When There Wasn’t Enough Hand Sanitizer, Distilleries Stepped Up. Now They’re Facing $14,060 FDA Fees.

For many American craft distillers, 2020 was already one of their worst years ever. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability to offer in-store sampling slashed their sales revenue and cut them off from their customers. Then this week, just as it seemed they’d made it through the worst of a terrible year, the Food and Drug Administration (FDA) had one more surprise in store: The agency delivered notice to distilleries that had produced hand sanitizer in the early days of the pandemic that they now owe an unexpected fee to the government of more than $14,000.

“I was in literal disbelief when I read it yesterday,” says Aaron Bergh, president and distiller at Calwise Spirits in Paso Robles, California. “I had to confirm with my attorney this morning that it’s true.” The surprise fee caught distillers completely off guard, throwing the already suffering industry into confusion.

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What a Frozen Cherry Pie Says About FDA Regulatory Foot-Dragging

American cherry pie manufacturers may soon be able to decide for themselves how many cherries their frozen pies should have, free of burdensome federal regulations.

Former Food and Drug Administration (FDA) head Scott Gottlieb tweeted out praise that his former staff have successfully arranged to deregulate the contents of cherry pies after—no kidding—two years of hard work (and he’s actually understating it, but I’ll get to that)…

So, is this now federal pie anarchy? No. (Unfortunately.) In 1971, the FDA established regulations imposing particular standards for frozen cherry pies. The lengthy regulations (read them here) determine not just how much of the pie must be made of cherries (25 percent by weight) and how many of the cherries may be “blemished,” or have scabs, or be of less than stellar quality (under 15 percent, even though pies are a great place to put blemished fruit to keep it from going to waste), but also establishes complicated rules for determining compliance.

While the FDA has been granted the power by Congress to regulate frozen foods and fruits, including pies, it’s very important to explain that these regulations were only implemented for cherry pies. There are no other similar regulations for other types of fruit pies. And there are no similar regulations for fresh pies to control the number and quality of the cherries in them. Just frozen pies, and only the cherry ones.

And so under Gottlieb and by request of the American Bakers Association (ABA), a trade association and lobbying organization, the FDA began rethinking this rule. The ABA argued that consumers, not the federal government, should decide whether they want to shell out more money for pies with more fruit in them or spend less money on lower-quality pies, if that’s what they can afford.

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FDA approves new genetically modified pig for allergy-free medical and food products

The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

It might help people who have an allergy to alpha-gal– an allergy sometimes triggered by a tick bite.”Today’s first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation,” said FDA Commissioner Dr. Stephen Hahn.The pigs, licensed to Revivicor Inc., a subsidiary of United Therapeutics, are called GalSafe pigs. Revivicor is a spinoff from PPL Therapeutics, which produced the first mammal cloned from an adult mammal: Dolly the sheep, in 1996.Products made from their bodies can be safely used by people with alpha-gal syndrome, FDA officials told a media briefing. These might include the blood thinner heparin, made from pig intestines, as well as tissue or organ transplants.A company called Xenotherapeutics has three patients enrolled in a Phase 1 safety trial of using skin from GalSafe pigs for skin grafts to treat burn victims with alpha-gal allergies. The company is working to enroll three more in the trial at Massachusetts General Hospital.

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Vaccine Makers Can Skip U.S. Inspections

The U.S. Food and Drug Administration inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a pharmaceutical company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies.

But that won’t be the case for Covid-19 vaccine developers that gain emergency authorization of a shot.

FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines.

Before approval, FDA inspections ensure compliance with regulations. Once a product is being made—as vaccines already are to get them out as quickly as possible—they can uncover quality breaches and assess whether pharmaceutical companies handled them correctly or are possibly downplaying or ignoring serious issues.

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The FDA is outsourcing COVID-19 testing to China

After reviewing the 161 emergency use authorizations granted by the FDA since February, I found that at least 10 Chinese companies were delivered the FDA stamp of approval to deliver diagnostic tests in the United States for SARS-CoV-2, which causes COVID-19.

These China-based companies have received FDA EUAs that grants them the ability to test for the coronavirus in America (including date of approval and link to FDA approval document):

  1. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (9/9/20)
  2. ZhuHai Sinochips Bioscience Co., Ltd (8/17/20)
  3. Xiamen Zeesan Biotech Co., Ltd. (7/31/20)
  4. Jiangsu CoWin Biotech Co., Ltd. (7/24/20)
  5. Jiangsu Bioperfectus Technologies Co., Ltd. (6/18/20)
  6. Genetron Health (Beijing) Co., Ltd. (6/5/20)
  7. Sansure BioTech Inc. (5/4/20)
  8. Seasun Biomaterials (4/27/20)
  9. Fosun Pharma (4/17/20)
  10. BGI Genomics Co. Ltd. (3/26/20)

China is the United States’ greatest adversary, and Beijing has not been forthcoming about the role it played in potentially negligently unleashing the novel coronavirus. These factors may cause many to raise concerns about the FDA’s decision to continue to authorize Chinese labs and companies to deliver U.S. coronavirus testing. Moreover, China’s one-party, top-down totalitarian system demands that corporations based in China are completely subservient to the state. There are no truly independent companies in China. All are ultimately beholden to the needs of the Chinese Community Party (CCP).

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US, UK Intel Agencies Declare Cyber War On Independent Media

In just the past week, the national-security states of the United States and United Kingdom have discreetly let it be known that the cyber tools and online tactics previously designed for use in the post-9/11 “war on terror” are now being repurposed for use against information sources promoting “vaccine hesitancy” and information related to Covid-19 that runs counter to their state narratives. 

A new cyber offensive was launched on Monday by the UK’s signal intelligence agency, Government Communications Headquarters (GCHQ), which seeks to target websites that publish content deemed to be “propaganda” that raises concerns regarding state-sponsored Covid-19 vaccine development and the multi-national pharmaceutical corporations involved. 

Similar efforts are underway in the United States, with the US military recently funding a CIA-backed firm—stuffed with former counterterrorism officials who were behind the occupation of Iraq and the rise of the so-called Islamic State—to develop an AI algorithm aimed specifically at new websites promoting “suspected” disinformation related to the Covid-19 crisis and the US military–led Covid-19 vaccination effort known as Operation Warp Speed.

Both countries are preparing to silence independent journalists who raise legitimate concerns over pharmaceutical industry corruption or the extreme secrecy surrounding state-sponsored Covid-19 vaccination efforts, now that Pfizer’s vaccine candidate is slated to be approved by the US Food and Drug Administration (FDA) by month’s end. 

Pfizer’s history of being fined billions for illegal marketing and for bribing government officials to help them cover up an illegal drug trial that killed eleven children (among other crimes) has gone unmentioned by most mass media outlets, which instead have celebrated the apparently imminent approval of the company’s Covid-19 vaccine without questioning the company’s history or that the mRNA technology used in the vaccine has sped through normal safety trial protocols and has never been approved for human use. Also unmentioned is that the head of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, is the former Pfizer vice president for product safety who covered up the connection of one of its products to birth defects.

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