.. I. A: cc I DEPARTMENT OF HEALTH st HUMAN SISRVICEZS . Public Health Service Food and Drug Administration Alison Young 2313 Rockville MD 20857 USA TODAY . 7950 Jones Branch Drive McLean, VA 22108 $31: Ms . Young: 3" 53590939 to Your Of October 30, 2013 for adverse event reports involving the dietary supplement 'Craze' marketed by Driven Sports from January - 1, 2012 to the present. XX Erb?losed are the records you requested. we have searched our files and find no responsive inforrnation. request is also being referred to one of our cmrpaooent offices. Certain material has been deleted from the records furnished to you because a preliminary review of the records indicated that the deleted information is not required to be publicly disclosed and that disclosure is not appropriate. FDA has taken this approach to facilitate the process of responding to you. If you dispute FDA's preliminary determination with respect to these records and would like FDA to reconsider any particular deletion, please let us know in writing at the following address: Food and Drug Administration, Division of Freedom of Information, 124 20 Parklaern Drive Room rose Rockville, MD 28350 within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed with respect to these records. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you would have the right to appeal that decision. Any letter of denial will explain how to make this appeal. The fo-Rowing charges for this request to date may be included in a rnouthiy invoice: Eleproductiorfi 0 Sea:-cl:S 0 Rcview$ 0 Other$ Tetai:$ 0 THE ABOVE TOTAL l"vfAY NOT REFLECT FENAL CHARGES FOR THIS REQ UEIST. PLEASE DO NOT SEND UNLESS YOU RECEEVE AN Sincerely yours, fl FGE E3:gcqr_i_ve Operations Staff Center for Food Safety aid Applied Nutrition Enclosure CAERS Disclaimer FDA's Center for Food Safety and Applied Nutrition's (CFSAN's) Adverse Event Reporting System (CAERS) is a post--rnarloE mx OH .m>Emoa mw?a w.m mtoflm 382 0310 _m.ozm,5zs.om zw>_m_D . .m>Emon_ m_Nm wnoaww mmxpo. mo wwo._ fioam: CO w_m__2mE "5 ?wum._ 2mo_u:_ mmfiv .5. 88% _onE:c team: m. m_ mflmanm cm mwocwumaxm E5 cm wmm_wo9 team: comm .05: .90 .35 Emu E96 ww._m..6m wzwm 595:: .Em_uEmE 6 uonuoa ._m_:uEmq 9 _uw:5_Em an cmu mm_w>um 65 bcfitwo o: m_ . .mtoam: Em>w Mo 9.: m9moW_aEoo 65:3 r_oE..s mEm%9mc_ Eflcoo Bozvoa new xbozuoa SE9 Umm: msm: .253. .Am::m_u9mc_ 5 ?wxozuoa 9: .5 moflsoum an Eccmu 9.: co=mE_o_E $89 wEom flosnoa zm Scam mtoam: Eow__oo Er: Emfimxm m. w_ nwm_m_m_ noon. he .250