Tag Archives: FDA

Totally Safe and Effective!

12 Thursday Jan 2023

Posted by in News and Notes

≈ Comments Off on Totally Safe and Effective!

Tags

, , , ,

Trust science! Trust government! Trust media! Trust known satanists who hate you, and this is what you get.

The FDA recently published a study which looked at the COVID-19 vaccine safety among elderly persons aged 65 years and older. Today it was published in the Vaccine Journal.

The study looked at 30,712,101 individuals who had received various doses of the Pfizer, Moderna and Johnson & Johnson vaccines between 11 December 2020 and 15 January 2022.

Worryingly they identified four statistical signals for elevated risk of acute myocardial infarction (ACI), pulmonary embolism (PE), disseminated intravascular coagulation (DIC) and immune thrombocytopenia following the Pfizer vaccine. They didn’t find any statistical signals for the Moderna or Johnson & Johnson vaccines for the 14 outcomes they were monitoring.

PEs (blood clots on the lungs) were 54% more likely, ACIs (heart attacks) were 42% more likely, DICs (blood clotting disorder) were 91% more likely and ITPs (platelet disorder) 44% more likely.

Evidently, it’s also bad for NFL players. And everyone else.

Send these devils to Iraq with T45 to stand trial for mass murder and crimes against humanity.

FDA War on Cigars, part 2??? – clearing the drafts

15 Saturday Dec 2018

Posted by in Legal/Political Columns

≈ 1 Comment

Tags

, , , , , , ,

***Note*** I’ve got a lot of drafts sitting around, some in existence and unpublished since 2013. It became obvious to me that I’m in no hurry to get around to them. But, they’ve survived various draft purges over the years. If they’re that important I can just come back and elaborate later. For now, I offer them, kind of as-is, in this, a lightning publishing round. The fun will continue while supplies last. Make of these what you will. Or not. I don’t care.

*****

Aha! I found this, just a list of links to past news stories. The FDA communist assault continues, though some fight it. I’ve covered that. I even published a submitted CFR comment. Entertain yourselves, particularly if you’re in the industry, with the following (if operable – not checking):

 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

http://www.washingtontimes.com/news/2016/may/23/diane-katz-fda-cigar-rules-threaten-industrys-smal/

http://dailycaller.com/2016/05/22/how-fda-rules-are-making-life-hell-for-cigar-lovers/

https://www.federalregister.gov/articles/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the

https://www.cigarrights.org/fda-response.php

http://archive.constantcontact.com/fs187/1102288667527/archive/1117218447736.html

The era of unregulated cigars may be going up in smoke

 

 

 

 

 

The FDA is Evil

09 Thursday Aug 2018

Posted by in Legal/Political Columns

≈ Comments Off on The FDA is Evil

Tags

, , ,

Forget typing those CFR comments. It won’t help. There’s no reasoning with this agency about cigars or anything else. They are literally out for innocent blood:

The U.S. Food and Drug Administration signed a new contract on July 25 to acquire “fresh” human fetal tissue to transplant into “humanized mice” so that these mice will have a functioning “human immune system,” according to information published by the FDA and the General Services Administration.

“The objective is to acquire Tissue for Humanized Mice,” said a June 13 FDA “presolicitation notice” for the contract.

…

“Fresh human tissues are required,” said the notice, “for implantation into severely immune-compromised mice to create chimeric animals that have a human immune system.”

According to GSA’s federal contract database, Advanced Bioscience Resources (ABR), a non-profit organization based in the San Francisco Bay Area, was awarded this $15,900 contract, which will run through July 25, 2019.

“Fetal tissue used in research is obtained from elective abortions,” says the Congressional Research Service.

In 2016, Harvard University provided the House Energy and Commerce Committee’s Select Investigative Panel on Infant Lives with a background paper explaining that mice with human immune systems “are engineered to this condition only by means of the use of human fetal material” and that this material can only come from aborted babies not from miscarriages.

I guess that’s why they included the following new bullshit warning for premium cigars:

WARNING: Cigar use while pregnant can harm you and your baby.
or
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.

