98% of FDA Regulations are Illegal

Lawful regulations must be adopted in strict compliance with the Administrative Procedures Act (APA) which starts with someone in the public submitting a Citizens Petition at Regulations.gov asking FDA to consider making a rule. 

The Petition usually has a 90 day comment period. Then the FDA can propose a draft regulation, which also has a comment period. It's important to comment since you must "exhaust your administrative remedies" if you want to complain (in Court) about the regulation after it's adopted. Finally the FDA responds to the comments and issues a final regulation.

Here is an example of that process, where we've filed a Citizens Petition demanding the suspension of all FDA vaccine drug approvals as violating the 1986 vaccine safety law.

https://tinyurl.com/stopillegalvaccines 

 As my friend and colleague (and "The Dean of the Patriot Lawyers") Larry Becraft JD always reminds me, nearly all Fed Regulations are illegally adopted. The FDA is no exception. This report from the Pacific Legal Foundation confirms it. And here is the Report showing FDA fails to abide by the law: https://pd.pacificlegal.org/HHSReport Report highlights:

The US Constitution makes lawmakers democratically accountable, yet Americans are subject to thousands of rules that are issued by bureaucrats without democratic accountability. But Who Rules the Rulemakers reviewed 2,952 final rules issued by the Department of Health and Human Services over a 17-year period. The report found that nearly 75% of these rules are unconstitutional because they were issued by low-level officials and employees with no authority to issue rules. The 2,094 unconstitutional rules we found have real consequences for individuals and small businesses. Among the thousands of rules issued without democratic controls by the Food and Drug Administration were 25 rules that each had an impact of $100 million or more. Each of the branches should act to rein in this undemocratic behavior—including striking down illegally issued rules and requiring senior appointees to take responsibility for rules issued by their agencies.

Supreme Court Justice Gorsuch was a strong voice in opposition to unlawful bureaucratic rule-making before he was appointed to the Supreme Court. I wrote a bit about him in January 2017 in comments about a bill that passed the GOP House and was directed at the administrative state. [*]   In August 2017 here is what then Judge Gorsuch said about the Chevron [**] case that allowed some "delegation" of rule-making power:

"There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth."

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[*] http://vitaminlawyerarchives.blogspot.com/2017/01/house-passes-h5-to-redress-judicial.html

[**] Here is how Wikipedia describes the Chevron case - https://en.wikipedia.org/wiki/Chevron_U.S.A.,_Inc._v._Natural_Resources_Defense_Council,_Inc. "Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), was a landmark case in which the United States Supreme Court set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers. Chevron is the Court's clearest articulation of the doctrine of "administrative deference," to the point that the Court itself has used the phrase "Chevron deference" in more recent cases."

Stop FDA Attack on Homeopathy

FDA ATTEMPTING TO
KILL HOMEOPATHY [HERBS NEXT!]
IN ILLEGAL ACTION WE MUST STOP!
MUST ACT BY MARCH 20, 2018
Short Link to this Message
https://tinyurl.com/FDA-homeopathy

TELL FDA “NO!” START WITH THIS LINK!
Subscribe for Regulations.gov Comment Link:
https://my.officevp.com/s/27312

The UK's National Health "Service" used to run special homeopathic hospitals and herbal dispensaries. Not any more, now the "single payer" will no longer pay for either and they are now being closed. [1]

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Unsurprisingly, the FDA is following suit, despite the fact that Homeopathy and the US Homeopathic Pharmacopoeia (USHP) are protected by specific statutes in the US.

Did Health Freedom end when 2017 made its exit? Yes, if the FDA has its way!

Bottom Line: If you are ready to take action to protect natural remedies, read on...

We have until March 20th to file formal comments with FDA.  Docket FDA-2017-D-6580 – scroll down to find the Comment Link.

This past year the DEA and the FDA came out publicly saying, for example, that Cannabidiol, CBD, a neurotransmitter produced by mammalian (including human) bodies, was not a lawful nutrient, although the agencies have stopped short of raiding health food stores [as FDA used to do in the 1990s, before the Dietary Supplement Health and Education Act (DSHEA)] to enforce their dictate. [2] 

Right now, although there is a century of laws protecting homeopathy, FDA is attacking homeopathy to “protect” you. They are the government and they are here to "help" — Big Pharma.

On December 18th of this past year FDA issued new regulations that attack homeopathic oral and injectable remedies despite the fact that they are protected by long-standing law. This blatant attack on your health freedom choices is part of a long-term, well-financed conspiracy and, sadly, comes as no surprise. [3]

On your behalf we told FDA, when they started their “regulatory review” of homeopathy to let our natural remedies alone! The attack began “innocently enough” during the previous presidential administration.  

