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FDA CONSUMER ALERT

Posted by Sandi Hammons on

The FDA is alerting consumers, microblading artists, permanent makeup artists, tattoo artists, physicians, and distributors of permanent makeup and tattoo inks of the potential for serious injury from use of permanent makeup inks and tattoo inks that are contaminated with bacteria. The colors listed include those manufactured and/or distributed by Scalp Aesthetics, Dynamic Color Inc. and Color Art, Inc.

For specifics about the products involved, visit the FDA site: FDA SAFETY ALERT 

In addition to FDA's Consumer Alert Premier Pigments is alerting practitioners to the potential risks of migration, allergic reactions, blurring and “bluing” from the use of tattoo inks advertised as “safe” for permanent makeup applications. Certain permanent makeup tattoo inks can and have resulted in adverse events including tattoo inks advertised as “pre-modified”.

Additionally, technicians need to know that colorants currently advertised as “organic” and/or “vegan” are, in fact, chemicals with known and sometimes unknown health risks.

The advertising term “vegan” is misleading and nonsensical when applied to colorants. The terms “vegan” and “organic” have very specific meanings related to the food we eat and, while they have positive associations in the public’s mind; they have either a different meaning or no relevant meaning at all when discussing cosmetic tattoo pigments. “Organic” is used to describe food free of pesticides. “Organic” pigment simply means “carbon-based” and has no relationship to safety, longevity or healthy.

For years, numerous supply companies have falsely advertised iron oxides as, “long-lasting”, “natural”, “organic”, “semi-permanent” or “FD&C approved”. These claims are blatantly false. Iron oxides are notorious for fading and changing color. Light brown iron oxides often turn peach or pink, dark browns turn pink or purple and taupes frequently turn blue. But, to call them “semi-permanent” is misleading as the undesirable long-term results usually remain forever unless they are removed, covered or lasered out.

There are no permanent cosmetic dispersions currently on the market that are “100% organic” as all organic pigments are formulated with inorganic colorants. The claim that some permanent cosmetic dispersions on the market that are “100% organic” is, in fact, “100% misleading” as all organic pigments must bind with inorganic colorants to be stable.

One manufacturer advertises: “Our colors yield 90% pigment retention”. While some colorants yield a higher pigment retention than others; this claim is exaggerated to the point of making it “90% Wishful Thinking”.

It is becoming easier and easier to jump into the market as a supplier and the explosion of untested tattoo inks and unregulated foreign suppliers have made experimenting with new products riskier than ever before.

Tattoo inks that have proved reliable and safe for body art can have disastrous results when used for cosmetic tattooing on the face. The latest “fad” colors can turn into painful “learning lessons” for vulnerable consumers and naive technicians.

WE WANT TO HELP!

We specialize in corrective permanent makeup. If you are an unhappy consumer with a procedure you don’t like; we can help you find a qualified technician. Call (800) 642-1096 for information.

As a courtesy to our technician customers and in the interest of promoting safety in the permanent cosmetics and microblading professions, we are including all the pigments mentioned in the advisory in our PIGMENT EXCHANGE program.

Send us any recalled, contaminated, old or out-of-date pigments or tattoo inks to Premier and we will give you 50% off any of our colors in exchange. Call us at (800) 642-1096 for details and to take advantage of the PIGMENT EXCHANGE program.


Any products we receive related to the advisory will be forwarded to the respective manufacturers to aid them in complying with FDA directives.

Thanks!


Sandi