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Two of nine cigarette warning labels from the FDA AP Photo/U.S. Food and Drug Administration, File

US court upholds block on graphic cigarette warnings

The government can’t force tobacco companies to put graphic warnings on cigarette packets.

THE FEDERAL US government has been told that it can’t force tobacco companies to put large graphic health warnings on cigarette packages to show that smoking can disfigure and even kill people.

In a 2-1 decision, the U.S. Court of Appeals in Washington affirmed a lower court ruling that the requirement ran afoul of the First Amendment’s free speech protections.

The appeals court tossed out the requirement and told the Food and Drug Administration to go back to the drawing board.

It’s a different story from earlier this month when Austalia’s highest court rejected an appeal from tobacco companies against new rules which will stop manufacturers from keeping their customised designs on their boxes – instead forcing them to carry graphic health warnings.

The decision is considered a blow to one of the Obama administration’s major public health initiatives, raises the prospect of another U.S. Supreme Court tobacco battle and opens the door to further challenges of FDA’s regulatory scheme.

Some of the nation’s largest tobacco companies, including R.J. Reynolds Tobacco Co., sued to block the mandate to include warnings to show the dangers of smoking and encouraging smokers to quit lighting up.

They argued that the proposed warnings went beyond factual information into anti-smoking advocacy. The government argued the photos of dead and diseased smokers are factual in conveying the dangers of tobacco, which is responsible for about 443,000 deaths in the U.S. a year.

The nine graphic warnings proposed by the FDA include color images of a man exhaling cigarette smoke through a tracheotomy hole in his throat, and a plume of cigarette smoke enveloping an infant receiving a mother’s kiss.

These are accompanied by language that says smoking causes cancer and can harm fetuses. The warnings were to cover the entire top half of cigarette packs, front and back, and include the phone number for a stop-smoking hotline, 1-800-QUIT-NOW.

In the majority opinion, the appeals court wrote that the case raises “novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest — in this case, by making ‘every single pack of cigarettes in the country (a) mini billboard’ for the government’s anti-smoking message.”

The court also wrote that the FDA “has not provided a shred of evidence” showing that the warnings will “directly advance” its interest in reducing the number of Americans who smoke.

Tobacco companies increasingly rely on their packaging to build brand loyalty and grab consumers — one of the few advertising levers left to them after the government curbed their presence in magazines, billboards and TV.

“It’s a significant vindication of First Amendment principles,” said Floyd Abrams, an attorney representing Lorillard Tobacco. “There’s never been any doubt that the government could require warnings on products that can have dangerous results. And what the court is saying is that there are real limits on the ability of the government to require the manufacturer of a lawful product to denounce the product in the course of trying to sell it.”

The FDA declined to comment on pending litigation and the Justice Department said it would review the appeals court ruling. Public health groups are urging the government to appeal.

“While the tobacco industry has grown increasingly aggressive in preying upon the American public with misleading and fraudulent marketing practices over several decades, the warning labels have not been changed in 25 years,” John R. Seffrin, chief executive of the American Cancer Society, said in a statement. “Existing warnings have failed to inform the public adequately of the risks of tobacco use. … We hope the government can identify ways that the FDA can move forward with the new cigarette warning labels.”

Warning labels first appeared on U.S. cigarette packs in 1965, and current warning labels that feature a small box with text were put on cigarette packs in the mid-1980s. Changes to more graphic warning labels that feature color images of the negative effects of tobacco use were mandated in a law passed in 2009 that, for the first time, gave the federal government authority to regulate tobacco.

The share of Americans who smoke has fallen dramatically since 1970, from nearly 40 percent to about 20 percent. But the rate has stalled since about 2004, with about 46 million adults in the U.S. smoking cigarettes. It’s unclear why it hasn’t budged, but some experts have cited tobacco company discount coupons on cigarettes and lack of funding for programs to discourage smoking or to help smokers quit.

In recent years, more than 40 countries or jurisdictions have introduced labels similar to those created by the FDA. The World Health Organization said in a survey done in countries with graphic labels that a majority of smokers noticed the warnings and more than 25 percent said the warnings led them to consider quitting.

Joining North Carolina-based R.J. Reynolds, owned by Reynolds American Inc., and Lorillard Tobacco, owned by Lorillard Inc., in the lawsuit are Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc.

Virginia-based Altria Group Inc., parent company of the nation’s largest cigarette maker, Philip Morris USA, which makes the top-selling Marlboro brand, is not a part of the lawsuit.

