U.S. DIETARY SUPPLEMENTLABEL CLAIMS –WHAT CAN YOU SAY ?
Steve Mister
President & CEO
Council for Responsible NutritionCouncil for Responsible Nutrition

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Who is CRN?
National trade association for manufacturers
and marketers of dietary supplements andfunctional foods in the United States.
Foster a climate for responsible industry
members to develop, manufacture andmarket their products.
Our global affiliate, CRN-International (CRN-I),
promotes science-based policy-making aroundthe world.
Council for Responsible Nutrition

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Association Facts
One Association—The Council for Responsible Nutrition (CRN)

Amount with CRN
Voting Members…………….…………………………......96
Finished Products.…..…….…………………………..52
Ingredient Suppliers ….……………………………….44
Associate members.……………..…………….………….46
Staff ……………………………………………..………….15
Annual budget ………………..…………………$5.2 million
Years in existence.…………..……………………….……41
Also contains: scientific, regulatory, international, media
relations and government relations expertise not foundanywhere else.
Council for Responsible Nutrition

ARE DIETARY SUPPLEMENTS REGULATEDIN THE UNITED STATES?

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What the media says . . .
“These views are often fueled by producthealth claims, consumer testimonials, and an
industry that is largely unregulated owing to
the 1994 Dietary Supplement and Health
Education Act.”
Archives of Internal Medicine,“The sentencing ends an unusual
criminal case that explored both illegal
online pharmacies and the legal but
barely regulated U.S. dietary
supplements industry.” MSNBC“So why aren't these products regulated?
Congress virtually exempted them fromoversight under a 1994 law…” Concord
Monitor“Fifteen years after Congress and theClinton administration put the dietarysupplement industry on a loose leash, the$25-billion-a-year business still sometimes
bites its customers.”“The dietary-supplement industry isessentially unregulated,”“How supplements can bite their buyers,”
Philly.com“The consumer should understand that the
dietary supplement market is mostly
unsupervised and unregulated. . . .” The
Legal Examiner“An unregulated industry” Consumer Reports“…supplements are not regulated…”
Nutrition-wise Blog, Mayoclinic.com
Council Nutrition
for Responsible
NutritionCouncil for Responsible
Tufts Friedman
School of Nutrition, Feb. 13, 2009

Council for Responsible Nutrition“Dietary supplements are notstrongly regulated or evaluatedfor claims by the FDA …”
NewsStar.com“. . . these products are both widely used
and largely unregulated by the U.S. Foodand Drug Administration.” NewsDay
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Council Nutrition
for Responsible
NutritionCouncil for Responsible
Tufts Friedman
School of Nutrition, Feb. 13, 2009

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Dietary supplements ARE
regulated.
Differently than pharmaceutical drugs, but regulated.
Treated as a category of food, except where they are
singled out for additional requirements – which theyoften are.
Extensive regulations, enforced by U.S. FDA and FTC,
regulate their formulation, manufacturing, labeling andmarketing.

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Why Supplements Should Be
Regulated Differently than Drugs
 Dietary ingredients are found in foods or have extensive
history of use; they are not novel compounds.
 Natural compounds have little intellectual property/patent
protection.
 Lack of exclusivity means less incentive to invest fundingin drug-like studies.
 Nutrients have more subtle, long-term effects vs.
immediate, life-saving results – they get less interest fromresearchers.
 Studying risk reduction and prevention vs. treatment andcure are more costly, time consuming and more arduous;
RCTs may pose ethical issues.
Council for Responsible Nutrition

Regulation is a Four-Legged Stool
Ingredient Safety

Manufacturing Controls

1. The ingredients are safe.

2. The product is manufactured
in a manner that assuresquality.

Claims Evaluation
4. The ingredients are effective;i.e., the product does what themarketer says it will do.

Council Nutrition
for Responsible
NutritionCouncil for Responsible
Tufts Friedman
School of Nutrition, Feb. 13, 2009

Council for Responsible Nutrition

Post-Market Surveillance
3. Someone is monitoring the
product in the marketplace.

