The Classification Of GHB In The USA

The Classification Of GHB In The USA

The following is a collection of articles and communications from Ward Dean MD about the GHB situation in the United States. They include his communication with the various authorities and comments on his court appearances as an expert witness on behalf of the defense. The articles appear in the order of the latest first, so in some cases you may wish to read on to learn of some of the earlier links and references.


Open Letter to the Board of Pharmacy, Florida

From; Ward Dean MD 3579 Highway 50 East Carson City NV89701

April 9, 1999

To; Jerry Hill, R.Ph., C.Ph. Chief, Bureau of Pharmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308

Dear Mr. Hill,

Reference your letter dated April 7, 1999, to Mr. Mitchel Downey (Incl. 1), regarding the current status of gamma butyrolactone (GBL) in Florida. Your letter contains a number of misleading and inaccurate statements that promote the officially cultivated misperception that GBL is currently a controlled substance in Florida.

Your letter mentions a "press release" issued by the FDA on January 21, 1999 advising consumers not to purchase or consume products that contain GBL. I believe you are probably referring to the FDA Talk Paper (T99-5) (Incl. 2). In your letter, you state that the FDA issued this press release on the basis of reports from the Centers for Disease Control of "41 cases of serious GBL toxicity requiring hospitalisations, coma, seizures, and even death."

Actually, the Talk Paper said FDA had received "reports of at least 55 adverse health effects, including one death." However, despite these assertions," we're not sure
(1) how many people were involved,
(2) where these "reports" allegedly came from, and
(3) whether they are credible. Furthermore, the Talk Paper did not say anything about the Centers for Disease Control (as you stated in your letter).

You wrote, "the FDA considers GBL-containing dietary supplements to be illegally marketed unapproved new drugs." While FDA may consider GBL-containing dietary supplements to be "new drugs" and therefore unapproved and illegal, this does not necessarily make them so. The Food Drug & Cosmetics Act definition of a dietary supplement, as amended by the Dietary Supplement Health & Education Act (DSHEA) of 1994,
(1) includes both GHB and GBL by two independent standards, and
(2) mandates that the FDA regulate them as foods, NOT DRUGS.
A Federal Court has already overturned the FDA's application of drug regulations to "Chinese red yeast rice powder" in violation of dietary-supplement regulations. It is quite clear that their "consideration" of GBL-containing dietary supplements is equally illegal under federal law.

The FDA's "considerations" regarding GBL are of no consequence to citizens of Florida for another reason. The FDA has no jurisdiction within a State, unless the State grants it to them (10th Amendment to the Constitution for the U.S.; Jurisdiction over Federal Areas Within the States - Report of Interdepartmental Committee for the Study of Jurisdiction over Federal Areas Within the States, Vols. I and II, U.S. Government Printing Office, 1956). If the FDA had direct jurisdiction at all, they wouldn't require the collusion of State and County officials to enforce their press releases and Talk Papers (and since when do press releases have the force of law?).

The most serious lapse in your letter regards the Florida Attorney General's Emergency Rule 2ER98-1 on 9 November 1999. According to Florida Statute 120.54 (9)(a)3.(c), (Rulemaking Procedures) (Incl. 3), "emergency rules expire after 90 days." Thus, the Attorney General's Emergency Rule expired on or about 9 February 1999. Furthermore, this same paragraph states that Emergency Rules "shall not be renewable." Enforcement of an expired Emergency Rule is
(1) illegal,
(2) a violation of the Florida Constitution, and
(3) a violation of the civil rights of law-abiding citizens engaging in legally protected activities.
Your knowing and official participation in such enforcement exposes you to civil and criminal liability.

It is clear that there is no rule or statute that would preclude anyone from manufacturing, selling or possessing GBL-containing dietary supplements in Florida at the present time, despite the erroneous statements in your letter.

It might be wise for you to personally review the pharmacology of GBL and GHB. GBL is among the safest substances known. Enclosed is a copy of an article I wrote, based on information from a U.S. government Website (OSHA), concerning the overwhelming safety of long-term high-dose GBL consumption in several species of experimental animals (Incl. 4).

Also enclosed is a copy of my Freedom of Information Act (FOIA) request (Incl. 5) to the FDA for substantiation of their allegations of "55 adverse effects, including one death." The HHS FOIA office responded (Incl. 6) stating that "we have no data in our adverse event file pertaining to your [my] request."

Clearly, it appears that you and the Attorney General have been "had" by an out-of-control federal agency, which has made reckless and unsubstantiated allegations regarding an extremely safe and highly beneficial natural substance. I trust that you will send Mr. Downey a correction.

Yours truly,

Ward Dean MD


GHB and Junk Science; The Making of a Myth

Ward Dean MD

The vast majority of those who have either not used gamma hydroxy butyric acid (GHB) responsibly, or studied the scientific literature (or my book, GHB, The Natural Mood Enhancer), "know" that GHB is an illicit designer substance that is highly toxic and is widely used by unscrupulous criminals as a "date-rape drug." The motivation for the viciousness of the "establishment" in propagating erroneous information and vilifying this highly beneficial natural substance is really no puzzle. GHB (and its dietary supplement precursors, gamma butyrolactone [GBL] and 1,4 butanediol [BD]) is often a better antidepressant than Prozac ®, Paxil ® or Zoloft; a better anti-anxiety agent than Valium or Ativan; a better relaxant and euphoriant than alcohol; and a better sleep-inducing substance than Dalmane or Restoril. GHB is stepping on some very large financial toes. Thus, the motive for GHB demonization is clear. However, the mechanics and coordination behind the demonization and prosecution/persecution of GHB manufacturers, salespeople and consumers was not, until recently, altogether clear.

However, this murky situation began to clear up to me as a result of a recent trial in which I testified for the defence in Deadwood, South Dakota. A Denver gym owner was accused of using GHB to facilitate rape. The defendant admitted that he had given GHB to a number of people at a party, after carefully advising everyone of the effects it might have on them. He also admitted having sexual relations with the complainant. The only point of contention in the case was whether the sexual relations were consensual or not, and whether GHB had incapacitated the complainant beyond her ability to resist. After hearing from all witnesses, who described the pre- and post- GHB "coming on" of the complainant, the issue was resolved by the jury after 20 minutes of deliberation "not guilty" on all counts. Normally, this trial would have been fairly routine, not worthy of mention in local papers. However, because the notorious "date-rape drug" was involved, the story became front-page news.

Gun for Hire

The prosecution had hired Jo Ellen Dyer, a pharmacist for the San Francisco, California Poison Control Center. I was vaguely familiar with Ms. Dyer's background. I knew of her as a third coauthor of one of the first articles to describe GHB as a dangerous substance. I was unaware, however, of her central role in the criminalization of GHB which resulted in the prosecution of many GHB manufacturers and retailers.

