GHB Letter

6 March 2000

Janet Reno
Attorney General of the United States
950 Pennsylvania Avenue N.W.
Washington, DC 20530 USA

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

Dear Ms. Reno,

I am writing to you today to express grave concerns for the consequences of HR 2130, which directs you to act to schedule gamma-hydroxybutyrate (GHB) as a Schedule-I substance under the emergency-scheduling provision of the Controlled Substances Act (21 USC § 811(h)(1)). I have a series of comments to make that relate to the appropriateness and legality of such an act. At the end, I have a few questions that require official decisions by you, in consultation with the head of the Drug Enforcement Administration. Please forward a copy of this letter at your discretion.

Before I relate my concerns, I’d like to establish my background and 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 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 expert court witness on the chemistry of GHB.

Item 1: Please refer to the enclosed photocopy of a forensic analysis of Texas beef which clearly shows that beef contains appreciable GHB. This analysis was conducted by the Chemical Toxicology Institute of Foster City, which does GHB analytical work for law-enforcement agencies. The director of the laboratory, Randall C. Baselt, Ph.D., is published in the field of GHB analytical techniques. This analysis confirms what scientific papers from around the world state: that GHB is an essential metabolite of animal metabolism and is therefore found in all animal-flesh foods (and some vegetable foods, as well).

Item 2: As you well know, the prohibition of Schedule-I substances is absolute. Any detectable amount renders the product in which it is contained a Schedule-I substance. If you place GHB in Schedule I on an emergency basis, you will be criminalizing the sale and possession of meat, and possibly the business of animal husbandry. I suggest that the scheduling of GHB, and the resulting prohibition of the meat industry, would be improper conduct on your part. Such action may even be overtly illegal.

Item 3: I also point out that 21 USC § 811(h)(1) provides three standards for scheduling something on an emergency basis: 1) that it be an “imminent hazard” to public safety, 2) that “the substance is not listed in any other schedule in 21 USC § 812,”" and 3) that “no exemption or approval is in effect for the substance under 21 USC § 355.” The first condition is met by a Congressional “finding” in HR 2130. However, the second condition may have been violated by HR 2130’s specific language placing GHB in Schedule III (Section 4). The third condition also appears to be violated by GHB’s exemption as an Investigational New Drug with the FDA (Xyrem-brand GHB, also known as sodium oxybate, manufactured by Orphan Medical, Inc.). If these facts are valid, it would appear that you are statutorily prohibited from scheduling GHB on an emergency basis.

Item 4: Even if you decide not to schedule GHB on an emergency basis, GHB will be so scheduled by HR 2130. You will be left with the decision about how to enforce the Controlled Substances Act with GHB in Schedule I. Given GHB’s readily detectable presence in beef, will you then shut down the US beef industry? If not, will you decide to enforce the law selectively, in violation of the Fourteenth Amendment to the U.S. Constitution? Or will you decide to not enforce the law at all?

I suggest that non-enforcement is your only Constitutionally viable option. Shutting down the beef industry is certainly consistent with your duty. However, this was not Congress’ intent, and GHB will ultimately be found in all meats, when and if anybody bothers to test for it. Elimination of all meat foods would be blatantly illegal on Constitutional, common-law and international grounds.

There is an even more comprehensive problem. GHB analogs (structurally similar molecules, also spelled “analogues” in legal contexts) are ubiquitous in meats, grains and vegetables. These analogs of GHB are Schedule-I substances under the provisions of the analog-drug statute. These Schedule-I, food-based, GHB analogs include:

1) alpha-hydroxybutyrate, a “fruit acid” found in apples and apple juice, and used in “alpha hydroxy” anti-wrinkle skin-care products;

2) beta-hydroxybutyrate, a primary “ketone” fuel for the human body, high amounts of which are excreted in urine during carbohydrate restriction and fasting conditions, also used in cosmetics;

3) succinic semialdehyde, a carbohydrate metabolic intermediate, used to make the amino acid GABA;

4) gamma-aminobutyrate (GABA), an amino acid and brain neurotransmitter which is widely sold in food and drug stores as a dietary supplement, and which is a monomer for Nylon fibers and plastics;

