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    206 views3 pages

    FDA Letter To Phusion Products Inc

    Uploaded by

    Helen Bennett

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF or read online from Scribd
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    of 3
    ‘Warning Letters > Phusion Projects Inc. 11/17/10 Page | of 3 FDA us. Food and Drug Administration ome sve Et etn Eases tin ae Lit Inspections, Compliance, Enforcement, and Criminal Investigations Phusion Projects Inc. 11/17/10 r ( ‘Public Health Service nn te at PEASE Socraton Catage ra 20a Nov 27, 2010 WARNING LETTER OVERNIGHT MAIL via UPS Me. disen Freeman te Chris Homer Nr Jo wah Phusion Projects, LLC (aba Ocnk Four Brewing Company) 41658 Miinaukee Aven, Ske 24 henge, 60087 Re: 334051 ‘ear Mess. Frooman, Hunter, and Wight ‘Te Food and Orup Administration (FDA) nas reviewed the raguatcry sats ofthe ingredients decared onthe label of your precuc, "Four Lak™* \ihigh cokains caffeine that has Been drecly added to an alcehote beverage end packaged In cmmbed caffeine an alco frm. As ks Used a you Brot, caffeine Is an unsafe fod eddie, ana theraors your proguc = adulterated under setion 402(a)2)(c) oe he Pacers! Feed, Ong, and {Cosmet Act the at) (21 U.S.C. §349{0)(2)(C)). Regulations on te general prowtsons for food adele ar ecatea in Tie 25, Code ot Fates Regulations, Pare 170 (21 CF 170}, You may find copies of tha At ond these regulations through inka in FON later home page ot pss ta gov [As deine in section 204) ofthe Act (21 U.S.C. § 323(¢), the trm “fod addtve™ refers toon substence the Intended use of wich resltsin ts ‘becoming a component of any food, unless the sublance lst subject ofa rir sanction ors generally recognized as ste (GRAS) among Quaid experts undar the conchions of ened use. Under section 409 of te Act (21 U S.C. 348) food aleve le tneata nessa aguleven in lffect that prescribes the candons under which the addive may be safly used, snd the ade and ts use or nganded use aren eonfory ith {hat reguinon, Theres n fod adetve regulation authorizing the use ofetfelna asa creck addon to alchelc beverages, ord we of nok aware of any information to establish thot eafeine added drety to atahoc beverages ithe subject of piorsancion. Lkewse, we are not aware omy Baus to concuude tot caffeine is GRAS under these cndtions of use, FDA's regulations in 21 CFR Par 170 cestrie th eighty eter for clasficaton ofa substance sad to ood 86 GRAS, Under 28 CFR 170,30(0)- (©, general recognition of safety must be base onthe views of qualia experts The Bans el such views moy be eather (1) sient procedures oF (2)'n the caso of» substance usa n food prior to January 1, 1988, trough expaviace Dased on commen ute food. Further geneelrecoonton ol fafetyreaires common knonladae abut the substance throughout the ssente community kewedgobie ebout the safety of subsrances deriy ‘ded (2 food FA's regulations in 21,CFR Part 179 deine “oman use in food” and estblen esas ctr for caesfcabon as GRAS through experiance bared ‘on common use n fend. Under 21 rs 170.3(0, coon use In food en's Substaa toy of consumption ofa substance for Fd uss by 2 Sonicant numberof consumes." Under 21 CFR 170,30(c}(0), "Le]eneralrecoenon o safety thrush experience Dased an eon cx fo oo: to Jancary 1, 1956, sel be basa soley on food use of Une substance prio fo January 1, 1958, and shal oxcnarly be basca upon generally Svakad ata and nfémation.