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Complex Structure Function Claims: A case study of inflammation claims
Complex Structure Function Claims:
A Case Study of Inflammation Claims
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Complex Structure Function Claims: A case study of inflammation claims
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Complex Structure Function Claims: A case study of inflammation claims
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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
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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
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Complex Structure Function Claims: A case study of inflammation claims
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