US Claim Statements Presentation (Josef Brinckman)

8/3/2019 US Claim Statements Presentation (Josef Brinckman)

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Review of Claim Statements

for Biodiversity Productsin the United States Market

By: Josef Brinckmann, ITC ConsultantDate: 26September 2011


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The Main Points.

Different types of claim statements are possible for differenttypes of products. Is your product a Health Food Product, an HerbalDietary Supplement Product, an Herbal Homoeopathic Drug Productor a Natural Cosmetic Product?

The Food and Drug Administration (FDA) and Federal TradeCommission (FTC) require different levels of evidence to supportlabel claims or advertising claims depending on the type of product.

What claim statements would be acceptable and non-acceptablefor camu camu, extracto de maz morado, lcuma, maca, sachainchi, sangre de grado, ua de gato, and yacn?

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Different Types of Products

= Different Types of Claim StatementsThe claim statements that can be made on the label of a finishednatural product are determined by the regulatory framework that theproduct is subject to.

the form of the product (e.g. herbal extract in capsule or tablet,

juice drink, herbal tea or tincture, nutrition bar, spray, cream or gel,etc);mode of administration (e.g. topical, oral, nasal or enteral); andrecommended use(s)

will place it into a particular regulatory category, i.e., dietarysupplement product, drug or non-drug cosmetic product, foodproduct, food for special dietary use, medical food product, andover-the-counter (OTC) drug product or prescription (Rx) drugproduct.

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Different Types of Products

= Different Types of Claim StatementsThe types of acceptable claim statements are limited to certaintypes of products.

In many cases claim statements are limited to specific definedsubstances that are expressly listed in a regulation to be allowedunder certain conditions.

Each regulatory framework has very different requirements for:

good manufacturing practice (drug, food or supplement GMPs);

quality of the substance that is the subject of the claim;

levels of evidence necessary to support a claim statement; and

listing (drug) or notification (dietary supplement) requirements.

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Different Types of Claim Statements

Cleansing, beautifying, promoting attractiveness claims(non-drug cosmetics)

Disease claims (OTC drugs and Rx drugs; including herbalhomoeopathic drug products)

Environmental benefit claims (any product type)

Health claims; Authorized (certain foods and supplements)

Health claims; Qualified (certain foods and supplements)

Nutrient content claims (certain foods and supplements

Structure / function claims (dietary supplements and OTCdrugs)

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Authorized Health Claim Statements

Authorized Health Claim Statements are:

allowable for certain dietary supplement products and

certain food products;limited to claims about disease risk reduction; and

cannot be claims about the diagnosis, cure,mitigation, or treatment of disease.

Use of a health claim on a product label requires pre-marketing review, evaluation and authorization of theclaim by FDA.

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Approved Claims Requirements Claim Statement

Fiber-ContainingGrain Products,Fruits, andVegetables and

Cancer

A grain product,fruit, or vegetablethat containsdietary fiber;

Low fat, andGood source ofdietary fiber(withoutfortification)

Low fat diets richin fiber-containinggrain products,fruits, and

vegetables mayreduce the risk ofsome types ofcancer, a diseaseassociated with

many factors

Examples of Authorized Health Claims


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Plant Sterol / StanolEsters and Risk ofCoronary HeartDisease

At least 1.7 g plantstanol esters perReference AmountCustomarilyConsumed (RACC)

of spreads, saladdressings, snackbars, and dietarysupplements.Low saturated fatand Low cholesterol.

Diets low insaturated fat andcholesterol thatinclude two servingsof foods that provide

a daily total of atleast 3.4 grams ofplant stanol esters intwo meals mayreduce the risk ofheart disease. A

serving of [name offood] supplies Xgrams of plantstanol esters



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Soluble Fiber fromCertain Foods andRisk of CoronaryHeart Disease

Psyllium husk thatcontains at least 1.7g of soluble fiber perRACC of foodproduct. Soluble

fiber from psylliumhusk with purity ofno less than 95%The amount ofsoluble fiber perRACC must be

declared in nutritionlabel. Low saturatedfat, Low cholesteroland Low fat.

