Email to FDA Group

Jan 13, 2012

Greetings,

       This is an update because a lot has happened in the past 3 days. Two days of discussions with US Attorney Gordon Giampietro indicated a plea agreement was within reach between us. On Jan 10th, I wrote to Magistrate Callahan and asked that the Federal Defender Joanna Perini, be appointed to represent both me and the corporation (VItal Health Products Ltd). I did this so as to not leave any loose ends.  A plea agreement was finalized the following day. As a result of these discussions, I entered a "Conditional Plea" of "guilty" for selling one bottle Perfect Colon Formula #1 in interstate commerce. The offense being that I provided information in a handout flyer that one of the ingredients in the formula, L Plantarum, helped to prevent and reduce food allergies.The FDA alleged that information made Perfect Colon Formula a "new drug" as they did had not approved of the information I used that came from an abstract from the National Library of Medicine. The fine for me personally was $100 plus a $25 special assessment. For Vital Health Products, it was $400 plus a special assessment of $125. 

          The most important concession is that in my Conditional Plea Agreement, I can raise all the legal issues I used in both of my Motions to Dismiss and the Motion for Reconsideration. Furthermore, I was allowed a full page in the plea agreement to outline the 8 areas of legal issues I reserved my right to appeal. Since the plea agreement is publicly available, I thought it was a significant concession. A copy of the eight legal issues are listed below. The final court hearing in this case will be April 20th. From that point on, I will have 15 days to file a Notice of Appeal and then write my brief in the following 30 days.

           My decision not to go ahead with the jury trial is for the following 3 reasons: First the FDA in their jury instructions asked the court for so many restrictions on what I could say that it would block all of my defenses based on legal arguments. Second, the stress on me personally would have taken a toll mentally, emotionally and physically. Third, if I won, it would have benefited me only in a legal sense and would have had no nationwide effect in curbing FDA's ongoing abuse of power . 

           I also decided against a trial before the Judge because in the past year, I gave the judge 3 opportunities to rule on my side of the legal arguments I raised in my motions to dismiss. He passed on all 3 opportunities. It made no sense to me to present the same issues all over again. The judge showed me his hand in his rulings. In my view, the judge was too timid to rule against the FDA and cause them to lose some of their regulatory powers. 

          At the Pretrial today, after answering some 30 questions under oath, a critical juncture arrived when the judge asked me if I was "guilty" of this one offense. I hesitated and told him that the US attorney cited case law that no state of mind was needed under a misdemeanor offense. I consulted with my attorney Joanna who told the judge that "guilty was within the meaning of how the court applied the law as a strict liability." The US Attorney and the judge accepted the answer. At the end the Pretrial Hearing, Judge Callahan said: "maybe I was wrong in how I ruled in this case, if so, the 7th Circuit (Court of Appeals) will tell me." The judge then wished me well for the future and raised his right hand as to salute me. I responded in kind and the meeting ended. Conrad LeBeau 

(Note: The next email update will be in May.)

The following is excerpted from the Plea Agreement. 

A brief description of some, but not all of the legal issues raised in Docs 28 and 43 that the defendant reserves the rights to appeal are

            1. Overbreadth - Definition of the word “drug” from the Food and Drug Act of 1906 (21 USC 321 (g)(1). FDA’s expansion of the definition of the word “drug” goes beyond “Patented Drugs” and “Nostrums” and includes “foods” that were not intended by the Congress of 1906 to be defined as drugs. The FDA’s expanded definition of the word “drug” to include “food” violates the Doctrine of Overbreath, and is an over-reach of regulatory powers. Defendant contends that Perfect Colon Formula was a food, and therefore, is not a substance intended to be regulated as a drug within the meaning of the original Food and Drug Act.

         2. Arbitrary definition of “New Drug.” per  21 U.S.C. Sec 321 (p)(1) The FDA has arbitrary standards for defining drugs as “new.” Arbitrary standards violate due process rights under the 5^th amendment when the FDA applies the law requiring a new material composition for a patented drug that is FDA approved while classifying a non-patentable foods or herb as “new drug” solely by its intended use only even though they do not have a new material composition.

            3. Doctrine of Legal Impossibility per 21 USC Sec 355. Is it legally impossible for a food or herb or other non-patentable products to ever be approved by the FDA with a New Drug Application when the required patent number is not possible to obtain for products that are not new in composition and patentable?

            4. Doctrine of Economic Impossibility - if the financial hurdle of filing and completing a New Drug Application for a non-patentable article could be brought to completion, could the sponsor ever recover the investment when a non-patentable article could never have exclusive marketing rights?

            5. Public Policy and 3rd party labeling. Does Congressional approval of making available to the public over 11 million scientific abstracts from the National Library of Medicine through computer access online also become 3rd party labeling of thousands of foods and dietary supplements for the prevention, mitigation and treatment of disease?

            6. Conflicts between FDA policy and the public policy of the NIH for access to and use of the National Library of Medicine (NLM). As distributors of food and nutritional supplements, did the defendant have a first amendment right to use and share information derived from the NLM with his customers? Was the defendant’s use of information derived from database searches at the NLM a lawful exercise of a right of commercial speech under the First Amendment?

            7.  21 USC Sec 335 Hearing before report of criminal violation. “Before any violations of this Act [21 USCS SS 301 et seq] is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the persons against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.” This hearing with the defendant was not held by the FDA. The defendant will ask the Appellate Court to overturn the 1943 case of United States v Dotterweich (1943) 320 US 277 that held the hearing was not required and to restore the original intent of this law as passed by Congress in 1906.

            8. Restraint of Trade and violations of the US Constitution. The FDCA as applied and enforced by the US FDA illegally restrains the trade of the defendant by totally censoring the use of speech on the intended uses of his health products, all in violation of the First Amendment, and further violates due process rights under the 5th Amendment by the arbitrary and capricious standards of defining a “new drug,” and further violates “freedom of choice in medicine” under the 9th amendment by assuming powers not delegated to Congress under Article 1 Sec 8 of the US Constitution that usurps the balance of powers delegated to the States under the 10th amendment.