The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 7 No.
4 • September 2004
A man has a property in his opinions and the free communication of them. He has an equal property in the free use of his faculties, and free choice of the objects on which to employ them. In a word, as a man is said to have a right to his property, he may be equally said to have a property in his rights. Where an excess of power prevails, property of no sort is duly respected. No man is safe in his opinions, his person, his faculties, or his possessions. … Government is instituted to protect property of every sort; as well that which lies in the various rights of individuals. This being the end of government, that alone is a just government which impartially secures to every man whatever is his own.
— James Madison, National Gazette, March 26, 1792
In all criminal prosecutions, the accused shall enjoy the right to a speedy and public trial, by an impartial jury of the State and district wherein the crime shall have been committed; … and to be informed the nature and cause of the accusation; to be confronted with the witnesses against him; to have compulsory process for obtaining witnesses in his favor, and to have the assistance of counsel for his defense.
— From the Sixth Amendment, U.S. Constitution
In Suits at common law, where the value in controversy shall exceed twenty dollars,* the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.
— From the Seventh Amendment, U.S. Constitution
The FDA and Your Right to a Jury Trial
All of the law governing crimes as defined by the rules and regulations of regulatory agencies, such as the FDA, has done a wild detour around the rights of Americans as specified in the U.S. Constitution, such as the major right to a jury trial as commanded by the Sixth and Seventh Amendments, above. When you are accused of crimes by a regulatory agency, you don’t get a jury trial at all.* You come under so-called administrative law, which is completely different from the common law. You get to appeal to an administrative court, in which the judge (actually a magistrate) is paid by the very agency that has accused you of a criminal act. There is no independent judiciary. If the judge allows you (and usually does, but he doesn’t have to), you can have an attorney represent you. You have no right to discovery for obtaining exculpatory evidence. The only right you have to information from the agency is that available through the Freedom of Information Act, and the agency can still stall in providing it, long enough to virtually prohibit its use by you during your administrative hearing. Any statements made by government agents are likely to be assumed true unless you can rebut them, whereas nothing presented by you will be assumed true unless you can document its truth (almost as bad as being considered guilty until you can prove yourself innocent). But, worst of all, you will be allowed no jury trial.
What would he have thought of the FDA?
If, after appearing before the first magistrate, you get a decision with which you are in disagreement, you can appeal to an internal appeal board (still under the authority and the pay of the agency that has accused you) that is often located on the other side of the country. You will probably have to hire a second set of attorneys to represent you at the new geographical location. All that the appeal board will review is what is already in the administrative record. You can present no new evidence. Moreover, the first magistrate has broad powers on what he/she will and will not allow into the administrative record. After you have appeared before the appeal board, you have “exhausted your administrative remedies,” and if you are still dissatisfied with the outcome and still have some money, you can appeal to a federal district court. But all the district court will review is what is in the administrative record, and you still do not get a jury trial!
It generally costs between $200,000 and $1,000,000 (if you have it) to “exhaust your administrative remedies” and the process may take 8 to 10 years (a far cry from a speedy public trial!). That is why most accused companies “settle” by paying the FDA’s fines without admitting any guilt, though failure to mount a defense probably makes most people assume guilt.
This may sound almost funny, but the results aren’t funny at all. When the FDA puts its dietary supplement Good Manufacturing Practices (GMPs) in place (and they have promised the final rule for public comments in October), there won’t be a First Amendment that can protect us from accusations of violating GMPs, as we have been able to do to protect ourselves from FDA attack for providing FDA-forbidden truthful information on labels. The dietary supplement industry will come under the administrative law regime of the FDA. The FDA will, if they have their way, have broad discretion to define whether you are meeting the vaguely written rules and can send in inspectors to hound you into doing whatever they want you to do (such as to stop suing the FDA …). If you don’t think that this will have a dramatic impact on the availability, price, and innovation of dietary supplements, as well as the exercise of constitutional rights, you are living in a dream world.
In the clear language of the U.S. Constitution, there are no federal actions that are not covered by the Bill of Rights. There is nothing in the Constitution that provides exemptions. The FDA used to think that they weren’t subject to the First Amendment; they know better now. (We were able to take advantage of recent U.S. Supreme Court jurisprudence favorable for “commercial speech” under the First Amendment, such as 44 Liquormart and Coors.) We don’t think that the FDA and other regulatory agencies should be able to impose criminal penalties and fines on people while stripping those people of their Sixth and Seventh Amendment rights to a jury trial. It is certainly inconvenient and undoubtedly costly for the government to have to provide jury trials for the accused, but the purpose of the U.S. Constitution was to limit the authority of government so as to avoid tyranny, not to make putting people in jail and imposing fines easy and inexpensive for the government. As we see it, the relatively unimpeded imposition of criminal penalties and (usually) large fines by regulatory agencies under administrative (not common law) rules and regulations, with near blanket denial of the right of trial by jury, is not only unconstitutional but a grave threat to freedom and the rule of law in the U.S.
So please don’t think that we are through with the FDA by bringing the agency into line with the First Amendment. We next have to deal with the imminent threats to the availability and cost of supplements posed by the agency with its Good Manufacturing Practices. We will continue fighting for freedom of informed choice to the limit of our resources. Please help us by sending a donation for any amount to the Durk Pearson & Sandy Shaw FDA Litigation Fund, Emord & Associates, 1800 Alexander Bell Drive, Suite 200, Reston, VA 20191. You can read our joint comments with others on the FDA’s proposed GMPs at www.emord.com.
Addendum to the above
FDA Announces Modernization of the Food GMPs
Oh no! With the dietary supplement industry reeling in anticipation of new costly and generally unreasonable Good Manufacturing Practices, the FDA has now announced that it will be “updating” the food GMPs.* One possible reason for this is that the dietary supplements are by statute supposed to be regulated as foods, and the GMPs for dietary supplements are by statute to be patterned after those of foods. The proposed new GMPs for supplements are, in fact, patterned after those of the drug GMPs, which is one of our strongest legal arguments against them. It may be that the FDA is about to “strengthen” its food GMPs in light of illnesses and deaths resulting from eating common foods (generally because of microbial contamination) and also to justify its unreasonably stringent dietary supplement GMPs.
Just what we all need—a significant increase in food prices from FDA regulations that, judging from past history, are unlikely to provide any additional safety. And, of course, the lovers of government controls (we call them left-wingers) will blame the greedy multinational companies for the price increases, and the uninformed and poorly educated public will mostly agree.