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LIVE INTERACTIVE LEARNING @ YOUR DESKTOP
Thursday, December 17,
2009
6:30 p.m. - 8:00 p.m. Eastern time
FDA: TATTOOS AND...
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1. Introductions
2. Tech-help info
3. Web Seminar tools
4. Presentation
5. Evaluation
6. Chat with the presenters
Agenda:
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Jeff Layman
Tech Support
NSTA
jlayman@nsta.org
703-312-9384
Supporting the
Presenting Team
is…
For additional Tech-help ...
4
5
We would like to know more
about you…
6
How many NSTA web
seminars have you attended?
A. 1-3
B. 4-5
C. More than 5
D. More than 10
E. This is my first web semin...
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How many NSTA web seminars
have you attended?
A. 1-3
B. 4-5
C. More than 5
D. More than 10
E. This is my first NSTA
web ...
8
Where are you now?
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What grade level do you
teach?
A. Elementary School, K-5.
B. Middle School, 6-8.
C. High School, 9-12.
D. I teach colleg...
10
LIVE INTERACTIVE LEARNING @ YOUR DESKTOP
Thursday, December 17,
2009
FDA: TATTOOS AND PERMANENT
MAKEUP
Marketplace and ...
TATTOOS AND PERMANENT
MAKEUP
Marketplace and Chemistry
Bhakti Petigara Harp, Ph.D.
Chemist, Color Technology Team
Office o...
12
Modules
• Regulatory status of tattoo inks and
pigments
• Marketplace
– General body tattoos
– Permanent makeup tattoos...
13
Module 1
• Regulatory status
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Regulatory Definitions
• Color additive – any material capable of imparting
color to a food, drug, cosmetic, medical de...
15
Are tattoo pigments regulated by
the FDA?
Yes No
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Regulatory Status of Tattoo
Pigments
• Color additives must be pre-approved by FDA
for use in food, drugs, cosmetics, a...
17
Regulation of Tattoo Inks and Tattoo
Pigments in the U.S.
• Tattoo inks are cosmetics
• Tattoo pigments are color addit...
18
Regulation of Tattooing in Other
Countries
• E.U. – Tattoos are “non-food products,” not
cosmetics
– See Opinion of Sci...
19
Let’s Pause Two
Minutes for Questions
from the Audience
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Module 2
• Marketplace
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Marketplace – Definitions
• Tattoo ink – a mixture of pigments and
diluents intended for introduction into the
skin
• P...
22
Inorganic vs. Organic Tattoo
Pigments
• Inorganic compounds are easily
obtainable from natural sources (e.g., iron
oxid...
23
Advantages of Organic Tattoo
Pigments
• More intense colors
than inorganic
pigments
• Give wider range of
colors
• Are ...
24
Marketplace – Inks and
implements
25
26
What percentage of people have
tattoos?
Multiple Choice
A. 10%
B. 40%
C. 90%
27
General Body Tattooing
28
29
30
Fluorescent Tattoo Inks
31
• General body
tattoo inks
• Tattoo parlors
historically
avoided the
face
______________
___
• Permanent
cosmetics inks...
32
Permanent Makeup
• Before and after
photos (Premier
Pigments web site)
• Eyeliner
• Eyebrows
• Lipliner
• Full lips
• B...
33
Examples of Permanent Makeup
EYELINER EYEBROWS
MOLE
34
Permanent Makeup Tattoo Machine
35
36
Problems with Tattoos
and Permanent Makeup
• Safety for skin injection has not been
demonstrated
• Adverse reactions ha...
37
Problems with Tattoo/Permanent Makeup
Industry
• Technicians diverse: amateurs to MDs/RNs
• Non-medical technicians hav...
38
Permanent
Makeup in
Medical Setting
• Injected anesthesia
• Clamp secures eyelid
• Calipers ensure
placement
• Varying ...
39
Tattoos/Permanent Makeup
in Salon, Home, Workshop Settings
• No injected
anesthesia
• Varying
sterile
techniques
40
Let’s Pause Two
Minutes for Questions
from the Audience
41
Module 3
• Adverse Reactions
42
Adverse Reactions to Tattoos
and Permanent Makeup
• Swelling, cracking, peeling, blistering,
scarring
• Granulomas (sma...
43
Adverse Reactions – Granulomas
44
Adverse Reactions in Sunlight
45
Adverse Reactions to Surgical
Removal
• Laser removal
– Painful
– Expensive
– Usually leaves
scarring
– Iron oxide and
...
46
Adverse Reactions to Permanent
Makeup
• 1988 to 2003 – FDA received only five reports of adverse
reactions
• 2003 to 20...
47
Adverse Reactions to Permanent
Makeup
48
FDA and CDC Actions
• July 2 2004 – FDA alerted public to concerns with Premier
Pigment brand of ink shades
– “FDA Talk...
49
• “The ingredients of “… “ UV Tattoo Inks: (PMMA)
Polymethylmethacrylate 97.5% and microspheres of
fluorescent dye 2.5%...
50
FDA Action – Starbrite Ink
Contamination
• (2004) Belgium withdrew “Starbrite Colors” tattoo ink from
market because of...
