For instance, the ingredients used by Hain Celestial Group, which sells baby food under the brand Earth’s Best Organic, were found to contain 352 ppb lead when the safe limit is only 5 ppb. Beech-Nut, which exited the baby food market in June 2021 after issuing a voluntary recall on its rice cereal, was discovered to allow products with over 900 ppb arsenic to go on the market when the safe limit is 10 ppb. In September 2021, a second congressional report was made public, stating that Hain Celestial Group had underestimated the levels of heavy metals in its baby food 100% of the time. The estimates were flagrantly wrong – the heavy metals level was 28% to 93% higher in its finished products.

What Action Has the FDA Taken to Tackle This Urgent Issue?

Shortly after the first congressional report was made public, the FDA developed the Closer to Zero plan, a four-step strategy meant to “reduce exposure to arsenic, lead, cadmium, and mercury from foods eaten by babies and young children to as low as possible.” However, the approach proposed by the Closer to Zero plan is quite problematic and ineffective, as it fails to solve the problem within a reasonable time. According to the agency, the plan would be finalized in 2024 or later, which is unacceptable since developing infants and toddlers need clean, non-toxic food.

The first two steps of the Closer to Zero plan, “evaluate the scientific basis for action levels” and “propose action levels,” can be skipped entirely, as the FDA should be aware that the safe limits for arsenic, cadmium, lead, and mercury have already been set by the Baby Food Safety Act of 2021, a bill proposed by Congressman Raja Krishnamoorthi. He also led the investigation of the Subcommittee on Economic and Consumer Policy on baby food companies. The agency could jump straight to worthwhile action by skipping these unnecessary steps, namely evaluating the “achievability and feasibility of action levels.” 

This is paramount if the FDA wants to see concrete, tangible results from baby food companies throughout the United States. By making sure every baby food company in the country has access to the means needed to manufacture safe, nourishing products, such as sourcing rice from fields with soil low in arsenic and using food strains that are unlikely to absorb heavy metals, the agency would achieve the goal of the Closer to Zero plan. Still, the FDA’s strategy is loose. It has other shortcomings, too, such as failing to consider the cumulative impact of heavy metals on children’s neurodevelopment and not being completely transparent by posting testing data online as soon as they are available.

A Sliver of Hope for Parents of Infants and Toddlers Could Be the Baby Food Safety Act of 2021

Proposed on March 25, 2021, the Baby Food Safety Act was the idea of Congressman Raja Krishnamoorthi. He decided to take the initiative and propose a solution to the severe issue of heavy metals lurking in most baby food on the American market, perhaps because he saw firsthand the utter disregard many companies have toward the wellbeing of children. If this bill enters law, it will immediately set maximum limits for arsenic, cadmium, lead, and mercury in baby food. As a result, parents would have access to quality food for their children without waiting years for new regulations. But – wait! – there is more to it.

In addition to enforcing safe limits for the four dangerous heavy metals, the Baby Food Safety Act would also force the FDA to become more involved in monitoring the activity of baby food companies by periodically reviewing and, if necessary, further lowering the maximum limits for heavy metals. Furthermore, the new law would make it mandatory for facilities that handle infant and toddler food to have controls and plans to ensure that their products comply with the maximum limits on heavy metals. Finally, the Baby Food Safety Act would also expand the FDA’s authority to recall tainted or misbranded baby food.

Advice for Baby Food Manufacturers on How to Stay Ethical Until New Regulations Take Effect

The first step baby food companies that want to maintain their reputation as ethical, reliable businesses must take is to regularly test their raw ingredients and finished products for heavy metals. Having a sample tested costs between $50 and $100, but if the manufacturer signs a mutually beneficial agreement with a trustworthy laboratory, it will not spend a fortune on testing. If the baby food facility must comply with the Food Safety Modernization Act (FSMA), it must implement the Hazard Analysis Critical Control Point (HACCP) and set preventive controls. Recognized internationally, the HACCP system helps manufacturers ensure the safety of consumers by avoiding dangerous levels of contaminants in their products.

An excellent idea for baby food companies is to switch to a sustainable manufacturing approach. This will be a win-win situation, as producing sustainable baby food is associated with a lower operating cost, more profitable business, and improved share prices because up to 78% of consumers will purchase a product if it is eco-friendly, the chances of the business having a more significant revenue with each passing year increase tremendously. Baby food companies that connect with consumers by embracing sustainability relish higher profitability, and corporate plans that consider climate change and make efforts to minimize the environmental impact of the business earn an 18.7% higher return on investment (ROI).

Some of the most effective ways of becoming sustainable as a baby food company are paying attention to packaging and using as few as possible, sourcing ingredients from organic farmers, producing more vegan food, and selling dry food in bulk. Not only will switching to manufacturing baby food sustainably increase revenue and earn the business more loyal clients, but it will also eliminate the threat of heavy metals existing in the products in too high concentrations. Lastly, baby food companies that seek to remain ethical should have clear, honest labels, even if they use not-so-healthy ingredients, recall products immediately after receiving positive test results for heavy metals, and work with accredited, reliable, and competent people.

