Madison Area Lyme Support Group

A new proposal from the FDA will compromise your ability to get the personalized medical care you need. Action Alert!

We reported a few months ago that the FDA was planning to propose a new rule to extend its power over laboratory developed tests (LDTs). That proposal was published last week, and, in line with our concerns, it represents a major attack on LDTs that we think will compromise patient health. We cannot allow the agency to regulate these critical tests out of existence. Use the forms below to post an official comment to the public docket.

This rule is the culmination of many years of effort from the FDA to extend its power over LDTs. Like previous attempts, what the FDA is trying to do is regulate LDTs like other medical devices, which means a boatload of additional regulatory requirements and, in many cases, premarket review.

This is a critical threat, as LDTs are crucial tools used in personalized medicine because labs can create custom diagnostic tests for all sorts of health conditions. LDTs are diagnostic tests developed and performed by local labs. They are important tools used by healthcare providers to diagnose and manage a wide range of conditions. They are widely used—thousands of different LDTs are available—and include genetic tests, heavy metal tests, tests for rare conditions, nutritional status tests, and hormone tests. They can be tailored to meet specific patient needs and can be used to respond rapidly to emerging threats like COVID-19. Currently, laboratories have the flexibility to adapt and modify tests based on evolving scientific knowledge and patient requirements. That could all change if this proposed rule goes through.  (See link for more and to take action)

The FDA has a long history of attempting to monopolize testing.  If they control testing, they control the entire narrative.

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https://anh-usa.org/ftc-clarifies-how-it-will-censor-supplement-claims/

FDA to Censor Supplement Claims

By ANH-USAOn 10/12/2023

While the FTC appears to have backtracked slightly on its draconian campaign to censor supplement health claims, it is really a classic example of doublespeak.  Action Alert!

The FTC is working to conceal the remarkable truth about the healing and disease-preventing powers of foods and nutrients. This is only good if you’re a drug company looking to sell more expensive drugs for preventable chronic illnesses that often do not work. This censorship keeps you from learning that magnesium can help lower blood pressure, for example, or that chromium can lower blood sugar, or any of the other innumerable benefits that come from natural vitamins, minerals, herbs, and amino acids.

The FTC has been censoring natural product health claims for years, but the latest threat is the December 2022 revision to the agency’s Health Products Compliance guidance coupled with the hundreds of warning letters sent in April this year to producers of supplements, homeopathic medicines, and functional foods. These letters warned companies that if they make claims without proper scientific substantiation (that is, evidence from more than one randomized controlled trial, or RCT), they will face large civil penalties. You can reference our earlier coverage for the details.  

Important excerpt:

The agency is talking out of both sides of its mouth. On the one hand, it says quite clearly in its updated guidance (see below) that most supplement claims will require substantiation by RCTs, and other kinds of evidence will not be sufficient. On the other hand, it’s saying there “may” be some exceptions, but it depends on what experts in the field say. But we know good and well that the “experts” the government consults with are often on the take from Big Pharma or are otherwise critics of the use of natural products as the mainstay in health. Just look at what’s happening with another natural medicine in the government’s crosshairs, compounded bioidentical hormone replacement therapy (cBHRT). The FDA asked an “independent” panel of “experts” at the National Academies of Sciences, Engineering, and Medicine to review the clinical utility of cBHRT, and lo and behold, they concluded that there wasn’t any evidence to support cBHRT because there weren’t RCTs supporting safety and efficacy.

In our view, this “clarification” about possible exceptions to the RCT standard is all a smokescreen from the FTC, perhaps to lure companies into thinking they don’t need RCTs to support a health claim so the agency can bring the hammer down on them later.

From Joseph Mercola, DO

If you think freedom of speech has gone down the tubes, you haven’t seen the half of it yet. September 19, 2023, the U.K. passed a new law to “regulate” (read, censor) online content. The so-called Online Safety Bill has been described as “one of the most far-reaching attempts by Western democracy to regulate online speech.

Interestingly, the bill has been in the works for the last five years, again proving that online censorship is not something that sprang up in response to COVID.  Governments have been steadily moving in this direction for a long time.

As reported by The New York Times, the bill forces online platforms to “proactively screen for objectionable material and to judge whether it is illegal, rather than requiring them to act only after being alerted to illicit content.”

Of course, we now know that flagging material for removal is how the U.S. government has illegally circumvented constitutional free speech rights for the past few years.

September 8, 2023, the Fifth Circuit Court of Appeals upheld part of the lower court’s injunction, banning the White House, surgeon general, the Centers for Disease Control and Prevention, and the FBI from influencing social media companies to remove “disinformation.”

Unfortunately, the appellate court also reversed, vacated and modified other parts of the original injunction, leaving the door wide open for certain federal agencies to continue their censorship activities.

Importantly, officials from the Cybersecurity and Infrastructure Security Agency (CISA) were excluded, even though CISA has played a major, if not central, role in the government’s censorship of Americans.

 (See link for article)

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**Comment**

In case you are unaware: the FDA is not our friend. 

For more:

• https://madisonarealymesupportgroup.com/2018/02/28/corruption-in-fda-states-constitutional-attorney/
• https://madisonarealymesupportgroup.com/2022/08/10/insider-states-the-fda-has-lost-its-soul/
• https://madisonarealymesupportgroup.com/2021/07/01/the-fda-is-broken-its-controversial-approval-of-an-ineffective-new-alzheimers-drug-proves-the-agency-puts-profit-over-public-health-project-onyx/
• https://madisonarealymesupportgroup.com/2022/01/03/bidens-fda-chief-pick-used-to-work-as-big-pharma-consultant-has-millions-in-pharma-investments/
• https://madisonarealymesupportgroup.com/2022/03/02/new-fda-chief-prioritizes-fighting-misinformation/
• https://madisonarealymesupportgroup.com/2023/03/17/the-real-reason-the-fda-is-attacking-nac/
• https://madisonarealymesupportgroup.com/2020/04/26/cdc-playbook-learning-from-lyme/
• https://madisonarealymesupportgroup.com/2020/05/08/update-cdc-playbook-learning-from-lyme/