9Ingredient Safety
An ingredient that was on the market in 1994, when DSHEA was enacted,
is presumed to be safe unless the FDA demonstrates that it is not.
Twenty years later, we have additional usage data to further support thesafety of these “old” ingredients.
New dietary ingredients (introduced since 1994) must be “noticed” to FDA
at least 75 days before entering the market.
Mfrs must describe the ingredient with specificity and provide FDA withevidence that the ingredient, and product that would contain it, are“reasonably expected to be safe.”
FDA can remove ingredients or products from the market if they pose asignificant or unreasonable risk of illness or injury – and has used that
authority.
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Manufacturing Controls
Dietary supplements are subject to their own Good
Manufacturing Practices (GMPs) regulations, effective forindustry since 2010.
GMPs govern all aspects of dietary supplement production, fromidentity testing of raw ingredients to testing of the final products.
Mfrs must register their facilities with FDA every two years.
FDA routinely inspects dietary supplement facilities, completingover 500 inspections in 2013.
Warning letters for uncorrected violations are posted on FDA’s
website.
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Post-Market Surveillance
2006 law imposed mandatory adverse event reporting –with support of the industry.
All serious adverse events reported to a company must
be reported to FDA within 14 days of receipt. No
determination of causality: all reports go to FDA.
Companies must preserve all adverse event reports for
six years; FDA has access upon request.

These adverse event reports have proven helpful toidentify manufacturing problems, safety concerns for
ingredients and discrepancies in labeling.
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Claims Are Regulatedby FDA and FTC
Disease Claims are prohibited – Foods anddietary supplements may not claim to treat,
prevent, mitigate, cure or diagnose a disease.
Other claims must have substantiation that they
are true – competent and reliable scientificevidence to support the claim.
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Advertising vs. Labeling
The FDA regulates DS labeling – anything affixed tothe product, or that would appear
The Federal Trade Commission (FTC) oversees all
consumer advertising, including DS – print ads,
television, radio.
Both FDA and FTC claim jurisdiction over internet –websites, banner ads, search engine tools, blogs,
social media, etc.

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Why Claims Are Important
Claims inform the consumer about safe use of the
product and provide information about its
ingredients.
Educate consumers available options for theirhealth interests.
Claims communicate to FDA the intended use of
the products.
– Is it a food, drug or supplement?

They support and facilitate marketing of products.
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Types of Allowable Dietary
Supplement Claims
Nutrient Content Claims
Nutrient Deficiency Claims
Structure / Function Claims
Health Claims – includes Qualified HealthClaims
These can all be used for either dietary
supplements or conventional foods
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Disease Claims Are NOT Permitted
A disease claim is a claim that the productprevents, treats, cures, mitigates or diagnoses a
disease.
Making a disease claim transforms the productinto a DRUG.

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What is a “disease”?
...damage to an organ, part, structure, or systemof the body such that it does not function
properly (e.g., cardiovascular disease), or astate of health leading to such dysfunctioning(e.g., hypertension); except that diseases
resulting from essential nutrient deficiencies(e.g., scurvy, pellagra) are not included in thisdefinition.
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Nutrient Content Claims
Characterize the level of a nutrient in the
product.
Examples: “High in antioxidants”
 “Good source of calcium”
 “Excellent source of Vitamin C”

Limited to those nutrients authorized by FDA.
Product must contain the prescribed amount.
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Nutrient Deficiency Claims
Very limited claims related to a known
deficiency-related disease.
Must also provide the known prevalence of thedisease in the general population.
Examples:– Vitamin C – scurvy– Vitamin D – rickets

As a practical matter, these are rarely used in the
U.S.
Council for Responsible Nutrition

20Structure/Function Claims• Describe the effect of a product on the (normal)
structure or function of the body, and also include:oClaims that describe the effect of the supplement on
general well-being.

• Manufacturer must notify FDA the claim is being made.
• Manufacturer must have substantiation that thestatement is truthful and not misleading.

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Examples ofStructure/Function Claims“Helps build strong bones”“Helps support a healthy Immune function”“Use for weight management”“For eye health”“Maintain a healthy circulatory system”“Helps build muscle – get strong and toned”
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Structure/Function Claims
Key Features:o May not claim or imply diagnosis, prevention,

treatment or cure of a disease

Label must bear an FDA disclaimer:

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Disclaimer has two purposes:

1.To distinguish structure/function claims from healthclaims, which are evaluated by FDA.
2.To distinguish structure/function claims from drug
claims, which do refer to preventing or treating disease.