51
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, M...
52
Problems with Tattoo Ink:
Claiming FDA Approval on Web Sites
• Polymethylmethacrylate in tattoo inks:
“We researched sc...
53
Problems with Tattoo Ink:
Citing FDA Approval for Tattooing Fish
• FDA letter dated April 3, 1995:
“Having reviewed the...
54
Temporary Tattoos – Decals
• Temporary tattoos are regulated as cosmetics
• Declaration of ingredients is required
• Ap...
55
Body Decoration with Henna
56
Is henna approved for
use on the skin?
Yes No
57
Henna Tattoos and Body Decoration
(Mehndi)
• Henna is derived from the leaves of the shrub
Lawsonia inermis
– Brown, or...
58
Body Decoration with Black
Henna
59
Adverse Reactions to Black Henna
• “Black henna” contains additional coloring ingredients
– Allows darker, more intense...
60
Let’s Pause Two
Minutes for Questions
from the Audience
61
Module 4
• Chemistry of Tattoo Pigments
62
Chemistry of Tattoo Pigments
• Basic concept of color
• Inorganic pigments
• Organic pigments
– Insoluble organic compo...
63
Why not use FD&C colors in
tattoos?
Type in the chat
64
Electromagnetic spectrum
www.owlnet.rice.edu/~psyc351/Images/Electroma
65
Basic Concepts of Color
• Interaction of visible light with a compound
– Wavelengths of light
– Types of atoms in the c...
66
Production of complementary
colors
25.198 Peak 20
236.9
316.1
493.8
660.7
nm
300.00 400.00 500.00 600.00 700.00
25.722 ...
67
What color would you see?
25.722 Peak 10
306.6 406.8
630.2
719.5 790.5
nm
200.00 300.00 400.00 500.00 600.00 700.00 800...
68
Absorptivity value
• Measure of dye’s ability to absorb light
• High absorptivity value: more efficient, more economica...
69
Early food and cosmetic uses
of dyes and pigments
• Foods colored with spices and minerals
– Paprika, turmeric, saffron...
70
Historically Used Tattoo Pigments
• Black – iron oxide, carbon
• Red – mercury sulfide, iron oxide
• Yellow – cadmium s...
71
Historically Used Minerals in Tattoo
Pigments
• Black
– Magnetite
(FeO•Fe2O3)
– Charcoal (C)
• Red
– Hematite (Fe2O3)
–...
72
FDA Analyses of Inorganic Pigments in
Tattoo/Permanent Makeup Inks
• Samples of sixty-three tattoo/permanent
makeup ink...
73
Inorganic Elements Found in Tattoo
Pigments
• Black – Fe
• Gray – Fe, Ti, Al
• Brown – Fe, Ti, Al, Ca
• Blue – Ti, Al, ...
74
FDA Analyses of Organic Pigments in
Tattoo/Permanent Makeup Inks
• Samples of thirty-five tattoo/permanent makeup inks
...
75
Organic Pigments in Tattoo/Permanent
Makeup Inks
Chemical
Class Quinacridone
Monoazo
Arylide
Sample
Pigment
Brown 25
Pi...
76
Organic Tattoo Pigments – Dye
Structures
• Anthraquinone
• Azo, Disazo
• Benzimidazolone
• Indigoid
• Phthalocyanine
•
...
77
C.I. Pigment Red 83
• C.I. 58000
• CAS No. 72-48-0
• Alizarin Red
• Anthraquinone dye
• 1,2-Dihydroxy-9,10-
anthracened...
78
C.I. Pigment Red 170
• C.I. 12475
• CAS No. 2786-76-7
• Fast Red F5RK
• Monoazo dye
• 4-((4-(Aminocarbonyl)
phenyl)azo)...
79
C.I. Pigment Orange 16
• C.I. 21160
• CAS No. 6505-28-8
• Dianisidine Orange or
Benzidine Orange R
• Disazo dye
• 2,2'-...
80
C.I. Pigment Yellow 151
• C.I. 13980
• CAS No. 31837-42-0
• Fast Yellow H4G
• Benzimidazolone and
monoazo dye
• 2-[[1-[...
81
C.I. Pigment Violet 32
• C.I. 12517
• CAS No. 12225-08-0
• Brillfast Vivid Magenta
• Benzimidazolone and
monoazo dye
• ...
82
C.I. Pigment Blue 66
• C.I. 73000
• C.I. Vat Blue 1
• CAS No. 482-89-3
• Indigo
• Indigoid dye
• 2-(1,3-Dihydro-3-oxo-2...
83
C.I. Pigment Blue 15
• C.I. 74160
• CAS No. 147-14-8
• Copper phthalocyanine
• Cyan Blue GTNF or
Heliogen Blue 7044T
• ...
84
C.I. Pigment Red 122
• C.I. 73915
• CAS No. 980-26-7
• Acramin Scarlet LDCN or
Fastogen Super Magenta
R
• Quinacridone ...
85
Tattoo Pigment Photodecomposition
Studies
• FDA’s National Center for Toxicological
Research (NCTR)
• Cui, Y., Spann, A...
