April 21, 2014

Sen. Paul Offers Amendment to Rein in FDA Abuses

UPDATE: The Senate voted 77-20 to table the amendment and not even debate or vote on it.

May 23, 2012

WASHINGTON, D.C. – Today on the U.S. Senate floor, Sen. Rand Paul introduced an amendment to the Food and Drug Administration User Fee Reauthorization bill, which would curb the Food and Drug Associations overreach and abuse of power. Sen. Paul’s amendment, No. 2143, would disarm the FDA, put an end to raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements.

TRANSCRIPT:

President, today I’m offering an amendment to the FDA. I’m troubled by images of armed agents raiding Amish farms and preventing them selling milk directly from the cow. I think we have bigger problems in our country than sending armed FDA agents into peaceful farmers’ land and telling them they can’t sell milk directly from the cow.

My amendment has three parts. First, it attempts to stop the FDA’s overzealous regulations of vitamins, food and supplements by codifying the first amendment prohibition on prior restraint. What do I mean by that?

The first amendment says you can’t prevent speech, even commercial speech, in advance of the speech. You can’t tell cheerios that they can’t say there’s a health benefit to their Cheerios. Under our current FDA laws, FDA says if you want to market prune juice, you can’t say that it cures constipation.

You can’t make a health claim about a food supplement or about a vitamin, you can do it about a pharmaceutical, but you’re not allowed to do it about a health supplement.

I think this should change. There have been several court cases that show this goes against not only the spirit but the letter of the law of the First Amendment. So this amendment would change that.

This amendment would stop the FDA from censoring claims about curative, mitigative effects of dietary supplements. It would also stop the FDA from prohibiting distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

Despite four court orders condemning the practice as a violation of the First Amendment, the FDA continues to suppress consumers’ right to be informed and to make informed choices by denying them this particular information. It’s time for Congress to put an end to FDA censorship.

Second, my amendment would disarm the FDA.

Now, some of you might be surprised the FDA is armed. Well, you shouldn’t be.

We have nearly 40 federal agencies that are armed. I’m not against having police, I’m not against the army, the military, the FBI, but I think bureaucrats don’t need to be carrying weapons and I think what we ought to do, is if there is a need for an armed policeman to be there, the FBI who are trained to do this should do it. But I don’t think it’s a good idea to be arming bureaucrats to go on the farm to, with arms, to stop people from selling milk from a cow.

I think we have too many armed federal agencies, and that we need to put an end to this. Criminal law seems to be increasing, increasingly is using a tool of our government bureaucracy to punish and control honest businessmen for simply attempting to make a living.

Historically the criminal law was intended to punish only the most horrible offenses that everyone agreed were inherently wrong or evil, offenses like rape, murder, theft, arson – but now we’ve basically federalized thousands of activities and called them crimes.

If bureaucrats need to involve the police, let’s have them use the FBI, but I see no reason to have the FDA carrying weapons.

Today the criminal law is used to punish behavior such as even fishing without a permit, packaging a product incorrectly or shipping something with an improper label.

Simply said, the federal government’s gone too far.

The plain language of our Constitution specifies very few federal crimes. In fact, the Constitution originally only had four federal crimes and now we have thousands of federal crimes.

We’ve moved beyond the original intent of the Constitution. We don’t even know or have a complete list of all the federal crimes. It’s estimated there are over 4,000, but no one has an exact number.

Finally, my amendment will require adequate mens rea protection. In other words, when you have a crime, you’re supposed to prove the intent. People have to have intended to harm someone, it can’t be an honest mistake where a businessman or woman have broken a regulation and didn’t intend to harm someone. If you want to convict someone of a crime and put them in jail, it should be a mens rea requirement.

This is something we have had for hundreds of years, it comes out of our common-law tradition.

This amendment would fix this problem by strengthening the mens rea component of each of the prohibited acts and the FDA acts by including the words “knowing” and “willful” before we address and accuse someone of a crime.

This I think would give protection to folks who are guilty of inadvertently guilty of breaking a regulation and would keep from overflowing our jails. We’ve got plenty of violent criminals without putting people in for honest breaches of regulations. If Congress is going to criminalize conduct at the federal level as it does with the FDA act, the least it can do have is have an adequate mens rea requirement. My amendment will attempt to do this.

It’s not that we won’t have rules at the federal level, but the rules ought to be reasonable. We ought to allow people to market vitamins. There’s no earthly reason why somebody who markets prune juice can’t advertise it helps with constipation.

We’ve gone too far, and we’ve abrogated the First Amendment and what we need to do is tell the FDA that the courts have ruled that the First Amendment does apply to commercial speech and the FDA has been overstepping their bounds.

TOP-LINE POINTS:

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).

Background:

  • The plain language of our Constitution specifies a very limited number of federal crimes. These include treason,[1] counterfeiting,[2] piracy or felonies on the high seas,[3] and offenses against the laws of nations.[4]
  • 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.

Background:

  • 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.

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