GHB Letter

7 February 2000

Representative Anna Eshoo
c/o Stacey G. Rampey
205 Cannon Building
Washington, DC 20515 USA

Re: The Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999.

Dear Rep. Eshoo and Ms. Rampey,

I am writing to you today to express grave concerns for the consequences of HR 2130 (EAS version). I have a series of questions that detail my concerns.

Before I start the questions, I'd like to establish my expertise. I am the Executive Director of CERI, which operates as a think tank and information clearinghouse for nutritional, herbal and pharmaceutical treatments for cognitive conditions of all types. We have been reporting on the nutritional and medical applications of gamma-hydroxybutyrate (GHB) for years. We publish a newsletter, Smart Life News, which is distributed to subscribers in 40 countries and all 50 states. Our website (www.ceri.com) contains considerable information about GHB. I am an organic chemist by degree and have been qualified as a court expert on the chemistry of GHB. I have supervised a forensic analysis of Texas beef which establishes that it contains GHB. I have scientific papers which document GHB-related chemical content of numerous foods.

Question 1: Does HR 2130, or any other provision of the Controlled Substances Act, provide any exemption for foods? I have been unable to find any such exemption myself. Since GHB is ubiquitous in foods, the new “emergency” Schedule-I status of GHB criminalizes, at minimum, a large portion of the human food supply, and possibly all foods. It is my understanding that any amount of a Schedule-I substance would make a food a Schedule-I substance. Vendors selling beef, which contains appreciable GHB, will now be “possessing with intent to sell” a Schedule-I product. Technically, the McDonalds Corporation could now be considered a felony drug conspiracy to distribute and sell Schedule-I Big Macs to the public. While I do realize that such a law would never be enforced in such a manner — for obvious political reasons — I do know that heroin-containing beef or marijuana-basted chicken would never be condoned in commerce.

As a citizen, I must strenuously object to any law which criminalizes food. Such a law is illegal, unconstitutional, and a violation of common law, upon which our Constitution stands. I also believe that selective enforcement of such a law would be equally unconstitutional. I trust that I do not have to remind you that the Fourteenth Amendment is supposed to prohibit unequal enforcement of the law. As far as I am concerned, the ability to recognize the Constitutional appropriateness of a law is a defining attribute of a statesman. (No gender bias implied or intended.)

Question 2: Does HR 2130 criminalize the use of GHB by patients not in FDA-supervised trials but with valid prescriptions written by state-licensed physicians in good standing? It appears to me that it does. If so, by what authority does Congress usurp the Constitutionally recognized authority of the many states to regulate the practices of medicine and pharmacy? If GHB were not suitable for medical use, Congressional powers to regulate safety would apply. But GHB is entirely suited for both medical and food uses, so any attempt to lawfully regulate it must not place undue burden on medical and food uses. Such approaches certainly exist, but they don't appear to have been considered by Congress. Why?

One reason is that you have been deceived. The FDA has taken extralegal action to lie to the public, press, coroners, medical personnel and law-enforcement agencies about GHB so that they could control GHB as a drug, when the Dietary Supplement Health & Education Act specifically forbids the FDA such direct power. To put it baldly, they have incited a riot. As a citizen, I am concerned that no checks and balances exist for this kind of FDA abuse. The courts only have review of the few individual cases that come before it. (For your information, the FDA is frequently unable to defend their interpretation of statutory and regulatory law in court. But that is another subject.) The administration will not intervene with the FDA. They are actively seeking the police powers that are resulting from the FDA's campaign. They are behaving like crazed addicts looking for their next law-enforcement “fix.” You've given it to them with HR 2130. On many prior occasions, Congress has had to deal with the FDA's dirty laundry, but genuine reform is never undertaken. It's past time to acknowledge that the FDA will never fix itself.

Throughout the 60s, public reaction to arbitrary FDA actions against natural foods, vitamins and dietary supplements rose to a crescendo with the passage of the 1974 Proxmire Amendments. The FDA went around them. During the 80s, the public reaction to further FDA abuses against dietary supplements (regulating them as “drugs” and “food additives”) rose to such a level that, by the early 90s, more mail to Congress dealt with that single issue than all other issues combined! (This was even true during the Gulf War.) This culminated with the passage of the Dietary Supplement Health & Education Act in 1994. The DSHEA defined dietary supplements as foods within the Food Drug & Cosmetics Act. The DSHEA (and FDC Act) specified that vitamins, minerals, amino acids, herbs and other dietary substances — including concentrates, extracts and metabolites of the above — are to be a new category of food. Since GHB is 1) a carbohydrate dietary substance, 2) a metabolite of the amino acids gamma-aminobutyric acid and glutamic acid, and 3) an herbal extract and/or concentrate, the FDA should be referring to GHB as a food, dietary supplement, dietary substance, or anything but a drug. Yet the FDA insists on calling GHB a drug. This is illegal! The FDA is supposed to follow Congressional law, not subvert it. Does Congress care? Do you care?

