FDA Update!

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 2 • April–May 2003

The human brain is not an organ of thinking but an organ of survival, like claw and fangs. It is made in such a way as to make us accept as truth that which is only advantage.

— Albert Szent-Györgi

But how can it be an advantage if it is not true?

— Sandy Shaw

Knowledge will forever govern ignorance. And a people who mean to be their own governors must arm themselves with the power which knowledge gives.

— James Madison


The Other War Heats Up: FDA Proposes Good Manufacturing Practices for Dietary Supplements

The FDA continues on its collision course with personal freedom. The agency has now released a 547-page proposal for Good Manufacturing Practices (GMPs) for the dietary supplement industry and requested public comments. The proposed rules include registration of every facility that manufactures dietary supplements with the FDA and permits FDA warrantless inspections (whatever happened to the Fourth Amendment?), presumably anytime they want to during regular business hours. They tell you how to design your plant, where to put your toilets, what quality control procedures to use, and how to store your products. There’s more, much more.

As we see it, there are several purposes of these GMPs: (1) to serve the interests of the FDA’s most important “clients,” the pharmaceutical companies, since the GMPs will reduce competition from dietary supplements by drastically increasing the cost of their production and, hence, their sales price; (2) to serve the interests of the few large dietary supplement companies—large companies are defined as those with 500 or more employees—that have pushed for GMPs because, among other things, the costs imposed by the GMPs eliminate competition by small companies (there are thousands of them) by driving many out of business or, at the least, making their products much more expensive; (3) to stop the troublemakers (all affiliated with small dietary supplement companies) who keep suing the FDA and winning for First Amendment violations, by drastically increasing their business expenses or driving them out of business. With the GMPs in place, the FDA will have dietary supplement companies under their thumb, with the constant threat of inspections, harassment, and fines, thus shutting up previously defiant voices. You will be able to read and download the public comments we and others filed on the proposed GMPs at www.emord.com soon after June 11 (the filing deadline).

Most of the myriad proposed rules and regulations in the new GMPs have nothing to do with health and safety, but with reducing competition. Of course, a group of us is once more filing public comments. We cannot stop the institution of GMPs, but we hope to modulate them with our comments. Although there is no overriding constitutional right that we can use to defend ourselves from centralized economic planning (such as federal GMPs), since limitations of federal regulation under the Commerce Clause and the requirements for warrants based upon probable cause under the Fourth Amendment have been drastically narrowed from original constitutional intent, we still have some potentially powerful arguments to use to modify the proposed rules. One is that the statute (the Dietary Supplement Health and Education Act of 1994) under which the FDA was authorized to develop and enforce GMPs required that they be no more onerous than the GMPs for foods. Yet the new GMPs are more like those for prescription drugs than for foods.

We also think the timing for the release of the GMPs is highly suspicious. The DSHEA, passed in 1994, contained a provision whereby Congress authorized the FDA to develop and implement a system of Good Manufacturing Practices. Yet nothing had happened for nine years. Then, suddenly, the FDA releases them. Well, coincidently (or not), just before the FDA released these GMPs, our group had filed an appeal of a federal district court ruling in our new lawsuit in which we challenged the constitutionality (under the First Amendment) of the FDA’s prohibiting “treatment” claims on dietary supplements. The 1994 statute clearly provided for claims for dietary supplements on any nutrient-disease relationship.

But even if the statute didn’t intend to allow for treatment claims and even if the Congress decided to amend the statute to explicitly prohibit “treatment” claims, neither the FDA nor the Congress can prohibit the communication of truthful, nonmisleading information (about treatments or anything else) and be in compliance with the First Amendment. As we see it and as the Courts have interpreted it, that Amendment prohibits the government from reserving the right to communicate certain kinds of information only to people of the government’s choice. Naturally, that has frightened the FDA because, if they lose, it will mean the end of most of their current control paradigm over medicine, and it will also mean the end of pharmaceutical companies being willing to pay them hundreds of millions of dollars a year in exchange for a monopoly on treatment claims. Regardless of what happens with the GMPs, the group of us will do our best to pursue this treatment-claims case to the U.S. Supreme Court, where it is sure to be decided. Our case is strong. The determining factor will probably be whether the Justices are willing to live with the consequences in this case of supporting the First Amendment.

This suit will, however, be our most costly endeavor yet. Our attorney, Jonathan Emord, has estimated the total cost to be about $500,000. We will need to raise money. Follow the suit by visiting www.emord.com. You can help change the world by donating any amount to the Durk Pearson & Sandy Shaw Litigation Fund; send it to Pearson & Shaw Litigation Fund, c/o Emord & Associates, 5282 Lyngate Court, Burke, VA 22015.

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