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Complex Structure Function Claims: A case study of inflammation claims Complex Structure Function Claims: A Case Study of Inflammation Claims Content developed and sponsored by: Complex Structure Function Claims: A case study of inflammation claims • If you miss a portion of this session, it will be recorded and archived on the INSIDER website at naturalproductsinsider.com/webinars • It should be available within five business days Complex Structure Function Claims: A case study of inflammation claims Questions & Answers • Please send questions by using the Q & A feature located on your screen. • There will be a Q & A period at the end of the Webinar. • Not all questions may be answered due to time constraints. If your question is not answered during the Q & A, please email it to [email protected]. Please add to the subject line, “INSIDER-CRN May Webinar.” Type question here Complex Structure Function Claims: A case study of inflammation claims Today’s Moderator Douglas “Duffy” MacKay, N.D. Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN) Dr. MacKay is a licensed Naturopathic Doctor and was a co-owner and practitioner in a family-owned New Hampshire complementary and alternative medicine private practice for seven years. In addition to his hands-on experience as a practitioner in the field of integrative medicine, he spent eight years working as a medical consultant for two companies in the dietary supplement industry, including four years as an executive with Nordic Naturals, in charge of clinical research. He previously served as Technical Advisor for Thorne Research. Dr. MacKay has published articles in peer-reviewed journals, and serves on the Editorial Board of two peer-reviewed publications: the clinical journal Alternative Medicine Review and the official publication of the American Association of Naturopathic Physicians, Natural Medicine Journal. Dr. MacKay earned his B.S. in Marine Sciences from the University of California, Santa Cruz and his N.D. from the National College of Naturopathic Medicine in Portland, Oregon. Dr. MacKay is licensed in the state of New Hampshire. Complex Structure Function Claims Inflammation as a Case Study: 1. 2. 3. 4. Background (D. MacKay) Regulatory Perspective (C. Hilmas) Scientific Perspective (A. Schauss) Integrating Science, Regulation, and Business Practices (J. Lassiter) Council for Responsible Nutrition May 7, 2013 Inflammatory Disease • Over 100 inflammatory diseases characterized by increased levels of inflammation – arthritis (osteoarthritis, rheumatoid arthritis, psoriatic), asthma, Crohn's disease, colitis, dermatitis, diverticulitis, fibromyalgia, atherosclerosis, hepatitis, IBS, lupus, nephritis, ulcerative colitis, etc. D.S. claims to treat or prevent are off-limits Council for Responsible Nutrition May 7, 2013 Inflammation is the end result of oxidative stress that can be caused by activities of daily living such as emotional or physical trauma, or nutritional and environmental exposure Is inflammation itself a disease? Council for Responsible Nutrition May 7, 2013 Adipose Tissue is a Source of Pro-inflammatory Cytokines Council for Responsible Nutrition May 7, 2013 Stress increases biomarkers of inflammation Council for Responsible Nutrition May 7, 2013 Council for Responsible Nutrition May 7, 2013 Exercise results in tissue inflammation Council for Responsible Nutrition May 7, 2013 Council for Responsible Nutrition May 7, 2013 Environmental irritants can result inflammation Council for Responsible Nutrition May 7, 2013 Council for Responsible Nutrition May 7, 2013 “There is growing evidence that some dietary factors can play important roles in maintaining health and even reversing the progression of chronic diseases, with anti-inflammatory effects as important underlying mechanisms” Council for Responsible Nutrition May 7, 2013 Are stress, exercise, air pollution, and adipose tissue diseases? Is the body’s innate response to these triggers a disease? Are food component that reduce excess inflammatory responses to these triggers drugs? Council for Responsible Nutrition May 7, 2013 Complex Structure Function Claims Inflammation a Case Study • How can companies communicate inflammation-reducing benefits of dietary supplements without crossing the