The case is separate from a lawsuit by several of the same tobacco companies over the 2009 Family Smoking Prevention and Tobacco Control Act, which cleared the way for the more graphic warning labels and other marketing restrictions. The law also allowed the FDA to limit nicotine and banned tobacco companies from sponsoring athletic or social events or giving away free samples or branded merchandise.

In March, a federal appeals court in Cincinnati ruled that the law was constitutional. The contradicting decisions mean the case could be settled by the U.S. Supreme Court on appeal.

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48 Comments
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    Mute Paul Hedderman
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    Oct 21st 2021, 2:43 PM

    Could have played an important role well over a year ago!

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    Mute John Black
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    Oct 21st 2021, 2:45 PM

    @Paul Hedderman: you can see why they didn’t use them though…

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    Mute SquintEastwood
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    Oct 21st 2021, 2:47 PM

    @John Black: how much worse would it have made it

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    Mute GrumpyAulFella
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    Oct 21st 2021, 2:49 PM

    @Paul Hedderman: important role in confusing people it seems. If they’re unreliable then they’re unreliable. We’re talking about people’s health here. This sounds like playing black jack with the devil.

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    Mute Paul Hedderman
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    Oct 21st 2021, 2:58 PM

    @John Black: No I cant, they should’ve been used along side PCR. I can understand they werent as accurate as PCR and there would be non health care professionals using them but its another tool in the fight against covid. Every positive test is one less person spreading to many. Regular testing would increase the odds of catching the positive cases if first test wasnt accurate, especially asymptomatic ones, which may never have been tested. As a society we would be better and more skilled at testing than now. Less covid, less icu and less deaths than we’ve accumulated now. Testing negative isnt an excuse to throw the hygiene measures out the window….. Danes had similar per capita cases to us at start of delta, they’ve had much less covid and deaths since. You can bet antigen tests helped

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    Mute John Black
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    Oct 21st 2021, 2:58 PM

    @SquintEastwood: would’ve led to many super spreader events as people who got false negatives would assume they’re all good to mix in with people

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    Mute John Black
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    Oct 21st 2021, 3:02 PM

    @Paul Hedderman: but people would take the negative to mean they don’t have it as oppose to still a maybe.
    For antigen testing to work each person needs to be taking antigen tests regularly which I don’t think anyone would want to pay for, they’re just too unreliable/inefficient.
    Denmark isn’t really comparable to Ireland, they don’t have an open border with the UK.

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    Mute Paul Hedderman
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    Oct 21st 2021, 3:08 PM

    @GrumpyAulFella: Why do other countries use them regularly, why are the govt being told they may play an important role? Why are they being used for the pilot night club event?……… Id rather test myself regularly with them than be walking around possibly asymptomatic spreading. With no symptoms why would an asymptomatic person go for a pcr test if also not a close contact. Many many people have picked it up without knowing where they got it from and passed it on. Antigen can stop that. Antigen can stop people entering pubs/clubs by a positive result. If they aren’t implemented well then that person would be in the pub/club spreading anyway……. Were are talking about peoples health here! And were not using a tool to help reduce covid in the community

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    Mute Aidan O' Neill
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    Oct 21st 2021, 3:12 PM

    @John Black: Denmark has plenty of borders. The state pays for PCR tests. Even at increased accuracy they are way more expensive than PCR tests. If the average person can get antigen tests at about a fiver each the state would surely have been able to get them for 3 quid a piece or under. 1 million tests or so a week in sectors where work from home is not possible and for school children would have caught 1000s of cases even with reduced accuracy. Buy them, put out an information campaign, distribute them. It was literally that easy and we didn’t bother.

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    Mute Paul Keenan
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    Oct 21st 2021, 3:16 PM

    @GrumpyAulFella: If you are positive on an antigen test you are positive for covid, if it catches 50% of cases early its a success, result in 10 mins versus approx 36 hours

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    Mute a
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    Oct 21st 2021, 3:17 PM

    @GrumpyAulFella: But they are not unreliable, that’s the thing.

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    Mute Paul Hedderman
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    Oct 21st 2021, 3:22 PM

    @John Black: One would hope that if people were symptomatic they would go for a pcr test through hse/gp. Antigen test would work alongside PCR in every day life to pick up asymptomatic or those that aren’t responsible to go for PCR themselves (ie…. tests at work, pub, public building) Antigen tests should be free through the govt like in the UK….. Denmark have an open border with Germany and a direct road link to Sweden into their capital city. We’re quite comparable to Denmark. Similar vaccinated, they have a slightly bigger population….. They were more open than us but they tested more. We have had way more covid. Testing catches and reduces spread…… Recent high incidences in cork, limerick or waterford hardly due to the north. Mainland UK doesn’t have much impact on our cases.