Now I understand why they don’t want any stillborns – makes it harder to create chimeras. Supporting, financing the murder to children to foster the growth of monsters. H. G. Wells had nothing on Washington.

Moreau

Wells.

Reviewing the New Cigar Warning Labels (With Added Warning)

19 Thursday Jul 2018

Posted by in Legal/Political Columns

≈ 2 Comments

Tags

, , , , , , ,

The gullible American people and their Chicken Little politicritters love a good epidemic. One woman gets Zika? Epidemic. Someone run over by a texting driver? Epidemic. Banksters and pols loot 99% of the value out of the Dollar while squashing civil liberties? Epid … oops, nevermind that one…

I just read about the next great epidemic – Benzos! Valium reminds some doctor a lot of the opioid crisis! Crisis. Epidemic. Same thing. We’ll need a new law and some more regs! Maybe the FDA can get around to that once they cure another great epidemic – pregnant women smoking cigars…

Come August 10th, retail cigars (to include individual units) must be accompanied by one of the following six warning labels: herein, my review:

WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.

A lie. See explanation below.

WARNING: Cigar smoking can cause lung cancer and heart disease.

A lie. See immediately below.

WARNING: Cigars are not a safe alternative to cigarettes.

Part lie, part category error. Cigars are safe (FDA studies say so). However, they’re not an alternative to cigarettes, at all, with next to nothing in common except the burning aspect. Cigarettes are paper wrapped chemicals, tar, and, maybe, a little cheap tobacco. Cigars are pure, 100%, natural, organic, Earth-friendly, environmentally responsible tobacco from the best fields. Not just a lie, an eco-lie (very bad).

WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.

Yet another lie.

WARNING: Cigar use while pregnant can harm you and your baby.
or
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.*

Now they involve the poor Surgeon General. This one is either a lie OR another false conflation. Again, it’s cigars, not cigarettes. And, women constitute something like 0.5% of all cigar smokers. Pregnant women are around, I’m guessing here, 0.000000%. Totally irrelevant and utterly stupid. I challenge the FDA to present one single case, ever, of any baby negatively affected by cigars. Scratch that. I challenge the FDA to pack up New Hampshire Avenue and just get the hell out of America and out our lives. I say they can’t do it. Let ’em prove me wrong!

WARNING: This product contains nicotine. Nicotine is an addictive chemical.

Believe it, or not, this one is not a complete lie. Rather, it’s a false syllogism of sorts, in reverse, kind of. Like this:

Major premise: Nicotine is bad.

Minor premise: Cigars contain nicotine.

Conclusion: Warrants a warning.

Again, again, again … cigars differ in many ways from cigarettes. Premium cigar makers do not add additional nicotine (or anything else) to the wrappers, binders, or fillers that constitute that lovely leafy goodness. Said leaf by itself does, in fact, contain a little nicotine. But, so do: tea leaves, eggplants, potatoes, peppers, cauliflower, and tomatoes.

Do these eggplant-IQ’d busybodies go around warning mums to be about the dangers of real eggplants? Could be; it’s a big CFR… Yet another government, elsewhere – the Royal Society for Public Health – just determined that scary, addictive nicotine is “no more dangerous than the caffeine in a cup of coffee.”

I get it, I get it. Warning labels on coffee come next…

With all these warnings floating around, I thought I might add one that isn’t based on complete BS. This:

****

GOVERNMENT WARNING!

Government is the most dangerous non-natural thing in existence, possibly more destructive than a gamma-ray burst. Government is not a safe alternative to freedom.

-or-

Take your labels and shove ’em.

******

Feel free to post that by the cash register.

april fools day cigar.0

Eric Newman Fights for Cigar Rights

10 Thursday May 2018

Posted by in Legal/Political Columns, News and Notes

≈ Comments Off on Eric Newman Fights for Cigar Rights

Tags

, , , ,

For freedom. For his customers. For his employees and their families.

Newman, of J.C. Newman cigars, seeks the exemption of premium cigars from FDA meddling:

But Newman and his industry now have a second chance under a new administration that touts itself as anti-regulation and pro-business.