disease claim line? – What is the type and scope of scientific evidence necessary to support appropriate structure function claims related to inflammation? Council for Responsible Nutrition May 7, 2013 Complex Structure Function Claims: A case study of inflammation claims Today’s Speaker Corey Hilmas, M.D., Ph.D. Team Leader of FDA’s Dietary Supplement Regulation Implementation Team Dr. Hilmas is a senior toxicologist, physician, and chief for FDA’s Regulations Implementation Branch (DSRIB) in the Division of Dietary Supplement Programs (DDSP) at CFSAN FDA. The DSRIB formulates dietary supplement (DS) policy interpretation, regulatory guidance to the FDA Field Offices to address and recommend regulatory actions. Dr. Hilmas develops, manages, and coordinates enforcement recommendations pertaining to labels/labeling, claims, GMPs, import detentions, DS exports, dietary ingredient safety, detentions/refusals and other aspects of DS regulation. He is the principal agency liaison and expert witness on labeling and claims for DS with industry, Federal, State, foreign governments, and other organizations. He was also a former toxicology reviewer for NDIs and a nuclear chemist at DOE in Golden, Colorado. He earned his Bachelor’s degree from the University of Colorado at Boulder, a Medical Degree from the University of Maryland School of Medicine, and a PhD in neurotoxicology from their School of Medicine Structure Function Claims Related to Inflammation Corey J. Hilmas, M.D./Ph.D. Supervisory Toxicologist Chief, Dietary Supplement Regulations Implementation Branch Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration [email protected] 19 Types of Dietary Supplement Claims Prohibited Disease Claims Permissible Health Claims/Qualified Health Claims Permissible Structure/Function Claims (unique to Dietary Supplements) Nutrient Content Claims 20 “Structure/Function Final Rule” January 6, 2000 Federal Register (65 FR 1000) defined the term “disease” identified 10 criteria to assist defining the term 21 “Structure-Function” Claims Section 403(r)(6) & 21 CFR 101.93 classical nutrient deficiency disease (ie. scurvy, pellagra) AND discloses prevalence of disease affect on structure or function mechanism of affect on structure/function describes general well-being 22 “Structure-Function” Claims May not claim to diagnose, treat, cure, or prevent any disease Disease defined in 21 CFR 101.93(g) See January 6, 2000 Federal Register (65 FR 1000) 23 Substantiation §(403)(r)(6)(B) Claim must be truthful and not misleading Must be supported by competent and reliable scientific evidence 24 Disclaimer Statement This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. 25 Intent of the Rule Define universe of claims that are explicit and implicit disease claims Not: Apply to other FDA regulated products Interpret other provisions of the Act Define “appropriate” s/f claims Address substantiation 26 Disease Claims Define the Product Disease (2 parts): “damage to an organ, part, structure, or system of the body such that it does not function properly….or a state of health leading to such dysfunctioning…” 27 Definition is Broad Not limited to serious diseases Includes signs/symptoms that do not require a drug or doctor Act doesn’t distinguish minor vs serious Congress was silent on this matter 28 Caveats of Disease Claims Context is CRITICAL Not always possible to draw a clear line Need to consider all information in labeling and elsewhere No claim is likely to be always or never appropriate 29 What is Inflammation A localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function (Stedman’s Medical Dictionary) 30 What is Inflammation The reaction of a part of the body to injury or infection, characterized by swelling, heat, redness, and pain. The process includes blood flow with an influx of white blood cells and other chemical substances that facilitate healing. (American Heritage Science Dictionary) 31 What is Inflammation A local response to cellular injury that is marked by capillary dilatation, leukocytic infiltration, redness, heat, pain, swelling, and often loss of function and that serves as a mechanism initiation the elimination of noxious agents and of damaged tissue (National Library of Medicine) 32 What is Inflammation? Inflammation: a localized protective response elicited