86
Photodecomposition of Pigment Yellow 74
in simulated solar light
N
O
O
O
CH3
NH
N
O CH3
NH
O
O
H3C
O CH3
NH
O
O
H3C
N
O...
87
N
O
O
CH3
N
N
HO NH
O
N
O
O
CH3
NH2
HO NH
O
N
O
O
CH3
Photodecomposition of Pigment Red 22
in 532 nm Nd:YAG laser light
88
Tattoo Pigments and Color
Additives
Indigo (tattoo pigment) 21 CFR 74.101
and FD&C Blue No. 2
21 CFR 74.3106 (for use i...
89
Tattoo Pigments and Color
Additives
• C.I. Pigment Blue 15
• Copper
phthalocyanine
• 21 CFR 74. 3045
[Phthalocyaninato(...
90
Tattoo Pigments and Color
Additives
• Aluminum oxide
– 21 CFR 73.1010
• Carmine
– 21 CFR 73.100
– 21 CFR 73.1100
• Iron...
91
Conclusions
• Marketplace – Wide variety of inorganic and organic
pigments and diluents in tattoos and permanent
makeup...
Thank you to the sponsor of
tonight's Web Seminar:
93
http://learningcenter.nsta.org
94
http://www.elluminate.com
95
National Science Teachers Association
Dr. Francis Q. Eberle, Executive Director
Zipporah Miller, Associate Executive Di...
96
• NSDL: Thinking Like a Scientist: Teaching
and Learning Through Current Science
Issues January 12, 2010
• Toshiba/NSTA...
97
Web Seminar Evaluation:
Click on the URL located on the
Chat Window
98
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  • No one has submitted a pigment for use to be injected in the skin- therefore an illegal color additive.
    FDA has not exercised jursidication because it’s not a high enough priority
    Local jurisdiction is concerned about hygiene
  • Canada- for hygiene
  • Over 50 years- pioneer for color tattoos
  • Needle assembly- 1-14 solid needles pushes ink into skin through the epidermis into the dermis, in a repetitive fashion (like a sewing machine)
  • In the last 5- 10 years, more people, different people getting tattoos- range in size, color, body parts etc
  • Although the permanent make up tattoo machine is smaller, the principle is the same: needle pushes ink into skin through the epidermis into the dermis, in a repetitive fashion (like a sewing machine) for finer lines
  • Anyone can buy from internet and set up own business in basement
  • Photosensitization because photodynamic pigment-
  • With no preservatives, Tattoo ink can grow microbrial contimination and if used can cause skin infections or internal bacterical growth causing serious problems
  • Imply’s fda approval- misinforming public and users
  • Temporary tattoos are sold to consumers so they are cosmetics- applied to the skin.. Except saloon products which tattoos and permanent makeup fall under.. Don’t have to list the ingredients – this is why most tattooists don’t even know whats in them.
    Import alert- we detain the product- enforcement actions..
  • Become allergic to other chemicals in sunscreen and jeans- cross reaction
  • <number>
    01/30/15
    this is an energy spectrum that ranges from cosmic rays with the highest energy (on the right) to radio waves with the lowest energy (on the left). Visible spectrum is from 400 nm to 700 nm. Each individual wavelength within the spectrum of visible light is representative of a particular color. That is, when light of that particular wavelength strikes the retina of our eye, we perceive that specific color sensation.
  • <number>
    01/30/15
    Every color- show absorption max or min in the visible spectrum
    If an absorption band is located in the 490 nm of the visible spectrum, that part of the incoming light will be absorbed. The rest of the spectrum will be transmitted and is visible to the eye as red.
    ** Each dye has its own absorbance spectrum that depends on its chemical structure
  • <number>
    01/30/15
    But each dye ranges in intensity due to its absorptivity values
    Molecular phenomenon
  • <number>
    01/30/15
    color additives from natural sources such as vegetable and mineral were used to color foods, and cosmetics since ancient times. Paprika, turmeric, saffron, iron and lead oxides, and copper sulfate are some examples. Wine was artificially colored beginning in at least 300 BC.
    Ancients romans used white lead to color their faces.
    Eyptians used kohl to blacken their eyebrows, lids and lashes and the green ore of copper for eye shadow
    Chinese women used vegetable extracts to color their skin.
  • Extraction of inks left insoluble residues showed both inorganic/organic pigments in all inks
  • Conjugation c=c- highly colored..
  • In a Photochemistry and Photobiology 2004 publication, the NCTR group showed that exposure of Pigment Yellow 74 to simulated solar light resulted in photo-induced cleavage at the azo group to form (in middle) N-(2-methoxyphenyl)-3-oxobutanamide, and (on right) the 2-(N-hydroxy imine) derivative. They did not detect 2-methoxy-4-nitro-aniline (on left – dashed lines); however its formation is implied. There work suggested that sunlight would lead to the cleavage of azo-based pigments, releasing the above mentioned and other products.
  • Pigment Red 22, also known as Cardinal Red, is reported as present in a large number of tattoo inks. It is formed from the reaction of the diazonium salt of 2-methyl-5-nitro-aniline with naphthol-AS to form the mono-azo pigment shown above.
