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.