The Unregulated Permanent Cosmetics Industry

Permanent Makeup Regulation

                  Permanent cosmetics, or micro cosmetics, is a group of procedures that focus on providing semi- permanent ‘makeup’ enhancements on areas such as the areas, lips, and eyes. Micro cosmetics can include eyebrow micro shading and microblading, permanent eye makeup such as eyeliner and lip blushing. The benefits of these procedures includes enhancing one’s features or covering any imperfections. Individuals may also choose to receive a micro cosmetic procedure because it reduces the amount of time it may take them to get ready in the mornings.

                  Microblading is a procedure that uses pigment to create hair- like strokes using stacked needles in a manner like tattooing. The needles deposit ink into the epidermis to create small incisions to create the illusion of hair. The needle used penetrates the epidermis up to 0.15 millimeters (mm), which is considerably more superficial than a tattoo needle, which can penetrate the epidermis at 1mm to 2mm (NiceBrows). This procedure relies on shaping the eyebrows and creating a fuller appearance, thus framing the face in a more flattering manner. Side effects include itching and scabbing as the skin heals after the procedure. Rarely, scarring can occur as well. Appropriate aftercare includes allowing the area to heal properly, applying A&D ointment as an occlusive, keeping the area clean and dry, and avoiding harsh products or makeup during the healing process, as well as avoiding sun exposure for up to 1 month.

Micro shading is similar to microblading; however, this technique creates a more defined brow shape by shading the full eyebrow without going as deeply into the epidermis. This technique is also known as ‘powder brows’ because it looks as though the eyebrow has been filled in with a powder product. Like microblading, a needle deposits pigment into the epidermis to create this effect. The same aftercare steps are followed as with microblading.

Tattooed eyeliner uses pigment to create a line on the superior or inferior lash line of the eyelid. This allows the lashes to have a fuller appearance. Side effects include local irritation, itching and swelling. More severe reactions include necrosis of the area, loss of eyelashes and

Lip blushing relies on depositing pigment using quick hand motions using a needle. This defines a patient’s lip shape and can make the lips appear fuller and more tinted. Individuals may prefer this procedure as an alternative to adjunct to lip fillers, with the addition of enhancing the natural color of their lips if they face discoloration in that area as well.

Side effects of these procedures are usually local and self- resolving. One can most commonly experience itching, scabbing and mild swelling of the area on which the procedure was completed. More severe side effects include allergic reactions and infections. This may be due to the equipment, or pigments used, which are unregulated by the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition). There are clinical reports of patients having granulomatous chronic allergic reactions for up to 3 years after receiving permanent makeup procedures with a line of ink that was recalled in September 2004. The FDA does not have the regulatory authority regarding the pigments in tattoo and permanent makeup ink due to lack of safety concerns, however, there are multiple documented hypersensitivities to pink and black pigments causing chronic dermatological allergies in patients that have received permanent makeup (Straetemans M).

Additionally, permanent makeup tools can be improperly sterilized and cause infections, such as mycobacterium. This may be a concern when individuals providing the procedure may not properly clean or replace their tools, whether in a private or business setting. It is important to consider and inquire about sterility before possibly receiving a procedure from an esthetician.

Ultimately, the lack of regulation regarding the use of the tools, pigments, and color additivies is what can make permanent cosmetic procedures more harmful than beneficial for patients. There is no overseeing entity to inspect these procedures and products. Only in retrospect after side effects are reported to the FDA, does the FDA investigate and potebntiually intervene with recalls or other measures. It is important to emphasize to patients the potential dangers of these procedures, their increased risk if they have food or contact dermatitis allergies to any dyes or color additives. Additionally, doing thorough research on the types of products, techniques, and equipment that an esthetician uses may help the patinet avoid any unwante dor unneeded side effects.

As pharmacists, we can explain to patients the dangers of unregulated products and procedures and the negative consequences. Additionally, we can provide education on preventive measures and aftercare if patienst do choose to receive permanent makeup. Lastly, as pharmacists we have the ability to lobby and advocate for increased regulation in an area of growing popularity.

Citations:

Center for Food Safety and Applied Nutrition. “Tattoos & Permanent Makeup: Fact Sheet.” U.S. Food and Drug Administration, FDA, June 2015, www.fda.gov/cosmetics/cosmetic-products/tattoos-permanent-makeup-fact-sheet#:~:text=However%2C%20because%20of%20other%20competing,pigments%20used%20in%20tattoo%20inks. 

NiceBrow. “Frequently Asked Questions (FAQ).” NiceBrow Microblading, 26 Feb. 2023, nicebrow.com/faq/#:~:text=Microblading%20penetrates%20the%20skin%20to,of%20the%20skin%20%2D%20the%20dermis. 

Straetemans M, Katz LM, Belson M. Adverse reactions after permanent-makeup procedures. N Engl J Med. 2007;356(26):2753. doi:10.1056/NEJMc063122