    In a publication in Photochemistry and Photobiology in 2004, Baumler and colleagues in Regensburg Germany demonstrated that exposure of pigment red 22 particles suspended in acetonitrile to 532 nm radiation from a Neodyium:YAG laser resulted in the photo-cleavage of Pigment Red 22 into (on left) 2-methyl-5-nitro-aniline, (middle) 4-nitro-toluene, implying also the formation of (on right) naphthol-AS. As a result, this work suggests that laser irradiation of Pigment Red 22 has the potential to form degradation products whose safetly is suspect also.
  • Listed in cfr but not for use in injection into the skin
    B2- related to indigo but its water soluble.. So cant be used in tattoos
  • Insoluble..
  • Permitted inorganic colors..
    Not listed for use to be injected in the skin..
  • Transcript of "Download"

    1. 1. 1 LIVE INTERACTIVE LEARNING @ YOUR DESKTOP Thursday, December 17, 2009 6:30 p.m. - 8:00 p.m. Eastern time FDA: TATTOOS AND PERMANENT MAKEUP Marketplace and Chemistry Presented by: Bhakti Petigara Harp, Ph.D.
    2. 2. 2 1. Introductions 2. Tech-help info 3. Web Seminar tools 4. Presentation 5. Evaluation 6. Chat with the presenters Agenda:
    3. 3. 3 Jeff Layman Tech Support NSTA jlayman@nsta.org 703-312-9384 Supporting the Presenting Team is… For additional Tech-help call: Elluminate Support, 1-866-388-8674 (Option 2)
    4. 4. 4
    5. 5. 5 We would like to know more about you…
    6. 6. 6 How many NSTA web seminars have you attended? A. 1-3 B. 4-5 C. More than 5 D. More than 10 E. This is my first web seminar Use the letters A-E located at the bottom right of the participant window to answer the poll.
    7. 7. 7 How many NSTA web seminars have you attended? A. 1-3 B. 4-5 C. More than 5 D. More than 10 E. This is my first NSTA web seminar
    8. 8. 8 Where are you now?
    9. 9. 9 What grade level do you teach? A. Elementary School, K-5. B. Middle School, 6-8. C. High School, 9-12. D. I teach college students. E. I am an Informal Educator.
    10. 10. 10 LIVE INTERACTIVE LEARNING @ YOUR DESKTOP Thursday, December 17, 2009 FDA: TATTOOS AND PERMANENT MAKEUP Marketplace and Chemistry Presented by: Bhakti Petigara Harp, Ph.D.
    11. 11. TATTOOS AND PERMANENT MAKEUP Marketplace and Chemistry Bhakti Petigara Harp, Ph.D. Chemist, Color Technology Team Office of Cosmetics and Colors December 17, 2009
    12. 12. 12 Modules • Regulatory status of tattoo inks and pigments • Marketplace – General body tattoos – Permanent makeup tattoos – Problems with tattoos and permanent makeup • Adverse reactions and FDA responses • Chemistry of tattoo pigments – Inorganic tattoo pigments – Organic tattoo pigments
    13. 13. 13 Module 1 • Regulatory status
    14. 14. 14 Regulatory Definitions • Color additive – any material capable of imparting color to a food, drug, cosmetic, medical device, or the human body • Types of color additives – organic dyes and pigments, inorganic pigments • Mixture – two or more color additives with or without diluents • Diluent – component of a color additive mixture added to facilitate the use of the mixture in coloring the human body
    15. 15. 15 Are tattoo pigments regulated by the FDA? Yes No
    16. 16. 16 Regulatory Status of Tattoo Pigments • Color additives must be pre-approved by FDA for use in food, drugs, cosmetics, and medical devices • Approved color additives are listed in the U.S. Code of Federal Regulations – See 21 CFR Parts 73, 74, and 82 • No color additives have been listed for injected use – See 21 CFR 70.5(b)
    17. 17. 17 Regulation of Tattoo Inks and Tattoo Pigments in the U.S. • Tattoo inks are cosmetics • Tattoo pigments are color additives requiring pre-market approval • FDA traditionally has not exercised its regulatory authority over tattoo inks or tattoo pigments • The practice of tattooing is regulated by local jurisdictions for sanitation • Recent adverse events have raised FDA’s concern
    18. 18. 18 Regulation of Tattooing in Other Countries • E.U. – Tattoos are “non-food products,” not cosmetics – See Opinion of Scientific Committee on Cosmetic Products and Non-Food Products, 17 February 2000 – Pigments and implements are being assessed • Canada – Infection control guidelines – In partnership with provincial and territorial governments – Developed for tattoo practitioners • Australia and New Zealand – Regulation is aimed at infection control – Oversight by individual States and Territories – Legislation does not address irritation, allergy, trauma
    19. 19. 19 Let’s Pause Two Minutes for Questions from the Audience
    20. 20. 20 Module 2 • Marketplace
    21. 21. 21 Marketplace – Definitions • Tattoo ink – a mixture of pigments and diluents intended for introduction into the skin • Pigments – wide variety of inorganic and organic compounds • Diluents – glycerin, propylene glycol, ethanol, witch hazel • Dyes – must be converted to pigments for use in tattoo inks to limit migration
    22. 22. 22 Inorganic vs. Organic Tattoo Pigments • Inorganic compounds are easily obtainable from natural sources (e.g., iron oxides) • However, –Iron oxides fade or change color –Historically used mercury and cadmium salts are toxic • Organic pigments first synthesized in mid- 1800s –Satisfied need for new pigments
    23. 23. 23 Advantages of Organic Tattoo Pigments • More intense colors than inorganic pigments • Give wider range of colors • Are removable with laser techniques
    24. 24. 24 Marketplace – Inks and implements
    25. 25. 25