Soluble fiber fromfoods such asPsyllium husk, aspart of a diet low insaturated fat and

cholesterol, mayreduce the risk ofheart disease. Oneserving of thisproduct supplies Xgrams of soluble

fiber from psylliumnecessary per day tohave this effect



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Qualified Health Claim Statements

Qualified Health Claim Statements are:

allowable for certain dietary supplement products and

certain food products.While Authorized Health Claims must meet thestandard of Significant Scientific Agreement (SSA),certain Qualified Health Claims are permissible basedon less scientific evidence as long as the claims arequalified and do not mislead consumers.

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Qualified Health

Claims

Eligible Products Claim Statement

Omega-3 Fatty Acids& Coronary HeartDisease

Conventional foodproducts and dietarysupplementproducts that

contain EPA andDHA omega-3 fattyacids

Supportive but notconclusive researchshows thatconsumption of EPA

and DHA omega-3fatty acids mayreduce the risk ofcoronary heartdisease. One servingof [Name of the

food] provides Xgrams of EPA andDHA omega-3 fattyacids

Examples of Qualified Health Claims


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Qualified Health

Claims

Eligible Products Claim Statement

Tomatoes and/orTomato Sauce &Prostate, Ovarian,Gastric, and

Pancreatic Cancers

(1) Cooked, Raw,Dried, or CannedTomatoes(2) Tomato Sauces

that contain at least8.37 percent salt-freetomato solids

Very limited andpreliminary scientificresearch suggeststhat eating one-half

to one cup oftomatoes and/ortomato sauce a weekmay reduce the riskof prostate cancer.FDA concludes that

there is littlescientific evidencesupporting thisclaim

Examples of Qualified Health Claims


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Nutrient Content Claim Statements

A Nutrient Content Claim Statement is:

a claim on a food product or dietary supplement productlabel that directly or by implication characterizes thelevel of a nutrient:

"low fat

"high in antioxidant Vitamin C

"good source of fiber

"high in oat bran "contains 100 calories"

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Acceptable

Nutrient Content Claims

Requirements for Use

of the Claim Statement

High in antioxidant vitamin C A Reference Daily Intake(RDI) has been establishedfor the listed nutrient.

Antioxidant claims are onlyallowed for beta-carotene,vitamin C and vitamin E.To bear the claim high inantioxidant vitamin C, the

product must contain 20percent or more of the RDIfor vitamin C.

Examples of Nutrient Content Claims


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Acceptable

Nutrient Content Claims

Requirements for Use

of the Claim Statement

Claims for nutrients that donot have an establishedDaily Value (DV):

"Contains x grams ofomega-3 fatty acids perserving

or

"Provides x grams of omega-3 fatty acids"

Content claims for a nutrientfor which there is noestablished DV areacceptable as long as the

claim specifies only theamount of the nutrient perserving.

To use the words "contains"

or "provides" for nutrientswithout DVs, the specificamount of the nutrient mustbe stated.

Examples of Nutrient Content Claims


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Structure / Function Claim Statements

Structure / Function Claim Statements are:

allowable for dietary supplement products (DSP) and certain over-the-counter (OTC) drug products.

DSP labels may bear statements that:

describe the role of a nutrient or dietary ingredient intended toaffect the structure or function in humans; or

that characterize the documented mechanism by which anutrient or dietary ingredient acts to maintain such structure or

function; provided that such statements are not disease claims (unlessthe claim is an authorized health claim for which the productqualifies).