As part of her packet to substantiate her qualifications as an Expert Witness, she was required to submit her CV (curriculum vitae). Gary Colbath, the defense attorney in the case, handed me her CV, and said "one thing for sure, she sure knows how to create "a CV." As I perused her CV, the picture became very clear. Dyer was clearly a "hired gun" for the government. Among her "Public Service" credits were appearances on the Oprah Winfrey, Geraldo Rivera, and CNN's notoriously inaccurate Impact shows. Her "Professional Activities," since 1990, included being a consultant to: (1) the Food and Drug Administration (FDA); (2) the Drug Enforcement Administration (DEA); (3) the FBI; (3) the US Dept. of Justice; (4) the Michigan State Police; (5); Representative Sheila Jackson Lee (author of the notorious "Hillory Farias Date Rape Drug" bill; Ironically, Hillory Farias had not consumed GHB nor had she been raped); and (6) the Florida Legislature, Senate Criminal Justice Committee; etc.; etc. Not exactly an unbiased background.

I was also unaware of the price she charged. Although I have testified five times on behalf of defendants in GHB cases, I usually charge only my travel expenses, because (1) usually, the lawyers have already gotten all the money from the now-destitute defendants; and (2) I don't like to see honest people sent to prison (Recently, VRP has been charging the defense the cost of my salary to recover their expenses for the days I am lost to VRP due to the trial). I was as surprised as the jury (their jaws dropped collectively) when Ms. Dyer smugly announced that she charged $300/ hour for 30 hours (i.e., $9,000 to the taxpayers South Dakota) for her approximately one hour on the stand (Nice pay if you can get it. This does not, in my mind, result in unbiased testimony). I doubt if she makes that much answering the telephone for the Poison Control Center in San Francisco.

In addition to her media appearances, and the articles I knew about, in her CV Dyer also claimed authorship of four additional early articles that were heretofore either attributed to others or were anonymously written (#s 1, 2, 4, and 5, below).

After 30 years of safe over-the-counter and clinical use of GHB for surgery, addiction treatment, relaxation and enhancement of natural sleep, the situation changed dramatically. Almost overnight, GHB has become a substance with allegedly little or no therapeutic value (in the states where GHB was labelled a Schedule I substance). Deep sleep was now redefined as "coma" (My patients on GHB now laughingly tell me how much they appreciate being able to "go comatose" every night). But the redefining of the positive effects of GHB with negative connotations is not a joke. By legislative fiat, our legislatures are now criminalizing many otherwise honest citizens, as well as depriving many people whose lives have been dramatically improved from obtaining this highly beneficial substance.

Bibliography of GHB-Demonizing Articles

Dyer's articles formed the foundation of the paradigm-shift. Review of adverse articles about GHB reveals that they have all been launched from the platform of her articles. Unfortunately, her articles are, however, masterpieces of fiction and contradiction. The articles below represent the entire body of scientific literature that describes GHB in an adverse light (with the exception of #6, which is a response to an adverse article, pointing out errors). We addressed in depth the veracity and/or significance of a number of these articles (designated by an asterisk) in our book (Dean, Morgenthaler and Fowkes, 1997). Such analysis will not be repeated here in order to maintain brevity. The articles are numbered in order of their dates of publication (i.e., earliest first, most recent last). Articles which were authored by Jo Ellen Dyer are in boldface type. My comments are enclosed in [brackets]. All adverse articles (with the exception of newspaper stories) that are cited as references in each article are listed within {curved brackets} for each article.

It can be seen that the first fourteen articles (remember, #6 was a response) to be published that portrayed GHB in an adverse light were authored by Dyer or used articles by Dyer as their sole adverse reference. Beginning with #16, non-Dyer-authored adverse articles began to be cited. Note, however, that even these non-Dyer articles used only Dyer articles as their references. So it becomes clear that what we have is a created paradigm-shift based on a "feeding frenzy" of cross- and self-citation/referencing, resulting from bad science that was largely the work of one woman with an agenda.

1. Grigg, Bill, and McLearn, Donald. GHB Warning. FDA Press Release, P90-53, November 8, 1990. [Dyer's CV states, "I (she) identified GHB as an over-the-counter nutritional supplement causing coma and seizures in 1990. My (her) reports to the FDA resulted in a ban on over the counter sales of this unapproved drug and removal from the shelves in California."]*

2. Anonymous [Dyer] Multi-state Outbreak of Poisonings Associated with illicit use of gamma hydroxy butyrate. MMWR, 1990, 39: 47, 861-863. {1}

3 Nightingale, Stuart L. Warning about GHB. JAMA, 1991, 265: 14, 1802. {No refs.} [Nightingale is the FDA's Associate Commissioner for Health Affairs. I wonder if he really wrote this article].

4. Anonymous. [Dyer] Gamma hydroxybutyrate GHB poisoning. The Medical Letter, 1991, 33: 836. {No refs.}

5. Anonymous. [Dyer] Multi-state outbreak of poisonings associated with illicit use of gamma hydroxybutyrate. JAMA, 1991, 265: 4, 447. {1}

6. Lane, Rosemary. Gamma hydroxybutyrate (GHB). JAMA, 1991, 265: 22, 2959. [Response to previous article, citing safety and efficacy of GHB in pediatric anaesthesia]. {5}

7. Dyer, Jo Ellen. Gamma hydroxy butyrate: A health food product producing coma and seizure like activity. Am J Emerg. Med., 1991, 9: 321-324. {5} * Chin, Ming-Yan, and Kreutzer, Richard A. Acute poisoning from gamma hydroxybutyrate in California. [Unpublished draft of the following article (#9) prior to Dyer being added as third author. There were several extremely significant differences between these two papers. In this draft, ten subjects were described all but one recovered with no adverse effects. The one patient who died succumbed to a bleeding esophageal varicose vein. This is a common result of hepatitis or alcohol-induced cirrhosis. The patient was taking a number of other herbal supplements, all intended to support the liver. GHB is used in Europe for withdrawal from alcohol addiction. Naturally, GHB was blamed for the death. The other significant difference was the report of one patient who accidentally consumed 15 tablespoons of GHB (that's about 75-85 grams, nearly a whole bottle!) who was discharged from the hospital 24 hours later with no ill effects! This report was deleted from the following paper]. {No refs.}*

9. Chin, Ming-Yan, Kreutzer, Richard A., and Dyer, Jo Ellen. Acute poisoning from gamma hydroxybutyrate in California. [This report mentioned only five patients (the worst five) including the one who died from the bleeding esophageal varicose vein (the remainder recovered spontaneously without ill effects). It also deleted any mention of any positive effects of GHB]. Western Journal of Medicine, 1992, 156: 4, 380-384. {{2, 7}*

10. Einspruch, Burton C., and Clark, S. Michael. Near fatality results from health food store sleeping potion. Texas Medicine, 1992, 88: 12, 10. {2}

11. Luby, Stephen, Jones, Jeffrey, and Zalewski, Alan. GHB use in South Carolina. American J Public Health. 1992, 82: 1, 128. {2}

12. Adornato, Bruce T., and Tse, Victor. Another health food hazard-- gamma hydroxybutyrate-induced seizures. Western Journal of Medicine, 1992, 157: 471. {9}