    26. 26. 26 What percentage of people have tattoos? Multiple Choice A. 10% B. 40% C. 90%
    27. 27. 27 General Body Tattooing
    28. 28. 28
    29. 29. 29
    30. 30. 30 Fluorescent Tattoo Inks
    31. 31. 31 • General body tattoo inks • Tattoo parlors historically avoided the face ______________ ___ • Permanent cosmetics inks (face/eyes)
    32. 32. 32 Permanent Makeup • Before and after photos (Premier Pigments web site) • Eyeliner • Eyebrows • Lipliner • Full lips • Blusher • Also called micropigmentation
    33. 33. 33 Examples of Permanent Makeup EYELINER EYEBROWS MOLE
    34. 34. 34 Permanent Makeup Tattoo Machine
    35. 35. 35
    36. 36. 36 Problems with Tattoos and Permanent Makeup • Safety for skin injection has not been demonstrated • Adverse reactions have occurred • Photosensitivity is a problem • Removal is a problem
    37. 37. 37 Problems with Tattoo/Permanent Makeup Industry • Technicians diverse: amateurs to MDs/RNs • Non-medical technicians have little training in sterile techniques • Medical personnel may have limited expertise in makeup application • Beauty salons/tattoo parlors regulated by State and local Health Departments
    38. 38. 38 Permanent Makeup in Medical Setting • Injected anesthesia • Clamp secures eyelid • Calipers ensure placement • Varying artistic ability
    39. 39. 39 Tattoos/Permanent Makeup in Salon, Home, Workshop Settings • No injected anesthesia • Varying sterile techniques
    40. 40. 40 Let’s Pause Two Minutes for Questions from the Audience
    41. 41. 41 Module 3 • Adverse Reactions
    42. 42. 42 Adverse Reactions to Tattoos and Permanent Makeup • Swelling, cracking, peeling, blistering, scarring • Granulomas (small nodules of inflamed skin) • Keloids (scars that grow beyond normal boundaries) • Serious disfigurement • MRI complications
    43. 43. 43 Adverse Reactions – Granulomas
    44. 44. 44 Adverse Reactions in Sunlight
    45. 45. 45 Adverse Reactions to Surgical Removal • Laser removal – Painful – Expensive – Usually leaves scarring – Iron oxide and titanium dioxide pigments turn black
    46. 46. 46 Adverse Reactions to Permanent Makeup • 1988 to 2003 – FDA received only five reports of adverse reactions • 2003 to 2004 – FDA received more than 150 reports of adverse reactions • FDA and CDC – identified 101 patients with adverse reactions • Adverse reactions – tenderness, swelling, itching, and bumps • Clinical diagnoses – allergic or granulomatous reactions
    47. 47. 47 Adverse Reactions to Permanent Makeup
    48. 48. 48 FDA and CDC Actions • July 2 2004 – FDA alerted public to concerns with Premier Pigment brand of ink shades – “FDA Talk Paper” (press release) – Web site (archived) • Sept 27 2004 – Product line recalled by manufacturer • July 2005 – Case study in Archives of Dermatology • June 28 2007 – Letter to New England Journal of Medicine • Current web site “Tattoos and Permanent Makeup” http://vm.cfsan.fda.gov/~dms/cos-204.html
    49. 49. 49 • “The ingredients of “… “ UV Tattoo Inks: (PMMA) Polymethylmethacrylate 97.5% and microspheres of fluorescent dye 2.5% suspended in UV sterilized, distilled water with no preservatives or other additives.” • “TATTOOISTS REMEMBER - these black light tattoo inks are made with sterilized distilled waters, do not add foreign objects into your ink bottles!. This is not an alcohol based tattoo ink.” Adverse Reactions to Tattoo Inks Without Preservatives
    50. 50. 50 FDA Action – Starbrite Ink Contamination • (2004) Belgium withdrew “Starbrite Colors” tattoo ink from market because of microbial contamination • FDA analyses found bacteria (Pseudomonas aeruginosa) and mold (Acremonium) • Resulted in manufacturer recall of Starbrite ink (Class II, reversible injury) • Starbrite ink became contaminated because the manufacturer removed alcohol preservative from their ink formula
    51. 51. 51 DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596 -7700 FAX: (781) 596 -7896 March 15, 2005 Meredith Nicholson President Papillon Supply and Manufacturing 118 Pearl Street Enfield, Connecticut 06082 Recall Number: F-213-5 Dear Ms. Nicholson: The U.S. Food and Drug Administration agrees with your decision to recall the Starbrite brand Black Magic Color , packaged in individual ½ oz., 1 oz., 2 oz., 4 oz. and 8 oz. size translucent plastic, codes 7996988, 7996989. We consider the product to be adulterated as it is contaminated with Acremonium mold and Pseudomonas aeruginosa. We have reviewed your action and conclude that it meets the formal definition of a firm initiated recall. This is significant, as your action is an alternative to a Food and Drug Administration (FDA) legal action to remove your product from the market. The recall will be reported in an issue of the FDA Weekly Enforcement Report. The recall has been classified as a Class II recall. A Class II recall is defined as a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Our evaluation indicates the “Depth of Recall” should be conducted to the direct account level. Level A effectiveness checks have been assigned to your recall. Effectiveness checks are actions taken by your firm to verify that consignees at user level have received notification and have taken appropriate action. Level C effectiveness requires that your firm conduct effectiveness checks on 10% of all direct accounts contacted. We request that you submit monthly status reports until your recall is completed. The status reports should contain the information outlined in Section 7.53(b)(1-6) of the Recall Enforcement Policy.
