Index of Files and Description of Contents

CODEX:  Public Comments submitted by Durk Pearson & Sandy Shaw to the FDA on Sept. 30, 1997 on Docket 97N-0218, whether FDA should harmonize U.S. standards on dietary supplements to those of the Codex Alimentarius, an international body.  We discuss constitutional, as well as scientific and cultural, reasons for not doing so.

GMPCOM:  Comments submitted by Durk Pearson & Sandy Shaw to the FDA in response to FDA's request for comments in the Nov. 20, 1995 Federal Register concerning consideration of the Natural Nutritional Foods Association's proposed Good Manufacturing Practices (GMPs) for dietary supplements.  We discuss reasons we oppose compulsory GMPs for dietary supplements.

EPHCOMAL:  Docket No. 95N-0304. Comments submitted by Durk Pearson & Sandy Shaw in response to a number of FDA's requests for comment on FDA's proposed regulations on the sale of ephedra-herb containing dietary supplements.  Includes detailed analysis of the comments and conclusions of an expert committee organized by the FDA to discuss this very issue.

EPHWHO: cover letter to EPHCOMAL. Docket 98N-0148, FDA Public Comments on abuse potential of ephedra, medical usefulness, as dietary supplement, trafficking in ephedrine, regulation under WHO rules.

EPHWHO2: Docket 98N-0148, continuation of Public Comments described in EPHWHO.

STRCFUNC:  Public Comments submitted by Durk Pearson & Sandy Shaw to the FDA on proposed  FDA rules on allowable structure-function claims for dietary supplements, Docket No. 98N-0044, submitted Sept. 23, 1998.  We consider serious constitutional (First Amendment) and other defects in the proposed rules.  The rules would reduce rather than increase truthful information available to consumers about dietary supplements, precisely the opposite of the intent of Congress in the DSHEA.

FOODSFTY:  Pearson & Shaw compare the safety of dietary supplements to ordinary whole foods.  We conclude that dietary supplements should not be required to meet higher safety standards than foods, since the historical evidence shows that foods in common form are far more hazardous than dietary supplements. For example, 9,000 Americans die of food poisoning every year.

D&SLTR9:  The Durk Pearson & Sandy Shaw LetterTM of March 1999 discusses the Jan. 15, 1999 Appeals Court victory of Pearson & Shaw et al vs. Shalala, FDA, and United States, in which court rules that FDA's process for approving "health claims" is unconstitutional and throws out its undefined "significant scientific agreement" standard.

TREATIES:  Sandy Shaw writes on the constitutional limits of what the federal government can do via treaty, which includes international "agreements" on dietary supplements.

FDICREG:  Pearson & Shaw submit comments to the Federal Deposit Insurance Corporation (a federal agency that "insures" bank deposits at many banks) on their proposed "Know Your Customer" program (should be called "Spy on Your Customers and Report to Big Brother" program), 12 CFR Part 325, RIN 3064-AC19.  We identify constitutional barriers to and statutory problems with the proposed program and ask that it be scrapped.  As of the end of the Public Comment period, some 85,000 comments (mostly critical) had been received by the FDIC and Congress was considering bills that would prohibit the proposed rules.

HACCPGMP:  Pearson & Shaw comments of 5 June 1997 submitted to FDA concerns the FDA's proposed creation of Hazard Analysis of Critical Control Points (HACCP) as part of Good Manufacturing Practices.  We point out that quality control of dietary supplements differs significantly from that of foods and that use of the same analytical framework would be inappropriate.

© Copyright 1999 by Durk Pearson & Sandy Shaw

NOTICE: The "Durk Pearson & Sandy Shaw Life Extension News" is for informational purposes only. Its contents are not intended as advice for the diagnosis, treatment, or cure of any medical condition. Pearson & Shaw are scientists, not doctors. If you have a medical condition, see a physician. Durk Pearson & Sandy Shaw® do not own any part of any dietary supplement company. They license their formulations and receive royalties on sales. The formulations they design and use are those which contain their names on the label.

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