Interview

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.

Authoritative source materials tell a relatively benign story about pigments in general. It would take a huge amount of pigment to be dangerous. Workers when making pigments at one time were harmed when exposed to inhalation over a long period of time. The pigment industry immediately ceased production of offending pigments.

MoCRA is a nail in our coffin, and "they" don't care if it is moral, immoral or hypocritical to destroy our lives by removing all pigments from the market that cannot be removed by laser.  It is all about seizing opportunities to increase profits: where ever. Tattoo is on the radar to buy, and removal is seen as a mind boggling opportunity by authorizing FDA to regulate this customary and usual American practice making tattoos by FDA rule, removable..

This is already the case in the EU and there is no reason to follow their folly.

Our Synthetic Organic Color Pigments are to be removed from the market so that Lasers can more easily remove all tattoos.
The Legislature passed MoCRA to do just that giving the FDA deniability.

Laser removal is the problem thst needs addressing.

300 degree boiling of pigments in the skin by lasers creates toxic substances. We call on the CDC for a study of those who have had laser removal to prove laser removal is safe before the FDA makes a terrible mistake banning our safe and effective colorants.
This is not the EU. We have Constitutional rights.

Dermatology teaches 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 180 degrees warning about infections from tattoos even though there is no greater infections 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 (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 new "medical prduct" regulations and would not even be able to obtain the pigments only available by licensing by the FDA. As an aside, how much will it cost to enforce compliance, and then use violence against dissenters? All this over tattoos.z

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 an interview of very well respected EU Dermatologist, Christa de Cupyer (deC) (30 years of Permanent Cosmetics) Board Member of ESTP who is singled out and credited with inspiring the makeover of tattoo inks by her book Dermatologic Complications with Body Art talking about "the dangers of Tattoos".
I have my comments indicated by  [ww.]
European Academy of Dermatology and Venereology (EADV) January 13, 2016. 

Before you watch the interview, do be aware that this is designed to frighten the 'be-Jesus" out of patients asking for advice: if they should get a. tattoo.

This is a perfect example of "Bias" overestimating the likelihood of an event that is actually RARE
 (like trying to dissuade a friend from traveling by plane  because you might be killed in a plane crash).
This is exactly what we witness here.

As an example if the Questioner asked if a person was at risk of dying by living in New York.

A similar answer to the interview might be:

There are many ways people are killed in New York City:

- cars, trucks, cabs even bikers kill.
- motor bikes put pedestrians in hospitals;
- you can get killed by things falling off buildings
- subway riders are pushed onto subway tracks,
- foods cause salmonella disease,
- homeless attack at random,
- desperate people grab cell phones, grab carry bags,
- innocent people are killed by stay bullets,
- people are suddenly punched, knifed even from behind

Watch the video below to see how rare events are presented as normal. that need not influence constant attention. They are anecdotal presented as if common occurrences. Lies.
The interview is meant to create the impression that any or all are likely that they all must be considered happening when you sit for a tattoo. Nothing in the interview is true.
 

 https://www.facebook.com/EADV.org/videos/564852857012968/
08/15/23 https://www.facebook.com/watch/?v=564852857012968

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 that tattooists in general 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.  The bacteria on the skin has no open skin wound to migrate to being constantly surface wiped. Tattoo inks have alcohol which kills bacteria. This anyone can see as part of the procedure. Infections are so rare a shop may go years without even hearing of an infection.]

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

[ww. There is no evidence that tattooing inserts bacteria from the skin into the tattoo causing an infection. This is "made-up" stuff.  And what is meant by "well" disinfected? The skin  either is - or is not disinfected.  The case cited above of the person tattooing in a park with guitar string and toner for ink the infections he spread are more likely from rubbing his sores on the tattoo directly, repeatedly.]

deC: the devices can be infected

[ww. Devices don't become infected. There is no evidence that the device transfers infection from the surface of a tattoo device. Another absurd claim.]

deC: especially the needles;

[ww. Needles are sterile. This is imagination inventing a possibility that has no evidence of having happened. Certainly nothing that deserves to even be mentioned,]

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

[ww. No case has ever been documented. In Sweden in the 80s during a wide breakout in the country some hep was blamed on artists using a common sponge and bucket technique, cleaning without changing the water. This is not a danger since Swedish health care promptly stopped the bucket-washing. The NYC case in 1950s cited below, again during a wide outbreak, was falsely blamed on tattooing according to a NYC Council person which led to the NYC ban in 1959.]

deC: and also the inks can be infected

[ww. No known case of hepatitis-containing ink has been shown. Some bacteria-containing inks were found by the CDC coming from a single producer of ink that lead to a handful of cases because he used tap water as an ingredient. This is a bizarre case of a lone actor making ink in the basement selling it at conventions, condemned by all tattooists.]

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

[ww. No evidence substantiates hepatitis from tattooing. The only case that can be found in the literature is from a rural area north of Hong Kong that had no medical personnel, no hospital no clinic in the 80s.  One other source of infection from tap water but not -hep, a bacterial infection has been documented by a lone actor (#A) of mixing tattoo ink having used Tap water to mix the ink, and then selling his ink at conventions and his distributor (#B) selling to others during 2011 and 2012. This was a bad lone actor. A separate tattooist diluting his ink with tap water caused a number of infections in NY. This is anecdotal which is not actionable.]

The Second Question presented to deC in the interview is:
"So tattoo inks are not safe or not always safe."

[WW. You can see this question does not follow from the interview but it shows how a person can be manipulated into believing by hearing scare tactics by exaggeration.]

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

[ww. "Concern" means "NO EVIDENCE" can be found. The FDA has been lobbied by Laser interests for 20 years to remove inks that are hard to remove and now that the EU has done so, it looks like the FDA may copy the EU. That would be a shame especially since the EU improperly banned 316L Stainless Steel requiring  the use of only Titanium for initial piercing. The FDA should not follow the politicized EU down this rabbit hole of harmonization of codes. It should be the other way around, the EU should be following the FDA. MoCRA 2022 has nothing to do with safety of tattoo inks. Hopefully the FDA will stand by safe and effective use over time as the criteria for continuing their stance.]

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  there is NO LINK to any harm to the body. There is no evidence of these claims, 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 skin, They are crystal shape, insoluble and are not dyes.Tattoos are permanent.]

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. Laser interests apparently do not study this.]

deC: All these materials are absorbed in the body,

[ww. Colors in other organs has been reported. But "absorption"? In the tattoo wound, cells phagocytose foreign bodies when encountered and remain in place. This isolates pigment crystals from interacting with the body. The claim of being absorbed is not a good description.

deC: they are drained through the lymph nodes.

[ww. If there were a problem with pigments in the Lymphatic system we would expect swelling or inflammation. But there is none. This is a good sign, further proof that pigments are not a threat to the body because there is no reaction by lymph nodes.]

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: the admission:
de Cuyper admits "we" know little about the effects of pigments, - MY GOD !! -- but want to make tattoos temporary -  regardless.]

25^th EADV CONGRESS, 28 September – 2 October 2016, Vienna Austria
 

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 with Body 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 (Quoted) though my two inquiries were not responded to. 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 must be in the form of a question.) Will the FDA openly declare that MoCRA does not and will not apply MoCRA of 2022 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 wrong in thinking that controlling Tattoo Ink  is the major intention of this Act? The Act 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