The FDA has announced it is willing to reconsider the 2016 decision. It began accepting public input in March on whether premium cigars should be exempt from oversight. The comment period runs through June 25.

In Tampa, known as Cigar City for its history as an epicenter for the industry, this is welcome news for those who roll premium cigars. They claim the governance could financially hurt or even put them out of business.

“Over regulation can harm small business,” said Newman, who employs 135 at his Ybor factory, the last in a city that once hosted dozens. The company has been in business for 123 years.

Those interested in helping the fight can do so at the Federal Register, right now. Make a comment, make your voice heard. Here’s mine:

Dear Public Servants:

The FDA (which I cannot find in the U.S. Constitution) has no legitimate business regulating premium cigars. Nor is any regulation, outside that of the free market, needed. The FDA knows well that casual, daily cigar smoking poses no risk of increased health problems. See: Article: FDA STUDY: CANCER RISKS NEARLY NIL FOR 1-2 CIGARS PER DAY, http://www.heartland.org, AUGUST 25, 2016, Dr. Brad Rodu (https://www.heartland.org/news-opinion/news/fda-study-cancer-risks-nearly-nil-for-1-2-cigars-per-day); Study: Systematic review of cigar smoking and all cause and smoking related mortality, Cindy M. Chang, et al, 2015 (https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-1617-5)(a comprehensive, multi-decade medical review of amalgamated study sources).

All regulation of the cigar industry is misguided, a waste of resources, and a dire threat to the well-being of those U.S. citizens employed in the cigar industry along with their dependent families, to say nothing of the millions of sensible American adults who happily enjoy cigars and freedom. Such regulation represents a real violation of associated liberty interests of the free people (interests which are found in the Constitution).

Accordingly, please abolish all FDA regulations concerning premium cigars and tobacco. Also, I suggest restitution be paid by the U.S. Treasury to all cigar companies previously affected by such existing regulation.

Kindly leave well enough alone.

Thank you.

The other side of this issue, the heavy-handed, anti-freedom, SJW side, which vaguely resembles the proponent side of gun control communism, relies on outright, known falsehoods:

On that point, Matthew Myers, president of the Campaign for Tobacco-Free Kids, noted in a statement that the agency has already weighed in.

“The FDA rightly rejected the option of exempting premium cigars,” Myers said, “finding all cigars increase the risk of disease, are potentially addictive and produce secondhand smoke that can cause disease to non-users.”

I’ve been in a lot of cigar shops over many years. I’ve never seen a single child smoke a cigar. I do, however, follow the facts, which conclusively demonstrate that cigars pose no additional health risks whatsoever. In fact, time was when cigars were recommended by doctors as curative treatment for a variety of ailments – even for the children. That’s how Teddy Roosevelt beat asthma.

Thank you, Mr. Newman.

Save Cigar City! Save freedom!

AR-305109981

Tampa Bay Times/ Scott Keeler.

What Do You Get When You Cross A Chinese Restaurant Name With A Cigar??

25 Sunday Sep 2016

Posted by in Other Columns

≈ Comments Off on What Do You Get When You Cross A Chinese Restaurant Name With A Cigar??

Tags

, ,

The Habano Esteli by The House of Lucky Cigar. Well, that and a corny joke from yours truly.

img_20160925_082904884-edited

This stick is straight Nica, with all the associated flavors. Very good construction and performance too. And she’s around $7 for a Toro. Not bad at all.

This is one of the many wonderful smokes which may be going the way of the Dodo thanks to the FDA and our friends in Washington (damn them all).

I must admit that upon first lighting I detected a bitterness in the smoke. It vanished and could have been a lingering product of my own mind – leftover thoughts about the UGA/Ole Miss game the day before. There followed a pleasant smoke – one that tasted much as the unlit cigar smelled. That is rare, as rare as sense in D.C.

Try one while you can.

Cigars Are Healthy: More Government Lies Debunked

26 Friday Aug 2016

Posted by in Legal/Political Columns, News and Notes

≈ 5 Comments

Tags

, , , , , , , ,

Two of my major themes here are that I: 1) hate government in all its evil lowliness, and; 2) I love cigars. Today I have greater reason to champion both of these worthy ideas.

