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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 I- .._ ._