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Waft 0 your letter of Janus ) pursuantto 2 and~~srnet~~ Act (theAct)). makingtie following claims,amongothers,for the product HeartHeafthFormula: ) makesclearthat s~tementincludedin tion may not Claimta diagnose,rn~t~gat~ iseaseor classof diseases.The s~tementthat you intendedto treat, prevent,cureor rn~t~gat~ a is claim doesnot meetthe requirement of 2 is product is intendedfor useasa drug when the mea&g of 21 md that it is subjectto r latianuxlderthe dmg ~ruvisi~nsof the ‘s Center for 0~ should contact makeclaimsof this na esearch(CDER),Office of Compliance,HFD-3f Q,7520S lace,Reveille, balled 20855, e2se contactus if we maybe of furtherassis anuary 14,20 Qtjfi~atj~n ofcertain t uant to section I with this sec$ion. Hea i. id~~t~f~~das ~s~~a~ address is 1195 Mc5 encl. appendix cc: copies (2) blin division of Chec Ii