Download ,. NOY - 1 2004

DEPARTMENT
OF HEALTH
& HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD 20740
,.
NOY- 1 2004
Mr. Micah S. Portney
President
ZEO Health Ltd.
29 SunsetView Drive
West Nyack, New York 10994
Dear Mr. Portney:
This is in responseto your letter of October4, 2004. Your letter respondedto our
September29, 2004concerningclaimsbeingmadeyour productEsdifanTM.Theseclaims
werethe subjectof a notificationto FDA under21 U.S.C. 343(r)(6)and 21 CFR 101.93.
In our September29, 2004, we statedthat the claims ‘Stops diarrhea,”“Relieves
diarrhea,”and “Preventsdiarrhea”suggestedthat the productis intendedto treat, prevent,
or mitigatea disease,namelydiseasesfor which diarrheais a characteristicsign or
symptorn,and that the productthat wasthe subjectof the claims, Esdifannd,appearedto
be subjectto regulationunderthe drug provisionsof the FederalFood, Drug, and
CosmeticAct (the Act).
In your letter, you assertthat diarrhea“is a symptomof anothercause”suchas “specific
diseases,suchas Irritable bowel Diseaseor Crohn’s Disease,from bacterialor viral
infection, or a symptomor sideeffect of taking a drug or antibiotic.” For this reason,you
askFDA to reconsiderthe positionset forth in our September29, 2004 letter that diarrhea
is a diseasewhich subjectsyour product to regulationunderthe drug provisionsof the Act
andaffirm to you that the diarrheaclaimsthat were the subjectof your notificationare
within the scopeof claimsthat may be madein the labelingof dietary supplements
pursuantto 21 U.S.C. 343(r)(6)(section403(r)(6) of the Act).
We disagreewith your assertionthat diarrheais not a diseaseas that term is definedin 21
CFR 101.93(g)(l). For purposesof 21 U.S.C. 343(r)(6), a “disease”is definedas
“damageto an organ, part, structure,or systemof the body suchthat it doesnot function
properly (e.g. cardiovasculardisease), or a stateof healthleadingto suchdysfunctioning
(e.g., hypertension).” See21 CFR 101.93(g)(l). The regulationalso statesthat “FDA will
find that a statementabouta product claimsto diagnose,mitigate, treat, cure, or prevent
disease....if it meetsone or more of the criteria listed below... . ” The regulationalso states
that FDA will considerthe contextin which the claim is madeand that a claim may
implicitly or explicitly be a diseaseclaim. Among other criteria, a claim may be a disease
claim if ir is a claim that the product “has an effect on the characteristicsignsor symptoms
of a specificdiseaseor classof diseases,using scientific or lay terminology”(21 CFR
Page2 - Mr. Micah S. Portney
11 or “treats,prevents,or mitigatesadverseeventsassociatedwith a therapy
101.9~@cw)
for a disease,if the adverseeventconstitutediseases”
(21 CFR 101.93(g)(2)(ix).
You statethat diarrheais a “symptomof anothercause”which may be specificdiseases
suchas Irritable Bowel Diseaseor Crohn’sDisease,infectiousdiseases,or a consequence
of drug or antibiotictherapy.Diarrheais unambiguously
a consequence
of damageto a
system(the gastrointestinal
system)suchthat it doesnot functionproperly, the dysfunction
beingevidenceby the diarrhea’. That it is a characteristicsign or symptomof various
diseasesplacesit squarelywithin the scopeof the definitionof “disease”in 21 CFR
101,93(g). We continueto behevethat the positionset forth in our September29, 2004
letter is correctandthat claimsthat a productis intendedfor useto diagnose,mitigate,
treat, cure, or preventdiarrheacausethe productto be subjectto regulationasa drug.
You also statein your letter that an FDA employeeverballystatedthat claimsabouta
product’saffecton diarrheawould be appropriatestructureor functionclaimsbecause
diarrheais a symptomandnot a disease.We regretany confusionthat may havebeen
causedby the informationyou receivedconcerningyour proposedclaims. However,it is
importantto recognizethat whethera particularstatementis or is not a diseaseclaim
dependson the contextin which the statementis made. Statements
aboutconditions,
includingsymptoms,that may resultfrom many causes,both diseaseandnon-disease,
may
be ableto be madein dietary supplementlabelingunder2 1 U.S.C. 343(r)(6)if the claim
makesclearthat the productis only intendedto affectthe non-disease
conditionor
symptom. In that your claim doesnot includesuchqualifying context,it remainsa disease
claim.
Pleasecontactus if we may be of further assistance.
Sincerelyyours,
Director
Division of Dietary SupplementPrograms
Offrce of Nutritional Products,Labeling
and Dietary Supplements
Centerfor Food Safety
and Applied Nutrition
“‘An abnormallyfrequentdischargeof semisolidor fluid fecal matterfrom the bowel”
Stedman’Medical
s
Dictionary,26’hedition.
Page3 -.Mr. Micah S. Portney
Copies:
FDA, Centerfor Drug EvaluationandResearch,Office of Compliance,HFD-310
FDA, Offlee of the AssociateCommissionerfor RegulatoryAffairs, Qfflce of
Enforcement,HFC-200
FDA, New York District Office, Office of Compliance,HFR-NE140
2X0 Health Ltd.
October 4,2004
Office of Nutritional Products, Labeling &
Dietary Supplements>I-IFS 8 10
Center for Food Sat?etyand Applied Nutrition
Food and Drug Administration
5 100 Paint Branch Parkway
College Park, MD 20740
Re:
Label ClaimdDidaimers
To Whom It May Concern:
This letter is in responseto your letter, dated September29,2004, respondingto our 30 day
notification for labeling claims.
According to every medical dictionary, diarrheais a symptom of another cau.se.The causecan be
due to specific diseases,such as Irritable Bowel Diseaseor Crohn’s Disease,from bacterial or
viral infection, or a symptom or side effect of taking a drug or antibiotic.
We contactedyour office and received a verbal responsefrom Angela Pope on 4/21/2004 stating
that your offrce, and that of the FDA, takes the position that diarrheais a symptom and not a
diseaseand therefore can be used in structure function claims. An associatedlegal firm also called
Ms. Pope for confirmation on 4/22/2004, inquiring with the samequestion about the position the
FDA takes on the definition of diarrheafor labeling, and received the sameanswerthat diarrheais
a symptom of a diseaseand not a diseasein and of itself
29 SunsetView Drive
WestNyack,New York 10994
(845)353-5185
ZEO Health Ltd.
We have included in this letter, for your further consideration,a copy taken fkom the website of
QaJ
8 ‘Q&
the FDA, clearly stating and listing diarrheaas symptomof other causes,and not a disease.We
respectfully requestthat you reconsideryour position as statedin the September29,2004 letter in
light of this additional, supporting [email protected] are hopeful that the outcome of this
reconsiderationis consistent with the prior confirmations we were given.
Thank you in advancefor your continued cooperation. We are eagerand willing to continue to
comply with the guidelines as set by the FDA.
If you have any questionsor need further imormation, pleasefeel free to contact me.
ZEO IIealth Ltd.
Name: Micah S. Portney
Title : President
29 Sunset View Drive
West Nyack,NewYork 10994
(845) 353-5 185
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