by injury or destruction of tissues, which serves to destroy, dilute, or wall off both the injurious agent and the injured tissue. (Dorland’s Illustrated Medical Dictionary) Body’s mechanism for coping with agents that damage it. Inflammation is one of the first responses of the immune system to infection. Protective response to rid the body of the cause of cell injury and the necrotic cells that cell injury produces 33 What is Inflammation? Part of the complex biological response of vascular tissues to harmful stimuli, such as pathogens, damaged cells, or irritants. The protective mechanism, experienced by pain, heat, erythema, edema and loss of function, to remove the injurious stimuli 34 Inflammation vs. Immune System? Inflammation is produced by eicosanoids and cytokines, which are released by injured or infected cells. The acute inflammatory response requires constant stimulation to be sustained. Inflammatory mediators have short half lives and are quickly degraded in the tissue. Hence, acute inflammation ceases once the stimulus has been removed. The immune system is always on for surveillance. If it wasn’t you would not have an adaptive immune system to “remember” previous antigens or macrophages traveling in and out of organs, blood, lymph 35 Structure Function Final Rule “improves joint mobility” – dz claim in final rule “reduces joint inflammation and pain” – dz claim in final rule “A statement that a product that is soothing to the stomach achieves its effects as a result of its ‘‘carminative (antispasmodic) properties’’ or as a result of its ‘‘anti-inflammatory effect on the gastrointestinal tract.’’ – the term “anti-inflammatory” is strongly associated with treatment of diseases 36 Structure Function Final Rule “…joint pain is a characteristic symptom of arthritis, and joint pain claims are therefore disease claims. Acceptable structure/function claims could be made, however, for pain associated with nondisease states, e.g., muscle pain following exercise.” 37 Inflammation Claims • FDA also believes that ‘‘joint pain’’ is characteristic of arthritis. According to the Merck Manual, joint tenderness is the most sensitive physical sign of rheumatoid arthritis (Ref. 6). The claim ‘‘helps support cartilage and joint function,’’ on the other hand, would be a permissible structure/function claim, because it relates to maintaining normal function rather than treating joint pain. 38 Markers of Inflammation as Implied Disease Claims • “The agency agrees that references in dietary supplement labeling to physiologic markers or symptoms of a disease that are quantifiably linked to that disease … would be appropriately treated as implied disease claims.” CRP and ESR 39 Class Participation - Claims treat cure prevent diagnose mitigate stimulate maintain support regulate promote helps • Are verbs disease claims?? 40 treat cure prevent diagnose mitigate vs. stimulate maintain support helps promote Structure Fn vs Dz. Claims (Verbs) Supplement X ….. …helps to ease discomfort and provide soothing comfort for your everyday foot inflammation ? …treats self-limiting foot pain and soreness that results after running a marathon ? …supports joint flare ups and inflammation from daily routines like walking your dog in the morning and evening ? …is designed to mitigate temporary joint inflammation that occurs from over-exerting oneself ?41 during intensive training treat cure prevent diagnose mitigate vs. stimulate maintain support helps promote Structure Fn vs Dz. Claims (Verbs) Supplement X ….. …supports your healthy inflammatory response ? …supports your healthy inflammatory response ………….. to something (to what) The first one is left unqualified and the second one ? could be qualified and limited in scope to a structure function claim Granulation tissue is healthy when it is beefy red and unhealthy when it is another color but both form in response to an injury (or infection) … claims 42 to support such a process are claims that have a role in the body’s response to dz or dz vector What to Focus On Writing Good Structure Function Claims & Recognizing Disease Claims Q: What do I focus on in the claim if it’s not about the verb? A: All the stuff to the “Right” of the verb which could qualify the claim and limit its scope to a non-disease state 43 Disease Claims 101: Criteria 