MoCRA 2022 - The End of Tattoo (maybe)...unless...we go about our usual and normal business using what we have always used: safe and effective pigment inks.

Source material expose the truth about pigments.

Our Synthetic Organic Color Pigments are to be removed from the market so that Lasers can more easily remove all tattoo$.
The Legislature passed the Act to give the FDA deniability.

Laser removal is the problem, not the pigments.

Blue 15 is the most produced color because the pigment crystal is virtually impervious to destruction. Why do you think blue jeans are blue? Blue 15 pigment does not disintegrate in almost any medium, including the body. Words to the contrary have no evidence,  Medical school teach that we use toxic chemicals as ink, like mercury and make would-be dermatologists memorize the names to dissuade patients from being tattooed, and surprise even now the CDC suddenly goes 10 degfrees warning about infections from tattoos even though there is no greater infectios of tattoos than anything else (they used to give tattoo a pretty clean slate - - a sudden change without evidence).

Dear Friends,

The end of Independent Tattoo Ink Producers.
MoCRA 2022 will monopolize the tattoo ink market by large scale producers (as is now going on). It is accepted that more stringent oversight is necessary for large commercial ink producers because of the order of magnitude of the tattooed who can be affected by their products. There are many independent small batch (400 to 800 oz. per lot) tattoo ink producers who cannot afford the costs to meet the regulations and would not even be able to obtain the pigments only available by licensing by the FDA..

The rational to regulate tattoo used to be based on the horrors of "infection" with HBV, Hepatitis C, and other strange sounding diseases. Today, this argument is all but abandoned because infections are rare and most easily treated. But, it is being used, as step one in a 2-step propaganda technique.

Step one in propaganda presents " a truth " that you already know as a truth, such as tattoos can become infected. Add disturbing pictures and it sets your emotions that tattoos cause horrors.

Propaganda Step 2 introduces the lie: tattoo inks possibly contain infectious materials, or the needles, or the artist can give it and the ink may have toxic substances that are a threat to health, carcinogenic, toxic, mutagenic. With the pictures you accept the lie.

Listen to this interview by very well respected EU Dermatologist, Christa de Cupyer who is credited with spurring this the Tattoo ink makeover.  This interview talks about the dangers of Tattoos and Piercings with comments by [ww.]

European Academy of Dermatology and Venereology (EADV)
January 13, 2016.  Recorded

Questioner: How can a Tattoo get infected?

deC: Oh, there are different sources for infection.
The tattooist can just make infection;

[ww. There is no evidence the tattooists can infect a client directly. Only one case is known of someone with no gloves, sores on his hands, tattooing in a public park. It is plainly not likely so this is an anecdotal case only.]

deC: the patient himself can carry some bacteria on his skin

[ww.Tattoo ink has alcohol which kills bacteria. The bacteria on the skin has no open skin wound to migrate to and is constantly being surface wiped. This anyone should be able to see as part of the procedure. Tattooist believe the skin bacteria of others after they leave the studio may cause an infection, not the person causing their own infection.]

deC: and if the skin is not well disinfected he can get infected by procedure;

[ww. There is no evidence that the tattooing inserts bacteria into the skin. The case cited above is likely from rubbing the infected artist's hand on the skin directly, repeatedly. This is anecdotal.]

deC: the devices can be infected

[ww. devices don't become infected. there is no such evidence.]

deC: especially the needles;

[ww.Needles are always sterile.]

deC: and transmission for example of hepatitis by non sterile (sterile) needle is possible,

[ww. No cases have been documented.]

deC: and also the inks can be infected

[ww. No known case of hepatitis-containing ink has been shown.]

deC: especially if the “novist” for example uses running water to dilute the ink.

[ww. Ludicrous, not substantiated as hepatitis, The only case they have is from a rural area in China that had no medical personnel, no hospital no clinic in the 80s. Tap water had been implicated from one supplier (A) and his distributor (B) during 2011 and 2012. This was a bad actor not a likely scenario.]

Question-2: So tattoo inks are not safe or not always safe.

deC: There are many concerns in the medical world about safety of tattoo ink

[ww. "Concern" means "NO EVIDENCE" can be found. FDA has been lobbied for 20 years to remove inks that are hard to remove and now that the EU has done so it looks like the FDA maycopy the EU.]

deC: because it has been demonstrated that tattoo inks contain contaminants

[ww. What is demonstrated is that if anyone looks hard enough they can find nano size particles of some things sometimes but not that there is any harm to the body. There is no evidence even after 20 years of searching to prove inks are toxic.]

deC: with carcinogenic mutagenic properties that these tattoo ink’s colorants in tattoo inks get decomposed in the skin

[ww. Pigments do not decompose in the body, They are crystal shape, insoluable and are not dyes.]

deC: and that this decomposition makes other dangerous components

[ww. It is the Laser application that causes the crystal to degenerate into new and different unknown chemicals that laser interests apparently do not study.]

deC: All these materials are absorbed in the body,

[ww. Where they go is sometimes found in other organs. They may also be excreted. There is no "absorption" other than phagocytosed when encountered. This isolates pigment crystals from interacting with the body. The claim absorbed is not what a good description of what is happening.]

deC: they are drained through the lymph nodes.

