COM 0078.008 1996-1998 - Laserfiche WebLink

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r, The following report was downloaded from the Internet from The Cognitive Enhancement Research Institute web page (www.ceri.com), edited, formatted and reprinted by the Centurian Aging Research Laboratory (www.GHBinfo. as a public service in the interest of truth. Please be advised that CARI~as a-standing offer of $10,000 for any scientifically documented report of any ca~~f p~a~nt harm or death resulting from ingestion of pure GHB taken alone z ~ ~ rn -~z ~ t7 o{ ti GHB Madness by Ward Dean, M.D., and Steven Wm. Fowkes D'~ ~ w Gamma-hydroxybutyric acid (GHB) is a natural substance found in many foods, and is both a precursor and metabolite of the amino acid GABA (see SDN v4n7p4). One might think, given its nutrient derivation, that GIiB would be accepted as just another food supplement in the over-the-counter health food market. While that may once have been the case, it certainly isn't the way GHB is currently perceived by the FDA. Prior to 1994, the FDA had the power to arbitrarily classify almost anything as a drug. 'I'hc FDA's definition of a drug included 1)non-food items "intended to affect the structure or function of the body of man or other animals," and 2)items intended to "treat, cure, mitigate or prevent" disease. The category of "food supplements" did not then exist. In the eyes of the FDA, food supplements could he classified in many different ways: as drugs, food additives, or even adulterants. By their ridiculously broad definition, almost anything and everything could be considered a drug, including water, exercise, sports equipment, classical music, or sunlight-all of which can citl~er affect the structure or function of the body, or treat or prevent disease. Although these arbitrary and capricious powers of the FllA to label nutritional supplements as food preservatives and adulterants were repeatedly ruled improper and illegal in a number of court decisions, the agency failed to restrain its actions. Finally, attempts to rein in this rogue Federal agency culminated in the passage of the Dietary Supplement Health & Education Act of 1994 (DSH&EA), wherein those powers were severely restricted. With the passage of DSH&EA, the FDA was absolutely prohibited from classifying nutrients as food preservatives or adulterants. Furthermore, they were permitted to remove food supplements from the market only if there was a threat to public health involved. Any such removals would require convening a set of public hearings to review the decision, at which public input would be accepted, all testimony would be open, and the proceedings would be published in the Federal Register. Never before had the internal decision-making process of the FDA been exposed to public scrutiny. Significantly, the FDA has so far avoided any decisions that would require such exposure. In November, 1990, 4 years prior to the DSH&EA, the FDA issued a national press release announcing that GHB was a drug. Instead of following formal regulatory procedures for assigning a status to GHB, the FDA took the unusual (and legally unsanctioned) step of p B11c I<o. NC..~ Ite+°. ?ai ~ i g 1997 ltet. Date ....s_,...__.