13. Mack, Robert. Love potion number 8½. North Carolina Medical Journal, 1993, 54: 5, 232-233. {7}

14. Dyer, JE, Isaacs, SM, and Keller, KH. Gamma hydroxybutyrate (GHB)-induced coma with serum and urine drug levels. Vet Human Toxicol, 1994, 36: 4, 348. {No refs.}

15. Galloway, Gantt P., Frederick, S.L., and Staggers, Frank. Physical dependence on sodium oxybate. The Lancet, 1994, 343: 57. {7}

16. Stephens, Boyd C., and Baselt, Randall C. Driving under the influence of GHB? J Analytical Toxicology, 1994, 18: 257-358. {5, 11, 3}

17. Ferrara, Santo D., Tedeschi, Luciano, Frison, Giampietro, and Rossi, Alessandra. Fatality due to gamma-hydroxybutyric acid (GHB) and heroin intoxication. [The causes of death were clearly described in this article. The pathological findings were all consistent with heroin use and intoxication. They were not in accordance with the known clinical effects of GHB. The individual was in a drug treatment program in which his GHB was prescribed for heroin addiction]. J Forensic Sciences, 1995, 40: 3, 501-504. {2, 7, 9}*

18. Ross, Tracy McIntyre, Gamma hydroxybutyrate (GHB) overdose: Two cases illustrate the unique aspects of this dangerous recreational drug. J Emerg Nurs, 1995, 21: 374-376. {2, 9, 15}

19. Steele, Mark T., and Watson, William A. Acute poisoning from gamma-hydroxybutyrate (GHB). Missouri Medicine, 1995, 92: 7, 354-357. {7, 4, 2, 9, 1, 13}*

20. James, Charose. Another case of gamma hydroxybutyrate (GHB) overdose. J Emerg Nurs, 1996, 22: 97. {18}

21. Friedman, Joseph, Westlake, Robert, Furman, M. "Grievous bodily harm:" Gamma hydroxybutyrate abuse leading to a Wernicke-Korsakoff syndrome. Neurology, 1996, 46: 469-471. [Claims GHB contributed to Wernicke-Korsakoff syndrome, a condition caused by alcohol abuse and vitamin B1 deficiency] {2, 9, 7, 12}*

22. Carrazanna, Enrique J. Grievous Bodily Harm. 1996, Neurology, 47: 1351. [Challenges role of GHB in previous article by Friedman, et al. Points out that the condition referred to was rapidly reversed with appropriate dosage of vitamin B1]. {21}

23. Galloway, Gantt P., Frederick, S.L., Staggers, Frank E., Gonzales, Marco, Stalcup, S. Alex, and Smith, David E. Gamma-hydroxybutyrate: An emerging drug of abuse that causes physical dependence. Addiction, 1997, 92: 1, 89-96. {7, 11, 2, 9,10, 15}*

24. Louagie, Henk K., Verstraete, Alain G., De Soete, Christophe J., Baetens, Dimitri G., and Calle, Paul A. A sudden awakening from a near coma after combined intake of gamma-hydroxybutyric acid (GHB) and ethanol. Clinical Toxicology, 1997, 35: 6, 591-594. {5, 7, 19, 9, 17, 21, 16}

25. Tunniclliff, Godfrey. Sites of action of gamma hydroxybutyrate (GHB) - A neuroactive drug with abuse potential. Clinical Toxicology, 1997, 35: 6, 581-590. {7, 9, 19, 15, 23, 21}

26. Sanguineti, Vincenzo, R., Angelo, Anita, and Frank, Marion Rudin. GHB: A home brew. Am J Drug Alcohol Abuse, 1997, 23: 4, 637-642. {9}

27. Anonymous: Gamma hydroxybutyrate use; New York and Texas, 1995-1996. MMWR, 1997, 46: 13, 281-282. {2}

28. Bismuth, Chantal, Dally, Sylvain, and Borron, Stephen W. Chemical submission: GHB, benzodiazepines, and other knock out drops. Clinical Toxicology, 1997, 35: 6, 595-598. {23, 27}

29. Anonymous: Gamma hydroxybutyrate use; New York and Texas, 1995-1996. JAMA, 1997, 277: 19, 1511. {"3 available" but not listed}

30. Marwick, Charles. Coma-inducing drug GHB may be reclassified. JAMA, 1997, 277: 19, 1505-1506. {No refs}

31. Chin, Rachel L., Sporer, Karl A., Cullison, Brian, Dyer, Jo Ellen, and Wu, Thomas D. Clinical course of gamma-hydroxybutyrate overdose. Annals of Emergency Medicine, 1998, 31: 6, 716-722. {5, 7, 9, 10, 18, 20, 16, 14, 13, 19, 11, 21, 25, 17, 12}

32. Li, James, Stokes, Sharon Arnaud, and Woeckener, Anna. A tale of novel intoxication: Seven cases of gamma hydroxybutyric acid overdose. Annals of Emergency Medicine, 1998, 31: 6, 723-728. {2, 11, 17, 18}

33. Li, James, Stokes, Sharon Arnaud, and Woeckener, Anna. A tale of novel intoxication: A review of the effects of gamma hydroxybutryic acid with recommendations for management. Annals of Emergency Medicine, 1998, 31: 6, 729-736. {2, 17, 11, 18, 19, 10, 15}

34. Hernandez, Michael, McDaniel, Charles H., Costanza, Christopher D., and Hernandez, Oscar J. GHB-induced delirium: A case report and review of the literature on gamma hydroxybutyric acid. Am J Alcohol Abuse, 1998, 24: 1, 179-183. {4, 2, 19, 7, 17, 9}

35. Hodges, Barbara, Everett, James. Acute toxicity from home brewed gamma hydroxybutyrate. J Am Board Fam Pract, 1998, 11: 2, 154-157. {30, 21, 19, 10, 18, 16, 9, 2, 7, 17, 15, 13, 11}

36. Gamma hydroxybutyrate, American Family Physician, 1998, 57: 9, 2078-2079.

Antidote Never Mentioned

In all these articles, Dyer and her accomplices express their concern for the "victims" of GHB overdoses. However, their motives may be suspect when it is learned that not one of these articles discuss the antidote for GHB-induced sleep, including the one article that purports to describe therapeutic protocols for management of GHB overdose (# 33). They all repeat the myth that "there is no way to awaken someone from GHB-induced sleep."

On the contrary, GHB-induced sleep can be rapidly reversed by using a drug that is readily available in every emergency room. The use of physostigmine to awaken surgical patients from GHB-induced anaesthesia has been known for over 20 years! In 1976, Henderson and Holmes reported that 2 mg of physostigmine administered intravenously resulted in awakening of their patients in 2-10 minutes. Only one patient in 25 failed to regain consciousness within ten minutes. This patient required a second dose of physostigmine, and awakened uneventfully. There were no adverse effects reported when using this regimen. Nevertheless, this safe, effective procedure is not mentioned once in any of the above articles perhaps because the perception that there is no antidote (even though not usually necessary) makes the offending substance seem even more dangerous.