1 • Criteria 1: Has an effect on a specific disease or class of diseases – Includes explicit and implicit claims 44 Implied Claims • “Implied Claims do not mention the name of a specific disease, but refer to identifiable characteristics of a disease from which the disease itself may be inferred. There are many possible ways to imply treatment or prevention of disease, from listing the characteristic signs and symptoms of the disease to providing images of people 45 suffering from the disease.” Disease Claims 101 Explicit Implicit Treats Rheumatoid Arthritis May improve grip strength, normalize hand function and prevent claw hand deformity 46 Disease Claims 101: Criteria 2 • Criteria 2: “effect on a characteristic sign or symptom of a disease” – erythema, heat, pain, swelling, and often loss of function “FDA also believes that ‘joint pain’ is characteristic of arthritis. According to the Merck Manual, joint tenderness is the most sensitive physical sign of rheumatoid arthritis (Ref. 6). The claim ‘helps support cartilage and joint function,’ on the other hand, would be a permissible structure/function claim, because it relates to maintaining normal function rather than treating joint pain.” 47 Disease Claims 101: Criteria 3 • Criteria 3: Has an effect on an abnormal state associated with a natural state or process Natural States Pregnancy, aging, adolescence, menopause, menstrual cycle, the body under exercise or training 48 Disease Claims 101: Criteria 4 • Criteria 4: Has an effect on a disease by the use of pictures, vignettes, and symbols: – Generally, case-by-case evaluation – Disease • Xrays/MRIs of Damage, abnormal organs, EKG tracings [case by case basis] – Structure/function • Normal organs, body outlines, medical caduceus 49 Disease Claims 101: Criteria 5 • Criteria 5: Belongs to a class of products intended to treat, cure, prevent, mitigate disease – Claiming membership in a product class that is strongly associated with use to treat or prevent disease is evidence of intended use 50 Disease Claims Define the Product • Criteria 5: • Class: NSAIDS, COX-2 inhibitors • Implied Class: “Inhibits cyclooxygenase” • “Inhibiting or decreasing platelet aggregation is the mechanism of action of a number of drug products approved for the treatment or prevention of stroke and heart attack. Thus, the agency would consider a claim to inhibit normal platelet function to be an implied claim to treat or prevent these disease conditions.” 51 Substitute for a Disease Therapy or Agent • Criteria 6: Substitute for a disease therapy or agent ─ Supplement X has fewer side effects but just as good as … COX-2 inhibitors/NSAIDS 52 Disease Claims 101: Criteria 7 • Criteria 7: Augments a therapy or drug action – Disease claim when the substance is implied to effect the disease – “take Supplement X with your NSAIDS for best results…” 53 Disease Claims 101: Criteria 8 • Criteria 8: Has a role in the body’s response to a disease or disease vector support the immune system?? vs support body’s antiviral ability?? support the body’s healthy inflammatory response?? (granulation tissue) 54 Thanks • DDSP: Daniel Fabricant, Director • ONLDS: Barbara Schneeman 55 Complex Structure Function Claims: A case study of inflammation claims Today’s Speaker Alexander G. Schauss, Ph.D., FACN, CFS Senior Director of Research, Natural and Medicinal Products Research, AIBMR Life Sciences Dr. Schauss has held academic positions as a Clinical Professor of Natural Products Research, Associate Professor of Research, Adjunct Research Professor of Botanical Medicine, and Lecturer in Biostatistics and Epidemiology. He has served on NIH advisory councils, and currently sits on one of US Pharmacopoeia Convention’s Expert Panels. In addition to being a reviewer for 28 scientific journals, author/co-author of over 130 peer reviewed papers, 23 books, 29 chapters, and 293 technical reports, he is a: Certified Food Scientist, Fellow of the American College of Nutrition, Emeritus Member of the New York Academy of Sciences, former Chair of the Food Policy Council, National Council for Public Health Policy, and represented the United States on the WHO Study Group on Health Promotion. He is a member of the: Am Chemical Society, Am Society of Nutrition, Am College of Toxicology, Society for Toxicology and Society for