About the Author

Jonathan Sharp is Chief Financial Officer at Environmental Litigation Group, P.C., headquartered in Birmingham, Alabama. The law firm specializes in toxic exposure. The attorneys and their legal team aid parents whose children developed autism due to being fed toxic baby food, as autism is linked to exposure to heavy metals.

The post Acute Heavy Metal Issue in Baby Food Met with Sluggish Efforts by the FDA appeared first on The Libertarian Republic.

In an over 18 minute interview with Dr. Fauci, Hewit asked him to address what Fauci claimed are hurtful lies regarding COVID-19 vaccines spread by Brooklyn Nets guard Kyrie Irving and other NBA players who refuse to get vaccinated, as well as the government overreach that occurred as a result of how the pandemic has been handled.

“These are people; they’re not stupid people, and yet they have somehow or other been convinced of things that are just not factual, Hugh. You look at the data. The data are overwhelming that these are highly effective and safe. If you look at the track record of vaccines in general, what they’ve done for society and the benefit-risk ratio overwhelmingly weighs in favor of the benefit.” Dr. Fauci said.

When asked if he would step down as head of the NIH if it would result in an overall increase in the number of vaccinated Americans, Dr. Fauci firmly stated that he would not resign.

“I’ve lost confidence in the CDC and the FDA, and I actually believe a lot of Americans, a significant part of America, now have lost confidence in you, Dr. Fauci.”

“Is there a point where you will say I do more harm than good because people don’t listen to me anymore and step aside?” Hewitt asked.

“No, absolutely, unequivocally no, Hugh. Sorry. I mean I agree with a lot of the things you’ve been saying. You come from a different perspective than I do, but I think the thing that gets lost in the discussion and that people need to understand—and I do know that some people don’t understand it and don’t accept it, you know smart people, who evaluate it in their own context—is that we have been dealing with an evolving situation,” responded Fauci .

Even when Hewitt asked Fauci if he’d resign in favor of a fresh face that hadn’t flip-flopped on their position on COVID-19 if many more Conservatives would get vaccinated, Fauci declined and suggested Hewitt was creating a false narrative.

“Hew, I think that is a completely false narrative that people are not getting vaccinated because of me. I am very sorry—I’ve known you a long time, and I respect you, but I totally reject that people are not getting vaccinated because of me. Are you kidding me, Hew? Come on!”

Watch the full interview below:

The post Hugh Hewitt Asks Dr. Fauci to Step Down to Increase Vaccinations. Fauci Says “No!” appeared first on The Libertarian Republic.

Andrew Trunsky on May 25, 2021

Moderna announced Tuesday that its coronavirus vaccine was 100% effective against infection in kids aged 12 to 17, and that it planned to apply for FDA authorization in June.

The company tested its vaccine in 3,732 participants in the age range, and found no cases of COVID-19 among those who received two doses or any “significant safety concerns” throughout its study. It was 93% effective two weeks after the first dose, and fully effective two weeks after the second, Moderna said.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents,” Moderna CEO Stéphane Bancel said in the announcement. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”

Moderna’s vaccine was first granted emergency use authorization for adults in December, one week after Pfizer’s became the first to be authorized in the United States. Trials for both two-dose vaccines have shown them to be overwhelmingly effective, with rates around 95%.

Pfizer’s vaccine, which was originally approved for people 16 and older, was approved for adolescents ages 12 to 15 two weeks ago.

The post Moderna Says Vaccine Is 100% Effective In Teens, Plans To Apply For FDA Authorization appeared first on The Libertarian Republic.

The proposed ban, however, has implications that reach far past its stated purpose and is set to be a far-reaching, all-out war on the civil liberties of the American people at large.

I have never smoked a cigarette, nor will I ever choose to partake in the practice due to the health risks associated with cigarettes. However, as an avid cigar and pipe smoker for around two years, I know all too well that government hates tobacco in all its various forms.

This regulation is no exception when it comes to the government trying to destroy the hobby of cigar and pipe smokers.

According to Cigaraficionado.com, the ban would also extend to flavored cigars.

“According to the FDA, the ban on flavored cigarettes inadvertently lead to increased use of flavored cigars.”

“Flavored cigars are quite different than traditional, handmade premium cigars that Cigar Aficionado rates on a regular basis. While this FDA ruling would not affect the premium sector directly, several companies that manufacture premium, handmade smokes also produce flavored cigars. Corporations such as Swisher, for example, the parent company of Drew Estate, make the best-selling flavored cigar in America, Swisher Sweets, an inexpensive smoke sold in convenience stores, not fine cigar shops. Drew Estate makes the unflavored Liga Privada and Undercrown brands but also makes the flavored (or infused) brand Acid.

European tobacco giant Scandinavian Tobacco Group would also be affected by the proposed flavor ban. STG not only owns General Cigar Co. and its portfolio of handmade cigars, but also makes flavored cigar and cigarillo brands including Flavours by CAO, Panter and Café Crème.”

As I have pointed out on numerous occasions, the war on tobacco is a horrid example of government overreach, just like the war on drugs. The primary difference is that the war on tobacco doesn’t get a fraction of the amount of press that the war on drugs does.

