Issue s with T attoo and PMU Ink - T he AF DO T atto o I nk - PowerPoint PPT Presentation

Issue s with T attoo and PMU Ink - T he AF DO T atto o I nk and Pe rmane nt Make up L ab e ling Guide line s 2019 CE HA Annua l E duc a tion Confe re nc e Ke ystone , Colora do L a ure l Arrig o na Jo di Zimme rma n Re g ula to ry, Ce utic a l L a b s E nviro nme nta l He a lth Spe c ia list II , E l Pa so Co unty AF DO BAC, Cha ir Pub lic He a lth BAEA, Cha ir BAEA, Co mmitte e Me mb e r NE HA BAMC, Co mmitte e Me mb e r AF DO BAC, Co mmitte e Me mb e r

As You Know - T attooing is on the Rise 2015 Ha rris Po ll sho we d tha t • a b o ut 29% o f Ame ric a ns ha ve a t le a st o ne ta tto o . T a tto o s a re mo re pre va le nt • a mo ng yo ung e r Ame ric a ns, with ne a rly 50% o f mille nnia ls.

T a ttooing a nd PMU Pr oc e dur e s Pra c tic e o f •T he pra c tic e o f ta tto o ing a nd PMU T a tto o ing pro c e d ure s a re re g ula te d b y State and a nd PMU isdic tions , fo c using o n sa fe L oc al jur Pro c e dure s pra c tic e s a t the ta tto o pa rlo rs a nd sa lo ns.

In the Shop - T a ttooing Re g ula tions Ac r oss the Countr y ► So me sta te s ha ve re g ula tio ns fo r e ntire sta te ► So me sta te s ha ve re g ula tio ns pe r c o unty o r c ity ► So me sta te s ha ve vo lunta ry pro g ra ms

Pr oble ms with the Cur r e nt Shop Re gulations ► Co nsiste nc y ► I nspe c tio ns a nd pra c tic e s within o ne jurisdic tio n ► I nspe c tio ns a nd pra c tic e s within o ne sta te ► I nspe c tio ns a nd pra c tic e s a c ro ss the c o untry ► E duc a tio n re q uire me nts ► L ic e nsing Re q uire me nts Ca use s ► Co nfusio n ► Adve rsia l re la tio ns b e twe e n industry a nd re g ula to rs ► I nc o nsiste nt sho p inspe c tio ns ► Risk to a rtist a nd the pub lic

F DA Re g ula te s T a ttoo Ink a nd PMU • Any pr oduc t inte nde d to be applie d to the human body for Co sme tic s c le ansing, be autifying, pr omoting attr ac tive ne ss, or alte r ing the appe ar anc e . (F D&C Ac t, se c . 201(i)) • "a mate r ial whic h ... is a dye , pigme nt, or othe r substanc e made by a pr oc e ss of synthe sis or similar ar tific e , or e xtr ac te d, isolate d, or othe r wise de r ive d, with or without inte r me diate or final c hange Co lo r of ide ntity, fr om a ve ge table , animal, mine r al, or othe r sour c e , and ... [that] whe n adde d or applie d to a food, dr ug, or c osme tic , Additive or to the human body or any par t the r e of, is c apable (alone or thr ough r e ac tion with [an]othe r substanc e ) of impar ting c olor the r e to ... T he te r m 'c olor ' inc lude s blac k, white , and inte r me diate gr ays..." (F D&C Ac t, se c . 201(t)) • “T attoo inks” so ld a nd use d in the US a re c o nside re d a s T a tto o I nks “Co sme tic s” c o nta ining “Co lo r Additive s”. As suc h the y fa ll unde r F DA jur isdic tion.

Pr oble ms with the Pr oduc t Re gulations ► Ma ny in industry a rg ue a g a inst the c o sme tic re g s b e ing a pplie d to ta tto o ink a nd PMU. ► No ne o f the c o lo r a dditive s a re a ppro ve d fo r the use . ► Histo ric a lly the re ha s b e e n little re g ula to ry a c tio n. ► Co nfusio n in industry a nd the pub lic ► I f no t a s a c o sme tic , ho w sho uld ta tto o ink a nd PMU b e c la ssifie d? ► BAM 23 spe c s

Ac knowle dg e me nt ● T he F DA Offic e o f Co sme tic s a nd Co lo rs ha ve g ive n the AF DO Bo dy Art Co mmitte e pe rmissio n to c o mmunic a te the info rma tio n the y pre se nte d a t the AF DO Annua l E duc a tio n Co nfe re nc e o f 2019. ● T he finding s pre se nte d b y F DA we re the re sult o f inspe c tio ns o f distrib uto rs a nd ma nufa c ture rs, ro utine surve ys o f ta tto o inks, a nd the sub se q ue nt mic ro b io lo g ic a l a na lysis o f ta tto o ink a va ila b le o n the Unite d Sta te s ma rke t.