Question 3: Was the Senate appraised of the details of agreements between Orphan Medical, Inc. and the FDA regarding 1) the impending approval of GHB as a drug, and 2) the “removal” of GHB as a dietary supplement? Prior to 1994, the FDA gave Orphan Medical various “assurances” about approving GHB as a drug under the Orphan Drug Act. After admitting this fact, Orphan Medical has refused to discuss the issue with the press or public. Do you think that any such “agreement” should have been disclosed during the legislative process?

Question 4: Do you believe that it is reasonable and appropriate for Congress to “determine” that GHB is unsafe “for any medical use” in Schedule I when HR 2130 contains a specific provision that simultaneously establishes Schedule-III status to FDA-approved brands of GHB?

Question 5: Do you believe it appropriate for Congress to prevent pre-existing nutritional and medical uses of GHB when:

• 1) Forty (40!) years of world-wide scientific research has established that GHB is “one of the safest therapeutic substances known to man” for a wide variety if important medical uses.
• 2) All 15 of the FDA's Investigational New Drug (IND) reports for GHB covering a wide variety of medical applications state explicitly that GHB's safety is unusually high or even “remarkable.”
• 3) The safety index (the toxic-to-therapeutic dose ratio) of GHB is 100:1, which is ten times (!) safer than Tylenol (10:1) or alcohol (10:1), and which exceeds that of almost all other drugs and many nutrients by far.
• 4) In some third-world nations, GHB has been found to be the safest pediatric anesthetic — and the most affordable.
• 5) GHB is used in Italy and France to facilitate childbirth because it a) enhances cervical dilation, b) reduces pain and anxiety in the mother without toxicity to the baby, and c) protects the baby's brain from hypoxia (oxygen deprivation) caused by various complications of birth.
• 6) GHB is the only drug-withdrawal aid that is safe enough to be used in pregnant addicts (alcohol and narcotics) because it has no general or specific toxicity to the fetus.
• 7) GHB has been in use by “alternative” medical doctors since the late 80s for a variety of medical uses, until recently, when the FDA, frustrated by Congressional restrictions on their arbitrary power over dietary supplements, started an extralegal campaign of misinformation and falsehood to convince the media, coroners, police, public, state legislators and Congress that GHB was a killer, designer, date-rape drug with no medical uses and no redeeming social value.

A tired-but-still-reliable joke in health-food stores: How do you know when the FDA is lying? Answer: When their lips are moving. This is common sentiment, not fringe lunacy!

My concerns that HR 2130 directly criminalizes “alpha hydroxy” and “beta hydroxy” skin-care products (as “isomers” of GHB) turns out to be unfounded. I was able to find an obscure section in the Controlled Substances Act (CSA) that defines isomers as “optical isomers only,” except in two specified sections that appear to have nothing to do with GHB's scheduling. However, despite this section, the analog-drug section of the CSA establishes that chemical “analogues” (structurally similar molecules) of controlled substances are equally controlled. Since alpha-hydroxybutyrate and beta-hydroxybutyrate are proper analogs of GHB, they are indirectly criminalized by HR 2130. Since GHB is Schedule I, analogs of GHB are Schedule I. These analogs also include:

• 1) 1,4-Butanediol, a component of animal skin lipids and a constituent of corn and yeast. 1,4-BD is a common monomer for polyester, polyether and polycarbonate plastics used in a plethora of consumer products. Some unreacted 1,4-BD remains in those plastics. Would heroin-containing plastic be permitted in retail commerce? Not likely, I think.
• 2) GABA, gamma-aminobutyrate, a food component and dietary supplement sold in almost every health food store and in a significant number of food supermarkets and drug stores. GABA is also a monomer for nylon polymers. Felony rope?
• 3) Gamma-Butyrolactone (GBL), a solvent chemical used extensively in industry, a major ingredient in some acetone-free nail-polish removers sold in drug stores and beauty shops, a common component of automotive-parts cleaners, floor wax strippers and paint and varnish removers, and a naturally occurring trace chemical of the human body. Although HR 2130 specifically lists GBL as a “List-I chemical,” it appears not to have been exempted from the analog-drug statute.
• 4) Polyester fiber, resins and plastics are made from GHB and/or 1,4-butanediol. These are used in harder-than-steel automotive parts, polyester and polyester-blend clothing, polycarbonate water bottles and solar greenhouse panels, and hundreds of other consumer products too numerous to mention. Some unreacted GHB and 1,4-butanediol remains in these polymers.
• 5) Butyric acid, a short-chain fatty acid found in milk fat, butter fat and lard, which is released in the colon by the natural bacterial fermentation of dietary fiber.

Although it is not directly relevant to the questions before us, I should point out that there are no optical isomers of GHB. None. It is interesting that HR 2130 specifically addresses something that does not exist.