References:

Dean, Ward, Morgenthaler, John, and Fowkes, Steven Wm. GHB, The Natural Mood Enhancer, 1997, Smart Publications, Petaluma, California.

Henderson, R.S., and Holmes, C. McK. Reversal of the anaesthetic action of sodium gamma hydroxybutyrate. Anaesth Intens Care, 1976, 4: 351.


Open Letter to State Representative of Florida regarding GHB

From, Ward Dean MD 3579 Highway 50 East Carson City NV89701

To, Representative Jerry Maygarden Tallahassee, Florida

3 April, 1999

Dear Jerry,

As you know, I have been in contact with Janice Gilley regarding pending legislation regarding scheduling of gamma hydroxy butyric acid (GHB). This legislation calls for scheduling of GHB as Schedule II, as well as any "salt, compound, derivative, or preparation of GHB" to include any "isomers, esters, ethers, and salts of isomers, esters and ethers of GHB," under FS 893.035, in accordance with a recently-expired Emergency Rule from the Attorney General.

I believe such legislation is ill-advised for a number of reasons.

First, the Attorney General's Emergency Rule is based on faulty information. It is based entirely on a recently-issued FDA talk paper (Incl. 1). The Talk Paper refers to "55 adverse events including one death" which are allegedly related to the GHB precursor, gamma-butyrolactone (GBL). I attempted to confirm this information with the FDA. I was told by the author of the Talk Paper (Ruth Welch, of the FDA) that the information was available on the FDA's website. I checked, and found only the sketchiest of information there. Ms. Welch then told me "that is all the information available to the public." I submitted a Freedom of Information Act (FOIA) request (Incl. 2), and was advised that "we [FDA] have no data in our adverse event file..." (Incl. 3). Thus, the Attorney General apparently used totally unsubstantiated allegations on which to base his Emergency Rule.

Second, I believe that GHB (and its precursors, GBL and 1,4 Butanediol [BD]) are among the safest and most beneficial natural substances known. GHB has a toxicity about 1/3 that of table salt. When used properly, it is highly beneficial to health in general, and as a treatment for a wide variety of clinical conditions, including sleep disorders, fibromyalgia, chronic fatigue, obesity, depression, anxiety, and many others. It is not the toxic, dangerous date rape drug that the media and the Attorney General would have us believe. I am enclosing a copy of an article I wrote about the overwhelming safety of long term use of extremely high doses of GBL

Third, the Attorney General's Emergency Rule and a similarly-worded statute are clearly so all-inclusive as to be void for vagueness, and therefore, unconstitutional. This broad category of substances which encompassed by the Emergency Rule includes nail polish remover, floor cleaners, engine degreasers, and even alpha-hydroxy acids in apples. Furthermore, we have identified GHB as being a natural constituent in meat, citrus fruits, and other products. Every grocery store owner is therefore in possession of GHB, and undoubtedly has an intent to distribute such products. Such legislation will make unindicted felons of many business owners and may reflect adversely on the wisdom of the Florida State Legislature.

I request that hearings be scheduled prior to voting or enacting into law such a poorly-written and ill-advised statute as has been proposed by the Attorney General and his legislative henchmen. I believe that the "other side" of the GHB story needs to be told, which is far different from the one portrayed by the media and the Attorney General. I have nearly three filing cabinet drawers full of scientific articles and Investigational New Drug (IND) studies from the FDA confirming the overwhelming safety and efficacy of GHB and its precursors. I and a number of other physicians and satisfied users of GHB and its precursors are anxious to testify before the Legislature, to tell the truth about this remarkable substance.

Please let me know how you intend to proceed on this important issue (aren't they all?).

Yours truly,

Ward Dean MD


FDA Talk Paper on Dangers of RenewTrient Appears to be Without Foundation

Ward Dean MD

On January 16, 1999, The FDA issued a "Talk Paper" (T99-5) (Fig. 1), titled "FDA warns about products containing gamma butyrolactone or GBL and asks companies to issue a recall." This Talk Paper claimed that "GBL related products have been associated with reports of at least 55 adverse health effects, including one death." Establishment newspapers and television stations across the country accepted the FDA's claims at face value without further investigation (after all, the government wouldn't lie, would it?) This resulted in a flurry of news features by some of the nation's top reporters and journalists (i.e., writers for the NY Times, San Francisco Chronicle, CNN, etc), blaring the dangers of this latest "date-rape" menace. Furthermore, it was largely on the basis of this FDA Talk Paper that the Florida Attorney General initiated legal action against manufacturers of GBL-containing dietary supplements.

Although I am not professionally an investigative reporter, I think I have already investigated this matter in more depth than our mainstream, orthodox press. These are the folks that believed Clinton when he wagged his finger at us and said, "Now listen to me. I'm only going to say it once. I did not have sex with that woman!"

We've just had the FDA wag its finger at us

From previous experience, I am all too familiar with FDA Talk Papers. Shortly after our book, Smart Drugs & Nutrients (1990) was published, the FDA issued a Talk Paper on Smart Drugs, which included a wealth of misinformation and deception about a number of cognitive enhancing substances. Fortunately I was able to respond to each of the FDA's allegations in a chapter in the book, Stop the FDA (Morgenthaler and Fowkes, 1992). Stop the FDA also included chapters by Dr. Linus Pauling, Senator Orrin Hatch, Durk Pearson and Sandy Shaw, and many others concerned by the FDA's propensity to warp the facts to meet it's altered view of reality. In my chapter I addressed each and every issue raised by the FDA, and, backed up by meticulous documentation, showed point-by-point, how they had either twisted the truth or simply lied outright.

Now, the FDA has been caught in the act again. Based on my previous experience with Talk Papers, I contacted the author of the most recent fabrication, Ruth Welch of the FDA Press Office. I asked whether she could provide me with any documentation to substantiate and analyze these "adverse events." Ms. Welch responded that the only information "available to the public" was on the FDA's website (www.fda.gov/foods/dietarysupplements/specialdietarysupplements/). However, when I went to the website, I found reference to only 10 alleged "adverse events," including one death, which involved the co-ingestion of other substances.

I was aware of the overwhelming safety of GHB and its precursor, butyrolactone (GBL) - the active ingredient in RenewTrient and similar products (see "BlueNitro, an Explosive Media Campaign" in this Supplement. Consequently, I submitted a Freedom of Information Act (FOIA) request to the FDA to obtain further information about these alleged adverse events. In response, the Department of Health and Human Services FOIA office informed me that "we have no data in our adverse event file pertaining to your request."

Now, either
(1) the folks in the FDA's FOIA office don't know what is going on or are not being truthful and are not releasing information they are obligated to divulge; or
(2) the folks who produce Talk Papers for the FDA are up to their old tricks.
In either case, the "press-release regurgitators" of the mainstream media were certainly not living up to journalistic standards, which obliges them to confirm the veracity of their stories, and to check multiple sources.