The problem when it comes to legislation is that legislators lump all forms of tobacco in together when it comes to a proposed bill. What has come to be classified as a premium cigar is made up of three parts, a wrapper, binder, and filler. All three parts are made of tobacco, unlike cigarettes which contain more than 600 ingredients and more than 7,000 chemicals, according to the American Lung Association.

The guise of public health is nothing more than a smoke and mirrors game aimed at restricting the liberty of all smokers. If legislators cared about public health, they would take into consideration the fact that the FDA conducted a study in 2016 that concluded that an individual could consume two premium cigars a day and still not be at an increased risk for lung cancer when compared to non-smokers.

Legislators would also consider the fact that infused cigars such as Drew Estate’s popular “Acid” line are not chemically altered in any way but are naturally infused with botanical oils and extracts after being hung in “aroma rooms” for an extended period of time.

Where the confusion comes in for cigar smokers is the fact that infused cigars do not meet the current legal definition of what is considered a premium cigar in spite of meeting every single requirement except for “having a characterizing flavor that is not tobacco.”

According to Halfwheel.com, a premium cigar is defined as:

• is wrapped in whole tobacco leaf;
• contains a 100 percent leaf tobacco binder;
• contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
• is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
• has no filter, nontobacco tip, or nontobacco mouthpiece;
• does not have a characterizing flavor other than tobacco;
• contains only tobacco, water, and vegetable gum with no other ingredients or additives
• weighs more than 6 pounds per 1,000 units.

As it sits, I could also see this ban easily making it’s way into attempting to ban aromatic pipe tobaccos, which are blends with an added flavor casing intended to complement the natural flavors of the blend. Just like with infused cigars, the process does not add any extra chemicals to the tobacco.

It remains unclear what the future holds for the cigar or pipe, but I am sure there will be many lawsuits as the ban is yet another attack on the cigar industry.

The current administration should also be called out for its soft racism as it will disproportionately target black Americans, who, according to the FDA’s own statistics, consume menthol cigarettes more than any other ethnic group (85.5%). NBC.com reported that the ban would not seek to target black Americans for smoking menthols, but rather the manufacture of menthol cigarettes.

I don’t buy this. Remember, we are talking about politicians who have played an active role in passing and carrying out laws that have made black and brown people targets. Remember Eric Garner, who was killed by police simply for selling loose cigarettes? If we allow the FDA to get away with this ban, we can expect to see many more cases of innocent people killed or jailed simply for trying to enjoy a little smoke in whatever form they see fit.

As a lover of the leaf, I call on my brothers and sisters in the cigar and pipe communities, as well as all my fellow countrymen, to rise up and oppose this ban on menthol cigarettes and infused cigars, because once they have effectively destroyed our hobby, they will come for all of the other liberties that were supposed to be protected by our Constitution.

Whether you realize it or not, the cigar smoker is on the front lines in the battle against government overreach. If we allow the government to win this battle, you can bet our other freedoms may dissipate quicker than my cigar smoke.

The post First, They Came for the Cigarettes. Then, They Came for the Cigars. appeared first on The Libertarian Republic.

On Thursday, the U.S. Food and Drug Administration announced that it was moving to ban menthol cigarettes and flavored cigars. Though the rumors had been swirling for months that this might happen, I was still somehow shocked to see them actually do it. I mean, it’s not like they already have their hands full with controversial COVID-19 vaccines or anything, right?

My instant reactions brought two well-known memes to mind.

First, this rather ancient one:

(In my defense, it really was the stupidest fucking thing I’d read all day. Maybe all year. We truly are in the dumbest timeline.)

The other meme I thought of was from the video game Grand Theft Auto: San Andreas:

Here we go again, indeed.

This move is profoundly imbecilic on so many levels that I honestly feel kind of bad even writing about it. It’s like beating up Peter Dinklage. Or drag racing a short bus. There’s really no sport in it. It’s low-hanging fruit. Or in this case maybe it’s… low-hanging mint?

As a libertarian (though not a “real” one), I am against the banning of almost everything. In my perfect world, you’d be able to buy black tar heroin from a vending machine and then go get a drive-thru abortion. (Watch out for those cloth seats!) So going after cigarettes seems rather pointless; flavored cigarettes, doubly so.

The FDA’s logic, if I understand it, is that menthol cigarettes and flavored cigars target children and black folks. (Think about casually lumping those two together for a moment and you realize how condescending these people are.) There is some truth to both of those things, however poorly the bedside manner is of those making the argument.

Black folks, for whatever reason, do smoke menthols far more often than other ethnic groups. Who knows why. Who cares?

Menthols are also a “gateway” cigarette for younger folks. How do I know? I smoked cigarettes for many years, and I started on menthols. I remember specifically being told that you wanted to try those first because they were a little easier on beginners.

You can accept these two things as fact and still not give a shit. Which is where I come down (obviously.) Whether these cigarettes are favored by black people or youngsters (or young black people), banning them is horrendously misguided. The FDA is basically saying: “Don’t you silly Blacks know what’s good for you?” Which brings to mind the old Ronald Reagan quote: “The nine most terrifying words in the English language are: I’m from the Government, and I’m here to help.”

