notables, and Other Matters FDA Presented by the Widener University Delaware Law School Food and Drug Law Association Wednesday, April 4, 2018 12:3 0–5:00 p.m. 8th Annual Food and Drug Law CLE