Report Finds Most FDA Regulations Illegal

Opinion by Ralph Fucetola JD

It’s a Federal Criminal Offense (18 USC 1001 and 18 USC 242) for a bureaucrat to issue a new government regulation without following the proper “due process” procedures.  Nonetheless, the big Federal Alphabet Agencies that try to rule our health care lives do that all the time, a Pacific Legal Foundation Report proves.

Lawful regulations must be adopted in strict compliance with certain statutes and rules. An Agency that fails to follow the rules in rule-making has created an unconstitutional regulation. These procedures, under the Administrative Procedures Act (APA) and other rules set up over a half dozen steps that must be taken before a new regulation can be binding.

Generally, Agency rules start either from an initiative by the Agency or as an Agency response to an APA Citizens’ Petition.  Sometimes an Agency will “cherry pick” the Citizens’ Petition it wants to use to impose new restrictions.  Nonetheless, the Agency has to follow procedures to make a valid regulation. What the Report shows is that most regulations fail to meet the legal standards.

A good example of the Citizens’ Petition route is the pending Suspend All Illegal Vaccines Petition filed this past March. That Petition to FDA shows, using the 2018 FOIA (Freedom of Information Act) lawsuit pursued by Robert F. Kennedy, Jr., that FDA failed to obey the restrictions in the 1986 vaccine safety law when approving all subsequent vaccines.  Such approvals are done under the rule-making authority and must be issued in strict conformity with the law. More about that here:

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 Health and Human Services Department’s agencies, like CDC and FDA are no exception. This Report from the Pacific Legal Foundation confirms it.

Here is the Report showing CDC and FDA (and the other eight branches of HHS) fail to abide by the law:

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.”

Not everyone in DC is a fan of the Deep State Rule Makers.  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.”

Judge Gorsuch wrote about the Elephant in the Room, but could have been talking about a giant Donkey in the Room too, since both “major parties” have allowed the Alphabet Agencies usurp Congress’s lawful authority, with barely a whimper. This Report from the Pacific Legal Foundation gives us the statistics to back the realization that the government acts unlawfully more often than lawfully.  The authors of this Report asked the right question: Who rules the rule makers?


[**] Here is how Wikipedia describes the Chevron case –,_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.”


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