The FDA is waging all out war on the premium cigar industry. Stupid law after draconian regulation threaten to disrupt if not kill the family of the leaf. It’s all part of the government’s larger war on freedom. They hate us, seeing us as little more than cattle to be milked of taxes until we die. Die will shall some day but not due to our cigars.

Cigars are bad, lies the state, because of children and health and safety and other BS – all of it dead wrong. It seems that the FDA has in its possession an in-house study which shows there are no significant health risks associated with smoking 1 – 2 cigars per day. The study was an amalgam of multiple independent medical studies conducted between 1965 and 2000.

The study noted that all examined types of cancers and maladies were in some way associated with cigars – they found that people will eventually die of something. Most people know that anyway. However, the increased risk associated with cigars is negligible, almost nonexistent; it looks to be an average increase of about 1%.

That’s it. One percent and cigars are bad. Most scientists and statisticians will tell you about something known as the margin of error in studies like this. It may be that cigars actually impart zero risk.

Of course the government spun its finding – when it finally released them – in the typical dishonest official way. (Seems to me they’ve been hiding this information). They summarized their findings, saying that cigar smoking is associated with death. They left out the contributing percentages which, again, are effectively nothing.

Here are some of the statistically insignificant findings (note all the single digits and zeros):

nimbus-image-1472257910922

Heartland Institute.

None of this should come as a surprise, especially to the cigar community. Government is a giant lie personified; it is pure Satanic evil from Hell.

As part of the new cigar regulations which took effect at the beginning of the month, cigars now come with warning labels, such as:

  • Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  • Cigar smoking can cause lung cancer and heart disease.
  • Cigars are not a safe alternative to cigarettes.

Lies, lies, and more lies. Government needs its own “Government Warning” label.

And even this study only looks at health risks (none) and not health benefits. Cigars were prescribed for decades as medical treatment for a variety of illnesses, from asthma to anxiety. Cigar smokers tend to be happier people. Now there’s more reason to be happy.

So it is that my love of cigars is well justified – now by medical science. Also vindicated once more is my atavistic hatred of the dread institution of the state. In coming posts I may explore ways to deconstruct the menace of government. For now, I’m going to enjoy a healthy cigar.

IMG_20160717_185822817_HDR

Smoke on that, my friends.

By the way, I was serious:

GOVERNMENT WARNING: Government is a known leading cause of death, destruction, disinformation, theft, hatred, general misery and human suffering. To Hell with it.

The War on Cigars

28 Thursday Jul 2016

Posted by in Legal/Political Columns, News and Notes

≈ Comments Off on The War on Cigars

Tags

, , ,

I’ve written in the past few months, briefly, about the FDA’s new authority over and campaign against the cigar industry. I was planning a larger, comprehensive story on the new regulations and the potentially devastating impact they will likely have. Christopher Westley, writing at mises.org, has done a lot of the heavy lifting for me – and you.

Check out his The FDA’s Cigar Fascism, July 26, 2016.

The FDA estimates that small businesses like El Titan, which produces 250,000 to 300,000 cigars per year, will pay $278,000 to $397,000 in application fees and other costs during the initial compliance period. While El Titan will be able to pass some of those fees on to the companies that hire it to make private-label smokes, it will still need to raise prices.

The new rules will have the greatest impact on companies less than a decade old, which will be required to apply for pre-market approval at an average cost of $6,560 per application, according to FDA estimates.

Westley, quoting a Miami Herald story.

These are extraordinarily high prices to pay – for nothing. The FDA asserts it has a duty to protect public health. So, cigars will now be subject to the same rigorous but useless testings and waiting periods that, as-is, keep new drugs away from needy patients, often until after the patient dies. Some doctors estimate the FDA process kills more people than it helps. Smoke on that.

IMG_20150528_093517093

As good as his article is, it doesn’t even begin to cover some of the other nonsense regulations which will start taking effect soon (like next week soon). I will probably still someday add my own spin on the subject. I may wait to see how it actually plays out in CigarLand on a daily basis. Higher prices and aggravation are assuredly in store for all.