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Case Study – Immunity• “A good source of antioxidant
vitamins C and E.”• “Supports a healthy immune
system.”• “Supports a healthy respiratory
system.”• “Enhances your naturalresistance.”• BUT NOT: Prevents colds,
allergies or fights sinus infection
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Substantiating
Structure/Function Claims
ALL Claims require competent and reliable scientificevidence for support.
FDA provides flexibility in the amount and type ofevidence while helping to preserve consumer
confidence.
Support should relate to the specific product andclaim, be scientifically sound, and adequate in thecontext of the surrounding body of evidence.
Source: FDA Guidance: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act

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“Competent and Reliable
Scientific Evidence”
To meet this standard, companies should consider:
1) The meaning of the claim(s) being made2) The relationship of the evidence to the claim
3) The quality of the evidence

4) The totality of the evidence

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…does not necessarily require
blinded, randomized clinical trials.
• Randomized-controlled trials (RCTs) are the “goldstandard” -- but they may not be appropriate fornutrients and food components.
• Prevention/health maintenance is difficult to “prove”
because benefits are realized over time.
• Nutrient effects may be subtle, and multi-functional.
• Observational data may be used.
• RCTs may be costly, impractical or unethical.
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…so FDA uses a flexible approachto substantiating claims.

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Health Claims
Discuss the relationship between the ingredientand the reduction of risk of a disease.
– Reduction of risk in NOT prevention.

Health claims require prior approval of FDA.
Use the standard of “substantial scientificagreement” with the proposed claim.

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Health Claim Examples“Calcium and vitamin D can reduce the risk ofosteoporosis.”“A diet rich in fiber may reduce the risk of heartdisease.”Council for Responsible Nutrition32

Qualified Health Claims
The result of court decisions in the U.S., notfound in the statute.
FDA cannot prohibit the dissemination of truthful
by not conclusive evidence of health benefits.
Authorizes FDA to create qualifications to ahealth claims to give consumers accurate
understanding of the strength of the claim.

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Qualified Health Claim Examples“Supportive but not conclusive research shows that consumptionof EPA and DHA omega-3 fatty acids may reduce the risk ofcoronary heart disease.”“Selenium may reduce the risk of prostate cancer. Scientificevidence concerning this claim is inconclusive. Based on its
review, FDA does not agree that selenium may reduce the riskof prostate cancer.”"Scientific evidence suggests, but does not prove, that eating
1.5 ounces per day of most nuts, such as almonds, as part of adiet low in saturated fat and cholesterol may reduce the risk ofheart disease.”
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Regulationof Advertising
ClaimsCouncil for Responsible Nutrition35

Federal Trade Commission
FTC has primary responsibility for claims inmost consumer advertising– Includes TV, radio, Internet, newspaper ads

Requires that dietary supplement manufacturers
should be familiar with the requirements underboth DSHEA (for labeling) and the Federal
Trade Commission Act (for advertising)Council for Responsible Nutrition

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FTC Standard for Advertising
Same standard as FDA:
Advertisers must have substantiation thatadvertising claims are truthful and not misleading.
Requires competent and reliable scientificevidence to support advertising claims.
FTC does not categorize claims (nutrient, S/F,
health) – holds all claims to same standard.

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Issues for Advertising
Looks at implied as well as express claims.
Testimonials and endorsements are claims.
Blogs, social media (Facebook, Twitter, etc.)
can be claims if controlled by the advertiser.

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Summary
Dietary supplements in the U.S. aresubject to comprehensive, robust
regulations to promote safe
responsible production and use of
these products.
The U.S. system of claims review is
flexible and allows consumers tomake informed choices and to haveaccess to a wide variety of products.
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Smart Prevention—
Health Care Cost
Savings Resulting
from the Targeted
Use of Dietary
Supplements

Council for Responsible Nutrition

Introduction—The Problem
Americans spend too much money on healthcare. As the population ages, both theactual dollars spent and the percentage of GDP targeted to health care spending areexpected to increase.

 75% of health care spending goes to addressing
preventable diseases.
 Only 3% of every health care dollar spent is used
for prevention.
 Numerous, rigorous studies demonstrate that thetargeted use of certain dietary supplements canactually help to reduce the risk of some chronic
diseases.

