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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. PAUL. Mr. President, today I am offering an amendment to the FDA.

I am troubled by images of armed FDA agents raiding Amish farms and preventing them from selling milk directly from the cow. I think we have bigger problems in our country without sending armed FDA agents onto 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 regulation of vitamins, food, and supplements by codifying the first amendment prohibition on prior restraint.

What do I mean by that? The first amendment says we can't prevent speech--even commercial speech--in advance of the speech. We can't tell Cheerios they can't say that there is a health benefit to their Cheerios.

Under our current FDA laws, the FDA says that if someone wants to market prune juice, they can't say it cures constipation. They can't make a health claim about a food supplement or about a vitamin. They can do it about a pharmaceutical, but they are 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, or preventive 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' rights to be informed and to make informed choices by denying them this particular information. It is 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 am not against having police. I am not against the Army, the military, or 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 is a good idea to be arming bureaucrats to go on the farms, 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 is increasingly used as a tool of our government bureaucracy to punish and control honest businessmen who are 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 murder, rape, theft, arson. But now we have 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 has gone too far.

The plain language of our Constitution specifies a very few Federal crimes. In fact, the Constitution originally only had four Federal crimes, and now we have thousands of Federal crimes. We have moved beyond the original intent of the Constitution. We don't even know or have a complete list of all the Federal crimes. It is 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 there is a crime, we are supposed to prove the intent. People have to have intended to harm someone. It can't be an honest mistake, where a business man or woman has broken a regulation and didn't intend to harm anyone. If we want to convict someone of a crime and put them in a jail, it should have a mens rea requirement. This is something we have had for hundreds of years that 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 in the FDA Act by including the words ``knowing'' and ``willful'' before we address and accuse someone of a crime. I think this would give protection to folks who are guilty of inadvertently breaking a regulation and would keep from overflowing our jails. We have 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, then the least it can do is have an adequate mens rea requirement. My amendment will attempt to do this. It is not that we will not have rules at the Federal level, but the rules ought to be reasonable. We ought to allow people to market vitamins. There is no earthly reason why someone who markets prune juice can't advertise that it helps with constipation. We have gone too far. We have abrogated the first amendment. What we need to do is tell the FDA the courts have ruled that the first amendment does apply to commercial speech, and the FDA has been overstepping their bounds.

I hope this amendment will pass. I will ask for the yeas and nays at the appropriate time.

I suggest the absence of a quorum.


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