Experimental Biology and Medicine. CRN Webinar: Complex structure function claims: A case study of inflammation claims. May 7, 2013 Differentiating Inflammation: A Pathway to Using the Word “Inflammation”? Alexander G. Schauss, PhD, FACN, CFS Senior Director of Research, Natural and Medicinal Products Research, AIBMR Life Sciences, Inc. Puyallup, Washington www.aibmr.com Inflammation comes from the Latin “inflammo”, meaning “I set alight, I ignite”. It is defined as the host’s attempt to self-protect. The aim is to facilitate removing anything that has caused harm and begins the healing process. It is a mechanism of innate (not adaptive) immunity. It is naturally present in our bodies from the day we are born. February 23, 1994 Chronic inflammation was subject of article. It explored "circumstantial" evidence linking inflammation to wide pool of ailments typically experienced by middle-aged and the elderly. Some Facts on Inflammation • Without inflammation we would die. Infections and wounds would never heal. • It is a biochemical and cellular process that occurs in vascularized tissues. • It is part of the body’s immune response. • It’s a natural defense mechanism in response to intense heat, irritating chemicals, physical trauma, or infection by bacteria or viruses. • It prevents the spread of damage to nearby tissue. • It sets stage for resolution, regeneration or repair process. Hence, it falls into the same category of other normal processes in humans (i.e., pregnancy, menopause, andropause). Cause of inflammation When a chemical alarm signals injury, phagocytes, mast cells, lymphocytes and blood proteins release inflammatory mediators: Histamine Kinins Prostaglandins Complement Lymphokines Cytokines These exudates dilate small vessels in vicinity of injury or infection. Pain results from localize swelling pressing on adjacent nerve endings. Role of Exudates The substances in the exudates defend against infection and facilitate repair & healing by: Removing injurious agents from site of inflammation; Confining injury to limit damage to surrounding tissues. Healing There are 3 types of healing following an inflammatory response to injury or infection: Resolute. Occurs when there is very little damage (e.g., mild sunburn). Regenerative. Occurs when cells in damaged tissue are replaced through mitosis by neighboring cells. Replacement . Occurs in connective tissue following extensive injury when mitosis is not possible. This is the type often referred to as the “repair” stage (rather than regenerative or resolute). Keeping in mind - inflammation is an essential part of the host’s effort to heal itself. The question is whether it is absolutely necessary to slow down the healing process. Does it need to be left uncontrolled? Understanding Difference Between Normal Essential, Primary, and Chronic Inflammation Normal Essential Inflammation Inflammation is at work at the molecular level on a constant basis without any symptomology. Primary or Acute Inflammation Inflammation is the immune response of tissues due to injury or infection: pain, swelling, redness or heat. Normally localized. A protective response following injury or infection. It is self-limiting. It continues only until the threat is eliminated. Symptoms are of short during (usually, 48-96 hours, but less than two weeks). Involves repairing cellular damage resulting from every day type activities and exposures. Chronic Inflammation It persists for more than two weeks, due to a failure to eliminate whatever is causing acute inflammation, such as a chronic irritant. Body is unable to repair tissue damage, so activation of inflammatory cascade continues involving such endogenously produced agents as IL-1, TNF-alpha, prostaglandins, cytokines, that perpetuate the pro-inflammatory response. Most often this results in a condition that end with “itis”. This includes autoimmune diseases in which the immune system attacks healthy tissue mistaking it as harmful. The “inflammatory”quandary Would using the word “inflammation” mislead consumers into believing that it will “treat” unresolved chronic inflammation? Would providing a qualified statement that states the product is not intended to mitigate or treat chronic or “prolonged” inflammation be acceptable? Why not allow non-disease related S/F statements that