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    Mute GrumpyAulFella
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    Oct 21st 2021, 3:27 PM

    @a: but they are. They produce false negative results on occasion, particularly in asymptomatic cases, so we’ll have carriers walking around doing non-carrier stuff oblivious to the fact that they have Covid. Sounds like a recipe for disaster. Agree that if it’s positive, it’s positive but saw a guideline yesterday that the person should still get a PCR test to confirm!!??!

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    Mute Paul Keenan
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    Oct 21st 2021, 3:29 PM

    @GrumpyAulFella: Yes get pcr to confirm but it shows positive in people who are actively shedding so false negatives are less significant

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    Mute John Black
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    Oct 21st 2021, 3:38 PM

    @Aidan O’ Neill: it’s only land border is with Germany who have handled the situation a lot better than the UK.
    Everyone would be taking an antigen test every week or few days, the cost of that adds up, when it’s everyone all the time. Not exactly cheaper.

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    Mute John Black
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    Oct 21st 2021, 3:39 PM

    @Paul Keenan: false negatives are a massive issue because people want to use them as the basis to mix into crowds

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    Mute John Black
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    Oct 21st 2021, 3:43 PM

    @Paul Hedderman: if people were properly educated and knew to use them regularly and not take a negative as a definite, then they’re usable but you have too much faith in people, one look through the comments section under any covid post shows lack of education, a lack of willingness to learn or have their opinion changed and even just general conspiracy theories.
    We’re not at all comparable to Denmark, culturally us and the UK are totally different from Denmark and Germany and have handled the pandemic totally differently.
    The UK has had a significant impact on our cases throughout.

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    Mute Paul Hedderman
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    Oct 21st 2021, 3:46 PM

    @GrumpyAulFella: How dont you understand this. The asymptomatic person wouldn’t be tested anyway unless a close contact and would be going around spreading, especially now were soon to be fully open.. Antigen tests wont catch covid in everyone but it will get alot.. it will slow the spread which will be needed this winter. Stop just one asymptomatic person spreading means many others aren’t infected. Multiply that and you’re talking many thousands. Think the health service would be glad of that.

    http://www.bbc.com/news/health-58899612.amp

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    Mute Paul Hedderman
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    Oct 21st 2021, 4:00 PM

    @John Black: NI has, UK mainland not so much. Non essential travel only opened July. 1% – 2% of cases now are traced to travel wit many on sun holidays.. Hard for mainland UK to have a significant impact on us with that. Sure Scotland and Wales had huge increases in September due to back to school and Englands remained relatively steady. If Scotland and Wales increase didnt effect Englands much how would they have a significant impact on our cases……. NI did, particularly on border counties. Doubt they had a significant impact on southern counties, more the locals fed up of govt rules and wanting normality…… Alot of Irish aren’t great at following rules which was our problem, blaming the UK is a cop out!

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    Mute GrumpyAulFella
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    Oct 21st 2021, 4:03 PM

    @Paul Hedderman: how do you mean that asymptomatic people won’t check themselves with antigen tests? There are all manner of reasons why they will. Are you saying that tests returning false negatives for these people is not a problem? Ever heard of meat factories?

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    Mute Paul Hedderman
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    Oct 21st 2021, 4:42 PM

    @GrumpyAulFella: *Asymptomatic people wont get tested (with PCR tests) unless close contacts*…… No not ideal but it is a side effect of the test not being 100% accurate, just like the vaccine isnt 100% and just like PCR tests aren’t 100% …… As I said, thats where regular testing comes into play, it will work along side PCR tests…… Imagine a venue, everyone feels fine attending, 2 asymptomatic arrive. Theres no antigen tests so both go in and spread away. Imagine they were both antigen tested and one was positive, the other false negative. One asymptomatic goes in and then theres less spread. Imagine both turn up positive then then they dont spread. Either way its better than not testing. Compound this effect throughout society and there’ll be alot less covid spread.

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    Mute John Fahy
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    Oct 21st 2021, 2:48 PM

    I hope Prof Philip Nolan issues an apology to the Irish people now for calling antigen tests snake oil.

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    Mute ▪️
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    Oct 21st 2021, 3:00 PM

    @John Fahy: The way some people talk about antigen tests like they’re the secret weapon to defeat Covid once and for all, you can see why his frustration got the better of him.