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Acceptable

structure/function claimsNon-acceptable

structure/function claimsLaxative for the relief ofoccasional constipation(irregularity)

Laxative for the relief ofchronic constipation

(occasional constipation is

not a disease but chronicconstipation is a disease)

Digestive aid

Helps promote digestion

For relief of occasional mildindigestion

For chronic indigestion

Examples of DSP S/F Claims

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Acceptable

structure/function claims

Non-acceptable

structure/function claimsRelief of occasional heartburnRelief of occasional acidindigestionRelief of sour stomach

Relief of upset stomach

Relief of heartburnRelief of acid indigestion(recurrent or persistentheartburn and acid indigestioncan be hallmarks of significantillness, and are thereforedisease claims)

For the prevention andtreatment of the nausea,vomiting, or dizziness

associated with motion

For ordinary morning sicknessassociated with pregnancy

Reduces nausea associatedwith chemotherapyFor severe morning sickness

(Hyperemesis gravidarum) (adisease because it is anextreme, persistent nausea andvomiting during pregnancy)


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Acceptable


Non-acceptable

structure/function claimsSoothing to the stomach due tocarminative (anti-spasmodic)properties

Soothing to the stomach due toan anti-inflammatory effect onthe gastrointestinal tract

Helps to maintain cholesterollevels that are already within thenormal range

Lowers cholesterol(however qualified, is an implieddisease claim). Lowering

cholesterol is inextricably linkedwith treating elevatedcholesterol and preventing heartdisease.


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Acceptable


Non-acceptable

structure/function claimsNighttime sleep aid

For the relief of occasionalsleeplessness

Promotes relaxation

Helps you fall asleep if youhave difficulty falling asleepHelps to reduce difficultyfalling asleep

(these claims imply treatment ofinsomnia, a disease)

Supports mood

For relief of occasional simple

nervous tensionFor nervousness due tocommon every day overworkand fatigue

For long-term or chronic moodchangesFor migraine headache

For nervous tension headache(headache is a disease)For depression (depression isa psychiatric disease)


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Acceptable


Non-acceptable

structure/function claimsStimulant - for occasionalfatigue and drowsiness

Helps restore mental

alertness or wakefulnesswhen experiencing fatigue ordrowsiness

For chronic fatigue ordaytime drowsiness

(these can be symptoms of

chronic fatigue syndromeand narcolepsy, which areboth diseases)

Improvesabsentmindedness

Supports normal mentalfunction

For Alzheimers Disease


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Acceptable


Non-acceptable

structure/function claimsPromotes joint health

Helps support cartilage andjoint function

Reduces the pain and stiffnessassociated with arthritisImproves joint mobility andreduces joint inflammation andpain (implies treatment forrheumatoid arthritis, a disease)

Arouses or increases sexualdesire and improves sexualperformance

For decreased sexual functionassociated with aging

Helps restore sexual vigor,potency, and performanceimproves performance, stayingpower, and sexual potency

(these are disease claimsbecause they use the termpotency, which impliestreatment of impotence)


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Acceptable


Non-acceptable

structure/function claimsSupports a normal, healthyattitude during PMSFor mild mood changes,cramps, and edema associatedwith the menstrual cycleFor temporary water weightgain associated with thepremenstrual cycle

For severe depressionassociated with the menstrualcycle

Supportive for menopausalwomen

For hot flashes associated withmenopause

Prevents bone fragility in post-menopausal women

Helps maintain normal bonedensity in post-menopausalwomen (implies treatment forosteoporosis, a disease)


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Cleansing / Beautifying Claim Statements

Non-drug cosmetics are defined as "articles intended to berubbed, poured, sprinkled, or sprayed on, introduced into, orotherwise applied to the human body

Their labels may bear claims such as for cleansing, beautifying,

promoting attractiveness, or altering the appearance"

Non-drug cosmetics include skin moisturizers, perfumes,lipsticks, fingernail polishes, eye and facial makeup preparations,shampoos, permanent waves, hair colors, toothpastes, anddeodorants, as well as any material intended for use as acomponent of a cosmetic product.

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Cleansing / Beautifying Claim Statements

A normal shampoo is a non-drug cosmetic because its intended use isonly to cleanse the hair. An antidandruff shampoo product is a drugbecause its intended use is to treat dandruff.

Toothpaste for merely cleaning or whitening the teeth is a non-drug

cosmetic while toothpaste that contains fluoride is a drug for preventingcavities.

Deodorants are non-drug cosmetics unless they also containantiperspirant active ingredients.