    52. 52. 52 Problems with Tattoo Ink: Claiming FDA Approval on Web Sites • Polymethylmethacrylate in tattoo inks: “We researched scientific articles on bone repair, plastic surgery, orthodontics, body modification, and other medical uses of polymethylmethacrylate (PMMA). The PMMA is what makes this ink absolutely safe, and gives this ink its FDA Approval.” • On “Chameleon Body Art Supply” web site: http://www.crazychameleonbodyartsupply.com/bmx-1000-
    53. 53. 53 Problems with Tattoo Ink: Citing FDA Approval for Tattooing Fish • FDA letter dated April 3, 1995: “Having reviewed the information supplied by you [our manufacturer of the ink] and your supplier ... FDA would have no objection to the use of your photonic dye marking [tattooing] system ...” • On “Captain Jack’s Tattoo Studio” web site: http://www.captainjackstattoo.com/content/black
    54. 54. 54 Temporary Tattoos – Decals • Temporary tattoos are regulated as cosmetics • Declaration of ingredients is required • Approved color additives are required • Import alert – for temporary tattoos containing non-permitted (illegal) color additives • http://www.fda.gov/Cosmetics/ProductandIngredientS
    55. 55. 55 Body Decoration with Henna
    56. 56. 56 Is henna approved for use on the skin? Yes No
    57. 57. 57 Henna Tattoos and Body Decoration (Mehndi) • Henna is derived from the leaves of the shrub Lawsonia inermis – Brown, orange-brown, or reddish-brown tints • Approved color additive for coloring hair – See 21 CFR 73.2190 • Coloring the skin is an unapproved use of the color additive • Import alert – for “Henna based skin color” products
    58. 58. 58 Body Decoration with Black Henna
    59. 59. 59 Adverse Reactions to Black Henna • “Black henna” contains additional coloring ingredients – Allows darker, more intense color – Speeds up tattooing process, makes tattoo last longer • p-Phenylenediamine (PPD) may be added – A hair dye – Not approved for direct application to the skin • Allergic reactions to PPD – Potent skin sensitizer, possibly for lifetime – Allergic contact dermatitis – Cross-reactions to PABA, benzocaine, indigo • Feb 13 2007 Article in Canadian Medical Assn Journal
    60. 60. 60 Let’s Pause Two Minutes for Questions from the Audience
    61. 61. 61 Module 4 • Chemistry of Tattoo Pigments
    62. 62. 62 Chemistry of Tattoo Pigments • Basic concept of color • Inorganic pigments • Organic pigments – Insoluble organic compounds – Dyes converted to insoluble pigments • None are FDA approved for use in injections (tattoos)
    63. 63. 63 Why not use FD&C colors in tattoos? Type in the chat
    64. 64. 64 Electromagnetic spectrum www.owlnet.rice.edu/~psyc351/Images/Electroma
    65. 65. 65 Basic Concepts of Color • Interaction of visible light with a compound – Wavelengths of light – Types of atoms in the compound • Dye molecules contain electrons at many energy levels – Some of the electrons can absorb visible light – These electrons undergo transitions from lower to higher energy levels • Absorption removes some visible light – We see the complementary color
    66. 66. 66 Production of complementary colors 25.198 Peak 20 236.9 316.1 493.8 660.7 nm 300.00 400.00 500.00 600.00 700.00 25.722 Peak 10 306.6 406.8 630.2 719.5 790.5 nm 200.00 300.00 400.00 500.00 600.00 700.00 800.00 D&C Red No. 6 FD&C Blue No. 1 • 400-430 nm (violet) see yellow • 430-480 nm (blue) see orange • 480-550 nm (green) see red • 550-600 nm (yellow) see violet • 600-700 nm (red) see blue Absorption bands
    67. 67. 67 What color would you see? 25.722 Peak 10 306.6 406.8 630.2 719.5 790.5 nm 200.00 300.00 400.00 500.00 600.00 700.00 800.00 Absorptions bands: • 400-430 nm (violet) see yellow • 430-480 nm (blue) see orange • 480-550 nm (green) see red • 550-600 nm (yellow) see violet • 600-700 nm (red) see blue Multiple Choice A. Red B. Yellow C. Blue