Everyone knows that cigarettes are bad for you. There is really no argument there. I have lost a family member to lung cancer that was almost certainly related to smoking and it’s no joke. But whether your bad habit kills you in forty seconds or forty years, it’s really not my concern either way. Unless we have national health care and I’m being forced via taxation to pay for your bad decisions. (Which is actually a better argument against national health care than against your bad decisions.)

But despite crazy rumors floating around for years that menthols were worse for you because they were filled with fiberglass or some such shit, or that they were intentionally made that way to kill off minorities, no one has ever actually proven that they are any more dangerous than regular cigarettes. And the FDA really isn’t even trying to argue that. So this isn’t about health per se. If that was the case, the FDA would ban all cigarettes and cigars. (Which I would also be against.) It’s more of a nanny state thing. You are being penalized not for wanting an inherently dangerous product; you are being penalized for wanting that inherently dangerous product to taste better. Or, at least taste better to you. This somehow becomes a social justice issue or an attack on a protected class. The logic escapes me.

The whole thing is also rather awkward because, in a post-George Floyd world where white folks are finally realizing that police have in fact been screwing black people over for decades, this gives police another tool to screw over those very same people. We even have a fairly recent example of a black man being killed by police over cigarettes in the Eric Garner case. (It would be ironic, in retrospect, if they were menthols.)

Oh, sure, the administration says they’re only going to target manufacturers and not consumers. How’d that work out in the drug war? Or Prohibition? I think you know.

A black (no pun intended) market will almost certainly develop overnight. First, people will start to hoard the current stocks of Newports, Kools, Salems, and so forth. After those are gone, people will start making their own menthol cigarettes. Stores will sell these menthol additives with a wink and a nod, kind of like how head shops have been selling bongs for years but labeling them as “exotic tobacco pipes.”

When a commodity is driven underground, prices skyrocket and quality suffers. Who benefits from that? Not your average law abiding citizen, that’s for sure.

Also, think about how this is also taking place against the backdrop of more and more states legalizing recreational marijuana. Or, as I call it, “the only good reason to set foot in Illinois anymore.” The juxtaposition is stunning. The optics are shit. Why would any level of government care what you were smoking in the first place, much less legalize one thing while criminalizing another? If you’d have told me twenty years ago that pot would be legal but menthol cigarettes would be banned, and that Democrats would be the ones pushing the menthol ban, I’d have asked you what you were smoking. (Spoiler alert: probably pot.) Have we surrendered in the “War on Drugs” only to start a new “War on Mint?”

(As a side note, I don’t think marijuana legalization has really been driven by any real thirst for freedom, or a recognition that people should be able to do what they want. It’s mostly because people just like marijuana. The thought process starts and stops there. Those same people often don’t think twice about banning other things because they happen not to like those other things.)

Why are we banning menthol cigarettes while you can walk into any liquor store and buy twenty different flavored vodkas? (Thanks, Burnett’s.) Or fifteen different kinds of Bud Light Lime-A-Ritas? (Whose motto should be: “It’ll take some hair off your chest.”) Or thirty kinds of crappy favored seltzers? Aren’t wine coolers still a thing? Isn’t Boone’s Farm still acting as a gateway booze for young tipplers? Speaking of flavors, you can drive across the bridge here over to Illinois and buy many different flavors of cannabis gummies. (At least, that’s what I’ve been told.)

Are we also going to ban flavored beers? Or malt liquors and fortified wines because they’re allegedly too strong, while also being popular in low income areas? Surely, no one would be silly enough (or perhaps racist enough) to try something so absurd, right? Think again. Meanwhile, Whitey McWhiteperson or Cracky McCrackerson is still free to buy his Busch Light and Marlboro Reds pretty much anywhere.

Instead of meekly going along with a menthol cigarette ban, will the tobacco companies fight? Or at least try and pull off a second “Tobacco Settlement”, in which they basically pay a bribe to the FDA (or the various states) in exchange for being left mostly alone? That worked well enough in 1998. Sure, it resulted in the absurdity of tobacco companies paying to advertise against themselves, and the settlement costs were passed along to smokers in the form of steep price increases, but Big Tobacco greased the palms that it had to grease.

I quit smoking twenty-one years ago. Not out of any serious concern for my health; one look at my monthly expenditures at Liquor Warehouse would attest to that. It was because smokes were just getting too damned expensive and I didn’t want to pay for them anymore. But when I did smoke, I was a brand-hopping tobacco whore. I tried about everything. I tried Salems, Kools, Newports, Marlboro menthols, and even weird stuff like Bel Air and Alpine back in the day.

I don’t often crave cigarettes anymore, but on the rare occasion that I do, it’s usually a full-strength Salem I’m jonesing for. Those suckers packed so much menthol punch that it was like French kissing a little jar of Vicks VapoRub.

I’m tempted to start smoking again, and specifically to start smoking menthols, just to stick it to Uncle Sam. I want to fire up a Salem, take a big gnarly drag of that minty goodness, and extend a middle finger in the general direction of the District of Columbia.

