FDA v. LeBeau Appeal Update from Dec 27, 2012 thru Feb 13, 2013.

This case involves an FDA allegation that I distributed Perfect Colon Formula, a fiber and probiotic health product that was linked to a health claim that listed among its many benefits that it "reduces food allergies." The FDA found the three words offensive and they branded Perfect Colon Formula an unapproved drug and charged me with a criminal misdemeanor offense for distributing it.

My legal arguments in today's brief begin with a review of 14 scientific abstracts retrieved from the United States National Library of Medicine that supports the truthfullness of statements I made about the fiber and probiotic health product. It follows with a detailed discussion on why FDA claims that Perfect Colon Formula is a drug is illogical and fundamentally flawed. Why FDA's objection to the label is not a drug issue but a violation of my 1st amendment right to "freedom of speech."

I also allege that FDA interprets the definition of "drug" too broadly (exceding the intent of the Congress of 1906) when foods and edible herbs are included in the definition of drug - a violation of the Doctine of Overbreadth. I also discuss why FDA actions violate the 9th amendment, and the 10th amendment by exceeding Article 1, Section 8, enumerated powers delegated to Congress in 1792 when they censor truthful speech in interstate commerce. The case of US v. Caronia that the government lost earlier this month on first amendment grounds is cited.

The federal government response brief was filed the lst week of Jan, 2013. My reply brief was filed on Feb 13, 2013. After that, Federal Judge Charles Clevert will decide the merits of this case. The losing party will then have the right of appeal to the 7th Circuit Federal Court of Appeals in Chicago. If needed, either party could appeal the case to the U.S. Supreme Court.

Note: Past issues of the Journal of Immunity for 2011 have reported on the origin, development and evolving legal issues of this case since it was "born" on December 5th, 2010. Conrad LeBeau