Skin moisturizers are non-drug cosmetic products unless the label bearssun-protection claims which would cause the product to become a drugproduct.

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Disease Claim Statements

In the U.S., there are a few biodiversity products (botanicals) thatare classified as Generally Recognized as Safe and Effective(GRASE) active ingredients for specific over-the-counter (OTC) druguses.

The labeling standards monographs, which provide the permitteddisease claim statements and/or structure/function claim statementsare published in either:

a Final Monograph (FM) in the Code of Federal Regulations(CFR); or

may appear in a Tentative Final Monograph (TFM) that hasbeen published in the Federal Register(FR).

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Selected OTC

Botanical Active IngredientsApproved OTC

Drug Claim Statement(s)Capsicum Oleoresin USP:the alcoholic extract of the driedripe fruits of Capsicum annumvar. minimumand small fruitedvarieties of C. frutescens(Solanaceae).

For the temporary relief of minoraches and pains of muscles andjoints associated with simplebackache, arthritis, strains,bruises and sprains.

Ipecac Oral Solution USPprepared from Ipecac USP:the dried rhizome and roots of

Cephalis acuminataKarsten, orof Cephalis ipecacuanha(Brotero) A. Richard (Fam.Rubiaceae).

Emetic for emergency use tocause vomiting in poisoning.

Examples of OTC Drug Claims

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Selected OTC

Botanical Active IngredientsApproved OTC

Drug Claim Statement(s)Cocoa Butter USP:fat obtained from the seed ofTheobroma cacaoLinn(Fam. Sterculiaceae).

For the temporary relief of: anorectal itching anddiscomfort associated withhemorrhoids anorectal disorders inflamed hemorrhoidaltissues anorectal inflammation the symptoms of perianal skinirritation.

Temporarily forms a protectivecoating over inflamed tissues tohelp prevent drying of tissues.

Examples of OTC Drug Claims

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Food, Dietary Supplement or Drug?

It is possible that a single natural ingredient could be allowed forseveral different recommended uses depending on the finishedproduct form, mode of application, the specified quality standardand the type of GMPs applied to manufacture the finished product.

Peru is a producer and exporter of capsicum fruit powder as wellas extracts and oleoresins of capsicum fruit a.k.a. paprika oleoresin.

Depending on the form, this Latin American botanical species canbe used in every type of product, dietary supplement product, drugproduct, food product, and non-drug cosmetic product, and even forpolice use or self-defense as a less-than-lethal force weapon forincapacitating dangerous or violently resisting suspects.

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Type of Product Capsicum Fruit Form Claim or Purpose

DietarySupplementProduct

Powdered cayennefruit, extract oroleoresin(for oral ingestion)

Supports digestivesystem functionStimulates gastric juiceproduction to promoteproper digestivefunction

OTCDrugProduct

Capsicum OleoresinUSP(for topical

application)

For the temporary reliefof minor aches andpains of muscles and

joints associated withsimple backache,arthritis, strains, bruisesand sprains

Capsicum FruitFood, Dietary Supplement or Drug?

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Type of Product Capsicum Fruit Form Claim or Purpose

FoodProduct Paprika powder orPaprika Oleoresin

(oral ingestion)Color additive and/orFlavoring agent(Spice, NaturalSeasoning, Flavoring)

Non-drugCosmeticProduct

Capsicum extract,juice or resin(topical application)

Skin conditioning andHair conditioningcomponent

SelfDefenseProduct

Oleoresin Capsicum(Pepper Spray for theeyes)

For self defense or forpolice use toincapacitate dangerousor violently resistingsuspects

Capsicum FruitFood, Dietary Supplement or Drug?

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Levels of Evidenceto Support Label Claims

The manufacturer or marketer of a dietary supplement product making anutritional deficiency, structure/function, or general well-being claim musthave substantiation that the claim statement is truthful and not misleading.The substantiation file should be written by a qualified person.

The FDA has published a guidance document: Guidance for Industry:Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6)of the Federal Food, Drug, and Cosmetic Act.