References:

Dean, Ward Does the FDA Need Smart Drugs, in: Stop the FDA: Save Your Health Freedom, by Morgenthaler and Fowkes (eds), Health Freedom Publications, Menlo Park, 1992, pp. 147-153.

Dean, Ward, and Morgenthaler, John. Smart Drugs & Nutrients, Smart Publications, Petaluma, 1990.

Morgenthaler, John, and Fowkes, Steven Wm. . Stop the FDA: Save Your Health Freedom, Health Freedom Publications, Menlo Park, 1992.

Contact State Representative to block GHB and related legislation in your state.

Contact U.S. Representative to investigate the deceptive press releases of the FDA


"BlueNitro" - An Explosive Media Campaign Or, Gamma Butyrolactone - A Legal Precursor for GHB With Multiple Therapeutic Uses

by Ward Dean MD

"BlueNitro Worries Poison Experts" screamed the headline of the San Francisco Examiner on Monday, January 11, 1999. The active ingredient in BlueNitro is butyrolactone (GBL), which is readily converted by the body into GHB (gamma hydroxybutyric acid). The same article states, "Medical professionals are warning that the chemical composition of the liquid creates more risks than benefits." Although this is the view of GBL that propagated by the media, there is another view that has a much more positive outlook.

The following article was written by Dr. Dean prior to the current excitement. As this issue goes to press (January 14, 1999), law enforcement officers have raided at least one manufacturer of GBL-containing nutritional supplements in Florida. The Attorney General of Florida has determined that butyrolactone (the active ingredient in RenewTrient) is within the purview of his new "Emergency Order" which makes "isomers, esters, ethers, salt isomers and ethers of GHB" a controlled substance (Schedule II) in Florida.

While this broad (overbroad, we believe) edict includes substances like RenewTrient, it also includes gasoline, paint thinner, nail polish remover, polyester and even apples. However, so far, this far-reaching provision has only been selectively applied in Florida against manufacturers of GBL-containing nutritional supplements.

For more information on GHB, see Dr. Dean's book, GHB, The Natural Mood Enhancer, and previous articles in VRP Nutritional News "A call to action-Stop Criminalization of GHB!" (April 1997); "VRP 'crashes' secret meeting to outlaw GHB" (September, 1997); and "Interview with John Morgenthaler" (March, 1998).

We suggest you contact your state legislators, to encourage them to vote against any pending legislation to further restrict sales of these beneficial dietary supplements.

Recently, a number of popular over the counter GHB-precursor supplements have been introduced, such as BlueNitro and Olympia's RenewTrient. These products share the same active ingredient, usually listed as "2(3)-furanonedihydro-." 2(3)-furanone dihydro- is actually an archaic chemical name for the commonly known solvent, gamma-butyrolactone (GBL). GBL is used industrially as an engine degreaser, paint stripper, and solvent.

In addition to its extensive use in industry, food grade and pharmaceutical grade GBL is also widely used in a number of products ultimately intended for human ingestion or infusion, including blood plasma extenders and as a clarifying agent in beer and wine. Thus, despite the unappetizing thought of consuming "the active ingredient in engine degreaser," GBL is an extremely safe and potentially highly beneficial substance, with industrial, dietary and pharmaceutical uses.

When discussing solvents and human health, we should also keep in mind that a number of "solvents" have beneficial dietary and therapeutic uses. Life itself could not exist without copious amounts of a solvent used for countless industrial and human applications-the "universal solvent" oxygen di-hydro better known as water. Also, when considering the safety of consuming "paint stripper," think of another "industrial solvent"-di-methyl-sulfoxide (DMSO).

DMSO-a by-product of the paper-making industry-is a solvent that is helpful for many conditions, and is widely sold in many health food stores. DMSO exerts powerful anti-inflammatory and pain-relieving actions. Because DMSO is able to rapidly and easily penetrate the skin and is easily absorbed into the body, it can reach areas that are hard to treat by other means.

Because of its safety and range of benefits, it is not such a great leap to move from the topical use of DMSO to considering intravenous and oral use as alternate means of getting it into the body. For example, to treat systemic arthritis involving multiple joints, I recommend that my patients consume about 1 teaspoon per day (in orange juice, it's really not that bad). DMSO is extremely safe.

Legality and Safety of GBL

Like DMSO, GBL has many beneficial effects, and is equally safe. GBL is converted rapidly and completely by the body into GHB, by the enzyme lactonase. Thus, products like RenewTrient are legal in nearly all states even where GHB is a controlled substance.

But what about its safety? Frankly, I had the same question. I had the same aversion to drinking "paint thinner" as everyone else. The answer, it turns out, lay in a mind-boggling article I found on the internet, from, of all places, a U.S. government website (http://ntp-server.niehs.nih.gov/htdocsLT-Studies/TR406.html)! The article described studies lasting two years, in which extremely high doses of GBL were administered to rats and mice of both sexes 5 days per week, via gavage feeding (i.e., stomach tubes). Female rats were administered doses of 450 mg/kg, male rats received 225 mg/kg, and male and female mice received 525 mg/kg. These doses were as much as ten times higher than equivalent, sleep-inducing doses in humans.

The results of the study revealed some surprising effects. Among the findings:

Male rats receiving GBL showed a slightly higher survival rate. This effect was attributed to a lower incidence of mononuclear cell leukemia. There was no change in survival of the female rats, but female dosed rats had lower incidences of mammary gland cysts and tumors. Additionally, liver tumors were decreased in both male and female mice. At the end of the study, the mean body weights of dosed mice (both male and female) were lower than the controls. This finding is consistent with the frequent reports of weight loss reported by human GBL consumers!

The overall conclusions of this study is that GBL in extremely high doses is exceptionally safe, and actually reduces the incidence of leukemia and mammary and hepatic tumors, and extends the life span of male rats (there was a reduced life span of male mice, due to increased deaths due to fighting!). Thus, despite any initial concerns, GBL is an extremely safe substance with a number of unique benefits for human health.

Benefits of GBL- Safe Natural Sleep

The most common use of GHB (and GBL) is as a safe, non-toxic, non-addictive sleep-inducing agent. In lower doses, rather than leading to sleep, these substances induce a mild euphoric state, much like a glass or two of wine. Unlike alcohol, however, which may damage brain and liver cells and produce free radical-generating toxins (acetaldehyde), GHB is cleanly metabolized (via the Krebs cycle) into carbon dioxide and water.

There are absolutely no toxic or addictive metabolites. And while GHB is being metabolized, it is converted into succinates, which actually enhance body metabolism. Consequently, when any dose of GHB wears off, instead of feeling "drugged," the person is alert and refreshed.

Clinical Conditions

Some of the clinical conditions for which GHB has been used include narcolepsy, depression, anxiety, schizophrenia, Parkinson's disease, ADD, fibromyalgia, and alcohol and opiate withdrawal. I believe it is also the substance of choice for a wide variety of chronic pain syndromes, including peripheral neuropathy, phantom limb syndrome, neuralgia from nerve root involvement, trigeminal neuralgia, and migraine headaches.

