SPCP Delegates Attend the FDA
Science Forum
SPCP- May, 2006
Kathleen Ciampi, CPCP
Elizabeth Finch-Howell, CPCP
Dixie Medford, CPCP
Upon notification of
the FDA Science Forum, April 18 - 20, 2006 in Washington, DC by our FDA
contact person who works continually with former Health and Safety Chair,
Mary Arnold-Ronish, CPCP, plans were immediately set into motion for the
SPCP to represent the permanent cosmetics industry at this event. Most
importantly, Executive Director, Kate Ciampi, CPCP, President Dixie Medford,
CPCP, and Director Elizabeth Finch-Howell, CPCP attended to hear and
participate in one of the breakout sessions: Body Markings: Tattoos,
Permanent Make-up and Laser Removal. The session covered the FDA interest
in regulatory status, chemistry, adverse events associated with Premier
Pigments, and the dermatological implications of tattoo removal.
The session was opened
and speakers were introduced by Paul Howard, Ph.D., Photosciences
Laboratory, NCTR, FDA. Dr. Howard has studied tattoo pigments for a
long time and SPCP Director Elizabeth Finch-Howell, CPCP has corresponded
with him for nearly the past two years on pigment issues.
Linda Katz, M.D.,
M.P.H., Director, Office of Cosmetics and Colors, CFSAN, FDA,
presented on the regulatory status and
knowledge gap in tattooing. Dr. Katz explained how the FDA originally
became involved with cosmetics in 1938 as a result of injury with eyelash
dye. Since that time under the Food, Drug, and Cosmetic Act and the Fair
Packaging and Labeling Act, certain information must appear on the labels of
cosmetic products.
The FDA does consider
that tattoo inks are professional use cosmetics and the pigments used in
them are unapproved color additives. 21 CFR 70.5 b are color additives used
in injections and no color additives are approved or listed in 21 CFR for
tattoo use, as safety has not been demonstrated. The FDA does not
traditionally regulate tattoo inks or the pigments used in them because of
other public health priorities and a previous lack of evidence of safety
concerns or problems prior to the 2003 onset of Premier Pigments reactions.
Until that time problems were centered on client dissatisfaction. Also the
practice of tattooing is regulated by state jurisdiction. So while labeling
controls do not specifically affect our industry, the information was
interesting and we feel very much “ahead of the game” in that the SPCP does
have its own packaging and labeling requirements.
The FDA conducted
inspections and follow-up regarding the Premier Pigment Allergies through
2005, examined records, and discussed recall procedures. They collected and
analyzed samples of ink shades to determine the identity of the pigments as
well as conducted experimental work on photocytotoxicity of selected
pigments. An allergic reaction case study was also presented. Overall the
concern was with the allergic reactions, ink shades [pigments] were of
organic nature rather than iron oxide. In summary of Dr. Katz’s
presentation, she stated that tattoo inks are professional use cosmetics.
Ink diluents or suspending agents are cosmetic ingredients and no pre-market
approval is required; however, ink pigments are color additives, therefore
pre-market approval IS required.
Bhakti Petigara,
Ph.D., Office of Colors and Cosmetics, CFSAN, FDA,
spoke on “The Marketplace:
Chemistry.”
The chemical makeup of
tattoo pigments used today was presented. Dr. Petigara spoke on the wide
variety of grades of organic and inorganic pigments. She explained there are
differences between a dye, a pigment, and a lake. As a side note, it is
common knowledge to us that a color additive is any dye, pigment or
substance that can impart color when added or applied to food, drug or
cosmetics or to the human body. Lake colors are a blend of dyes and
pigments such as disazodiarylide (orange), disazodiarylide (yellow). FD&C
Blue #1 Aluminum Lake is considered organic. Synthetic organic pigments are
carbon-based molecules manufactured from petroleum compounds, acids, and
other chemicals, usually under intense heat or pressure. They are made by
taking a pigment substrate such as calcium, barium, aluminum or sodium and
dying it with one of the various dyes. Dyes are color additives that are
soluble in a medium such as water, alcohol, glycerin or oils. Pigments are
color additives that are insoluble in mediums such as sand in the ocean.
People have been
placing color in their skin for a very long time and through the years a
generally accepted list of color additives that are expected to perform well
and to be safe have been used.
Pigments can be
purchased which are “cosmetic grade” or not. Cosmetic grade pigments are
refined to help reduce known hazardous elements such as lead and arsenic.
Dr. Petigara emphasized that at this time the FDA does not regulate the
colors used in tattooing. Tattoo inks are for professional use and not
generally sold to retail consumers; therefore there has been no requirements
placed on the manufacturers and the pigments are unapproved color additives.