This guidance document is intended to describe the amount, type, and

quality of evidence FDA recommends a manufacturer have to substantiate aclaim. The guidance document is available at the FDAs website.

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Levels of Evidenceto Support Advertising Claims

FTC and FDA work together under a long-standing liaison agreementgoverning the division of responsibilities between the two agencies.

As applied to dietary supplement products (DSPs):

FDA has primary responsibility for claims on product labeling,

including packaging, inserts, and other promotional materialsdistributed at the point of sale; and

FTC has primary responsibility for claims in advertising, includingprint and broadcast ads, infomercials, catalogs, and similar directmarketing materials. Marketing on the Internet is subject to regulationin the same fashion as promotions through any other media.

The FTC has published guidelines for levels of evidence to support claimstatements for the advertising of DSPs: Dietary Supplements: AnAdvertising Guide for Industry, which is available at the FTC website.

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Levels of Evidenceto Support Advertising Claims

FTC has also developed Green Guides for the use ofenvironmental benefit claim statements e.g. biodegradable,compostable, photodegradable, recyclable, recycled content,refillable, and reusable.

The FTC Green Guidesapply to environmental claims included inlabeling, advertising, promotional materials and all other forms ofmarketing, whether asserted directly or by implication.

The guides apply to any claim about the environmental attributesof a product, package or service in connection with the sale,offering for sale, or marketing of a product, package or service.

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Acceptable and Non-acceptable ClaimsSelected Peruvian Natural Products

This section provides examples of claims that have been made forPeruvian natural products in the U.S. market, some acceptable and somenot.

Many Peruvian products have been the subject of Import Refusals, FDALetters of Objection, FDA 15-day Warning Letters, and Nationwide Recalls.

Usually the reasons include non-acceptable claim statements or otherlabeling violations.

Explanations are provided for acceptability or non-acceptability of claimsto help Peruvian companies better understand U.S. market accessrequirements for claim statements and labeling.

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Acceptable claim statement(s) Reason it is acceptable

A natural source of Vitamin C.

Extensive research onVitamin C, of which camu-camuis a natural source, suggeststhat camu-camu standardized to8% Vitamin C promotes a

healthy immune system andsupports mood balance.

The product may containenough Vitamin C to make anutrient content claim.

Supports mood structure /function claims are acceptablebecause in order to substantiatethe claim it is not necessary tostudy the effects of the product

on clinical depression (adisease).

Camu-camu (Myrciaria dubia)

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Scientific researchdocuments the effects ofVitamin C to promote a healthy

immune system. Camu-camu, afood source of Vitamin C, hasbeen noted clinically to havethese effects.

Supports the immunesystem structure / functionclaims are acceptable because a

statement of support for theimmune system, by itself,conveys no specific referenceto disease treatment orprevention.


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Non-acceptable claim statement(s) Reason it is non-acceptable

Camu-Camu, a fruit with thehighest concentration of vitamin Cof any plant.

The highest concentration isan unsupported nutrient contentclaim.

Research has shown that Camu-camu is used to ward off viralinfections

Research has indicated thatCamu-camu provides natural

protection from Colds and Flu.

Claims that a product supportsthe bodys antiviral capabilities orsupports the bodys ability toresist infection are disease claims.

Claims that imply that a product

will prevent colds and flu or willmitigate the symptoms of thosediseases are disease claims.


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An extract with [%] naturally

occurring c3g (cianidin-3-b-glucose).

Even though there is no

established Daily Value (DV) forc3g, this could be an acceptablenutrient content claim statementif the amount of c3g per servingis quantified in the SupplementFacts box on the Information

Panel of the product label.

Extract of Andean Purple Corn Cob(Zea maysL. var.subnigroviolacea)

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Non-acceptable claimstatement(s)

Reason it is non-acceptable

Source of potentantioxidants.

This is an unauthorizednutrient content claim.

No Reference Daily Intake(RDI) has been established byFDA for purple corn extract.Presently beta-carotene, VitaminC and Vitamin E are the only

substances authorized forantioxidant claim statements.