Other effects of GHB include normalization of abnormal EKGs, reduction of cholesterol, reduction of brain and heart oxygen requirements (thereby potentially reducing the risk of strokes and heart attacks), and stimulation of growth hormone release. I believe it is the combination of growth hormone release and enhancement of metabolism that results in the weight loss that many GHB users experience. Although all of the previous clinical effects are well documented for GHB, the same results will be experienced by GBL users, because of its rapid and complete conversion into GHB in the body.

Differences in effects between GHB and GBL

Oral GBL is rapidly converted into GHB-over half of a consumed dose of GBL is converted into GHB in less than one minute! GBL is also absorbed much faster than GHB, and appears to have even greater activity than when GHB is consumed directly (Lietteri and Fung, 1978). Blood plasma concentrations of GHB rise faster and remain elevated longer when GBL is administered, compared with an equal dose of GHB. This longer action of GBL often prevents the early awakening which frequently occurs with GHB. Consequently, GBL has been considered by some to be almost a "timed-release" form of GHB.

How to use GBL (RenewTrient)

Most GBL products, like RenewTrient, have a pre-measured cap for administering sleep-inducing doses. However, like many other products, there is an individual variability in the effects that GBL has on different people. Therefore, I always advise people just starting to try GBL to start with a low dose, usually not more than a teaspoonful, and then increase the dosage as tolerated. Most people find that extremely low doses have both an energy-producing as well as mood-enhancing effect. At low doses, many people report improved performance. A slightly higher dose causes a mild euphoria. A dose of one ounce (more or less) normally induces a sound, restful sleep. If awakening occurs in the middle of the night, I recommend repeating the dose to return to sleep. GHB greatly enhances the depth and efficiency of stage III and IV sleep which results in a significant elevation of growth hormone release.

GHB/GBL Cautions

It is important to avoid combining GHB or GBL with alcohol, tranquilizers, sleeping pills, depressants, sedatives, or barbiturates, as the depressive effects may be addictive. As a precaution, people should inform those around them that they are taking GBL or GHB, and therefore may be un-arousable for several hours. There have been instances where people have been inappropriately taken to an emergency room when their friends found them unconscious and un-arousable, and assumed they were in danger. These individuals invariably woke up about 3 hours later, wondering where they were and why all these strange people were doing things to them. Unless other drugs or alcohol have been consumed with these substances, the only treatment necessary is to allow the sleeping person to wake up naturally.

I believe that GHB/GBL is one of the most beneficial substances known to man. It is effective in alleviating a wide variety of conditions, as well as enhancing sleep and overall quality of life for people of all ages. But, like many other beneficial substances, it must be used wisely and judiciously. I strongly recommend that people be knowledgeable about all substances they take. Consequently, I recommend my book, GHB, The Natural Mood Enhancer, as a primer on the benefits, cautions, history and politics regarding this much-maligned but very safe and beneficial substance. To order call toll-free at 1-888-366-9909.

References

1. Lettieri, John, and Fung, Ho-Leung. Improved pharmacological activity via pro-drug modification: Comparative pharmacokinetics of sodium gamma-hydroxybutyrate and gamma butyrolactone. Research Communications in Chemical Pathology and Pharmacology, Vol. 22, No. 1, October 1978, 107-117.

2. Roth, R.H., and Giarman, N.J. Evidence that central nervous system depression by 1,4-butanediol is mediated through a metabolite, gamma-hydroxybutyrate. Biochemical Pharmacology, 1968, Vol. 17, 735-759.


GHB Found to Occur in Postmortem Blood of Non-Users of GHB

Ward Dean MD

Gamma hydroxy butyric Acid, commonly known as GHB, is a naturally-occurring substance in the brains of all mammals. GHB is known to act as a neurotransmitter, and is a precursor and metabolite of the amino acid, gamma amino butyric acid (GABA). GHB is also formed by the body from butyrolactone, or GBL. GBL is the active ingredient in a class of popular nutritional supplements, like RenewTrient.

The reason for the popularity of GHB (and GBL) is its multitude health-promoting and mood-enhancing effects. Probably its most popular use is as a safe, non-toxic, non-habit forming inducer of sound, restful sleep. GHB is also classified as a "socializer." In doses less than that required to produce sleep, GHB produces a mild, exhilarating euphoria-most users describe it as "it just makes you feel good." And, unlike alcohol, GHB enhances mood without leaving the consumer with a headache, upset stomach, or damaged brain and liver cells. When it wears off, a GHB user feels amazingly refreshed and alert.

GHB has also been used to treat narcolepsy, depression, anxiety, schizophrenia, Parkinson's disease, ADD, fibromyalgia, and alcohol and opiate withdrawal. I believe it is also the substance of choice for a wide variety of chronic pain syndromes, including peripheral neuropathy, phantom limb syndrome, neuralgia from nerve root involvement, trigeminal neuralgia, and migraine headaches. GHB also normalizes abnormal EKGs, reduces cholesterol, reduces brain and heart oxygen requirements (thereby potentially reducing the risk of strokes and heart attacks), and stimulates growth hormone release.

With such a wide range of therapeutic benefit, it is not surprising that the pharmaceutical industry and its government hit-men (FDA and DEA) have been working so hard to control its sale and use. After years of trying to demonize GHB as a dangerous "date rape drug" with no legitimate uses, these agencies were almost deliriously happy when they found what they portrayed as the first GHB related death.

The case involved an unfortunate Texas high school volleyball player who died without any apparent cause. Six weeks after her puzzling death, a reanalysis of her blood revealed a GHB level of 27 mg per liter of blood. This girl thus became the "poster child" for GHB demonizers, as the police agencies deliriously propagated the myth that she died from an overdose of GHB. Subsequent events, however, indicate that this was not likely the case.

First, there is no evidence that the victim had ever consumed GHB at all. Second, assuming that a person has about 5 liters of blood, this would mean that she might have consumed about 150 mg of GHB. That is really a trace amount, which would not even produce a slight buzz. Sleep-inducing doses are in the range of 2,500-3,000 mg. In FDA-sanctioned studies, patients consumed doses in excess of 30,000 mg daily for months on end, without evidence of adverse effects. I know of 3 people who have consumed as much as 50,000 mg on a regular basis. Clearly, this young woman did not consume a toxic dose, if she had even taken any at all.

GHB Found Routinely in postmortem Blood of Non-GHB Users

A breakthrough in this case occurred last year, with the publication of a finding that GHB is produced in the body after death - even by people who have never consumed GHB. Dr. Randall Baselt, and colleagues, performed an analysis of the blood of 20 cadavers (none of whom were known to have consumed any GHB), in order to evaluate a new GHB analytical protocol (Feiler, et al, 1998). To the researchers' surprise, they found detectable levels of GHB in 15 of the 20 cadavers, with levels as high as 168 mg/L (more than 6 times the concentration in the Texas girl)! Dr. Baselt surmised that GHB was produced post-mortem by the breakdown of substances in the blood.

