Download OCT 152003

DEPARTMENT
OF HEALTFI 8z HUMAN SERVKXB
P&c lie’alth Service
Food andDrug Administratbn
College Park, MD 20740
Ms. ThereseP. Cemy
Owner
HerbalSource
6618SalomaAvenue
Van Nuys, California91405
OCT152003
DearMs. Cemy:
This is in responseto your lettersof September25,2003 to the FoodandDrug
Administration(FDA) pursuantto 21 U.S.C.343(r)(6)(section403(r)(6)of the Federal
Food,Drug, andCosmeticAct (the Act)).
Your lettersstatethat the following statementswill madefor the following products:
Nut+Lin
Nut&Chol
Nutri-Ban
PromotesHealthyBlood SugarLevels
PromotesHealthyCholesterolLevels
PromotesHealthyBlood SugarLevels;PromotesHealthyBlood
Pressure
In the preambleto the January6,200Ofmal rule on structure/functionclaims(see65 FR
1000at 101S),FDA statedthat claimsaboutthe maintenanceof normalcholesterollevels
did not necessarilyconstituteimplied diseaseclaims. We stated,however,that because
“many peoplethink of cholesterolsolelyin termsof the negativerole of elevated
cholesterolin heartdisease,”in orderto avoid implying that the productpreventsor treats
heartdisease,a cholesterolmaintenanceclaim would haveto clarify that the productis
only for maintenanceof cholesterollevelsthat are aheadywithin the normalrange. The
sameprincipleappliesto claimsaboutthe control of blood glucoselevelsand blood
pressure;that is, a claim that doesnot establishthat the claimsare aboutblood glucose
levelsor blood pressurethat is alreadywithin normal limits impliesthat the productis
intendedto treat elevatedblood glucose(diabetes)or blood pressure(hypertension),
which arediseases.Therefore,becausethe claimsyou aremaking for theseproducts
representthat the productsare intendedto affect blood glucose,blood cholesterol,and
bloodpressurebut do not alsoincludea statementaboutthembeing intendedto aI%&
blood glucose,blood cholesterol,and blood pressurethat are alreadyin the normal
ranges,they areimplied diseaseclaims.
21 U.S.C.343(r)(6)makesclearthat a statementincludedin labelingunderthe authority
of that sectionmay not claim to diagnose,mitigate,treat, cure,or preventa specific
diseaseor classof diseases.The statementsthat you are makingfor theseproducts
Page2 - Ms. ThereseP. Cerny
suggestthat they are intendedto treat,prevent,or mitigatediseases,Theseclaimsdo not
meetthe requirementsof 21 U.S.C.343(r)(6). Theseclaimssuggestthat theseproducts
arc intendedfor use asdrugswithin the meaningof 21 U.S.C. 321(g)(l)(B), andthat they
are subjectto regulationunderthe drug provisionsof the Act. If you intendto make
claimsof this nature,you shouldcontactFDA’s Centerfor Drug EvaluationandResearch
(CDER), Office of Compliance,HFD-310,MontroseMetro II, 11919Rockville Pike,
Rockville, Maryland20855.
You also submitteda letter that statesyou intendto marketa productnamed“NutriDerm”that is intendedfor useas an “Anti-FungalLotion For The Skin.”This product
doesnot appearto meetthe statutorydefinition of a dietarysupplementcontainedin 21
U.S.C. 321(fQ andtherefore,cannot be marketedas a dietarysupplement.We explain
the basisfor our opinionbelow.
The term ‘dietary supplement”is definedin 21 U.S.C. 321(fQ. 21 U.S.C. 321(fQ
providesthat the term meansa product(otherthan tobacco)intendedto supplementthe
diet that bearsor containsa vitamm, a mineral,an herb or otherbotanical,an amino acid,
a dietarysubstancefor useby man to supplementthe diet by increasingthe total dietary
intake,or a concentrate,metabolite,constituent,extract,or combinationof any of the
aboveingredients.21 U.S.C. 321(fQfurther statesthat dietarysupplementsare intended
for ingestionin a form describedin 21 U.S.C. 350(c)(l)(B)(i) or in compliancewith 22
U.S.C. 35O(c)(l)(B)(“)ii , are not representedas conventionalfood or as a soleitem of a
meal or the diet, and are labeledasa dietarysupplement.
