FDA FOLLIES – The FDA is Big Pharma’s Best Friend…..

The US FDA is FAR MORE CORRUPT Than The CDC.  Not Even Close…

What Trump is up against…

Watch our two (2) minute video, just below, before you read the rest of the article.

By Elissa Meininger – Health Policy Analyst

“When a republic has been corrupted, none of the ills that arise can be remedied except by removing the corruption and recalling the principles; every other correction is either useless or a new ill.”     – Montesquieu

Eight years ago…

I wrote a review of Jonathan Emord’s book, The Rise of Tyranny:  How Federal Agencies Abuse Power and Pose Risks to Your Life and Liberty which I republished here on Bolen Report.  It’s a great book to learn the original intent of our Founding Fathers and how what they laid out for us got corrupted in the 1930s and how the FDA now operates.

Those of us who treasure “health freedom” hold Jonathan Emord in very high esteem.  Emord is a Constitutional and Administrative Law specialist who has won more lawsuits against the FDA than any other lawyer in American history.  His clients are doctors and product manufacturers who offer serious competition to Big Pharma.

Now that we have hope to see real change in the way Washington works,

I thought it was time to provide  y’all with some big picture information on just how deep the whole swamp is, and why we need to help Trump muck it out.  Emord explains the problem this way.

“Americans must come to the realization that the Congress of the United States and the agencies and commissions of the federal government are infested with a corruption born of the self-interest of those in power and the infection is widespread.  They must come to realize that abysmal failure because it ceded governing control to industry, has witnessed industry use regulation as a vehicle to create barriers to competition, block competition, and punish competitors, and has been given a large part of the nation’s purse to the biggest monopoly government has ever created, the pharmaceutical industry.”

”Those appointed to run agencies and commissions have an inherent conflict of interest.  They are aware that the decisions they make will either please of displease favored regulatees.  They are aware that their decisions will either enhance or diminish their prospects for employment and business opportunity when they leave government.”

As a longtime member of the “health freedom movement”,

I’m real familiar with some of the regulatory abuses the FDA along with the FTC and the USDA, have heaped on small business people.  It is quite obvious that many of these sometimes gunpoint raids are designed to intimidate and run out of business providers of products and services that are competition to Big Pharma.

This hostile attitude on the part of the FDA first hit me in the face when I obtained a copy of the FDA’s 1992 Dietary  Supplement Task Force Final Report.  It said, as big as life, that the agency would take…

“what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.”

Hello!  How much more black and white do you want to make it?

Around that same time, the FDA launched a gunpoint raid on the patient-filled clinic of Jonathan Wright, MD, a highly-regarded doctor who treated patients with dietary supplements.   His crime?  He was using dietary supplements that were preservative free.

The catch was, vitamins without preservatives had not been approved by the FDA. Vitamins without preservatives were legally classified as drugs.  This raid, now known in the annals of health freedom lore as the “The Vitamin B Bust”, was the shot heard ‘round the world for millions of Americans to take to arms, so to speak…. with pencils and telephones  along with attending  public servants’ town hall meetings in droves.  Wright hired Emord to, shall we say, “sue the bastards”.

This was not the FDA’s first regulatory assault on dietary supplements. 

Back in 1962, Congress passed the Kefauver-Harris Amendment that required drugs to prove efficacy as part of the approval process.  This gave the FDA a chance to go after vitamins and supplements.  The agency proposed regulations that denied there were any benefits for using supplements.

It would have required warning labels stating that an abundant supply of vitamins and minerals could be found in commonly available food (implying that supplements were unnecessary).  In addition, the FDA wanted to also ban health claims, statements about dietary deficiencies or soil deficiencies, and listing of non-essential vitamins.  Worst of all, the regulations would have defined supplements in potencies exceeding 150 percent of the RDA as drugs.  Thus, this would have outlawed larger dose vitamins and minerals.

Well, this didn’t sit well with the general public…

And, after all sorts of litigation, various legislative remedies introduced over the years, in 1976, thanks to ONE MILLION letters to Congress (letters = handwritten communications you put on paper with a pen, fold into an envelope, stick a stamp on and drop in the mailbox), the Proxmire Amendment was passed that describes vitamins and minerals as “increasing the total dietary intake” and prohibits their classification as drugs due to potency.

Just so you know, any time Congress passes a law, the agency that is to implement it, gets to write the rules to implement it.  It is then you have to really watch these people.  The Proxmire Amendment was the result of the passage of the Kefauver-Harris Amendment which was supposed to crack down on the drug industry for peddling worthless but expensive pills.  It took TEN YEARS to get this vitamin crisis straightened out.

As the result of passage of Nutrition Advertising Coordination Act of 1991 that was to tighten the regulations regarding supplement labeling, the FDA used it to crack the whip again.  The agency’s 1992 announcement that it was gunning for vitamins that might represent competition for Big Pharma, and flashing a lot guns in the patient-filled waiting room of Dr. Wright’s office, turned millions of us into road warriors for health freedom again.

By 1994, we sent more letters to Congress than any other issue in the history of Congress (estimates are 3,000,000)…

We saw passage of the Dietary Supplement Health Education Bill of 1994 passed.  Known as DSHEA, (don’t you love these names for bills), the idea was to declare dietary supplements as food and spell out a mind-numbing list of regulations that these days, has given Jonathan Emord a chance to show his legal muscle often.

Seems FDA doesn’t read very well and every time they try to re-interpret the limits of their authority, Emord slaps another lawsuit on ‘em in Federal Court.

I suggest you rummage around his site just for fun.  This page regarding the fight over health claims discusses the various lawsuits and how the FDA never follows the law even after Emord wins the case.  He’s a prolific writer and there are gems all over the website for those who are interested in what our Founding Fathers had in mind when they wrote the Constitution.

Now that we’ve got Trump in the White House…

It looks like we might have a chance to really clean the swamp.  So, with that in mind, I’m providing a brief list of suggestions Emord lists in his Rise of Tyranny book.

(1)  Vote Corrupt Members of Congress Out of Office

(2)  Enact Legislation to Prevent Congressional Relinquishment of the Law-Making Power

(3)  Enact Legislation to Prevent Industry Capture

(4)  Enact Legislation to Require Meaningful Federal Judicial Review

(5)  Enact Legislation to Punish Appointed Officials Who Violate the Constitution, Agency Rules, or Commission Enabling Statutes for Personal Gain

(5)  Enact Legislation to Protect the Public from Unsafe Drugs

(6)  Enact Legislation to Eliminate FDA Jurisdiction Over Health Claims and Structure/Function Claims and Establish New Anti-Fraud Protections

(7)  Enact Legislation to Mandate Due Process in Medicare Part B Reimbursement Cases

By Elissa Meininger – Health Policy Analyst