The Libertarian Republic’s fearless leader once famously said:

Would a world where gay black married couples are free to protect their menthol cigarettes with fully automatic machine guns also be too much to ask?

TLR image composite source: LibertyLover2 Instagram

The post They Can Pry Your Menthols From Your Cold, Dead Hands appeared first on The Libertarian Republic.

One Texas gubernatorial candidate made the exact opposite journey, traveling from a beach house in Cancun to Austin for a campaign rally where he illegally sold insulin on the Texas Capitol grounds to make a point about healthcare. Upon his arrival, he encountered hotels without power, a disruption with the sound equipment rental companies who were to service the rally, and many who were set to attend the rally had to stay home due to road conditions.

Daniel “Taxation is Theft” Behrman held his “Rally to Free Healthcare” (as opposed to rally for free healthcare) in order to highlight what he describes as a big healthcare/big pharma monopoly inflating the cost of essential medicines through regulatory capture of government. Following the rally, the boogaloo bois brought needed food, water, and warmth to those affected by the winter storms crippling the state for days and killing over fifty people.

During the rally, he sold insulin for $12. Why $12?  As he explained during the rally,

“Insulin costs about $3 to manufacture a month’s supply, and they sell it to us here in America for $100. Now, of course, if you live close enough to the border, you can actually walk right across the border over to Mexico, and you can buy the same insulin for $12. An 88% discount. Now, of course, if you don’t live by the border, you have to pay these really high prices. If you’re lucky enough to have insurance, well… your insurance isn’t just coughing up that money for free—that’s built into your premium. That’s one of the reasons premiums are so high.

A lot of people say ‘oh, but if Mexico has insulin for $12, it must be some cheap knock off stuff’. No. Actually, the stuff that they sell, the insulin they sell in Mexico is the exact same stuff that they sell in the United States. In fact, it was manufactured in the United States. It is FDA approved to be sold in the United States, but they export it to a place that cannot afford the $100 price tag that we have here.

So, I went down to Mexico. And in the United States, you need a permit from the government. And that permit has to be given to you by a doctor. They call it a prescription. It’s a government permit to get medication to save your own life. I went down to Mexico, I walked into a pharmacy… and I was a little bit scared because I was worried that what I was doing was illegal. I was going to try to buy some drugs and bring them back to the United States. Sounds scary, right? We’ve seen all these movies where people try to do that. The feds are after them, all this crazy stuff goes on, 100 years in prison.

So, I walked into a pharmacy. And man, I was like a teenager with a fake ID trying to buy alcohol. I went up to this pharmacist and I was trying to speak broken Spanish to him. My Spanish is already not that great, but I was trying to make it worse just to be like, ‘Okay, this gringo was given what he’s asking for’. And of course, that whole plan went south when I realized the pharmacist spoke perfect English. And he was just rolling his eyes at me. But it was funny because there was nothing odd about that to him.

Because in Mexico, there’s no requirement for government permission to get medication, or most medications to keep you alive. This is super important. Because in the United States, there are people dying because they don’t have access to lifesaving medication. Sometimes because they don’t have the right prescription. Sometimes because they don’t have the money to pay the extortion—the extremely high costs that our government imposes.

So this stuff, you can go to Mexico, you can get it for $12 and bring it across to the United States. Sounds great. I was only able to bring a little bit with me because if I brought a whole lot of it, that might give me some problems. So, some people reached out to me and they said, ‘so what’s your solution to this problem?’ I said, ‘Well, if you get rid of the government regulations, you might have have somebody in Mexico or another country who has access to this insulin for $12, who might open up an online pharmacy, and send it to the United States for $12 plus shipping.”

Right now, that’s illegal. It’s not for your safety—the government wants to tell you it’s for your safety. It’s not for your safety. It is to protect the extortion from Big Pharma, so they can charge you $100 for insulin that they’re already selling in other countries for $12.”

Is his sale of insulin to diabetics during a campaign rally on the Texas Capitol grounds illegal? He thinks that’s the wrong question to ask.

“Martin Luther King said, if a law is unjust, we not only have a right to ignore the law, we have a duty. This law is unjust. It’s telling us that even though we can buy lifesaving medication for what we can actually afford, it’s illegal. And so many Americans have so fallen for this brainwashing that they are afraid to save their own lives.”

But, even if he’s right, isn’t he running for a state level position? If the feds enumerate the rules of the road for healthcare, what could he even do as Governor about it?

“I’m running for governor of Texas, and we’re here at the Texas State Capitol. And a lot of this is federal law. So what can the state do if this is federal law? Ignore it. We can ignore it. We can nullify it. I mean, if we wanted to, we could build our own bridge across the Rio Grande and allow cars to drive right over… we could send helicopters and allow state protection against federal agents. We have the power to do that. A lot of people don’t like that idea. But do you like the idea that people are gonna die because they don’t have access to health care?”

Were those $12 sales making him money? Nope. That was the exact price he could buy it for in Mexico. And the extra?

“And whatever I have left? Actually, some of my friends here—what should I say—the boys with the guns? They’ve got food and water for the homeless. So we’re gonna head out and we’re going to distribute that after this. And when we do that, if we run into any diabetics who are homeless and in need, we will give them access for free. We’re not going to charge them for any leftovers that we have here.”