An articlethat is appliedexternallyto the skin as a lotion is not “intendedfor ingestion.”
As statedabove,the definition of dietarysupplementin 21 U.S.C.321(fi) statesthat a
dietarysupplementis a product“intendedfor ingestion.”The term “ingestion”hasbeen
addressedby the court in United Statesv. Ten Cartons.Ener-BNasalGel, 888 F. Supp.
381,393-94(E.D.N.Y.), affd. 72 F.3d 285 (2d Cir. 1995),which states:
The ordinaryandplain meaningof the term “ingestion”meansto take into the
stomachand gastrointestinaltract by meansof enteraladministration.&
Stedman’sMedical Dictionary(4th Lawyer’s Ed. 1976)(defining ingestionas the
“introductionof food and drink into the stomach.“);Webster’sThird New
InternationalDictionary (1976)(defining ingestionas “the taking of material(as
food) into the digestivesystem.“)...
The interpretationof the term “ingestion”to meanenteraladministrationinto the
stomachandgastrointestinaltract is also supportedby the languageof the
statutorysectionsimmediatelyprecedingand following section35O(c)(l)(B)(ii).
Section35O(c)(l)(B)(i) statesthat the vitamin must be intendedfor ingestionin
tablet,capsuleor liquid form. Eachof theseforms denotesa methodof ingestion
that involvesswallowinginto the stomach. Section350(c)(2)statesthat a food is
intendedfor ingestionin liquid form under sectionSSO(c)(
l)(B)(i) “only if it is
Page3 - Ms. ThereseP. Cerny
formulatedin a fluid carrierandis intendedfor ingestionin daily quantities
measuredin dropsor similar smallunits of measure.”This elaborationof “liquid
form” alsodenotesingestionby swallowingthe fluid.
Therefore,becausethe term “ingestion”meansintroducedinto the gastrointestinaltract,
productsthat areintendedto be appliedexternallyto the shin are not subjectto regulation
as dietarysupplementsbecausethey arenot “intendedfor ingestion.”Moreover,your
product is representedfor useasan anti-fbngallotion. This claim suggeststhat this
product is intended to treat,prevent,or mitigatedisease,namely,fungal shin diseases.
This claim suggeststhat this productis intendedfor useas a drug within the meaningof
21 U.S.C. 321(g)(l)(B), andthat it is subjectto regulationunderthe drug provisionsof
the Act. If you intendto makeclaimsof this nature,you shouldcontactFDA’s Centerfor
Drug EvaluationandResearch(CDER), Office of Compliance,HFD-310,Montrose
Metro II, 11919Rockville Pike,Rockville,Maryland20852.
Pleasecontactus if we may be of further assistance.
SusanJ. Walker,M.D.
Director
Division of Dietary SupplementPrograms
Office of Nutritional Products,Labeling
andDietary Supplements
Centerfor Food Safety
and Applied Nutrition
Copies:
FDA, Centerfor Drug EvaluationandResearch,Office of Compliance,HFD-300
FDA, Office of the AssociateCommissionerfor RegulatoryAffairs, Office of
,
Enforcement,HFC-200
FDA, Los AngelesDistrict Office, Office of Compliance,HFR-PA240
NOTIFICATION PURSUANT TO
SECTION 6 OF DSIIEA
AND 21 CFR ~101.93
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This notificationis beingfiled on behalfof
which is
of the product(s)which bear the statementsidentiCedin this
the
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notification. Its businessaddressis: 6618 %sma hue- \la~ &S
This notificationis beingmadepursuantto Section6 of DSIIEA and R;ufe2 1 C.F.R. $101.93.
The dietary supplementproduct on whose label or labeling the statementsappears is
Nlhi
-#erm
.