Westley does call it what it is, perfectly – fascism.

Invasion of the Super-Bugs

11 Monday Jul 2016

Posted by in News and Notes

≈ Comments Off on Invasion of the Super-Bugs

Tags

, , , , , , , , ,

As from the beginning of a horror/zombie movie, scientists have positively identified a strain of E Coli bacteria which is resistant to the “last line of defense” antibiotics. Please read: A ‘slow catastrophe’ unfolds as the golden age of antibiotics comes to an end, Melissa Healy, LA Times, Science, July 11, 2016.

Ms. Healy and the LA Times did a wonderful job with this story. The Times science section impresses at times (get it….).

The devious little bacterium seems to have developed a new gene, “mcr-1”, which makes it resistant to colistin. Colistin is the “last line” drug given when other antibiotics are not effective. Now, for this particular bug, even that doesn’t work. It seems that the infection at issue in the case study was beaten off with a combination of other treatments. However, doctors and researchers are not overly optimistic about what this portends for the future of medicine. Some are downright pessimistic.

“It’s a slow catastrophe,” said Army Col. Emil Lesho, director of the Defense Department’s Multidrug-resistant Organism Repository and Surveillance Network.

The problem goes beyond treating infections. As bacterial resistance grows, Lesho said, “we’re all at risk of losing our access” to medical miracles we’ve come to take for granted: elective surgeries, joint replacements, organ transplants, cancer chemotherapies. These treatments give bacteria an opportunity to hitch a ride on a catheter or an unwashed hand and invade an already vulnerable patient.

…

“It’s not apocalyptic until it is,” said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner of the FDA. “Shame on us if we wait till bodies are in the street.”

Whoa, apocalyptic? Bodies in the street! This story made me think of several things:

First, we’ve been being warned for years now, by experts, about our overuse of antibiotics. Drugs given to patients who don’t need them. Drugs given to our cows, hogs, and chickens. And, so on. Maybe it’s not to late to heed the warnings. I haven’t had an antibiotic since I can’t remember when. Since I lost the weight and started working out, I don’t find myself seeing the doctor much at all.

Second, medical science has a history of outmaneuvering the bugs. The Times story included this chart:

nimbus-image-1468286810078

This isn’t the first time there’s been a gap between drugs. They’ll make a new one.

Third, the Times notes the high FDA regulatory costs of developing these new drugs. The drug companies prefer to concentrate on fields where the patient uses the medication for a lifetime. The return on the R&D (and regulatory compliance) isn’t worth the return for antibiotics. Another case of government getting in the way and potentially getting people killed. The author suggests the government might find some incentives (our taxes) to ease the process. Rather than more corporate welfare, I say get the state out-of-the-way. If the FDA had been around in 1928, we might still be waiting on basic penicillin.

Fourth thought – the government which makes it cost prohibitive to develop new miracle drugs is the very same government which is madly trying to bring as many “refugees”and other non-Westerners as possible into the country. Many of these folks, regardless of their intentions, carry diseases we haven’t had here in years. If they’re not going to curb the flow, maybe they could at the very least implement some better medical screenings.

Fifthly and finally, there is something you can do right now to circumvent the government, the scientists, and the culture. Get in shape. A healthy body does an unbelievably good job fighting off disease. Since I went “health nut” – and, yes, cigars are a component – I haven’t been sick once. It’s simple – drink water, sleep, exercise, and don’t eat as much and not as much junk. You can survive the apocalypse.

Odd little critters. BBC.

I’m not worried about these developments.We’re human beings. We can beat the bugs. We might even beat the government.

Better Not Get Hurt

11 Saturday Jun 2016

Posted by in Legal/Political Columns, News and Notes

≈ 2 Comments

Tags

, , , , , , , , , , , , , , , , , ,

There was a kindly gentleman a few years ago who wanted to bring healthcare to the masses. It was his dream not no American should go without medical insurance and care. I think his name was Hussein Obama. Maybe it was Barry something. Anyway, he convinced Congress to pass a law. The law did nothing to help the uninsured or those without access to doctors. What it did do was raise taxes and health insurance rates and made a lot of money for big insurance. Ah well, it’s the lie … the thought that counts, right? People needed healthcare.