A second study, performed by the Los Angeles County Coroner's Department resulted in similar findings (Anderson and Kuwahara, 1997). In this study, GHB was found in the post mortem blood of 96 randomly selected subjects-again, none of the subjects were known to have ever consumed GHB.

Conclusion

The above findings thus cast doubt upon the claims in the few cases in which GHB was attributed as a cause (or contributing cause) of death, due to finding GHB in post-mortem blood of the "victims." I have investigated nearly every case of death in which GHB was allegedly involved, and have not found one yet where the death could be attributed to any purported toxic effects of GHB (GHB is known to be less toxic than table salt). I contend that GHB (and GBL) are extremely safe substances, which have been demonized unjustifiably by the police, government, and the pharmaceutical industry. This demonization is due to the broad range of clinical benefits of these substances, and because they are safer and more effective mood enhancers than prescription drugs or alcohol. Consequently, the wide availability and use of GHB and GBL would certainly adversely effect the profits of the pharmaceutical and liquor industries.

References

Anderson, Daniel T., and Kuwahara, Tiffany. Endogenous gamma hydroxybutyrate (GHB) levels in postmortem specimens. CAT/NWAFS/SWAFS/SAT Combined Meeting, Las Vegas, Nevada, November 7, 1997 1104 N. Mission Road, Los Angeles, California 90033).

Fieler, Erin L, Coleman, Daniel E., and Baselt, Randall E. Gamma hydroxybutyrate concentrations in pre- and postmortem blood and urine. Clin Chem, 1998, 3: 692.


'Date Rape' Drug Safer Than Table Salt, Beneficial in Many Conditions

On 10 November 1998, Ward Dean MD, testified as an expert witness in a criminal case hearing in Carrollton, Georgia, before Judge Aubrey Duffey. The defendant, Clint Phillips, is charged with "possession of a controlled substance with intent to distribute." In this case, the substance in question is the controversial substance, GHB (gamma hydroxy butyric acid). GHB has been characterized by the media as a new designer steroid, and more commonly, the "date rape drug." Mr. Phillips is challenging the Constitutionality of Georgia's new law which makes possession of any amount of GHB a felony.

Dr. Dean, a West Point graduate and former flight surgeon for the Delta Force, is currently Director of Research and Development for Vitamin Research Products in Carson City, Nevada. Dean was called as an expert witness specifically regarding whether GHB occurs naturally in humans. Dean provided extensive documentation confirming that GHB is present in the tissues of every human being. Dean pointed out that this law ironically made every inhabitant of Georgia an un-indicted felon.

In addition, much to the consternation of the prosecutor, Thomas Jones. Dean produced a plethora of scientific data much of which came from the FDA's own secret files -- regarding the safety, numerous beneficial effects, and apparently deliberate campaign of disinformation that has been promulgated by the FDA and DEA, in collusion with the police agencies of many cities (especially, Los Angeles). Dr. Dean claimed that far from being a "dangerous designer steroid," GHB is actually one of the safest, most beneficial, non-addictive, non-habit-forming sleep inducing substance known to man. He provided evidence of its many beneficial clinical uses, including sleep disorders, depression, anxiety, chronic fatigue, and even obesity many chronic pain syndromes.

The prosecution produced no expert witnesses nor other evidence to challenge Dean's statements. With an apparent total disregard of logic and legal wisdom, Judge Duffey made his decision immediately upon conclusion of arguments by both sides. To the stunned, jaw-dropping obvious surprise of most spectators, the judge read what appeared to be a pre-prepared decision. Judge Duffey dismissed Phillips' motion on the incredible legal technicality that because Philips was also being charged with "intent to distribute," it didn't matter that the law making mere possession of any amount of the substance was Un-Constitutional on its face, claiming that he lacked standing to challenge this part of the law. In so ruling, the judge also holds that ordinary citizens lack standing until actually jailed on an offense.

Phillips' attorney, David S. West of Atlanta, plans to appeal on the grounds that Mr. Phillips does indeed have standing, and in fact all citizens have standing to challenge any unconstitutionally vague criminal law. West also has another case pending, in which the defendant is charged with only possession, so he believes that the government will have no recourse but to rule against the Constitutionality of the Georgia law.

Dr. Dean praised West as "the first defense counsel in the many GHB cases I've been involved in to recognize early on that we were not involved in a drug case-we were dealing with fundamental Constitutional issues involving food supplements, health freedom, and abuse of power by out-of-control federal agencies. Mr. West is an intelligent, gutsy, no-holds-barred attorney who prepares thoroughly and defends from a direction most lawyers rarely use today - the Constitution and Bill of Rights." Dean believes this case could have nation-wide ramifications, due to the recent criminalization of GHB in 18 states (For more background on this remarkable substance, see VRP Nutritional News, April, 1997, Vol. 11, Number 4, and Volume 12, Number 4, and Dr. Dean's book, GHB, The Natural Mood Enhancer, available from Smart Publications, Petaluma, California, (707) 769-9308).

Attorney David S. West, 146 Nassau Street, N.W., Atlanta, Georgia 30303; (404) 681-3953.

Please send polite letters and make polite phone calls to the judge, informing him of your personal experiences with GHB and its cousins, RenewTrient and SomatoPro. Judge Duffey's address is: Judge Aubrey Duffey, Carroll County Courthouse, P.O. Box 1620, Rm 207, Carrollton, Georgia; Phone (770) 830-5871


VRP "Crashes" Secret FDA Meeting to Outlaw GHB
This article first appeared in the September 1997 issue of VRP's Nutritional News

Like hungry wolves, huge pharmaceutical companies are licking their chops in anticipation of the FDA's removal of GHB from the over-the-counter (OTC) marketplace. Following a nearly year-long propaganda campaign where the government has falsely attributed a number of deaths to GHB, and where 'political pressure' has actually been applied to influence coroner reports and implicate GHB as the cause of death, the FDA (with the assistance of its squad of paid propagandists) stands poised to snatch GHB away from its present OTC category so it can be approved as a prescription drug by Orphan Medical, Inc.

On July 17 and 18 of this year, the FDA held a closed door meeting at the Federal Building in Oakland, California. To the dismay of the FDA, Vitamin Research Products' representatives and customers, along with a number of supporters and members from Menlo Park-based Cognitive Enhancement Research Institute showed up in front of the building as early as 7:30 AM to protest with signs and flyers to alert the public to this dangerous precedent being set.

According to an FDA flyer, it was a conference involving health, education, regulatory and law enforcement issues associated with the illicit use of GHB.

There appears to be an alarming increase in the illicit use of GHB in Northern California in recent months. The goals of this conference is [sic] to bring together individuals and agencies involved in these issues in order to communicate, educate and facilitate future approaches to dealing with these problems.