The text of eachstructure-functionstatementfor which notificationis now beinggivenis:
(Statement1):
(Statement2):
(Statement3):
fiyyii -Fbycd
LatiW
FrTW-
S-h
The following summaryidentifiesthe dietary ingredient(s)or supplement(s)for which a
statementhasbeenmade:
Identity of Dietary Ingredient(s) or
Suuulement that is the Subiect of the Statement
Statement
Number
The followingidentifiesthe brandnameof eachsupplementfor which a statementis made:
Statement
Number
Brand Names
Label or Labe’iinq
I, Tb@
9 &OLV , am authorizedto certify this Notification on behalf of
e&d
SinAf
. I certify that the
containedin this Notificationis completeand accurate,and that
hassubstantiation
that eachstructure-functionst
Date Signed:&#a>k
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026175.01
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NOTIFICATION PUBSUANT TO
SECTION 6 OF DSF54
AND 21 CFR §101.93
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This notificationis beingfiled on behalfof
of the product(s) which bear the statementsidentified in this
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notification. Its businessaddressis: 6618’
This notification is being made pursuantto Section6 of DSHEA and Rufe 21 C.F.R $101.93.
The dietary supplement product on whose label or labeling the statements appears is
Nurh-i ~Chol
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The text of eachstructure-fit&on statementfor which notiftcationis now being givenis:
(Statement1): fj-efk&S
(Statement2):
(Statement3):
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The following summaryidentifiesthe dietary ingredient(s)or supplement(s)for which a
statementhasbeenmade:
Identity of Dietary Ingredient(s) or
Susdement that is the Subiect of the Statement
Statement
Number
1.
t
2.
3.
The following identifiesthe brandnameof eachsupplementfor which a statementis made:
Statement
Number
Brand Names
Label or Labeiing
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and accurate,and that
hassubstantiationthat eachstructure-function
Date Signed:%t
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NOTIFICATION PURSUANT TO
SECTION 6 OF DSHEA
AND 21 CFR 5101.93
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This notification is being filed on behalfof
mmer
of the product(s) which bear the statementsidentified in this
the
notification. Its business.address is: 6618 &loma #&a j/~ lduy~ CA 9 I voq
This notification is being made pursuant to Section 6 of DSHEA and Rule 21 C.F.R. $101.93:
The dietary supplement product on whose label or labeling the statements appears is
&Atri - lh
.
The text of each structure-fimction statementfor which notification is now being given is:
(statement1): Promotes
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Sugar h/S
.
(Statement 2):
(Statement 3):
The following summary identifies the dietary ingredient(s) or supplement(s) for which a
statementhas been made:
Identity of Dietary Ingredient(s) or
Suuulement that is the Subiect of the Statement
Statement
Number
The following identifies the brand name of each supplementfor which a statementis made:
Statement
Number
Brand Namq
Labei or Labeling
, am authorized to certify this Pjotification on behalf of
. I cer@ that the tiormation presented and
contained in this Notification is complete and accurate, and that
~eflu4
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has substantiationthat each structure-function statementis truthful and not misleading.
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Date Signed: ge$t.
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NOTIFICATION PURSUANT TO
SECTION 6 OF DSEEA
AND 21 CFR 8101.93
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This notificationis beingfiled on behalfof
which is
of the product(s)which bear the statementsidentifiedin this
the
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notification. Its businessaddressis: 6618 Salotwa fke. Vhn Nays Cfl qlUO5
This notificationis beingmade pursuantto Section6 of DSHEA and Rule 21 C.F.R. $101.93.
The dietary supplementproduct on whose label or labeling the statementsappears is
&Afri - 6uLz
.
The text of eachstructure-functionstatementfor whichnotificationis now beimg&en is:
The following summaryidentifiesthe dietaryingredient(s)or supplement(s)for which a
statementhasbeenmade:
Identity of Dietary Ingredient(s) or
Suunlement that is the Subject of the Statement
Statement
Number
1.
2.
1
2
Banabq
Cles+>
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3.
The followingidentifiesthe brandnameof eachsupplementfor which a statementis made:
Statement
Number
Brand Names
Label or Labeiiug
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, am authorizedto certify this Notification on behalf of
. I certify that the information presentedand
containedin this Notification is completeand accurate,and that
tferbd Smwce
hassubstantiation
that eachstructure-functionstatementis truth&l andnot misleading.
Date Signed:Sep - 25” , e
a03
024175.01
By:
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