All in all, I must say that HR 2130 appears to be singularly dysfunctional piece of legislation. What I'd like to know is: Would you like to fix it? One helpful idea would be to allow proponents of GHB, critics of the bills, and critics of the FDA's lies to testify before Congress, instead of refusing them standing, as was the case last year during committee hearings. Second, you could actively investigate the FDA's conduct in crafting the lies that prompted this legislative travesty.

For example, despite what you have been told by the FDA and your colleague Rep. Richardson, Hillory Farias was not date-raped, she was not drugged with GHB, and GHB played no role in her death. This is forensic fact, provable in court — and in Congress, too, if somebody will listen.

Question 6: Was the impact of HR 2130 on small businesses considered during the course of this legislation? I use gamma-butyrolactone (GBL) in my business to clean ink-jet cartridges when I refill them (saving money and reducing environmental waste). I use GBL because I know that indoor air pollution from GBL is completely non-toxic, unlike acetone, methanol, ethyl acetate or methyl-ethyl ketone. GBL is one of the EPA's “solvent migration pathways” to eliminate toxic and environmentally hazardous solvents (like chlorinated hydrocarbons) and replace them with “green” solvents. Did the EPA judge HR 2130? Was the environmental impact of List-I status for GBL ever considered?

Question 7: In any case, as a small business owner using GBL, I'd like to know, by what procedure do I come into compliance with HR 2130? I have asked an almost identical question of my local police, my state Senator and Assemblyman, the Assembly Committee on Public Safety, and the Chemicals Regulation Unit of the California Department of Justice, starting about one month before a new law went into effect in California (January 1st) which 1) makes GHB isomers, esters, ethers and precursors (and indirectly analogs) Schedule II substances, and 2) GBL a List-II chemical. To date, nobody has been able to answer my question. Now that GBL is Federally controlled, I ask you, too.

It might interest you to know that GBL-containing products spontaneously produce GHB when they come into contact with water. This is the same reaction that takes place when citizens “home brew” GHB. So, should otherwise law-abiding citizens who are cleaning their car's engine or stripping wax off their floors be arrested, jailed, prosecuted and imprisoned for manufacturing a scheduled substance in an unlicensed facility? Should the clerks and businesspersons who sold it to them serve 30-years-to-life sentences? I think not.

Question 8: Which of the following substances are, or are not, analogs of GHB:

• a) GBL,
• b) gamma-hydroxybutyraldehyde,
• c) 1,4-butanediol (gamma-hydroxybutanol),
• d) succinic semialdehyde,
• e) succinic acid,
• f) GABA (gamma-aminobutyrate),
• g) butyrate (butyric acid),
• h) beta-hydroxybutyrate, and/or
• i) alpha-hydroxybutyrate?

On page 6 you will find a molecular diagram, prepared for the California authorities and Nebraska state courts, which shows precursor, isomer and analog relationships to GHB. The green broken arrows indicate analog relationships. Any second-year college student could have prepared this diagram from a few biochemistry texts and chemical dictionaries. It is basic chemistry, not rocket science. I am incredulous that no chemical expert was consulted by California legislators prior to passing their laws against GHB. It looks like Congress didn't consult a chemical expert either. As a voter, I think this looks like legislative negligence.

I will take this opportunity to apologize for the strenuousness of this letter, which might provoke offense to you, especially if you were unaware of any of these consequences. I plead outrage. I am deeply offended by the injustice embedded in this bill. Despite intentions one way or the other, HR 2130 is likely to ruin innocent people's lives. These are people I work for and care about. Their homes can be seized, their assets forfeited without due process, they can be put in jail, subjected to hundreds of thousands of dollars bail, and their reputations can be ruined by simple allegations of drug use, drug trafficking or date rape brought by ambitious law enforcement agents or zealous prosecutors. I am talking about citizens who otherwise would have no dishonest or harmful intent against anybody, rather an honest interest in overcoming disabilities and bettering their health. I can assure you that many citizens will risk some of the most severe penalties that are possible under the law, rather than give up the therapeutic benefits of GHB that they have received. That's how important GHB is to them. If you won't allow them to testify, read between the lines of Orphan Medical's recent press release about the results of their clinical studies of Xyrem (sodium oxybate, aka sodium GHB).

Who will be morally responsible for such people spending time in jail?

One last item. I specifically request that copies of this letter not be sent to the FDA. I have no wish to be subjected to FDA retaliation or harassment as a result of exercising my Constitutionally protected rights to speak freely and petition the government for redress of grievance. Until the FDA officially gets out of the book-burning and censorship businesses, I must insist.

I thank you for your attention to these matters.

Sincerely,

Steven Wm. Fowkes
Executive Director

cc: Senator Barbara Boxer
Senator Dianne Feinstein
Ward Dean, M.D.
John Morgenthaler
Steven Brill
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