    68. 68. 68 Absorptivity value • Measure of dye’s ability to absorb light • High absorptivity value: more efficient, more economical – Dye absorbs a large amount of energy so you only need a small amount in the product • Low absorptivity value: not as efficient, less economical – Dye absorbs less energy so more is needed in the product 400.0 500 600 700 750.0 0.00 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.08 NM A 629.56 408.42 400.0 500 600 700 750.0 0.00 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.00 nm A 644.94 FD&C Blue No. 1, α = 0.16 D&C Green No. 5, α = 0.02
    69. 69. 69 Early food and cosmetic uses of dyes and pigments • Foods colored with spices and minerals – Paprika, turmeric, saffron, iron oxides – Wine artificially colored in 300 B.C. • Cosmetics from vegetable and mineral sources – White lead – Kohl (contains lead or antimony) – Copper ore for eye shadow – Vegetable extracts for the skin • Tattooing – Charcoal, inorganic pigments
    70. 70. 70 Historically Used Tattoo Pigments • Black – iron oxide, carbon • Red – mercury sulfide, iron oxide • Yellow – cadmium sulfide, iron oxide • Blue – cobaltous aluminate, ferric ferrocyanide • Green – chromium oxide, chromium hydroxide • White – titanium dioxide
    71. 71. 71 Historically Used Minerals in Tattoo Pigments • Black – Magnetite (FeO•Fe2O3) – Charcoal (C) • Red – Hematite (Fe2O3) – Cinnabar (HgS) • Yellow – Limonite (FeO•OH•nH2O) • White – Corundum (Al2O3) – Rutile (TiO2) – Zincite (ZnO)
    72. 72. 72 FDA Analyses of Inorganic Pigments in Tattoo/Permanent Makeup Inks • Samples of sixty-three tattoo/permanent makeup inks from three different manufacturers • Analyzed by x-ray fluorescence spectrometry • Results found Ti, Al, and Fe to be most common • Historically reported Hg, Cd, Co, and Ni were not found
    73. 73. 73 Inorganic Elements Found in Tattoo Pigments • Black – Fe • Gray – Fe, Ti, Al • Brown – Fe, Ti, Al, Ca • Blue – Ti, Al, Cu • Green – Fe, Ti, Al, Ba, Br, Cr, Cu • Red and Magenta – Ti, Al, Fe • Orange – Ti, Fe, Al • Yellow – Ti, Fe, Al • White – Ti, Al
    74. 74. 74 FDA Analyses of Organic Pigments in Tattoo/Permanent Makeup Inks • Samples of thirty-five tattoo/permanent makeup inks analyzed from four different manufacturers • Compounds in inks extracted and separated by HPLC • Organic pigments identified by comparison of UV- visible spectra and HPLC retention times with reference standards • Results showed mixtures of organic pigments from different chemical classes
    75. 75. 75 Organic Pigments in Tattoo/Permanent Makeup Inks Chemical Class Quinacridone Monoazo Arylide Sample Pigment Brown 25 Pigment Orange 36 Pigment Orange 62 Pigment Red 170 Pigment Red 22 Pigment Red 122 Pigment Yellow 74 1 x x 2 x 3 x x x 4 x x 5 x x 6 x x 7 x x x 8 x x x 9 x 10 x x 11 x 12 x x 13 14 x 15 x 16 x 17 x 18 x 19 x 20 x x 21 x x 22 x x 23 x x 24 x x 25 x x 26 x 27 x 28 x x 29 30 x 31 x 32 x 33 x 34 35 **Other unidentified peaks were found Benzimidazolones Monoazo Naphthol
    76. 76. 76 Organic Tattoo Pigments – Dye Structures • Anthraquinone • Azo, Disazo • Benzimidazolone • Indigoid • Phthalocyanine • Quinacridon e
    77. 77. 77 C.I. Pigment Red 83 • C.I. 58000 • CAS No. 72-48-0 • Alizarin Red • Anthraquinone dye • 1,2-Dihydroxy-9,10- anthracenedione
    78. 78. 78 C.I. Pigment Red 170 • C.I. 12475 • CAS No. 2786-76-7 • Fast Red F5RK • Monoazo dye • 4-((4-(Aminocarbonyl) phenyl)azo)-N-(2- ethoxyphenyl)-3-hydroxy- 2- naphthalenecarboxamide
    79. 79. 79 C.I. Pigment Orange 16 • C.I. 21160 • CAS No. 6505-28-8 • Dianisidine Orange or Benzidine Orange R • Disazo dye • 2,2'-((3,3'-dimethoxy (1,1'-biphenyl)-4,4'- diyl)bis(azo))bis(3-oxo-N- phenyl-butanamide)