FDA asked for comments on how it should “modernize” homeopathy regulations. That’s the government’s first step toward ratcheting-up control.

That’s the step to which we had previously replied, telling them, among other things:

"FDA does not have authority from Congress to interfere with traditional homeopathy, nor does Congress have authority to permit such interference. Individuals have the right, under international humanitarian law binding on the United States, of Informed Consent to exercise their Freedom of Choice in health care without government burdening that fundamental right." [4]

These new regulations followed similar recent action in the UK by its “one payer” nationalized health care system. The UK National Health “Service” has ended its long-standing history of support for safe, gentle and effective homeopathy and herbalism (the UK even has special homeopathic hospitals and homeopathic/herbal dispensaries) in favor of dangerous, deadly and ineffective pharmaceuticals. This trend for medical tyranny has “crossed the pond” as the FDA has attacked legally protected homeopathy in the USA.

This was done in three steps that I have documented.

First in 2015, when the FDA asked for public comments about regulating homeopathy. That's when we submitted the comments referenced above. By the way, by submitting comments telling FDA they were acting illegally, we preserved the legal right to complain to the courts; we preserved "standing to sue."

Second, as noted in a blog entry I posted January 2017, FDA was toying with the idea of requiring "disclaimers" on homeopathic products, disclaimers not required by the statute that protects homeopathy in the USA [5].

Third, the most recent action, which illegally attempts to treat HPUS standard homeopathic remedies as unapproved pharmaceutical drugs, requiring a "risk/benefit analysis" which will effectively ban many, if not most, homeopathic remedies. This pseudo-scientific analysis starts with the false claim that homeopathic remedies have no benefit and alleges a "risk" that people using such remedies will fail to use Big Pharma's government approved, dangerous "side-effect" drugs.

What risk? Since government approved pharmaceutical drugs are the main cause of preventable death in the USA, what risk? [6]

The natural product industry has two choices: let Big Pharma and the globalists have their way or force them back, step by step.  I am sure that large producers of homeopathic remedies will realize they have no choice but to challenge the regulation. Strong public support for natural remedy freedom will encourage resistance to agency overkill.

Since we have preserved the right to object to this latest FDA action, cooperation between the industry and the health freedom movement during 2018 may be the only way to preserve our access to homeopathy, and, while dodging the FDA's left punch, we'll need to watch it's right arm for the next attack on herbs and other nutrients, like CBDs.

The new President, failing to keep his promise to "drain the swamp" seems to be appointing swamp-creatures to run the FDA and empower it to further attacks!

We must choose to force them back. I know you will want to do so, too.

FIRST -- Subscribe here: https://my.officevp.com/s/27312 to be linked directly to the Regulations.gov web page for comments. This is where you can tell the FDA “NO!”

Share this link on social media!

SECOND -- Contact me directly if you or your company want to be part of the advocacy and litigation that will likely be needed to stop this latest FDA outrage. Our half century of health freedom advocacy positions us to coordinate this urgent action.  We need your support -- email me here: ralph.fucetola@usa.net
 
File your comments prior to March 20, 2018

When you Subscribe you will be sent to a link that you can click to file your comment to the FDA.

It is simply bad science to apply the "risk/benefit" analysis that may be appropriate for the dangerous drugs and interventions of modern medicine to traditional nutritional, herbal and homeopathic approaches to achieving and maintaining health.  

Biological individuality suggests that the "risk/benefit" analysis will miss the benefits of these natural modalities, giving the governing authorities an excuse to ban the natural competition to treatments that are known to cause harm. Let us remember that a large portion of the FDA's budget comes from large pharmaceutical companies. [7]  The risk of systemic corruption is so high that the agency should refrain from interfering with freedom of choice in health care. [8]

Ralph Fucetola JD
President
Institute for Health Research
www.InHeRe.org
www.VitaminConsultancy.com

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[1]  http://www.telegraph.co.uk/news/2017/07/21/nhs-ban-homeopathy-herbal-medicine-misuse-resources/
[2] http://vitaminlawyerhealthfreedom.blogspot.com/2017/01/ftc-wants-disclaimers-on-homeopathy.htm
[3] https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm589373.pdf
[4]  We told FDA to leave our natural remedies alone; when they started this latest attack on Homeopathy, back in 2015, here are the comments I filed with FDA: http://vitaminlawyerhealthfreedom.blogspot.com/2015/06/comments-to-fda-re-homeopathy-fda-has.html
[5] http://www.hpus.com/legal-status.php
[6] http://www.webdc.com/pdfs/deathbymedicine.pdf

[7] http://www.businessinsider.com/fda-user-fees-from-pharmaceutical-companies-2016-8 
[8] http://www.opensourcetruth.com/what-peer-reviewed-science-2/