Scalp micropigmentation (SMP) is an advanced technique that employs specialized inks and needles to create the illusion of hair follicles, effectively restoring a fuller and thicker appearance to the scalp. The question of safety naturally arises—what is the stance of the Food and Drug Administration (FDA) on this process? Is the FDA taking any measures concerning SMP pigments that may have adverse effects?

Understanding Scalp Micropigmentation (SMP)

SMP involves the precise placement of pigmented follicles on the scalp, resulting in the appearance of stubble or a denser hair cover. Similar to tattooing, microdot tattoos are strategically applied to the scalp, achieving the desired aesthetic effect.

Exploring FDA’s Involvement with SMP Pigments

Recent updates have highlighted the FDA’s actions against certain SMP brands and the removal of specific SMP pigments from the market due to potential health risks. This prompts the question: does the FDA consider ink pigments a health hazard? Let’s delve into this matter.

The Regulatory Landscape

An incident from 2014 garnered attention when White & Blue Lion, a company, recalled tattoo inks and needles due to the risk of bacterial infections. This event underscored the need for stringent oversight over SMP-related products.

However, a challenge arises with SMP—the absence of federal regulations governing tattoo or SMP ink composition. This stems from the FDA’s jurisdiction, which primarily covers substances applied onto the skin’s surface, not those implanted beneath it. As SMP pigments fall under the cosmetic category, they do not fall within the FDA’s purview.

A Closer Look at SMP Pigments

News of the FDA removing specific pigments or taking action against certain brands should be taken with caution. The legitimacy of such reports should be verified before drawing conclusions.

Nevertheless, it’s a misconception to assume that SMP companies have unrestricted use of pigments. FDA regulations under Title 21 Parts 73 & 74, subpart D outline a list of safe pigments for use in medical and surgical devices.

Safety Concerns and Industry Responsibility

Questions about the safety of pigments employed in SMP have arisen, particularly regarding potential carcinogenic elements. While SMP providers often claim to use organic and hypoallergenic products, the lack of transparency regarding product composition raises concerns.

Commonly used pigment components include ethyl alcohol and propylene glycol, a derivative of petroleum. Due to the absence of comprehensive FDA guidelines on chemical usage and ingredient disclosure, the responsibility of choosing a reputable SMP provider lies with the customers.

Prioritize Your Health and Safety

When considering SMP, it’s imperative to choose an established and trusted brand with a solid track record. Thoroughly review testimonials before selecting a provider. After all, your well-being is paramount, and careful decision-making ensures a safe and satisfactory procedure.