What if dietary supplements could contribute to reducing overall
healthcare expenditures?
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The Hypothesis
We hypothesized that if the selected dietary
supplement regimens were taken at the same
preventive levels as used in the clinical research bythose at-risk populations, there would be a costsavings to the health care system and to individual
providers and payers from reduced medical expenses
associated with those lower risks of disease.

Council for Responsible Nutrition

The Research
Objectives:•To critically review the research
literature which examines theassociation between dietary
supplement intake and disease risk
reduction to quantify the risk
reduction; and then
•To determine the potential net
health care cost savings from the useof those dietary supplements as aresult of avoided disease-related
medical events.
Council for Responsible Nutrition

Research Scope• Coronary heart disease (CHD) and the potential net health care cost savings
when using omega-3 fatty acids, three B vitamins (folic acid, B6, and B12),
phytosterols and psyllium dietary fiber.
• Diabetes and the potential net health care cost savings from diabetesattributed CHD when using chromium picolinate.
• Osteoporosis and the potential net health care cost savings when using the
combination of calcium and vitamin D or when using magnesium.
• Age-related eye disease (ARED), specifically age-related maculardegeneration and cataracts, and the potential net health care cost savings
when using lutein and zeaxanthin.

Council for Responsible Nutrition

Overarching Research Methodology—
Part 1: Analytical Process to
Ascertain Disease Risk Reduction

Review of thescientific literature

Identificationof qualifiedstudiesCouncil for Responsible Nutrition

Determine overall
expected impact of
dietary
supplement
interventionOsteoporosis• In 2012, 1.2 million fracture events related to osteoporosis.
• Average treatment cost: $11,020 per event.
• More than $14 billion in annual direct health care costs.
• Calcium and vitamin D utilization yields:•18.6% relative risk reduction.
•An average of 151,053 avoided events per year.
•1,208,422 avoided events accumulated through 2020.
• Magnesium utilization yields:•6.0% relative risk reduction.
•An average of 68,536 avoided events per year.
•548,284 avoided events accumulated through 2020.
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Coronary Heart Disease (CHD)• 16% of adults over 55 with CHD will experience a
CHD-related medical event each year.
• Average cost of CHD-related inpatient procedures andemergency room visits = $13,317.
• Between 2013 and 2020, average direct health carecosts related to CHD events among adults over 55 =$77.92 billion a year.
Council for Responsible Nutrition

Coronary Heart Disease (CHD)• Omega-3 utilization yields:•An average of 137,210 avoided events per year.
• B vitamins utilization yields:•808,225 avoided events accumulated through 2020.

• Psyllium dietary fiber utilization yields:•11.5% relative risk reduction.
• Phytosterol utilization yields:•An average of 283,389 avoided events per year.
Council for Responsible Nutrition

Diabetes-Related CHD• Over 17 million U.S. adults have Type II Diabetes.
• Of them, over 6.9 million have diabetes-related CHD and 1.9
million experienced a diabetes-attributed CHD-related inpatient
procedure and/or visited the emergency room in 2012.
• Average expenditure per person = $13,317.
• Chromium picolinate utilization yields:•10.2% relative risk reduction.
•An average of 81,243 avoided events per year.
•649,944 avoided events accumulated through 2020.

Council for Responsible NutritionAge-Related Eye Diseases(AREDs)• Through 2020, an average of 4.8 million people over the ageof 55 will experience an AMD or cataract event.
• Total cumulative health care costs related to ARED events:
more than $164.4 billion—an average annual cost of nearly$20.60 billion.
• Lutein and zeaxanthin utilization yields:•23.0% and 15.3% relative risk reduction of AMD and cataracts,
respectively.
•An average of 971,724 avoided AMD and cataract events per
year.
•7,773,791 avoided events accumulated through 2020.
Council for Responsible Nutrition

Part 2: Determination of HealthCare Cost Savings
Once the expected risk reduction factor is derived from the literature review, the potential
cost savings derived from increasing dietary supplement intake among a given high risk
population can be calculated.