Inks are sold by brand name and not by chemical composition. One
manufacturer red might be Monazo Napthol in an alcohol/glycerin base or it
might be Cadmium Red in a propylene glycol/wax base. There has been no way
of knowing, which make labeling important.
Of great interest were
several slides presented that showed false advertising claims made by a
popular “fluorescent” pigment manufacturer. Some of these claims stated or
alluded to FDA approval. Quotes from an FDA letter were actually taken out
of context:
“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 ...” The FDA reported they were actually
referring to it being acceptable for marking fish, not humans.
Masja Straetemans,
Ph.D., National Center for Environmental Health, CDC, Atlanta,
spoke on “Adverse Events: Premier Case
Study.”
She presented an
overview of the industry and stated there are at least 25 permanent cosmetic
pigment manufacturing companies. The study was a result of the allergic
reactions that had been reported to the FDA in 2004 and 2005 with a total of
259 adverse event reports. She explained that an adverse reaction included
pain, swelling, bumps, cracking, bleeding, fluid, itching, burning,
tenderness, scabbing, blisters, and peeling.
The case study had
eighty-eight potential cases. Over the next few months several more cases
were added for a total of ninety-two, which include four technicians that
qualified for the study. The average age group was fifty-four years old.
Seventy-six percent had a history of reported allergies. Out of 120 ink
shades, 113 shades were Premier colors. Seventy-seven of the cases showed a
reaction to Premier True Colors (73%). There were others that showed
reactions to Enhanced True Color (2 cases) and Premier Original Colors (4
cases), and both combined (2 cases.) It was determined that an individual
of previously reported allergies is seven times more likely to result in a
reaction. It was presented that there is a need for allergenicity tests of
ink shades before they are released to market and people with a history of
allergic reactions should consult their doctor prior to having a tattoo.
The test for
benzidimidalazone (benzimidazole) reaction in Premier pigment was reported
as negative. Reaction from photo toxicity also proved to be negative. Dr.
Straetemans indicated the FDA would continue its study on the Premier
allergic reactions.
Rox Anderson, M.D.,
Professor in Dermatology, Harvard Medical School,
Director, Wellman Center for Photomedicine, Massachusetts General Hospital,
Boston, MA, presented:
Dermatological Implications: Tattoo Removal.
Dr. Anderson discussed
the successes and failures of laser tattoo removal and overall, the
disappointment of not obtaining the desired results with even the latest
technology. Currently, laser can remove only seventy-five percent of
pigments and they do not know why. One of the problems is not all chemicals
in the pigments are detectable. The inks are impure mixtures that are
injected by the artist. It was reported that about half of the ink cleared
via the lymph nodes and the ink left in the resident skin cells make up the
actual “tattoo.”
Our research reveals
there are many medical laser systems available today, but they all use the
principal of selective photothermolysis, which means getting the right
amount of the right wavelength of laser energy to the right tissue or matter
to damage or destroy only that tissue or matter, and nothing else. The
selective light absorption is a fast local heating for selective damage.
What happens to the ink or carbon is thermal stress and fracture. The
light pulses are absorbed by the intracellular pigment particles, and they
reach extreme temperatures. The particles fracture, undergo chemical
changes, violently boil water in the cell cytoplasm, rupture the cells, and
release laser-altered ink in the dermis. This is called a transepidermal
eliminator. Lymphatic uptake is noted in the lymph system because some of
this free ink is eliminated by lymphatic and transepidermal transport.
Lymphatic transport seems to account for most of the ink removal. Scarring
is always a possibility and scarring may be present prior to any treatment
for removal.
Pigments vary widely in
size and structure. Elements also vaporize at different heats further
making even removal difficult. Green is still the most difficult color to
remove according to Dr. Anderson.
Dr. Anderson reported
that efforts are in place to create safe, removable ink. Freedom 2,
will be a composite microencapsulated with biocompatible materials.
Ideally, these materials will be removable with complete safety and no
residual effects. Dr. Anderson would like to study what pigments cannot be
removed. Permanent cosmetics is clearly a rapidly growing industry and this
information may be helpful so as to have choices in the selection of
pigments.
After the question and
answer session we were able to verify several points speaking to the
presenters personally. While Dr. Straetemans reported that pigments cannot
be washed off and are considered permanent, permanent cosmetics color will
fade away after 3-5 years, she did not realize this was not the norm but an
inappropriate end result in a very small percentage of procedures. All
tattoo pigments fade and “fading away” was inappropriately stated. She was
thankful for the information provided.
Interestingly, the FDA
reported they did not find lead in tattoo pigments while there have been
reports contrary to this.
A wonderful outcome of
this event is that Dr. Rox Anderson has agreed to be part of the SPCP
Medical Advisory Board. We are both honored and grateful for his acceptance
of President Dixie Medford’s request.