Adve r se E ve nts Re por te d to F DA fr om 2004- 2016 ► 363 fro m 2004-2016 ► So me re po rts re sulte d in vo lunta ry re c a ll o f inks

T a ttoo Ink a nd Pe rma ne nt Ma ke up Re c a lls, 2003- 2015 Br a nd Color Ink Ye a r of Issue s Sour c e of Issue s T ype Re c a ll 1 All Co lo rs PMU 2003, 2004 Alle rg ic Be nzimid a zo lo ne wa s susp e c te d a s a c a use o f a lle rg ic re a c tio n b ut no t c o nfirme d 2 Bla c k T a tto o 2004 Mic ro Pse ud o mo na s a e rug ino sa Mo ld : Ac re mo nium sp p . 3 Bla c k T a tto o 2011 Mic ro NT M: Myc o b a c te rium a b sc e ssus, M. c he lo na e 4 Gre y T a tto o 2012 Mic ro NT M: Myc o b a c te rium c he lo na e wa she s 5 Bla c k T a tto o 2014 Mic ro No c a rd ia . fa rc inic a a nd No c a rd ia sp p . 6 All c o lo rs T a tto o 2014 Mic ro Multip le Mic ro b e s: Sp hing o mo na s p a uc imo b ilis, Ba c illus sp p . 7 Gre y T a tto o 2015 Mic ro NT M: M. c he lo na e , wa she s Mo ld : Pe nic illium sp p ., a nd Cryp to c o c c us a lb id us

Case Re por t: T attoo- Assoc iate d Nontube r c ulosis Myc obac te r ial Skin Infe c tions – 2011- 2012 ► Oc t 2011 – A p e rso n (Ro c he ste r, Ne w Yo rk), p re se nte d with a p e rsiste nt p a p ula r ra sh b e g inning 1 we e k a fte r b e ing ta tto o e d ► Ja n 2012 – T he Mo nro e Co unty De p t. o f Pub lic He a lth (NY) inve stig a te d a n o utb re a k: ► M. c he lo na e wa s iso la te d fro m a skin b io psy ► 14 c o nfirme d with M. c he lo na e o ut o f a to ta l o f 19 infe c tio ns ► Co mpa ny A pre dilute d g ra y ink wa s use d ► M. c he lo na e wa s iso la te d fro m tissue spe c ime n, o ne o pe ne d a nd o ne uno pe ne d b o ttle o f c o mpa ny A pre dilute d g ra y ink (indisting uisha b le ) ► Wa te r a nd e nviro nme nta l sa mple s: ne g a tive fo r M. c he lo na e ► F e b 2012 – CDC d isse mina te d a n E p i-X p ub lic he a lth a le rt: ► Ide ntifie d a dditio na l ta tto o -a sso c ia te d NT M skin infe c tio ns fro m thre e sta te s (Wa shing to n, Io wa , a nd Co lo ra do )

Nontube r c ulous Myc oba c te r ium (NT M) ► NT M sp e c ie s (e .g . M. a b sc e ssus a nd M. c he lo na e ) ► E nviro nme nta l myc o b a c te rium (fo und in wa te r) ► NT M c o nta mina tio n c a n o c c ur: ► During the ink ma nufa c turing pro c e ss a s a re sult o f using c o nta mina te d ra w ma te ria ls ► As a re sult o f dilutio n o f inks with no n-ste rile wa te r b y the ta tto o a rtist b e fo re use ► T a tto o -a sso c ia te d NT M infe c tio ns ► Ra ng e fro m mild infla mma tio n to se ve re a b sc e sse s re q uiring e xte nsive a nd multiple surg ic a l de b ride me nt ► Diffic ult to tre a t a nd c a n re q uire a minimum o f 4 mo nths o f tre a tme nt with a c o mb ina tio n o f two o r mo re a ntib io tic s

F DA’s T a ttoo Ink & Pe r ma ne nt Ma ke up Re se a r c h ► Co nduc te d multiple surve ys o f ta tto o a nd pe rma ne nt ma ke up inks o n the US ma rke t. ► NCT R de ve lo pe d e ffe c tive de te c tio n me tho do lo g ie s fo r mic ro b ia l c o nta mina tio n o f ta tto o a nd pe rma ne nt ma ke up inks. ► T his re se a rc h is pub lic ly a va ila b le . ► Pub lishe d in the Jo urna l o f Applie d Mic ro b io lo g y Ja nua ry 2018. ► “Mic ro b io lo g ic a l surve y o f c o mme rc ia l ta tto o a nd pe rma ne nt ma ke up inks a va ila b le in the Unite d Sta te s” Ac tion: Ide ntify Sur ve ys Inspe c tions & Pr oble ms Re c alls

F DA’s T a ttoo Ink Sur ve y Re sults Ye a r s / L a b Numbe r of Numbe r BAM 23* Non- Sa mple s Positive Complia nt 2013-2015, 75 32 (43%) 12 (16%) priva te Sur ve ys 2015-2017, F DA 85 42 (49%) 16 (18%) 2017-2018, F DA 41 18 (44%) 10 (24%) T o ta l 201 92 (46%) 38 (19%) *Sa mple s we re e va lua te d fo llo wing Ba c te rio lo g ic a l Ana lytic a l Ma nua l, Cha pte r 23 ● BAM 23 Microbiological Methods for Cosmetics ○ E ye -a re a pro duc ts, no g re a te r tha n 500 CF U/ g ○ No n-e ye -a re a pro duc ts, no g re a te r tha n 1000 CF U/ g

Wha t Wa s L e a r ne d F r om the Sur ve ys ► Muc h o f the ta tto o a nd PMU inks a va ila b le in the US tha t we re a sse sse d we re c o nta mina te d with Mic ro . ► So me ha d hig h le ve ls o f mic ro o rg a nisms, mo re tha n 1000 CF U/ mL (CF U/ g ) (e .g ., 16 o ut o f 42 c o nta mina te d ta tto o Ide ntify inks). Pr oble ms ► So me we re o ppo rtunistic huma n pa tho g e ns. ► Hig he r risk fo r pe o ple with we a ke ne d immune syste ms

F DA Ac tion: T attoo Inspe c tion and Sampling ► F o c use d o n firms ide ntifie d during re c a ll inve stig a tio ns ► 12 firms inspe c te d ► 61 sa mple s te ste d Ac tion: Inspe c tions & ► 31 sa mple s po sitive (51%) Re c alls ► 7 o f 31 sa mple s re sulte d in the ne e d fo r a vo lunta ry re c a ll (23%)