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Non-acceptable claimstatement(s)

Reason it is non-acceptable

Reduces cholesterol and helpsfight obesity.

References to loweringcholesterol are implied diseaseclaims (hypercholesterolemia). An

acceptable structure/function claimfor maintaining cholesterol wouldbe helps to maintain cholesterollevels that are already within thenormal range.

Being overweight, but less than

obese, is not a disease whileobesity is a disease. Obesity claimsare not acceptablestructure/function claims.


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Lcuma (Pouteria lcuma)

No FDA Notification Letters have yet been filed for any lucuma-containing dietary supplement products.

It appears that the use of lucuma fruit in the U.S. is presentlylimited to food products (as a flavor component of smoothies,

puddings, and ice creams or as a flour component of pies andpastries).

If a lucuma-based dietary supplement product or health foodproduct can be shown to meet the requirements as a good source

of dietary fiber, certain authorized health claim statements could beallowed on the product labeling.

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Any fruits that are low fat and also a good source of dietary fiber(without fortification) may make the following health claimstatement: Low fat diets rich in fiber-containing grain products,fruits, and vegetables may reduce the risk of some types of cancer,a disease associated with many factors.

If the lucuma product is low in cholesterol, as well as low in fatand saturated fat and also provides at least 0.6 grams of solublefiber per Reference Amount Customarily Consumed (RACC)(without fortification), the label could possibly carry the followinghealth claim statement: Diets low in saturated fat and cholesterol

and rich in fruits, vegetables, and grain products that contain sometypes of dietary fiber, particularly soluble fiber, may reduce the riskof heart disease, a disease associated with many factors.

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For possible future use as an active ingredient of drug cosmeticproducts, researchers at Rutgers, the State University of NewJersey, have applied for a patent for the Preparation and Use ofPouteria lcuma Extract (from lucuma nut oil), with claimsincluding:

wound healing, enhancing tissue regeneration, promotingskin healing, reducing skin senescence, healing skin burns,

reducing, eliminating or preventing a skin condition (acne, skinaging and wrinkled skin).

A product with these claim statements however would need FDAauthorization through a New Drug Application (NDA) process.

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Anti-fatigue. Anti-fatigue can be an acceptablestructure / function claim so long asthe overall context does not implyuse of the product for chronicfatigue which is a disease.

Occasional fatigue anddrowsiness are not characteristic ofsymptoms of a specific disease orclass of diseases.

The ideal dietary supplement fora natural boost. Promotes staminaand endurance.

Claims like boosts stamina areacceptable structure/functionclaims, because they do not refer toany disease.

Maca (Lepidium meyenii)

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Promotes Healthy SexualAppetite, Function & Fertility.

Alkaloids isolated from themaca root act upon thehypothalamus-pituitary axis,supporting and boosting energylevels and encouraging theproduction of sex hormones.

Scientists are studyingmacas ability to supporthealthy sexual endurance,energy and performance.

Arouses (or increases orpromotes) sexual desire andimproves sexual performanceis an acceptablestructure/function claimstatement because it does notimply treatment of a disease.


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Non-acceptable claim statement(s) Reason it is Non-acceptable

Helps restore sexual vigor,potency, and performance,improves performance, stayingpower, and sexual potency, andbuilds virility and sexual potency

These are disease claimsbecause they use the termpotency, which implies treatmentof impotence, a disease. If, however, these claims made

clear that they were intended solelyfor decreased sexual functionassociated with aging, they couldbe acceptable structure/functionclaims

Maca powder has been used to

help relieve the symptoms ofchronic fatigue, depression.

Depression is a psychiatric

disease. Chronic fatigue or daytimedrowsiness can be symptoms ofchronic fatigue syndrome andnarcolepsy (a sleep disorder),which are both diseases.