* Importantly, nomever, the foc tht e substance was ade to fod bare 1958 dose no, ieee, demdoatate that Sic ae ‘ole, unless the pre-i958 us te sfent to demonstrate to uated exoets thot the substance esate when added to f00d, See section 201s) ot ‘et (21 US. 9'323(0)]; soe also Pa Hero, Ine. Heckler, 715 #23 1385, 1989-90 (Sth Cr. 1983) ("Under the statute, connoen we (008 of & Ingres doesnot autometically exempt te substance from pretestingreurerents. isteaa, cammien uae in food meray Gesrbes ane fn of levizence Vat may be troduced by 3 proponant forthe purse of meeting the utmate sandra"). Simiterty, FDA's ulations n 21 CFR Part 170 deine "scent procedures" and astabish elgity Cites or easeicabion 86 GRAS through scent) brocedutes,Uncer 21 CFR 170), scentfic procedures "icidde ase human, animal, analy, and other Suen suns, whet ubehed or tinpunisied, appropriate to estasin the salty of 9 substance” Under 21 CF 190.50(0), general recognition of softy bose tne selec procedures “shal requte the samc quarly end quaity of scent evdence os gested to sbtsh approval of a food adciverepuation for tbe Ingredient." Section 170.30(b) further states that general recognition af ste tcugh scete procedures ie ordnanly bass upon Published Sees whch may be corrboratar by unpublahes stixes ane eter Gata and oration, DA's regulations n 21 CFR Part 170 aso dot “sae” and “stety.” Under 21 CFR 170.39, "alae a softy neon that there ls reasonable crtanty in tie minds of compton scones thatthe substances nt harm under te mad cenditons of use" The regllsons any lactrs {tobe considered in determining the sefry of 9 substance added to food. 27 CFR 170.30) By etter dated November 12.2009, FOA requested tat, within 30 days, your company provide evidence of ha ronan, alone wth aipparting dats {bd information, for concluding tat the use of eatare in your product GRAS or ver sancaed. Th ler informed your company tat FOA ‘etermined thatthe Use of caeine in your accoic boveraga ts nethor GRAS nor the ubjet ofa prior section, the open woud take approprate ‘ation te encure thatthe products emoved from the marRetolece. FDA's ler ats reiterate thet she coneng espana of Your company torensure that the fods k markets oe sfe ends conplance wath al apoleabe loge! ed raqulaoryrequrement FDA eckrowledges thot, in respons to the agency’ November 17 ltr, your em suet a letervthin tha 30 day tmetame requested, Indicating that you would submit» GRas Neuce ureuartto prepased 71 CrR 170.36 (62 Fh 18038; Apr 17, 199?) a later date. The gercy received your GRAS Notice (GRN No. 000347) ("GRAS Note"), dated June 25,2030, ond flee fon June 30,2030, ut, ea ccussed in more detail below, FDA has reviewed tet notice and continues to have safety concerns about yur caflanated seahaic aeverage product Acorn, che ayency |S esung tis warring eter. To establish thatthe use fe substance food Is GRAS under ts spetiecondvons oF us for ample, the GRAS status Of cating vinen dectly sulla to an alconac: beverage), tre must be consensus among auoiice oxprts tat the substance ese under conations ose, aed on http:/www.fda.gov/ICECI/EnforcementActions/Warningletters/uem234023.htm 11/17/2010 ‘Warning Letters > Phusion Projects Inc, 11/17/10 Page 2 of 3 bly eveicble data and formation. FO Is aware that, based onthe pubicyaunableIteratur, a numberof qualiies experts have concerns bot the safety of caffenates aiconotc beverages. Waraover, the agency enol snore of ota or ether Information to etanieh the aaety ef he relevent ‘conditions of use for your product, Terefora, tia cars Tor GRAS stots hove not been mst or the caffeine you bevege "sed pon the publey avaiable erature, DA as he olewing specie conceme abou the safety ef cafene when ust in he presence of coho + Reports nthe siontiic Itereture have describes behoviora fects that may occur in young els when enerpydrnks are consumed long with eeahote Beverages (OBrien eta, 2000; Thombs eal 2020; Mier, 2008)- + Stuses Sugvest thal tne combined ingen of cafehe and atchol may lea © hanacdous an fethrtaning stuatlons because ceffaine “ousierets sone, but at al of scot adverse effects. In one stay, a mitra ofan anergy drink