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2005>Chukar Cherry Company 17-Oct-05 http://www.fda.gov/ICECl/EnforcementActions/WarningLetters/2005... <br /> i4 Department of Health and Human Services Public Health Service <br /> Food <br /> AdministrationandDrug <br /> Seattle District <br /> Pacific Region <br /> 22201 23rd Drive SE <br /> Bothell, WA 98021-4421 <br /> Telephone: 425-488-8788 <br /> FAX: 425-483-4998 <br /> October 17,2005 <br /> CERTIFIED MAIL <br /> RETURN RECEIPT REQUESTED <br /> In reply refer to Warning Letter SEA 06-01 <br /> Pamela Auld,C.E.O. <br /> Chukar Cherry Company <br /> P.O.Box 510 <br /> Prosser,Washington 99350 <br /> WARNING LETTER <br /> Dear Ms.Auld: <br /> The Food and Drug Administration(FDA)has reviewed the labeling for your cherry and chocolate covered cherry products on your web site at www.chukar.com.This <br /> review shows serious violations of the Federal Food,Drug,and Cosmetic Act(the Act)in the labeling of these products.You can find the Act and implementing regulations <br /> through links on FDA's Internet home page at www.fda.gov t. <br /> Under the Act,articles intended for use in the diagnosis,cure,mitigation,treatment,or prevention of disease in man are drugs[section 201(g)(1)(B)of the Act,21 USC <br /> 321(g)(1)(B)].The labeling for your products bears the following claims: <br /> "Cherries prevent cancer growth,relieve arthritis and gout pain...." <br /> "[C]ocoa can help prevent blood clots and artery hardening with polyphenols,which lowe the risk of heart attack....[C]ocoa also has the'highest source of antioxidants <br /> [which reduce heart disease and cancer]in the plant kingdom." <br /> "Cherries May Help Fight Diabetes Cherries may one day be part of diabetes treatment.The sweet and tart versions of the fruit contain chemicals that boost insulin,which <br /> helps control blood sugar levels.""Cherries may well be an effective remedy for many gout sufferers!" <br /> This list of claims is not intended to be all-inclusive,but represents the types of claims found in your product labeling.These claims cause your products to be a drugs,as <br /> defined in section 201(g)(1)(B)of the Act[21 USC 321(g)(1)(B)].Because these products are not generally recognized as safe and effective when used as labeled,they an <br /> also new drugs as defined in section 201(p)of the Act[21 USC 321(p)].Under section 505 of the Act(21 USC 355),a new drug may not be legally marketed in the United <br /> States without an approved New Drug Application(NDA).FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the dru <br /> is safe and effective. <br /> The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling.It is your responsibility to ensure that products marketed by <br /> your firm comply with the Act and its implementing regulations. <br /> Failure to promptly correct these violations may result in enforcement action without further notice.Enforcement action may include seizure of violative products,injunction <br /> against the manufacturers and distributors of violative products,and criminal sanctions against persons responsible for causing violations of the Act. <br /> Please advise this office in writing,within 15 working days of receipt of this letter,as to the specific steps you have taken or will be taking to correct these violations, <br /> including the steps taken to assure that similar violations do not recur.Your reply should be sent to the Food and Drug Administration,Attention:Lisa M.Althar,Compliance <br /> Officer,22201 23rd Drive SE,Bothell,Washington 98021-4421. <br /> Sincerely, <br /> /s/ <br /> Charles M.Breen <br /> District Director <br /> 1 of 1 3/7/2012 4:38 PM <br />