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Non-acceptable claim

statement(s)

Reason it is Non-acceptable

Use it to treat numerousproblems and diseases ...maleimpotence, infertility andosteoporosis... for memorydisorders aids in correctingand preventing prostatitis

For hormonal balance andrejuvenation (avoid HRT)supplants hormone

replacement therapy increasebone density, combatsosteoporosis

These are not structure /function claims but instead areall disease treatment claimsstatements.


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Supportive but not conclusiveresearch shows that consumptionof EPA and DHA omega-3 fattyacids may reduce the risk ofcoronary heart disease. One

serving of [Name of the food]provides [X] gram of EPA and DHAomega-3 fatty acids.

Conventional foods and dietarysupplements that contain EPA andDHA omega-3 fatty acids may bepermitted to use this qualifiedhealth claim statement.

Helps maintain cholesterollevels that are already within thenormal range.

Although an elevated cholesterollevel is a sign ofhypercholesterolemia and an

important risk factor for heartdisease, a cholesterol level withinthe normal range is not a sign orrisk factor for disease.

Sacha inchi (Plukenetia volubilis)

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Controls and regulates thecholesterol and triglyceridesimproving the blood irrigation

Can reduce levels of badcholesterol in the blood andinvigorates the heart, helps toreduce cardiovascular problems.

Cholesterol: Prevent bloodclotting by keeping saturated fats

mobile in the blood stream, helpingto reduce the risk of coronarydiseases.

Lowers cholesterol, howeverqualified, is an implied diseaseclaim. Lowering cholesterol isinextricably linked with treatingelevated cholesterol and preventingheart disease.

Claims like Promotescholesterol clearance are implieddisease claims because it isdirected at lowering cholesterol

rather than maintaining levelsalready determined to be within anormal range.


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Hypertension: Reducetriglycerides levels andhypertension.

Elevated blood pressure(hypertension) is a disease. Claimsto reduce hypertension are diseaseclaims.

Depression / Mental health:

Regulate nerval transmission andcommunication. Maintain thefluidity and rigidity of cellularmembranes.

Depression is a disease

condition that is not amenable toself-diagnosis and treatment byindividuals who are not medicalpractitioners.

Arthritis: Reduce arterialinflammation.

Reduces joint inflammation andpain (rheumatoid arthritis) is a

disease claim. Act as antioxidant agent. This would be an unauthorized

nutrient content claim.


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Acceptable claim statement(s) Reason it is acceptable Supports intestinal health. A claim to support normal

intestinal health is anacceptable structure / functionclaim statement.

Promotes normal stoolformation.

So long as the overall contextof the claim(s) do not suggest

or imply use for treatment of adisease (e.g. diarrhea), thisclaim, on its own, could be anacceptable structure / functionclaim statement.

Sangre de grado (Croton lechleri)

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Controls diarrhea withoutcausing constipation.

A standardized extract from thesap of the Croton lechleritree thathas been used for centuries by

shamans (traditional healers) in theAmazon rainforest to relievediarrhea without causingconstipation.

Clinical studies demonstrated

that this compound normalizesexcess water flow in the intestinaltract and relieves diarrhea, withoutcausing constipation.

Diarrhea is a disease. Thestatements suggest that theproduct is intended to treat,prevent, or mitigate disease,namely diarrhea.

Sangre de grado (Croton lechleri)

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For general health;

Supports healthy immune

function; Stimulates theimmune system

Patented and clinicallystudied to benefit the natural

and acquired immune systemsand enhances the protectivepower of critical B- and T- cells.

A statement of support for theimmune system, by itself,conveys no specific reference

to disease treatment orprevention.

Claims to the effect ofSupports the immune system

are not specific enough to implyprevention of disease.

Ua de gato (Uncaria tomentosa)

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Cats Claw is a nativePeruvian vine that is used tosupport the immune and

digestive systems.

Supports normal cleansingof the intestinal tract andnutritionally supports the

immune system.

Immune system and digestive/ gastrointestinal systemsupport claims are acceptable

structure/function statementsbecause they are not specificenough to imply prevention ortreatment of any disease.


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Supports joint health.

Musculoskeletal and jointsupport.