Session topics included: Poison Center Experiences; Forensic Dry Lab Issues; Adverse Reactions and Deaths; IND, Orphan Drugs, NDA; What's Legal and Illegal; FDA Cases Pending; The L.A. Date Rape Case; Pending Federal & State Legislation; and Controlling the Epidemic.

Even though VRP and other representatives expressed real concern at what kind of educational material was being presented, Dr. Wallace Winters of the FDA and the FDA educational officer in charge refused them entry using the excuse of it being a "closed door training session". Basically, U.S. citizens were arbitrarily denied access to educational information being disseminated by the FDA. Obviously, (from session topics and the meeting being "closed") it was therefore designed to school selected individuals on how the FDA plans to remove GHB and punish/jail manufacturers, retailers and supporters.

The FDA, which is increasingly perceived as a "lap dog and gopher" for large pharmaceutical companies, is conducting a media campaign of innuendo, slanted statements, and in some cases, outright untruths. While the agency has quietly (and gladly) accepted 15 Investigational New Drug Applications (IND's), each asserting that GHB is remarkably safe and effective for a number of conditions, it has, on the other hand, purposely misled Americans through print and broadcast media by falsely claiming that GHB has "no legitimate medical uses," that it has "killed about a dozen people," and that it is "dangerous, unsafe," and "illegal". Despite this grim picture painted for citizens, the FDA has given the fat cats at Orphan Medical "assurances" that GHB will be approved as a drug sometime in the near future.

Already the natural herb, ephedra, is being outlawed, after being used safely for over 5,000 years. The FDA is also trying to ban melatonin and DHEA, both of which are produced naturally in the body and are absolutely necessary for good health. It remains to be seen what will happen with GHB, Melatonin, and DHEA or at which other nutritional supplements the FDA will take its deadly political aim.


A Call to Action - Stop Criminalization of GHB!
This article first appeared in the April, 1997 issue of VRP's Nutritional News by Ward Dean MD

Gamma hydroxy butyric acid (GHB) is a substance that was quietly sold in health food stores in the late 80's. GHB is a naturally-occurring substance that is present in small amounts in every cell in the body and is both a precursor and metabolite of the neurotransmitter, GABA (gamma amino butyric acid). Because of (1) its prior sales in health food stores, (2) its being a natural substance and metabolite of an amino acid, and (3) its never having been issued a New Drug Application (NDA), GHB falls within the definition of a food supplement, as determined by the Dietary Supplement Health and Education Act (DSHEA) of 1994. Some of the effects of GHB include relieving anxiety, promoting euphoria, stimulating the release of growth hormone, acting as an aphrodisiac in some people, inducing a deep and restful sleep, normalizing abnormal EKG's, and reducing blood cholesterol.

GHB is one of the safest substances known. Unlike sleep-inducing drugs, GHB is non-addictive, non-habit forming, has no toxic metabolites (in fact, it breaks down in the body into harmless, energy-producing Krebs cycle intermediates), and does not cause respiratory suppression (it actually protects the heart and brain from low blood levels of oxygen). GHB is so non-toxic that one person who "accidentally" took 15 tablespoons woke up 24 hours later, feeling sedated with a headache, had no other negative effects, and recovered completely within hours upon awakening.

With such a wide variety of beneficial effects, and such a wide margin of safety, one would think that GHB would be touted as a wonder substance of the ages! Which many GHB-users of all ages believe it to be. However, GHB is not viewed in this light by the FDA or DEA. Instead, these agencies, and the gullible major-media, have demonized GHB by falsely and maliciously:
(1) labeling it "the date-rape drug" (intentionally confusing GHB in the minds of the public with Rohypnol);
(2) nicknaming it "Grievous Bodily Harm";
(3) referring to it as an illegal designer drug with 100% abuse potential; and
(4) attributing a number of deaths to GHB use.
None of the above claims are true. Furthermore, I have extensively investigated these alleged GHB-induced deaths and found that not one could be attributed to any toxic effect of GHB.

A number of people, many of whom were honest, tax-paying owners of health food stores, have been prosecuted and even sent to prison for selling GHB! In a recent federal court case in Boston where I testified as an Expert Witness on the clinical uses and safety of GHB, I was astonished to find that the FDA had never followed their own formal procedure for determining that GHB was a dangerous drug.

In addition, I learned that when a substance is thought to be hazardous to the public welfare, and there is little time to follow formal procedures, FDA agents are authorized to seize the substance immediately. However, instead of seizing GHB upon discovery of its being sold, the FDA in most cases chose to play "Junior G -Man". For example, the agency had their undercover agents repeatedly place large orders for GHB until they amassed enough of the product to prosecute the business -owner for a felony with the guarantee of major prison time. At the same time, the agents allowed sales of the "dangerous substance" to continue to countless non-police customers. This is hardly a procedure that should be followed if GHB were truly the toxic substance the FDA and DEA would have us believe.

Another remedy available to the FDA, in lieu of the two above (formal procedure or seizure) would be to obtain an injunction against the seller pending administrative resolution of the status of the substance. None of these three procedures were ever followed in any of the cases.

Fortunately, the FDA's outlaw behavior has been exposed in court. As a result, many of the people who had been unjustly prosecuted and imprisoned are now having their convictions appealed and reversed. Judicial recognition of prosecutorial misconduct by U.S. Attorneys and the deliberate withholding of exculpatory evidence by the government has completely undermined the FDA's anti-GHB courtroom strategy. Consequently, the agency has been forced to adopt a new strategy.

Using the same misinformation and disinformation about GHB, the new "end run" tactic of the FDA is to promote the enactment of legislation in several states to criminalize GHB at the state level. While this is Constitutionally a more appropriate level to regulate something (if regulation were necessary), the state legislatures frequently just rubber-stamp the illegal directives of federal regulatory agencies without performing their own independent analyses of the merits of proposed legislation.

At the present time, the DEA/FDA are promoting bills to "Schedule" GHB as a Class I Narcotic by state legislatures. A Class I Narcotic is a substance that has been determined to have no medicinal value with a high potential for addiction and abuse. Such bills are in various stages of enactment in four states: California, Texas, Massachusetts, and Hawaii. Florida, Georgia and Rhode Island have already succeeded in criminalizing GHB.

Such criminalization of a food supplement will be an extremely dangerous precedent. Without the DSHEA, the FDA would probably not have allowed the sale of melatonin, DHEA, pregnenolone, and a number of other substances. If the FDA succeeds in criminalizing GHB at the state level, using false information, they will be able to criminalize any food supplement despite federal law prohibiting such activity. Who knows what supplement will be next?

Call to Action

There is still time to stop these bills and revoke the bills that have been passed. We urge you to contact your state (not U.S.) representative or senator immediately, and politely but strongly urge them to vote against any criminalization of GHB and revoke the bills that have been passed. If you don't know the name of your state legislators, call the Secretary of State or Capitol Switchboard in your state to find out your legislators' names and phone numbers and in many cases, their FAX numbers, and E-Mail addresses. If you are in a state that has not yet been identified as having proposed GHB legislation, please check with your state legislators to determine if GHB bills are pending, and let us know.

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