5) gamma-hydroxybutyraldehyde, a carbohydrate intermediate and immediate precursor for GHB;

6) gamma-hydroxybutanol, also known as 1,4-butanediol, butylene glycol and tetramethylene glycol, a constituent of corn, yeast and animal skin lipids, with widespread industrial uses in the manufacture of polyester fibers (cloth), polycarbonate plastics (water bottles), polyvinylpyrrolidones (PVP-iodine), polyurethane elastomers (Spandex), blood plasma extenders and printing inks;

7) succinic acid (succinate), a dietary supplement and structural component of polycarbonate and polyester plastics;

8) butyrate, or butyric acid, a short-chain fatty acid found in milk, butter, and tropical oils, which is released by the fermentation/digestion of dietary fiber;

9) homoserine, an amino acid and intermediate in methionine metabolism; and

10) gamma-butyrolactone, the anhydride of GHB, a trace chemical of the human body, and one of the most important “green” industrial solvents in commercial use today.

It is my considered opinion that there are no whole foods which do not contain detectable levels of several of these GHB-analog substances. To enforce the Controlled Substances Act (CSA) against all of these (technically) Schedule-I substances would, therefore, necessarily starve the American public to death. I suggest that this would qualify as a blatant “crime against humanity,” in addition to its gross violation of every other legal basis of law.

Selective enforcement of the law would be unconstitutional under the Fourteenth Amendment and a presumed violation of your oath of office.

Item 5: There is a further difficulty in which you are placed by HR 2130. Congresses actions are supposed to be Constitutionally “checked” and “balanced” by judicial review, yet 21 USC § 811(h)(6) states that your “order issued under paragraph (1) is not subject to judicial review.” So Congress has ordered you to do something illegal by a means that is specifically intended to prevent judicial review. I suggest that this heightens your responsibilities towards the U.S. Constitution.

Item 6: There is an additional risk that you face by following Congress’ ill-conceived notions regarding GHB, namely that it creates another precedent for the conflict between states’ rights to regulate the practice of medicine and pharmacy and the Federal governments’ claimed right to be able to override that on an arbitrary assessment of public safety risk. I am speaking about marijuana, of course. States are challenging the Federal Schedule-I classification for marijuana, citing that marijuana has definite medical uses and that, therefore, states have the jurisdiction to regulate its use. In point of fact, they are correct. Marijuana has medical uses. It is quite safe when not smoked. Its position in Schedule-I is patently unreasonable from both rational and scientific perspectives. Regardless of marijuana’s merits, GHB’s medical uses are extensively documented. First, hundreds of scientific and medical papers published over forty years cover dozens of therapeutic uses of GHB. Second, the FDA has 15 IND reports of medical uses of GHB on file. And third, GHB has been prescribed in the many states by nutritionally oriented physicians for ten years. The Federal authority to override these state-regulated prescriptions, and thereby directly interfere in the practices of medicine and pharmacy, must be based on commerce powers and/or public-welfare powers, the latter of which may possibly be defensible in the case of GHB. However, federal authority for interfering in the use of safe and nutritious foods is non-existent.

So, after all this is said, what is to be done? Is GHB going to be Schedule I? If so, will the Controlled Substances Act be enforced against GHB? Will it be enforced against beef (see enclosed forensic analysis)? Will it be enforced against any or all of the above ten GHB analogs? These questions must be answered before any citizen can be expected to be able to comply with the law.

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 free speech and to petition the government for redress of grievance.

I thank you for your attention to these matters.

Sincerely,

Steven Wm. Fowkes
Executive Director

cc: Barbara Boxer, US Senate
Steven Brill, Brill’s Content
William Dailey, Attorney at Law
Ward Dean, M.D., Center for Bio-Gerontology
Pat Dwyer, Palo Alto Police Chief
Gretchen Embry, Institute for Justice
Anna Eshoo, US House of Representatives
Dianne Feinstein, US Senate
Don Horsley, San Mateo County Sheriff
John Morgenthaler, Smart Publications
Dominic Peloso, Menlo Park Police
Playboy Forum, Playboy Magazine
Laurie Smith, Santa Clara County Sherrif