You can follow Daniel Behrman’s Texas gubernatorial campaign on Facebook and Twitter.

The post Texas Gubernatorial Candidate Travels from Cancun to Austin to Illegally Sell Insulin at the Capitol appeared first on The Libertarian Republic.

Two vaccines have since been approved for use, but the virus is claiming lives faster than ever in large part because officials are struggling to distribute them fast enough.

Medical experts say the bottleneck could be loosened if the Food and Drug Administration approved Oxford-AstraZeneca, a vaccine developed by Oxford researchers that is more affordable than other vaccines currently available and far easier to distribute.

“The FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine. It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute,” says Dr. Marty Makary, a professor of surgery and health policy at the Johns Hopkins University School of Medicine. “It does not require freezing and is already approved and being administered in the United Kingdom.”

Others agreed.

Economist Alex Tabarrok pointed out that AstraZeneca’s coronavirus vaccine is being produced at a Baltimore plant right now, and is capable of producing tens to hundreds of millions of doses annually.

“Thousands of people are dying every day. We have a vaccine factory ready to go,” Tabarrok wrote on the economics blog Marginal Revolution. “The FDA should lift its ban on the AstraZeneca vaccine.”

Delaying a Vaccine We Had from the Start

Some may be shocked that the FDA is holding up a cheap, durable vaccine that is already being used in other countries even as thousands of Americans die from the virus every day.

But this is hardly the first time the agency has faced the ethical dilemma of delaying a product that could be saving lives until that product has been approved by government officials through appropriate channels.

In March, when the coronavirus arrived in the US in earnest, governments around the country locked down economies to prevent the spread of a virus that to date has claimed the lives of nearly 400,000 Americans. While these actions were being taken, a vaccine had already been developed. The mRNA-1273, a lipid nanoparticle–encapsulated mRNA-based vaccine, was made in a single weekend in January, two days after Chinese researchers published the coronavirus’ genetic code.

Developing the vaccine was the easy part, it turns out. Testing the vaccine and navigating it through the federal bureaucracy was the real challenge. Not until March 16, more than two months after the vaccine was developed, were the first trial participants vaccinated. And these trials were followed by more later-stage clinicals.

There was another option that would have made the vaccine available much sooner: challenge trials, a process that would have involved deliberately infecting healthy volunteers with SARS-CoV-2 to accelerate vaccine development. Reports show at least 25,000 people volunteered to do just that.

The FDA rejected this course.

The Invisible Graveyard

To date, nearly 2 million people worldwide have died of (or with) COVID-19. Meanwhile, government lockdowns intended to slow the spread of the virus triggered the largest economic contraction since the Great Depression.

That a bureaucracy delayed the distribution of a vaccine, and continues today to delay approval of a vaccine cheaper and more durable than alternatives, during a deadly pandemic raises important ethical questions.

Does the government have the right to deny people vaccines or medicines that can save them?

How many lives could have been saved if the government had not used coercion to prevent individuals from purchasing a vaccine that could have protected them?

Did the risks of fast-tracking a vaccine outweigh the costs of delaying approval?

What is the actual purpose of bureaucracy?

Many might assume that the purpose of the FDA is to protect Americans and save lives. Unfortunately, this is not the nature of bureaucracies. Their purpose is not to save lives, but to follow processes.

But it’s also a matter of basic incentives, as Tabarrok explained in an article for the Independent Institute. He points out that although drug reviewers at the FDA are immune from legal liability, they are not immune from humiliation during congressional hearings, TV exposés, and newspaper denunciation.

This causes them to err lopsidedly on the side of caution. But for many, such “caution” proves to be lethally dangerous.

The FDA, Tabarrok summarizes, “has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.”

This “invisible graveyard” may hold far more dead bodies than the publicized ones. But that has no bearing on an FDA bureaucrat’s career.

Sadly, because of this flawed incentive structure, we are only left to wonder how many lives of COVID victims might have been spared in a system based on voluntary choice, not bureaucracy and coercion.

This article was originally published on FEE.org. Read the original article.

The post The FDA Is Holding Up a Cheap Vaccine as COVID Deaths Surge appeared first on The Libertarian Republic.

First and foremost, the COVID-19 pandemic posed enormous challenges to American institutions, and continues to do so. Frankly, we were not prepared. We need to diagnose what went wrong, so that we are never caught unaware like this again. Fortunately, the diagnosis is straightforward. COVID-19 was going to be bad, no matter what. But the failures of big government made it much, much worse.

In particular, the Centers for Disease Control, Food and Drug Administration, and public teachers’ unions are the great American villains of 2020. Meanwhile, the heroes of this year are almost entirely in the private sector. From Zoom to vaccine development, Big Pharma and Big Tech—yes, you read that right—made this horrible year bearable. Even amid a crisis that led so many to cry out for vigorous government action, we saw that private markets still work best.

For progressives and so-called “national” conservatives who support big government, 2020 represented the ultimate test for their philosophies. Although they disagree on cultural issues, they see eye-to-eye on the role of government. Both want a big, energetic state promoting what (they believe to be) the good of the nation. Well, here was their chance for the government to shine.