    80. 80. 80 C.I. Pigment Yellow 151 • C.I. 13980 • CAS No. 31837-42-0 • Fast Yellow H4G • Benzimidazolone and monoazo dye • 2-[[1-[[(2,3-Dihydro-2- oxo-1H-benzimidazol-5- yl) amino]carbonyl]-2- oxopropyl]azo]benzoic acid
    81. 81. 81 C.I. Pigment Violet 32 • C.I. 12517 • CAS No. 12225-08-0 • Brillfast Vivid Magenta • Benzimidazolone and monoazo dye • N-(2,3-dihydro-2-oxo-1H- benzimidazol-5-yl)-4- [[2,5-dimethoxy-4- [((methylamino)-sulfonyl]- phenyl]-azo]-3-hydroxy-2- naphthalene-carboxamide
    82. 82. 82 C.I. Pigment Blue 66 • C.I. 73000 • C.I. Vat Blue 1 • CAS No. 482-89-3 • Indigo • Indigoid dye • 2-(1,3-Dihydro-3-oxo-2H- indol-2-ylidene)-1,2- dihydro-3H-indol-3-one
    83. 83. 83 C.I. Pigment Blue 15 • C.I. 74160 • CAS No. 147-14-8 • Copper phthalocyanine • Cyan Blue GTNF or Heliogen Blue 7044T • Phthalocyanine dye • Copper, (29H,31H- phthalocyaninato(2-)- N29,N30,N31,N32)-
    84. 84. 84 C.I. Pigment Red 122 • C.I. 73915 • CAS No. 980-26-7 • Acramin Scarlet LDCN or Fastogen Super Magenta R • Quinacridone dye • 5,12-Dihydro-2,9- dimethylquino(2,3- b)acridine-7,14-dione
    85. 85. 85 Tattoo Pigment Photodecomposition Studies • FDA’s National Center for Toxicological Research (NCTR) • Cui, Y., Spann, A. P., Couch, L. H., Gopee, N. V., Evans, F. E., Churchwell, M. I., Williams, L. D., Doerge, D. R., and Howard, P.C., “Photodecomposition of Pigment Yellow 74, a Pigment Used in Tattoo Inks, Photochemistry and Photobiology, vol. 80, pp. 175 -184, 2004
    86. 86. 86 Photodecomposition of Pigment Yellow 74 in simulated solar light N O O O CH3 NH N O CH3 NH O O H3C O CH3 NH O O H3C N O O O CH3 NH2 N O CH3 NH O O H3C HO
    87. 87. 87 N O O CH3 N N HO NH O N O O CH3 NH2 HO NH O N O O CH3 Photodecomposition of Pigment Red 22 in 532 nm Nd:YAG laser light
    88. 88. 88 Tattoo Pigments and Color Additives Indigo (tattoo pigment) 21 CFR 74.101 and FD&C Blue No. 2 21 CFR 74.3106 (for use in food, drugs, D&C Blue No. 6 cosmetics, sutures, (for use in sutures only) and bone cement)
    89. 89. 89 Tattoo Pigments and Color Additives • C.I. Pigment Blue 15 • Copper phthalocyanine • 21 CFR 74. 3045 [Phthalocyaninato(2-)] copper (for use in sutures only)
    90. 90. 90 Tattoo Pigments and Color Additives • Aluminum oxide – 21 CFR 73.1010 • Carmine – 21 CFR 73.100 – 21 CFR 73.1100 • Iron oxides – 21 CFR 73.2250 – 21 CFR 73.3125 • Manganese violet – 21 CFR 73.2775 • Mica – 21 CFR 73.1496 – 21 CFR 73.2496 • Titanium dioxide – 21 CFR 73.575 – 21 CFR 73.1575 – 21 CFR 73.2575 – 21 CFR 73.3126 • Ultramarines – 21 CFR 73.50 – 21 CFR 73.2725 • Zinc oxide – 21 CFR 73.1991 – 21 CFR 73.2991 • Luminescent zinc oxide – 21 CFR 73.2995
    91. 91. 91 Conclusions • Marketplace – Wide variety of inorganic and organic pigments and diluents in tattoos and permanent makeup • Adverse reactions – and FDA responses • Chemistry – Some tattoo pigments have been shown to photodecompose – C.I. Pigment Yellow 74 – C.I. Pigment Red 22 • Misleading web sites!!! No pigments have been approved by FDA for tattooing humans
    92. 92. Thank you to the sponsor of tonight's Web Seminar:
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    95. 95. 95 National Science Teachers Association Dr. Francis Q. Eberle, Executive Director Zipporah Miller, Associate Executive Director Conferences and Programs Al Byers, Assistant Executive Director e-Learning LIVE INTERACTIVE LEARNING @ YOUR DESKTOP NSTA Web Seminars Paul Tingler, Director Jeff Layman, Technical Coordinator
    96. 96. 96 • NSDL: Thinking Like a Scientist: Teaching and Learning Through Current Science Issues January 12, 2010 • Toshiba/NSTA How to Avoid Disqualification in ExploraVision January 13, 2010 • NOAA: Monitoring Climate Change from Space January 14, 2010
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    98. 98. 98 Q and A with the Presenter(s)
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