Why Senator Paul's FDA Amendment is Necessary

When you contact your senators to support Senator Paul's amendment #2143 to the FDA User Fees Bill, S. 3187, here's some background to why each provision of the amendment is necessary to begin restoring common sense to the FDA and federal regulations. 

Are Cheerios a drug? In a 2009 warning letter the FDA issued to the company said their health claim that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law.

Stephen Sundlof, the director of the FDA's food-safety center, said the agency has noticed a tendency by food companies to cross the line into the drug category by making specific health claims on packaging.

"We try to make a bright line here between what can be said about a drug and what can be said about a food," said Dr. Sundlof. He said a more general claim about reduction in heart-disease risk from eating whole-grain foods may be permissible as long as specific language is used.

This sort of nonsense clearly infringes on the free speech of food companies like Cheerios about the potential health benefits of their product. As another case regarding cherry farmers highlights, the warning letters not only have a chilling effect on free speech, but are actually used to ward off customers and intimidate business owners:

LIVING WITH FEAR. The highly respected Casewatch.org, which monitors "health fraud and quackery-related legal matters," cautions in its listings of companies that have received warning letters (including the cherry farmers and distributors) that "it is wise for consumers to assume that the product is problematic and should be avoided." In addition, such a letter officially opens the door to a raid by federal agents in which they may seize products, computers, and other such items and shut businesses down—and possibly even file criminal charges against the owners.

All of that helps explain why Michael Berst, sales manager of King Orchards, a 300-acre cherry farm not far from Traverse City, Mich., that was one of the recipients of theFDA letter, "lived all winter in terror they would come after us." Just because the FDA hasn't come doesn't mean it won't. The warning letter is open-ended, meaning the marshals could show up tomorrow, or could show up 10 years from now.

The agency's letter to King Orchards quoted several examples of statements from King Orchards' Web site that it said had the effect of placing tart cherries into the category of a drug. One example: "Perhaps George Washington wouldn't have chopped down his father's cherry tree if he knew what chemists now know. They have identified a group of naturally occurring chemicals abundant in cherries that could help lower blood sugar levels in people with diabetes."

Part one of Senator Paul's amendment would rein in the FDA by forcing them to comply with the First Amendment's prohibition on prior restraint.

As Senator Paul said in his floor speech last night, "There’s no earthly reason why somebody who markets prune juice can’t advertise it helps with constipation."

The second part of Senator Paul's amendment would prohibit FDA and HHS agents from carrying firearms and should be common sense to Americans. In an age of increasing militarization of our police, we now find ourselves in a situation where executive branch agencies wield their own 'police powers' with armed agents carrying out warrentless raids on American citizens.

C4L members should be familiar with the case of the Pennsylvanian Amish Farmer Dan Allgyer, where the FDA conducted a two year sting operation and several raids on his farm for the crime of selling "raw" milk straight from a cow to willing customers who were members of a private food buying club in Maryland.

In addition, numerous other food co-ops and "raw milk and cheese" producers have been raided by the FDA, including the "Rawesome Foods" in Venice, California.

Remember when this Mel Gibson spot seemed hyperbolic? http://www.youtube.com/watch?v=_F_ZZvdHqPM

Such an abuse of force is tantamount to the King's men raiding homes to enforce the Stamp Tax Act in colonial times. Our forefathers would be ashamed we've allowed things to come this far.

The final provision in Senator Paul's amendment strengthens the mens rea or "guilty mind" component of each of the prohibited acts under the Federal Food, Drug, and Cosmetics Act.  It adds the words "knowing and willful" to each of the prohibited acts.

Mens rea is fundamental component of our criminal justice system.  The prosecution must establish that the defendent had criminal intent to break the law.

A 2010 report by the Heritage Foundation and the National Association of Criminal Defense Lawyers called Without Intent: How Congress Is Eroding the Criminal Intent Requirement in Federal Law found that 57% of the offenses considered by the 109th Congress alone failed to include adequate mens rea components, leaving the innocent at risk for criminal prosecution.  The study also found that due to poor legislative drafting, Congress was leaving the duty to create criminal law at the federal level to unelected bureaucrats working in executive branch agencies -- "criminalization by regulation."

For all of the above reasons, this is why the Senate must adopt the Paul amendment #2143 to S. 3187, the FDA User Fees Bill.  A vote on the amendment will come later this afternoon after 2pm EST.

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