support normal inflammation? Caveat Chronic inflammation may persist following an acute episode when the cause is not known or removed, resulting in chronic irritation requiring continued immune overstimulation. Typically characterized by less swelling but more fibrocytes, lymphocytes, and macrophages, that can lead to more tissue destruction. This is why the question is raised as to whether any effort should be made to interfere with inflammation at any stage, since it is involved in healing. Factors that Retard Inflammation Eat healthy diet Increase physical activity; avoid injury & infections Eliminate/reduce proinflammatory foods Obesity Promotes Inflammation White adipose tissue (WAT, or “fat”) is now known to secrete a variety of substances that help to regulate metabolic homeostasis, some of which also promote inflammation. These include: Leptin Adiponectin Serum amyloid A (SAA) Tumor necrosis factor-a (TNF-a) Interleukin-6 (IL-6) Angiotensinogen Visfatin Retinol-binding protein-4 Resistin, or Adipose tissue-specific secretory factor (ADSF) Serum amyloid A (SAA) Monocyte chemoattrant protein-1 (MCP-1) Plasmogin activator inhibitor-1 (PAI-1) Supplements that Support Normal Essential Inflammation Multi-vitamins/mineral complex supplements Vitamin D Vitamins A, C and E EFA’s Bioflavonoids and Anti-inflammatory/anti-oxidant botanicals Using Ice to Mitigate Tissue Damage Soft closed tissue damage to muscles results in inflammation. Prolonged application of ice to affected area: Restores functional capillary density; Decreases elevated intramuscular pressure; Reduces number of adhering & invading granulocytes; Attenuates tissue damage. Results in nutritive perfusion and attenuates leukocyte-mediated tissue destruction. Prevents further irreversible aggravation. Schaser, et al. Am J Sports Med, 2007; 35: 93. Conclusion Since without normal essential inflammation we would die, why not allow non-disease related S/F statements that would state that the product supports normal essential inflammation, but is not intended to treat chronic inflammation (of longer than two weeks duration)? If using ice can promote the healing process, then why can’t the same be said for supplements that contain ingredients at concentrations that studies have shown can perform some of the same function in promoting the healing process by decreasing the inflammatory response that ice does? Wu X and Schauss AG. Mitigation of inflammation with foods. Journal of Agricultural and Food Chemistry, 2012; 60: 6703-6717. Thank you Contact info: Alexander G. Schauss, PhD, FACN, CFS AIBMR Life Sciences [email protected] AIBMR’s resource library Complex Structure Function Claims: A case study of inflammation claims Today’s Speaker Jim Lassiter co-founder/COO Ingredient Identity Jim Lassiter has over 30 years of Regulatory Affairs and Quality experience in the Pharmaceutical, Dietary Supplement and Natural Products industries. Expertise ranges from product design and regulatory agency responses to registration of products/ingredients in the U.S. and international markets. His work and views have received notable recognition in the Food and Drug Law Institute Update, The Tan Sheet and other numerous publications. Jim was also instrumental in garnering industry support for the passage of the Dietary Supplement Health and Education Act (DSHEA). Prior to Ingredient Identity, Jim spent the last decade consulting for numerous distributors and contract manufacturers to support FDA Responses, optimize Quality Systems and provide ongoing regulatory guidance. He began his career in the pharmaceutical industry, which set the stage for a fifteen-year career with Nutrilite, division of Amway Corporation where he held positions as the head of the Product Development, Quality Control and Regulatory Affairs departments. GUIDANCE DEVELOPMENT COMPLIANCE© ©2013 Company Overview Founder - Jim Lassiter, M.Sc. MBA Navigating The Complexities Understanding the complexities relating to natural products marketed under the umbrella category of “inflammation” Refer to 21 CFR Part 101.93 and Rulemaking Obtaining a new perspective 403(r)(6) Claims Must state relationship between a nutrient and a classic nutrient deficiency disease e.g. scurvy Describes general well-being obtained from consumption of a nutrient Characterizes the