Part of healthcare usually involves seeing a doctor for some sort of treatment. Sometimes the physician prescribes medication for a patient in the course of ameliorating an ailment. This is where things get funny.

Marlon Jones, one of the millions deeply cared about by Barry Whatshisname, saw his doctor about some knee pain. Jones received a double knee replacement as a result. The surgery caused considerable discomfort for which Jones was prescribed pain medication. Fits the narrative above, eh? Now the funny part.

Jones was arrested and charged with 14 felony drug and fraud charges. One can only imagine how amused he when they were handcuffing him. Ha ha. Jones was a fire chief in Utah. His friend, the police chief, told him the arrest was to “help” him. Very nice.

The state police targeted Jones after reviewing the state’s Prescription Drug Monitor Program database. The database was created under a nefarious law in order to allow the tracking and harassment of citizens in such fashion. Prescriptions and other medical information are supposed to be protected and private material for the use of doctors, patients, and pharmacists. HIPPA was another law enacted to help keep this information private. Why have a database and why allow (warrantless) fishing expeditions into it?

This isn’t just a Utah problem. Many (most?)(all?) states have such databases. Some protect the information. Others use it as Utah does for witch hunts. The feds desperately want in on the fun.

The Department of Justice [SIC] is linking all the state databases together into a super-system. The DEA wants access so they can do what Utah does on a national scale – ruin lives in larger numbers and faster. They have a few roadblocks.

In 2012 Oregon sued the federal government arguing that the personal information in its database was protected by the Fourth Amendment and not accessible outside of a warrant. Federal Judge Ancer L. Haggerty agreed:

In his 2014 ruling against the DEA, District Court Judge Ancer L. Haggerty called warrantless searches of such data an egregious invasion of privacy.

“It is difficult to conceive of information that is… more deserving of Fourth Amendment protection,” Haggerty said. “By obtaining the prescription records for individuals like John Does 2 and 4, a person would know that they have used testosterone in particular quantities and by extension, that they have gender identity disorder and are treating it through hormone therapy.

“Although there is not an absolute right to privacy in prescription information… it is more than reasonable for patients to believe that law enforcement agencies will not have unfettered access to their records,” he added.

The case is now before the Ninth Circuit Court of Appeals. There the FDA and that man who thought everyone needed health insurance argue people have lost their rights to privacy when their information is added to the database so the Fourth Amendment protection does not apply – the adding process is not voluntary, by the way. Actually, they don’t think the Fourth Amendment (or any others pertaining to individual freedom) apply at all any more.

Congress, not wanting to be left out of the Bill of Rights desecration party, passed this March the The Comprehensive Addiction and Recovery Act or “CARA” which will ease the sharing of database information pursuant to the DOJ’s and DEA’s plans. “CARA” is like “care” but with an “a”. The truth is these criminals do not care – not about you at any rate. They do care about expanding their police state powers. You should care. You should be alarmed.

Given this flurry of idiotic laws flying around concerning mandatory healthcare and database sharing and reporting, maybe one is better off forgoing any and all medical treatment. Jones surely could have lived a long (if painful) life with his old knees. Then again, they could just pass another law forcing people to have medical procedures. The Doctors And Medication Nationalization Act or “DAMN”? The doctors could just operate right in the prisons to make things logistically feasible.

The problem isn’t limited to medicine either. Heck, it’s everywhere the government touches – which is everywhere. The new FDA regulations developed illegally under the federal Family Tobacco Demonization Act may have similar implications for cigar smokers in the near future. Buy a box of Padrons and you’ll trigger the database police. A 10-year felony for cigar fraud. America, post America.

Google.

The solution is to get rid of these damned laws and their attendant regulations. Get rid of the agencies that enforce them. Get rid of the War on Drugs, the War on Freedom. Leave us alone. The government, if it must exist at all, should be a tiny little office in the D.C. swamp where the workers are terrified an angry mob of citizens might be at the door at any hour.

Until then maybe one should avoid seeking medications and medical care. You better not get sick, better not get hurt.