ane seaho! reduced subjects svbectve Dercartion oF tasestion but di not improve ciminshad metoreaordinetion or slower visu reaion times sig objective meesures evel £21, 2005). ns due-tack moda, subjects co aamristetedeafeine and alcoho ported reauesd perception of itoxcatom Dt No redoconc ‘akcfiohinduced impairment of task accuracy (Marcanse ord Fitnre, 2006). + Because caffe ater th peccepton af aloha ntxiaton, the consumption ofpre-mixed produc containing adeed cafe ad scchol ‘may feauk in higher amounts of lech consumed per drakingoeras, a stuaton thot le portevlany dongeraue fr nalvecrnkers (fer et 33007, GRAS statu is oct. an inherent property of @ substance, but must be assessed n the context ofthe Intended! conions a use ofthe substance seco 20U(8) of We Act [21 USC. § 321(3}). The assusenetncies a consceravon ofthe fepulaton tat wih consume the substance (21 CFR 170.30 (0) section 405(0) of te Act [24 U'S.c. 8 $84(0)). Therefore, he szentie dat ane information tha upeort a GRAS determination muse consider {he conditions under whic the substance is cao or ee use for whch marketed. Razor nthe scenic erature have red cncemsregerding {he formulation and packaging of premixed products containing ace eafeine and aca. For sxampe, these produc, resented os uty so drinks colorful snge-servng packages, seemingly tarps the young aauk veer, Furthermore, tne marketing ofthe eafeted vesons ove Sake 2f alcohol beverage eppea's to be specncally rected to young adut (Bonne and O'Cannel, 2004). FOA concerned tat te young oat 0 ‘hom these pre-med aed afer an alechel produc ae hareled ae especial vlneiebe tothe aeverse banaiorl efless soriated with onsuming cfeine edded to alcohol, 2 concarn reflected in te publy evalable literture (Bien & a, 2008; Sima ard Mosher, 2007). 1s FOR’ view tet the cine content of your beverage could resut in central nervous system effec Ita consumer drank ane o more containers © Your product, Mereloe, FDA believes that the consumption of yeu prod, "our Lak may result in averse behaveraleatcomos becaves the Catftne i hey to cunterat ceva, but otal he aaveee effect f accra. The agency ts unewere of ay date tot assrene he comples, potently nazaraous bonawers that Rave Geen lertiod i te soenteMeratare as associated mth these Gevoreses ot ot otherwise afesste OU ‘eancerns bout Use effects of consuming thase pre-mixed caffeine and alco! beverages, Morsver, FDA fe not swore of ny publ valle data t ‘estabchsffrmativey safe cendtions of se for cane added recto alate beverages snd packaged ea combed rr As noted, "DA hes reed the information In your GRAS Notice as we as exer publically aeiable information and consrues to have safaty ‘cancers evout your caffenatessianoie Daverape product. In cansierng te teat ofthe formation presented in tre GRAS Nose, FDA Nokes the the GRAS Note cid not te any selnbcVerature of wich the agency was rot already aware. Furthermore, we wish to comment genereby on two Ines of argument prasentca in Your GRAS Nati, Fist, your GRAS Notice relies prenarly upon safety studs of cain plone (i.e, notin the presence of altel o support your wew thet caffeine Is safe under the retevantconditons of use (tat In combinabon wah alee). inpartanby, however, the cure ste Ierature, whch we ce ‘bove estabishes that sgnfcent safety concerts ae rsd by the co-consumpton of catfine and scone. Accord, dts and niomaten dsressing ie safety of caffeine ale are not sumcient to establish te sefey, ana Ue goseralrocognin of the sare, of beverages tat combine tena ts Sia. ‘Second, we note that ane section of your GRAS Notce reviews some ofthe stacies that have reported te adverse behavieral fects etd bythe o> ensumation of caffeine ond elcohel and identies purported deicencies Inte des ane intrpretaton of ese sie. Evon I certain ses 9 