Determine Hospital Utilization Costs in the Current State
Avoided Hospital Utilization Costs Given 100% Use of Dietary
Supplement Regimen at Preventive Intake Levels

Revised Hospital Utilization Costs Accounting for
Dietary Supplement Usage

Costs of Dietary Supplement Utilization
Potential Net Cost Savings from
Dietary Supplement Usage

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Benefits of Calcium and Vitamin D—
Potential Osteoporosis-attributed Cost
Savings
Average Expend. on Osteoporosis
Events ($US B)

Net Annual Average Cost Savings due to Avoided Health Care Expenditures through Calcium and Vitamin D
Supplementation, 2013–2020
17.25

16.75

$16.98 B

16.25
15.75
15.25

Full utilization* of calcium andvitamin D yields:• 18.6% relative risk reduction• An average of 151,053 avoided
events per year
• 1,208,422 avoided events
accumulated through 2020

14.75
Current Scenario$1.87 B in
AvoidedCosts$1.52 B in Net
Savings$355.8 M in
Required
Supplement$15.10 B Utilization Costs
Supplementation Scenario

Total Cost of Osteoporosis-attributed Fractures Minus Avoided Costs Plus Dietary Supplement
Costs, Annual Average, 2013 - 2020
Total Costof Osteoporosis-attributed
Proportionof Target
Population* that are Fractures Minus Avoided Costs, Annual Average, 2013 2020
Regular Users of Calcium and Vitamin D,
Cost Savings Yet to Realized:
2012• 107,248 avoided events per
NonRegular
Regular
year
Users
users
29%
• $1.08 B in savings per year
71%
Source: Ipsos Public Affairs

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Note: * Among all females over the age of 55 with
Osteoporosis, **Time horizon = 2013 to 2020
Source: Frost & Sullivan analysis.

Benefits of Psyllium Dietary Fiber—
Potential CHD Cost Savings
Net Annual Average Cost Savings due to Avoided Health Care Expenditures through Psyllium Dietary Fiber
Intervention, 2013–2020$4.38 B in
Avoided
Costs
Full utilization* of psyllium
dietary fiber yields:• 11.5% relative risk reduction• An average of 292,165 avoided
events per year
• 2,337,318 avoided events
accumulated through 2020

NonRegular
Users
92%

Regular
Users
8%
Source: Ipsos Public Affairs

Council for Responsible Nutrition$2.48 B in Net
Savings$1.90 B in
Required
Supplement
Utilization Costs

Cost Savings Yet to Realized:• 268,647 avoided events per
year• $2.28 B in savings per year
Note: * Among all adults over the age of 55 with CHD, **Time horizon = 2013 to 2020
Source: Frost & Sullivan analysis.

Benefits of Calcium and Vitamin D—
Potential Osteoporosis-attributed
Cost Savings

Council for Responsible Nutrition

Benefits of Lutein and Zeaxanthin—
Potential Age-related Eye Disease
Cost Savings

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Benefits of B Vitamins—
Potential CHD Cost Savings

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Benefits of Phytosterols—
Potential CHD Cost Savings

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Benefits of Chromium Picolinate—
Potential Diabetes-attributed CHD
Cost Savings

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Outcomes
Understanding the link between smart prevention and health care cost savings will help key
stakeholders, including patients, health care professionals, governments, insurancecompanies and employers, make better-informed decisions on the best course of action thatminimizes current and future health care costs and maximizes long term potential benefits.

• A significant amount of scientific research has
been conducted involving dietary supplements
and many studies demonstrate a positive impact
on reducing the risk of a disease event throughsupplement use.
• Disease events require costly treatment services,
but until now there has been little effort toeffectively calculate the cost-effectiveness of suchsupplement use.
• This report demonstrates that significant costsavings can be realized through the smart use ofscientifically-substantiated dietary supplements
among high risk populations.

Council for Responsible Nutrition

Research Caveats• The results from these eight regimens may not be
generalizable to all supplements.
• This report is not intended to be a prescription foreveryone to begin these eight regimens.
• Results of each supplement regimen should not besummed together for overall cost-savings effect.
• Results of each regimen are notcomparable to one another for either:o Absolute savings, oro Cost/benefit ratio,
although each regimen independently demonstrates
significant cost savings for that supplement.
Council for Responsible Nutrition

www.supplementforsmartprevention.org

Council for Responsible Nutrition

Implications• What does this report mean for those interested in
reducing health care spending?
• For Employers, Insurers and the Prevention
Community• For Healthcare Practitioners• For Policy Makers• For Consumers

Council for Responsible Nutrition

Thanks for listening!

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