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    Mute John Fahy
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    Oct 21st 2021, 3:16 PM

    @▪️: he’s a medical PROFESSIONAL, he’s paid not to let anything get the better of HIM.

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    Mute Roy Dowling
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    Oct 21st 2021, 3:25 PM

    @John Fahy: wouldn’t hold my breath. He has never apologised for any other of his mistakes so he won’t start now.

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    Mute Contrary Mary
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    Oct 21st 2021, 7:51 PM

    @John Fahy: Why should he? The majority of people here do not understand in what situations they are important and in what situations they give a false sense of security. Our experts need to work together and release one statement, not 10 different ones, of which media and commenters usually misconstrue.

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    Mute a
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    Oct 21st 2021, 2:51 PM

    Snake oil….no wait

    34
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    Mute GrumpyAulFella
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    Oct 21st 2021, 2:47 PM

    “A negative rapid result should not be used as a green light”. Cue mass confusion. Have I got Covid, have I not got Covid? Sounds like you’ll end up at a PCR test clinic anyway. Take the antigen test and of positive restrict movements and go for PCR anyway to confirm that your €5 kit from LIDL is actually working. Take the antigen test and if negative, don’t trust it and go for PCR test anyway.

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    Mute Paul Keenan
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    Oct 21st 2021, 3:31 PM

    @GrumpyAulFella: but with symptoms for covid being the same as for almost any other seasonal illness an antigen test gives you a positive covid result in 10 mins instead of 48 hours

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    Mute Paul Hedderman
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    Oct 21st 2021, 3:32 PM

    @GrumpyAulFella: Finish the sentence… “a negative rapid result should not be used as a “green light” for an individual to ignore or bypass current public health advice”………. Its the same with a negative PCR test. We shouldn’t be ignoring the public health advice at all!

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    Mute GrumpyAulFella
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    Oct 21st 2021, 4:05 PM

    @Paul Hedderman: yes except that we can almost be 100% sure that the PCR result is correct whereas it’s anyone’s guess with an antigen. Not sure how you don’t see a problem with this.

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    Mute Dave
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    Oct 21st 2021, 4:15 PM

    @GrumpyAulFella: PCRs run at 45 cycles are a farce & everyone knows it. Explain to me how I can get tested today & an infection from 6 months ago can detected, yet someone else who tested positive just 3 days ago is negative today?

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    Mute Paul Hedderman
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    Oct 21st 2021, 4:54 PM

    @GrumpyAulFella: yes correct, a person with a negative PCR test has a 99% chance of being negative at the time of taking the test. Cant you pick up covid at the test centre or in the time since the test….. So its a past indicator. People still shouldn’t ignore or bypass current public health advice whether negative from an antigen or a PCR test. Where is the confusion?

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    Mute sandra clifford
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    Oct 21st 2021, 2:54 PM

    Tony won’t like that snake oil lol

    23
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    Mute SquintEastwood
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    Oct 21st 2021, 2:45 PM

    Surely somebody who knows somebody in hse/government can guarantee them if they wanted them.. ring a friend

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    Mute trevormurphy
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    Oct 21st 2021, 4:13 PM

    The EU has already provided 200 million euro in a fund for EU member states to pay for testing.

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    Mute thesaltyurchin
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    Oct 21st 2021, 3:43 PM

    Got a bunch from the UK, been handy with Flu’s and colds appearing. Apparently they can be inaccurate tho, so you go through them in no time.

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    Mute Will Roche
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    Oct 21st 2021, 3:04 PM

    Does anybody know what the current Vaccine inventory is like in the country? I assume we have so many Pfizer vaccines in storage for boosters?

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    Mute David Stapleton
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    Oct 21st 2021, 5:09 PM

    Antigen tests are used to see if you have been exposed to a virus. While they could make a good statistical tool to examine the extent and patterns of infection, they aren’t suited for front line detection. So I don’t know why they are being touted as such now. It’s a bit like a firefighter fighting a fire and an investigator investigation the cause and spread of the fire. Generally speaking, the fire investigator isn’t doing his job while the fire fighters are trying to put the thing out.

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    Mute Contrary Mary
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    Oct 21st 2021, 7:48 PM

    Tony told us today to ignore the results.

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    Mute Csilla
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    Oct 21st 2021, 9:15 PM

    He probably had a very bad experience with snake oil.

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    Mute Furze
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    Oct 21st 2021, 4:41 PM

    Who’s on this expert group?
    Sounds like they have a ready to go contract awaiting signature to supply basically useless kits.

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