The result was shameful failure. The COVID-19 crisis put left-wing and right-wing statism on trial—and both were found guilty of ill-intent and gross incompetence.

After all, the CDC is the reason America lagged behind other nations for so long in terms of COVID-19 testing. We had the virus genome fully mapped in January, which enabled the rapid production of private testing kits. But the CDC forced these operations to shut down, coming up with its own test—which was flawed, and even contaminated! Testing and tracing could have stemmed the worst of the COVID-19 tide.

On this issue alone, CDC ineptitude is likely responsible for tens of thousands of deaths. Its red tape and incompetence made containing the COVID-19 pandemic, like a few other countries were able to, impossible.

How about the FDA?

It is no secret that the vaccine was delayed because it needed FDA approval. Indeed, several working vaccines could have come much earlier, were it not for our bungling bureaucrat gatekeepers. (Dear FDA: Can you please speed things up a little, so people do not, you know, die? It would make us ever so happy if you did. Thanks.)

As for schools, the data show that young people and children are at very low-risk from COVID-19, and that schools are not “super spreaders.” Despite this, largely due to pressure from public teachers’ unions, many schools remained closed in the fall. In fact, the US was pretty much the only country to pursue the alarmist policy of keeping schools closed.

The toll on school-aged children is immense, from psychological trauma to impeded learning. Low-income families were hit especially hard. They often lacked the means to participate in distance learning, and having their kids at home made it harder for parents to earn much-needed income.

Fortunately, there seems to be some well-deserved backlash against the crony public education establishment. Hopefully a mass exodus to more effective and accountable learning platforms will follow, whether that is charter schools, private schools, or homeschooling. Even more hopefully, parents will realize public education racketeers are not their friends. They should demand loud and clear: Fund students, not systems!

In stark contrast to these unacceptable failures by government agencies and employees, the private sector delivered.

Big Pharma and Big Tech are the winners here. Pfizer, Moderna, AstraZeneca, and many other companies did amazing work getting the vaccines developed as quickly as they did. Public health “experts” repeatedly claimed a vaccine would not be available for 18 months, at the earliest. (Shows what they know!)

As for Big Tech, companies like Facebook and Twitter helped us stay connected while we were forced physically to remain apart. Amazon responded well to a huge surge in demand, stemming from the curtailment of in-person shopping. Faced with an immense logistical challenge, the online retailer surpassed expectations.

These sectors and their star performers are not perfect, of course.

In the past, Big Pharma lobbied for many of the regulatory roadblocks that made fighting COVID-19 so hard. Big Tech got egg on its face for covering up the Hunter Biden laptop story. Nevertheless, the takeaway is clear: 2020 would have been much, much more miserable without these supposedly evil big businesses in our corner. We owe them far more than we give them.

2021 is the perfect time to revisit our basic beliefs about the role of government and business in society. Both were unexpectedly challenged by the greatest public health crisis in recent memory.

Government failed. Business triumphed. Statism should be discredited, hopefully for an entire generation. Any coherent political philosophy for the 21st century must start from this basic truth.

This article was originally published on FEE.org. Read the original article.

The post Why the Real Villain of 2020 Was Big Government appeared first on The Libertarian Republic.

But the government wouldn’t let you take it.

The vaccine, a triumph of medical science known as mRNA-1273, was designed in a single weekend, just two days after Chinese researchers published the virus’s genetic code on January 11, 2020.

For the entire duration of the pandemic, while hundreds of thousands died and the world economy was decimated by lockdowns, this highly effective vaccine has been available.

But you, and all the people who died, were prohibited by the government from taking it.

There are some who claim that the FDA “saves lives” by putting the brakes on medical innovation with their requirements for years-long, and often decades-long, billion-dollar medical trial procedures.

Missing here is the obvious counterpoint—How many lives did the FDA sacrifice to disease in the meantime?

In the case of COVID-19 we know the answer: more than 300,000 deaths so far in the United States and counting.

So why was this vaccine delayed for a full year? Because the FDA prohibited rapid “challenge trials”—where volunteers take the vaccine and then expose themselves to the virus in a lab, rather than waiting agonizing months to see how many catch the virus “in the wild.”

Challenge trials would have proven the vaccine’s effectiveness in a matter of weeks. But the FDA considered the risk to trial volunteers too high.

But why? Why are hundreds of thousands of “natural” deaths from a rampaging disease considered acceptable to the FDA—while the remote possibility of one or two deaths, in the absolute worst case scenario, among well-informed vaccine-testing volunteers are not?

There is no rational answer. The tragic truth is that we are ruled by a cowardly medical bureaucracy, one that would rather allow hundreds of thousands of people to die than face any potential criticism for allowing an accelerated vaccine trial.

By contrast, in a free society, immediately after the vaccine was created, volunteers would have been allowed to participate in challenge trials. The trials would have been conducted either by the vaccine company itself, or more likely by third-party medical-trial specialists, to remove any concerns about bias in the results.

The first small group of volunteers would be vaccinated, and then exposed to the virus. If the vaccine appeared to be safe and effective, then a larger group would be vaccinated.