documented mechanism of action to maintain structure or function Describes the role/effect on structure or function What they are NOT Claims relative to disease or disease states Identified as curing, treating, diagnosing, preventing or mitigating any disease Evaluated by the Food and Drug Administration Per the statutory disclaimer Clarifying Diseases More obvious examples Cancer, Influenza, Heart Disease and Alzheimer's, etc. Less obvious examples Perceptions within the consumer’s mind Cholesterol, Blood Pressure or Glucose Levels Some known grey areas Menopause, Stress & Anxiety, Sleeplessness, Pain or Inflammation, etc. The Grey Area 21CFR Section 101.93 Proposed Rule (April, 1998) Opened some doors and requested comment Began to redefine disease from the 1993 definition Carved out some areas for claims generally No mention of Inflammation Public Hearings (1999) Definition of disease Permit implied disease claims Claims involving “natural states” Final Rule (January, 2000) Retained the definition of disease found at 21CFR Section 101.14(a)(5) Allows reference citations that include names of diseases Allows for claims involving “natural states” that do not cause significant or permanent harm Identifying “Natural States” Under ALL circumstances a Claim must NOT be False or Misleading What Kinds of “Natural States” are there? Constipation Menstruation Menopause Heartburn Absentmindedness Adolescence Inflammation(?) Defining “Natural States” The Signs and Symptoms Criterion The Mild Common Criterion Keeping Things Normal Healthy Individuals Individuals that are NOT trying to be UNHEALTHY Not Allowed: Maintaining healthy lung function in smokers The term “Anti-inflammatory” – Not Acceptable Inflammatory Response(?) The “Natural” Challenge States of being that are “Natural” With respect to pain: Headache – not natural enough Joint Pain – can be With respect to Inflammation – perhaps Improvements that are “Natural” Stamina Muscle Mass Normal = Natural “Near” Drug Claims Allowances that are close to OTC Claims “Not an Antacid” vs. “Relief of a sour stomach” “Not a sedative” vs. “Helps with occasional sleeplessness” Stool softener Digestive aid Weight control Nocturnal leg muscle cramps Navigating the “Complexities” Assumptions Truthful and Nonmisleading Nothing in the rest of the presentation Substantiation exists Areas of Interest that are “natural states” Inflammation from specific circumstances Areas of Interest from Mechanism of Action Normal Inflammatory Response “Complexity” Requirements Insure NO Implications Specific Organ Inflammation Symptoms Expressed as Inflammation Cause of the Inflammation Insure NO Permanent Condition Occasional Temporary Transient (even this deserves caution) Normal Works In Nearly All Cases Define “Normal Inflammation” Identify the Inflammation as a Natural State “Complexities” Can Work Normal Digestive Health – Yes Gastrointestinal Inflammation – No Normal Inflammatory Levels – WHAT? Temporary Inflammation – Mostly Natural Inflammatory Response – Sometimes Trigger, Support, Assist but not Cause Two Primary Issues Cause of the Inflammation Nature of the Inflammation Follow The Process General Steps to Develop a Claim: Gather the Information Substantiate Review Notify Disclaim Thank You Q&A How can we help you navigate? Ingredient Identity PO Box 1537 Laguna Beach, CA 92652 P: 949.415.7795 F: 949.281.7384 e: [email protected] www.ingredientidentity.com Complex Structure Function Claims: A case study of inflammation claims Q & A Session Alexander G. Schauss, Ph.D., FACN, CFS Senior Director of Research, Natural and Medicinal Products Research, AIBMR Life Sciences Jim Lassiter co-founder/COO Ingredient Identity Corey Hilmas, M.D., Ph.D. Team Leader of FDA’s Dietary Supplement Regulation Implementation Team • Please submit your questions to our moderator using the Q & A feature on your screen • Not all questions may be answered due to time constraints. If your question is not answered during the Q & A, please email it to [email protected]. Please place in the subject line, “INSIDER-CRN May Webinar.” Complex Structure Function Claims: A case study of inflammation claims Thank you for attending today’s Webinar sponsored by: Visit naturalproductsinsider.com to register for future events and to view our extensive library of On Demand Webinars.