Supports structural health

Claims to the effect of Supportsjoint function would bepermissible structure/functionclaims, because they relate to

maintaining normal function ratherthan treating joint pain.

Researchers report that CatsClaw may relax blood vessels,stimulate immune response, and

promote neuromuscular wellbeing.

So long as the overall contextdoes not imply prevention ortreatment of any specific disease,

statements of promoting wellbeingand immune system support shouldbe acceptable structure/functionstatements.


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Antiviral; Antirheumatic;Uses: Rheumatism and arthritis.Gastritis and ulcers. As adjuncttherapy in the treatment of cancer.

The product is not generallyrecognized as safe and effective(GRASE) for the referencedconditions and therefore, theproduct is a "new drug. New drugsmay not be legally marketed in the

U.S. without prior approval fromFDA.

An herb used to treat arthritis,gastritis, cancer, asthma, dermaland genito-urinary tract infections,and female hormone imbalances, as

well as for the treatment ofrheumatism, genital herpes, ulcers,systemic candidiasis, organicdepression, and HIV virus.

These claims cause this productto be a new drug because there isno evidence that it is GRASE for itsintended uses. New drugs may not

be legally marketed in the U.S.without prior approval from FDA.


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"A powerful combination ofantioxidants and anti-inflammatories that help reducestress and inflammation of the

skin;

"A uniquely formulated lotion thathelps to reduce inflammation aswell as minimize and potentiallyprevent bruising;

"Can be used in conjunction withPost-Op to minimize scarring."

This topical application product isan unapproved new drug.

It does not conform to FDAs

Tentative Final Monograph (TFM)for over-the-counter (OTC) ExternalAnalgesic drugs or to any otherrulemaking under FDA's OTC DrugReview.

It is not eligible for the OTC DrugReview and it violates variousprovisions of the FD&C Act.


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"Cat's Claw appears to providecystic action, thus preventing thedevelopment and growth ofmalignant cells in cancer and othertumorous conditions. It helps theimmune system, including AIDS byincreasing the production ofleukocytes (white blood cells), andblocking the advance of many viralillnesses. Its anti-inflammatoryeffects are well known for thetreatment of conditions such asarthritis (inflammation of the joint),rheumatism, gout, fibromyalgia,and Carpal Tunnel Syndrome."

The product is not generallyrecognized as safe and effective(GRASE) for the referencedconditions and therefore, theproduct is a "new drug.

New drugs may not be legallymarketed in the U.S. without priorapproval from FDA.


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Glucose management system.

Supports glucose metabolismand assists in weightmanagement.

A general statement that a DSPprovides nutritional support can bean acceptable structure/functionclaim, provided that the statementdoes not suggest that the DSP isintended to augment or have the

same purpose as a specific drug(e.g. insulin), drug action, ortherapy for a disease (e.g.diabetes). For example, use as partof your diet to help maintain ahealthy blood sugar level would beconsidered acceptable. Anotheracceptable structure/function claimwould be use as a part of yourweight loss plan.

Yacn (Smallanthus sonchifolia)

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Non-acceptable claim

statement(s)

Reason it is Non-acceptable

"Great source ofantioxidants."

This would be anunauthorized nutrient contentclaim.

Keeps your arteries free ofcholesterol and triglycerides.

References to loweringcholesterol are implied diseaseclaims (hypercholesterolemia).

Yacn safeguards againstcolon cancer.

This is a unapproved diseaseclaim and/or an unauthorizedqualified health claim.

Yacn (Smallanthus sonchifolia)

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FDA Notification

No later than 30 days after the first marketing of a dietarysupplement product (DSP), the manufacturer, packer, ordistributor must submit a Notification Letter to FDA (a signedoriginal and two copies) which includes the text of thestructure/function statement among other required

information.

The notice must be signed by the companys responsibleperson who can certify the accuracy of the information

presented and contained in the notice and also certify that thenotifying firm has substantiation that the statement is truthfuland not misleading.


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QUESTIONS?

Documents

US Claim Statements Presentation (Josef Brinckman)