As each challenge group proved successful, the number of volunteers for the next group would grow. Week by week the challenge groups would grow larger, until after just a few months—instead of taking nearly a year by the FDA’s “in the wild” method—the results would be definitive and the trials complete.

This means that in March or April of 2020—instead of the first wave of COVID deaths and lockdowns in the United States—we could have seen a wide vaccine rollout, leading to rapid herd immunity, nipping the pandemic in the bud.

But that path would have been possible only in a free society.

Instead, we have the FDA, backed by government force, dictating medical policy and drawing out the trial process for nearly a year, while death and economic destruction reign.

A free society, by contrast, would have a minimal government—one which leaves its people at liberty and which only exists to protect their rights against physical force and fraud.

Such a government would have no FDA slowing down medical progress. Pharmaceutical companies would be free to invent new treatments as rapidly as possible, and consumers would be free to voluntarily test them—while being protected by civil and criminal penalties aimed at any company who caused harm or perpetrated a fraud.

No foot-dragging, self-protecting, innovation-slowing bureaucracy is required.

It’s almost a tautology, but worth observing in this context: People, if left free, will by definition act in ways that they think best. If they had been allowed to do what they thought best, free private volunteers would have proven the safety and efficacy of the Moderna vaccine by as early as April 2020, ending the pandemic.

On the other hand, a government—an entity defined by its monopoly on the use of force—can only interfere with the free action of people. It can only prevent individuals from doing what they think best, and/or force individuals to do what they think is not best.

In the case of the COVID-19 pandemic, the government did both: (a) It used force, via the FDA, to prevent people from voluntarily taking a highly effective vaccine that existed since the start of the pandemic; and (b) it forced people to take actions which they did not think best—such as closing their businesses.

As a result, the economy was devastated in ways that will take years, if not decades, to recover from, and hundreds of thousands of Americans were told to sit, wait, and die.

This article was originally published on FEE.org. Read the original article.

The post We Had the Vaccine from the Start—You Just Weren’t Allowed to Take It appeared first on The Libertarian Republic.

U.S. District Court Judge Amit P. Meheta of D.C. ruled that the FDA can’t enforce premarket regulations on premium cigars until they consider a more streamlined approach that would apply strictly to the premium cigar industry, according to cstoredecisions.com

Meheta’s ruling reinforced the August 2020 definition of premium cigars which reads:

“a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand-rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, non-tobacco tip, or non-tobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.”

This is at least a temporary victory for the cigar industry and cigar consumers everywhere against a bunch of government bureaucrats who clearly don’t smoke cigars or know how cigars are made, as they continually attempt to group cigars and pipe tobacco in with regulations regarding vapes or cigarettes. The court ruling means that cigar companies can continue to produce the same blends that brothers and sisters of the leaf know and love without any additional regulations for the foreseeable future.

As an avid cigar and pipe smoker, I am angered, but not surprised that the government would try to keep freedom-loving Americans like myself from engaging in a hobby that for so many is about relaxation and community. Premium cigars are handmade products made up of three parts, a wrapper, binder, and filler. The three parts of a cigar are nothing more than bunched up tobacco leaves held together by a little bit of fruit pectin. There’s honestly no way an individual could make a more organic product than that.

The FDA’s attempt to further regulate cigars is not about any sort of safety concerns, but yet another attempt to control both the means of production and consumer market freedom. The reality of the FDA’s war on cigars should concern every libertarian even if they don’t smoke cigars as it is a glaring assault on self-ownership.

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‪Just your favorite bearded libertarian here reminding you that taxation is theft and enjoying an Arturo Funte on #America’s 244th Birthday.‬

A post shared by Caleb Shumate (@calebshumate1776) on Jul 4, 2020 at 7:03pm PDT

The government has a nasty habit of ruining everything it touches. If the FDA has its way, it could lead to absolutely disastrous consequences like the destruction of family-owned companies that have been around for generations. The effects of regulating the cigar industry further could mean economic disaster for many of the Latin American countries whose economy depends heavily on the manufacturing of premium cigars. The truth of the matter isn’t merely a smoke and mirrors game. In fact, Martinez Cuenca of Joya De Nicaragua says that more than 45,000 families depend on the cigar industry in Nicaragua, according to Cigar Aficionado.

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Tunes and a post-meal cigar. This time it’s a @perdomocigars Lot 23 Connecticut.

A post shared by Caleb Shumate (@calebshumate1776) on Jun 8, 2020 at 5:05pm PDT

In this way, the personal freedom of the cigar smoker and the economic security of these Latin American countries are linked, and if the FDA is allowed to persist in its war on tobacco, both could be in danger.
As a Libertarian and a student of history, I know that much more than the hobby of the cigar smoker is at stake, but also an entire world of craftsmanship, artistry, and the legacy of countless proud families is at stake. Anyone who loves liberty should appreciate the endurance of the cigar industry, which continues to fight against the numerous attacks of government goons.

As for me, I’m going to have a cigar and enjoy the cigar industry’s burn on the FDA!

The post Opinion: The Cigar Industry’s Court Victory Burns the FDA appeared first on The Libertarian Republic.