[ww. Pigments are not drained as if wandering around floating loose, non-phagocytosed?]

deC: But we know little about the bio kinetics, about the transport in the body and the action of the different components on different organs.

[ww. WOW here it is: Admitting they know nothing about the effects of pigments, but nevertheless continue the pitch?]

25^th EADV CONGRESS, 28 September – 2 October 2016, Vienna Austrial
 https://www.facebook.com/EADV.org/videos/564852857012968/
08/15/23 https://www.facebook.com/watch/?v=564852857012968

In my opinion the Kruger publication quoted above, Industrial Organic Pigments, and the CPMA are informative.

But, we cannot argue about the existence of unwanted contents citing "expert" "scientific" arguments. That would be fighting with their rules. We should not even consider debating so-called "scientific findings." It would be insane to hire our own chemists to find what their chemists find.

It would seem better to argue that colorants synthetic organic pigments should continue as a “carve-out,” as an exception from MoCRA-2022.

On Permanent Cosmetics
Tattoo had in the early 1900s, especially the nine years between the two great wars (George Burchett, Memoirs of a Tattooist) - and continue to have - a purely cosmetic application of blush on the cheeks, lip and eyebrow using Tattoo methods, copying tattooist techniques, the tools and the inks (but wearing a white jacket in a salon and never using the word tattoo).

I can't be more enthusiastic for George Burchett's Memoirs which fill the gap from late 189s to WWII.  Order today from UnimaxShop.com.

For the past 80 years the FDA side-stepped Tattoo to avoid the dilemma that Tattoo does not fit into a cosmetic meaning.

Tattoo has one argument that should win the day: Tattoo has the right to use customary and normally used pigments that are proven safe and effective over time.

To wit, the Tattoo argument is:

Tattoo’s current customary and normal ink and practices have merit,
proven over a span of the last 80 years, by
consistent safe and effective usage over time,
In hundreds of millions of tattoos
by hundreds of thousands of tattooists.

USA FDA does not need animal testing to prove the safety of our pigments as recommended by the so-called EU "experts" in the book Dermatologic Complications of Tattoo Art.
 

Our argument to allow usage is recognized around the world
by all Standards Making Bodies, such as ASTM, WHO and WTO,
accepted as the sine qua non of proof: safe and effective use
over time.

Tattoo cannot be consider cosmetic though some can use it so.

Tattooists have sympathy for those who have psychological dissatisfaction and buyer’s regret but they "knew what they were doing" and will have to deal with their problems.  Their problem, should not be made into our problem but it is precisely this that is driving the effort to ban all pigments that makes Tattoo permanent. If MoCA 2022 paplies to tattooists inks then we are temporary tattooists and reduce our art to meaningless butterflies, easily removed.

MoCRA 022 is the result of 20 years lobbying to ban pigments that cannot be removed easily by lasers, in fact, to ban all synthetic organic pigments because lasers turn them into unknown substances.
No discussion is possible on these issues.
 

Tattoo does not enter into debate about these principles.

And in my opinion we should Raise Our Voice.

Respectfully submitted,

Westley Wood
August 16, 2023

YIKES-#2!  The Modernization of Cosmetics Regulation Act of 2022 Quoting from MoCRA Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer and is not part of such conditions of use. Quoting From R. Rox Anderson. MD, distinguished Harvard Professor and Inventor, who started this idea to remove from the market those inks that could not be removed by lasers: "If the FDA did regulate tattoos and they were made of safe materials, sterile, well tolerated by the skin, and could be removed, it would be a game-changer. ...I still love the idea of a safe removable tattoo. What I learned from this is that when you come up with an idea make sure you understand the ecosystem that the invention has to fit into. Tortured language obscures the obvious: remove tattoo ink pigments from the market that cannot be successfully removed by Lasers. The words in the Act “removal by the consumer” makes it clear that Tattoo is the target, an about-face of their historic 80 year recognition of Tattoo.  The FDA looks as if it is being used to ban the use of color pigments in tattoo in the US “…the most significant expansion of the FDA's authority…since…1938: Raise your voice. Westley W Wood, Pres. Unimax Supply Co Inc. NY NY 10013 (est. 1989) wes@unimaxsupply.com https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022  07/09/2023 See below for 05/27/23 YIKES! -1 05/27/23 See -2 Below Updated 07-09-23 YIKES! Write the FDA – This could be trouble … (MoCRA) The Modernization of Cosmetics Regulation Act of 2022 The FDA has invited you to write with questions.(Qouted) Inquiries about MoCRA can be directed to QuestionsAboutMoCRA@fda.hhs.gov https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022  Your Email Subject line might be something like: My Question is about MoCRA of 2022 and Tattoo/Piercings. (Reply requested as a question.) Will the FDA openly declare that MoCRA does not and will not apply to TATTOO and PIERCING? Respectfully submitted. by "Your info" Send CC or BC to wes@unimaxsupply.com if you might be interested in sharing your take. ...or am I an alarmist thinking that controlling Tattoo Ink is the major intention of this Act? It does NOTHING to enhance the already very high safety of Tattoo and Piercing.  Westley W Wood, Pres. Unimax Supply Co Inc. NY NY 10013 05/27/2023