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How Pearson v Shalala Became a Reality

How Pearson v Shalala Became a Reality

(Landmark First Amendment Victory allowing Structure Function Health Claims)

(See Health Freedom Lawsuits Won by Attorney Jonathan Emord at the Above Link)

(Notes from Durk Pearson)

Here is how Pearson v. Shalala became a reality:

  1. We filed a Citizens Petition with the FDA to allow health claims for fish and fish oil, antioxidant vitamins, selenium, and fiber with the FDA.
  2. The FDA ignored it.
  3. We got our friends in Congress to pass a law requiring the FDA to consider these claims within a stated time.
  4. The FDA eventually stated that there was no scientific substantiation for our desired claims.
  5. The FDA proposed a regulation, published in the Federal Register, prohibiting these claims under penalty of Federal law, and, as required by the Administrative Procedures Act, opened a period for public comments on their proposed regulation.
  6. During this time period, we made a public comment and provided substantiation; 170 published peer reviewed scientific papers supported our position, and 4 did not.
  7. The FDA announced that there was no significant scientific support for our claims, and that its proposed regulation was final.
  8. Since we had commented during the public comment period, we had the key to the District Court for a lawsuit reviewing the regulation, with the evidence that we had provided with our public comments being legally entered into the judicial record.
  9. The District Court for the District of DC ruled against us.
  10. We appealed.  We won a 2-1 decision in the DC Circuit Court.  The FDA did not appeal to the Supreme Court, which was wise in light of the SCOTUS 24 Liquormart and Coors decisions.
  11. The FDA published a notice in the Federal Register announcing that they would continue to enforce their regulation until they decided to do something else.  We asked our attorney, Jonathan Emord, whether he had heard of any prior refusal of the Feds to obey a final Federal court decision.  After a long pause, he said, yes – one case – when Lincoln ordered the US Army to arrest Chief Justice Taney for a decision that Lincoln didn’t like.  We asked what happened.  Jonathan explained that every month an Army officer reported to President Lincoln that they were unable to find and arrest Taney.  Throughout this time, Taney was at his Supreme Court office in the US Capital building five days per week.  The US Army had a great deal more respect for the Constitution than did Lincoln.
  12. Jonathan suggested that we apply for a writ of mandamus from the Court ordering the FDA to comply with their decision, but said that the Court would be unlikely to do so because it did bnot have the resources to take over the FDa and micromanage its regulatory activity.  We suggested that Jonathan also ask the Court for a declaratory judgement that the FDA officials issuing that Federal Record statement were willfully and knowingly violating our constitutional rights.  If such a judgement were issued, those officials would be personally liable for damages and our legal costs – without limit – under Bivins v. Six Unknown  Named Agents. Bivens v. Six Unknown Named Agents 
  13. In the fastest Federal Court response we have ever heard of, we had our declaratory judgement about 5 weeks later, in exactly the form that we had reqested.  No mention by the Court was made of our request for a writ of mandamus – the judge was smart, and knew that this would be totally unnecessary because of the potential catastrophic personal consequences for the law defying FDA officials as a result of the declaratory judgement if they continued to refuse to comply with the Court’s decision in Pearson v. Shalala.  If the FDa had not caved, their officials would have lost their homes, bank accounts, and everything else when we filed suit against them personally, since they would no longer have had the protection of Sovereign Immunity. 
  14. A few weeks later the FDA caved, publishing in the Federal Register that they would engage in “prosecutorial discretion” to not prosecute qualified health or structure-function claims that had sufficient scientific basis under the Pearson v. Shalala Circuit Court For the DC District decision. The rest is history.  This landmark decision made the modern huge dietary supplement industry possible. It cost us about $500,000 personally (we think that it was worth every cent!), with about another $500,000 being donated in later stages by other parties.  It took about 8 years…