The iron oxide compounds typically found in inexpensive pigments are approved by the FDA for use in foods, drugs and cosmetics applied daily; but, these ingredients are inappropriate for use in permanent cosmetic applications.
The use of Iron Oxides in permanent cosmetics may only be due to its extremely low cost and its approval by the FDA for use in foods, drugs and conventional cosmetics; allowing unscrupulous manufacturers just enough legal license to deceive the public into believing that their products are approved for use under the skin.
Iron oxide is a binary compound consisting of iron and oxygen, most commonly seen as rust, hence the base colors , reds and browns. Iron oxide based pigments implanted in the lips or brows will sometimes disappear in a few days or worse, turn pink or purple in a few months. Pigments are no more magical than the ingredients that build them; therefore it is nonsensical to believe that implanted pigment could perform a disappearing act.
The inexperienced technician will too often blame their technique for lack of a better reason.
Mapping the mechanics of a permanent cosmetic procedure, Dr. Narayan Hosmane, professor of inorganic chemistry theorized that iron oxide, when broken down, is both iron and oxygen, elements common to the hemoglobin found in human blood cells. The dermal layer of the skin is lined with blood vessels. When iron oxide or any pigment is implanted into the blood cells, it is interacting directly with the hemoglobin in each cell. The body, performing its natural functions and processes, does not distinguish iron in pigment to be any different from iron in blood and accepts part of the iron oxide base into the blood vessel. Therefore part of the pigment base is absorbed by the body as it would a Geritol iron supplement.The remaining cosmetic color will disperse in the dermal layer either leaving a faint pink discoloration or disappearing completely.
Technicians seeking natural pigments must understand that any natural pigment can be processed through the blood, much like food and therefore cannot be used to achieve a permanent color. Any technician performing procedures with iron oxide pigments is doing a disservice to themselves as well as their client. The client is paying a large sum for a procedure that will not be permanent and the technician is wasting valuable time doing repeated touch-ups.
Permanent cosmetic enhancement can be one of the most lucrative services the beauty industry can offer; it has the opportunity for enormous growth. However, technicians who insist on using inferior pigments may see the business opportunities vanish along with the pigment they implant.
FDA Science Forum
During the FDA’s annual Science Forum, Dr. Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors, presented an overview of allergic reactions to permanent pigments through a historical prospective.
“Allergic reactions and photosensitivity were a problem with the inorganic (i.e. iron oxide) pigments as were color challenges. These problems prompted a need for new pigments. Many colorants used in permanent cosmetics and tattoo formulations are manufactured for industrial purposes and also, there are a wider variety of organic pigments being used and different grades which is leading to more contaminants in them. This can lead to unknown identity and unknown safety issues.”
Bhakti Petigara, Ph.D., from the Office of Colors and Cosmetics, additionally said, “Historically, iron oxides were used in permanent makeup tattoos. But there was a need or a desire for more stable pigments,” said Petigara. “And that is because iron oxides fade and change color over time. Organic pigments are used because they are more stable than iron oxides. These organic pigments are used for plastics and paints and they are known to have brighter colors and a wider range of colors. The safety has not been demonstrated for these pigments and they are manufactured for purposes other than contact with the skin.”
“The industry’s movement from the use of inorganic metals (e.g. iron oxides, HgS, inorganic salts, etc.) to more organic based pigments isn’t limited to fading colors,” says the FDA. The agency cites safety considerations associated with iron oxides. Several reports documented by the FDA describe intense burning during magnetic resonance imaging of individuals tattooed with iron oxides.
Some Alliance members argue the FDA assertion of MRI burns associated with iron oxide pigments is inaccurate. However, the FDA states there has been no safety demonstrated regarding MRIs and iron oxides.
R. Rox Anderson, M.D., Professor of Dermatology at Harvard Medical School, discussed the dermatological implications of tattoos and tattoo removal at the FDA’s discussion.
“The pigments that react during an MRI are all iron oxides,” said Anderson. He then further explained that iron oxide particles migrate to the lymph nodes, where they “light up” during an MRI.
Anderson also described iron oxide reduction reactions as they pertain to laser removal. According to him, laser can remove only seventy-five percent of pigments, even with the latest technology. He listed iron oxides, titanium and yellow irons as colors that will darken under laser but cannot be removed. Anderson cited a case where one woman wanted to remove a barely visible lip line that she didn’t like. “The faint pink iron oxide turned black following laser and the black color required surgery to remove it.” Anderson explained the reason for the darkening is due to a reduction reaction of Ferric Oxide.
Vernon Porter, PhD, material safety chemist, also noted the reduction reactions with ferric oxide: “The reason iron oxide browns turn to pink is due to a reduction reaction. Iron Oxide (Fe2O3) turns into Ferrous Oxide (FeO) and then Fe by reduction. Fe is reddish in nature and when implanted in the skin after a few months, it will appear pink.”
“Still,” argue some vendors, “iron oxides offer manufacturers a wider palette of colors to choose from.” It is easier to formulate eyebrow colors from iron oxides because they are mostly brown and flesh colored in nature. But the idea that permanent cosmetic vendors think that iron oxides are “hypoallergenic” and therefore, more safe just because they are FD&C approved is a misconception. One recent claim from a vendor said, “Iron oxides are FDA approved for uses in food, drugs and cosmetics and therefore hypoallergenic and safe for use in permanent cosmetics.”
Not true! says FDA’s, Dr. Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors. “There are no pigments that have demonstrated safety. The FDA does not approve of any pigments for use in the skin.”
Petigara of the FDA cited similar claims on numerous websites; “There are misleading websites and misleading information. People are misinforming the public and implying FDA approval.” Here’s a quote taken from a tattoo pigment manufacturer’s website:
“We research scientific articles on bone repair, plastic surgery, orthodontics, body modification and other medical uses of polymethylmethacrylate but PMMA is what makes this ink absolutely safe and gives this ink its FDA approval.”
Petigara said, “It makes no sense. Just because it was approved for medical uses does not mean it is approved for tattoo inks. This is misinforming the public and its users.”
Another vendor makes this claim: “Our pigment brands contain only FDA Approved Certified Cosmetic Ingredients manufactured by a U.S. State Certified Cosmetic Establishment with over 20 years of pigment formulation experience. Color ingredients used in our brands may contain FD&C (Food, Drug & Cosmetic), D&C (Drug & Cosmetic) pigment/dyes, Ultramarines, Titanium Dioxide, Chromium Oxide Greens and Iron Oxides.”
This information is misleading. Just because the ingredient is FDA approved for use in foods, drugs and cosmetics does not mean the product is FDA approved for injection into the skin.
William Lowry, PhD, toxicologist and consultant to the Alliance, “Nickel is a widely know allergen. Nickel can and has been found in both inorganics and organics.
Masja Straetemans, Ph.D., Epidemic Intelligence Service Officer for the Center for Disease Control recommended manufacturers test products for the presence of metals that are commonly known to result in allergic reactions. “There is a need for allergenicity tests of ink shades before they are released to the public. And people with a history of allergies should consult their doctor prior to having a tattoo.”
Manufacturers of permanent cosmetics need to understand there is a need for different pigments used in the face because the face is more sun exposed than other areas of the body. Sun exposure can lead to phototoxicity and photoallergenicity.
Material safety chemist, Vernon Porter, Ph.D., also suggests purifying pigments. Others on the panel for the Committee for Safe Practice emphasize educating manufacturers, and implementing manufacturing and safety testing protocols.