the ‘Scent steratare have litaions dua to thar aesgn or the Intsepretston of ther raul, the pesr-revioned erature ss a whole ie auisent to False, among qualities experts, safely concerns abut alcohol bevereges Co wich cafeng has bean dvectly oases. Smiony, even the resuts fram ‘fe single say are sufisenty comprehensive to characterze fly the poten respanses to beverages conoireng caffeine eed to let, these Stusies ere colectively scent to rese concerns ebout consumption cf tis cosinston an to support te conesion that more resoarh fe req Furthermore, FDA ot swareof any reparts in the leeratre that ref the assocaton between te co-consumpten of acon and cafe snc ‘averse behavoral resort oerwise aematvely eabieh the saat of hese Deverages. Indeed. eur review of hs heroture 9s we as Ertan rated studies in ama, shows that thre ae currently no stules or ote: informoteon tot refute the cfatycenceme or otherwise, siete establish the safety of ctfene dresly added fo alzohcle beverages. Therefore, wn ere not avare ofa sificint basco Saport 2 frcsin tat cafere, when direct addes te sich to form a angie beverage, is goneralyrecopnaed 85 soe ‘The euency is are tat your company ceived a Cortncaton/txemption of tabel/Site Approval (COLA) fram the Aleehl sna Tabacco Tax and Trade Gureas (TS) and We, 28 part of your application forthe COLA, you formed TTB that your product would coneancafene. ACOLA doesnot onsite a food addve pation approval a statement regarding GRAS sat, oro prersancion, end you ere obliged to bide by te pesos © the Federal Food, rug, and Cosmese Ac In tght ofthe safety concerns identified above, the use of added cafe in te aleahoe beverage proc “Four Lok" des at sats the tera for ‘GRAS status outlined apo. Furter, FOR avare ora ator exemption from the food addleve cfintson thst mould app to cafere we eset 38, ‘an ingredient m an altanole beverage product: Therefor, caffelne be sod Your product ea food edtve under seston 201(0) ofthe het 21 USC 5 21(3}] and is subject to the provisions af secon 409 ofthe Act [24 U.S.C-§ 348] Under the ltt ood add ie required to De approved by FA fers proposed condtions of use prt to marketing. Bees taveia snot an approved foad adatom fort rs In Your product “Four LOK tis products eduterated wiehin the meaning f section 2O2(\A)C) ofthe het [2k Use § 382 (92ND) ‘You should take prompt action to cores this wilson and prevare ts recurrence. Flue to do so may resi in enforcement action without futher notes The Act atorzes the sere of legal products and njunchona and prosecwtians sane manufeczrers and dtiter f those yoda ‘Ais, wo want you tebe avare Wat FDA didnot conduct an ainsi review of your procuc, “Four Loko” any ober pdt tht you May. monuocture or distribute. under te apa law, fis your respons, ase amatuer ofthis prac, to ana hak te foods your fan ‘arkets are sae and others a compuance isha applcabe legal reguamens, Plase aise ts fic nwritng within ffteen (35) days trom your recip f this tar as to the spect steps you have taken to cores he Vt \denthessbove and to ossure tat sila viabons donot eur. Your reponse should include sn dovamentlin secessry to shaw tht correction has been schieved. f you connot complete all orections wth the 15 day, please expan the tease for your Cel ond the cate by wen each sae em wil be coed and documented lease send your reply to Sayra Hammond, Food snd Ora Aninistaton, Center for Food Safety and Appia Nutrton, Ofice of Comalance (HFS 608), 5100 Paint rar Parlay, College Pork, MO 20780. Shear, “a doaen N Givens ‘ating Director rice oF Compliance http://www. fda. gov/ICECI/EnforeementActions/ WarningLetters/uem234023.htm 11/17/2010 Waming Letters > Phusion Projects Ine. 11/17/10 Page 3 of 3 Cater for Food saety ane Apple Muon,

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