Health Freedom Amendment Background

Paul Amendment #2143 to S. 3187, the Prescription Drug User Fee Act

Part I:  Health Freedom Act –

·         The amendment forces the FDA to at last comply with the commands of Congress, the First Amendment, numerous federal courts, and the American people by codifying the First Amendment prohibition on prior restraint.

·         Stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.

·         Stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

·         Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and/or misleading.

Part II:  Prohibitions on FDA Officials Carrying Firearms and Making Arrests Without Warrants

This section disarms FDA agents (and any and all employees of HHS).


·         The plain language of our Constitution specifies a very limited number of federal crimes.  These include treason, counterfeiting, piracy or felonies on the high seas, and offenses against the laws of nations.

·         Yet today, we have over 4,450 criminal offenses in our federal statutes alone.  This number does not include the thousands of criminal offenses scattered throughout federal regulations.

·         In order to enforce all these crimes, we’ve armed our federal agencies, and there are now over 30 federal agencies that have employees authorized to carry firearms and use them.

·         This cycle of criminalizing everything at the federal level and then arming all of our federal agencies needs to stop. 

·         Recent FDA armed raids of Amish dairy farmers selling “raw” milk directly from the cow present high-profile examples of why we need to have fewer armed federal agents (and fewer federal crimes).

Part III:  Mens Rea Component/Reform –

This section amends the “Prohibited acts” section of the Federal Food, Drug and Cosmetic Act (21 USC § 331) to strengthen the mens rea (“guilty mind”) component of each of the prohibited acts.  It adds the words “knowing and willful” to each of the prohibitions.


·         In 2010, the Heritage Foundation and the National Association of Criminal Defense Lawyers conducted a study and issued a report regarding the problem of not only the massive proliferation of federal criminal law in general, but particularly the erosion of any meaningful mens rea (“guilty mind”) component to these federal laws.

·         This report—Without Intent:  How Congress Is Eroding the Criminal Intent Requirement in Federal Law—found that over 57% of the offenses considered by the 109th Congress alone contained inadequate mens rea requirements, putting the innocent at risk of criminal punishment.  The study also discovered consistently poor legislative drafting and broad delegation of Congress’s authority to make criminal laws to unelected officials in administrative agencies—“criminalization by regulation.”

·         If Congress is going to criminalize conduct at the federal level as it does in the Food, Drug and Cosmetic Act, then the least it can do is include an adequate mens rea component.

  U.S. Const. art. III, § 3.

  U.S. Const. art. I, § 8, cl. 6.

  U.S. Const. art. I, § 8, cl. 10.



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