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From the February 23rd, 2000 issue of Smart Life News [v7n7]. Copyright (c) 2000. All rights reserved.
Smart Life Update:
The latest news on GHB is that Congress has just passed House Resolution 2130 (the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999). HR 2130 directs the Attorney General to use an emergency provision of the Controlled Substances Act [21 USC § 811(h)] to place GHB (gamma-hydroxybutyrate, gamma-hydroxybutyric acid) in Schedule I, the category reserved for substances of the highest possible abuse potential. The Schedule-I category is supposed to be reserved for substances with no recognized medical uses, like marijuana (?) and heroin. But despite GHBs extensive medical and food uses, Congress has ordered that GHB be placed in Schedule I. As a consequence, all GHB-containing foods are about to become temporarily illegal in the United States for a 12-month period.
The Schedule-I prohibition is absolute, meaning that any detectable amount is sufficient to make a substance, product or food illegal to sell, buy or possess. The GHB content of meat is easily measured. A forensic analysis of Texas beef, commissioned by me and conducted by the Chemical Toxicology Institute of Foster City, California in February of 1999, showed 3.6 mg/kg of GHB (1.6 mg per pound of beef). That analysis is now posted on our website (www.ceri.com).
While this GHB content of meat may be a surprise to some lawmakers, is well known by scientists. It is impossible to do a literature review of GHB without finding numerous scientific papers about GHBs role in animal brain function and tissue metabolism. There are papers citing the presence of GHB in yeast and corn, and GHB may turn out to be as ubiquitous in plants as it is in animals. Some enterprising scientists have even reported grafting GHB genes into cotton plants, making the worlds first natural polyester-blend cotton fiber. The cotton contained only 0.4% GHB polymer, a far cry from the 25-50% polyester-cotton blends common in commerce. However, the researchers were hopeful that they could increase this yield with further experimentation.
Man-made polyester fibers and plastics can also be made from GHB. More importantly to HR 2130, a wide range of chemical analogs of GHB are frequently used in commercial polymer plastics (see The Commercial Chemistry of GHB article in this issue).
When GHB becomes Schedule I, analogs of GHB will become equally controlled under the analog-drug provisions of the Controlled Substances Act. The term analog (also spelled analogue) refers to nearly identical molecules. There are two legal contexts that define analogs, either of which is sufficient to establish illegality. The first is simple chemical structural similarity to the Schedule-I or Schedule-II substance. The second is a pharmacological similarity to the Schedule-I or Schedule-II substance. Such analogs shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I [21 USC § 813]. In other words, the full measure of legal penalties apply.
So what constitutes a structurally similar molecule? There is no statutory definition beyond the chemical one. So the strictest answer would be molecules that differ by only one chemical feature. Some chemists might argue that, under certain conditions, an analog might easily have two or three differences. However, a minimalist standard of only one chemical change would be a consensus position for defining analogs.
What kinds of molecules are we talking about? Follow along with these descriptions in Figure 1 (above). If GHBs alcohol group is changed to an acid group, we have succinic acid, a human metabolite and common food constituent (with widespread industrial and commercial uses). If the acid group is changed to an alcohol, we have 1,4-butanediol, a constituent of corn, yeast and animal skin lipids (also with extensive industrial and commercial uses). If we change the alcohol or acid to an aldehyde, we get gamma-hydroxybutyraldehyde and succinic semialdehyde, both of which are human metabolites and food-based chemicals. If we change the alcohol to an amine, we get GABA (gamma-aminobutyrate), an amino acid, human metabolite, and constituent of food (and a monomer for Nylon plastics). If we remove the alcohol group, we get butyrate, a short-chain fatty acid found in butter, whole milk, lard, coconut oil and other tropical oils. If we reduce the acid, we get n-butanol, a short-chain fatty alcohol (and industrial chemical). If we move the alcohol (hydroxy) from the gamma carbon to the alpha carbon, we get alpha-hydroxybutyrate, popularly called alpha hydroxy, an ingredient in premium anti-wrinkle skin-care products and a natural fruit acid in apples and apple juice. If we move the alcohol from the gamma carbon to the beta carbon, we get beta-hydroxybutyrate (i.e., beta hydroxy) also an ingredient in skin-care products, foods, and a primary natural by-product of fasting human metabolism (and which is found in urine). If we add an amine on the alpha carbon, we get homoserine, an amino acid and intermediate in methionine metabolism. If we dehydrate GHB, we get gamma-butyrolactone (GBL), an industrial solvent and trace chemical of the human body. All in all, GHB analogs are a pretty impressive bunch of chemicals.
In addition to whatever status it may have as a GHB analog, HR 2130 names GBL as a List-I chemical, which requires the greatest documentation for purchases. I do not yet know the full legal impact of List-I status on possession of GBL purchased before the law went into effect. I have made inquiries and will discuss this matter in a later issue.
There are hundreds of other chemicals which are analogs of GHB. I do not want to take the time to discuss them here because they are primarily used for scientific and industrial processes, and not for nutritive or therapeutic purposes. There are a dozen chemical elements which can be substituted for any of the 15 atoms that comprise the GHB chemical structure, each of which would become a different analog of GHB.
All of the previous analogs of GHB, and GHB itself, meet the statutory definition of dietary supplement contained within the Federal Food, Drug and Cosmetics Act. The FDC Act defines dietary supplements as a category of food, which may contain vitamins, minerals, amino acids, herbs or other nutritional substancesincluding metabolites, extracts and concentrates of the above.
Dietary supplements may also be considered drugs, if they are so approved by the FDA. However, the FDC Act makes it quite clear that the FDA may not revoke the food status of a dietary supplement when they approve it as a drug. The only legitimate basis for removing a dietary supplement is that it presents a threat to public health. Because of the FDAs historic untrustworthiness towards dietary supplements, the FDC Act now requires the FDA to hold open hearings on any such removals, the proceedings of which must be published in the Federal Register. The FDA has yet to do this, despite their many regulatory actions against GHB, GBL and 1,4-butanediol-containing dietary supplement products.
Every one of these GHB-analogs, to a greater or lesser degree, is commonly found in foods. It is hard to imagine that there could be a whole food which might not have detectable levels of one or more of these GHB-related substances. Certainly, water, air, table salt and refined sugar would be likely to survive the enforcement of HR 2130. But people and animals above the level of bacteria cannot survive on such limited fare. I predict that all meats, vegetables and grains will be found to contain detectable levels of either GHB or some GHB analog(s).
Fortunately, the scheduling of GHB is only temporary. We only have to stop eating these felony foods for 12 months.
There are a few other things we have to avoid. 21 USC § 861(a) states that it is unlawful for an adult to knowingly or intentionally employ, hire, use, persuade, induce, entice or coerce, a person under 18 years of age to violate any provision of this title. So business owners should therefore avoid hiring teens. And parents should not tell their children to clean their plate or they wont get dessert. Thats enticement or coercion to eat Schedule-I food, depending on your point of view.
The same section makes it illegal to receive a controlled substance from a person under 18 years of age, other than an immediate family member. Just avoid buying burgers from fast-food restaurants that give teens job experience, unless you are going to be served by your own daughter or son who works there. If you are not sure how old they are, card your server.
The people who violate these provisions are subject to twice the maximum punishment otherwise authorized and at least twice any term of supervised release otherwise authorized for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year.
Parents should also note that if they knowingly provide or distribute a controlled substance or analogue to any person under 18 years of age, they shall be subject to a term of imprisonment for not more than five years or a fine of not more than $50,000, or both, in addition to any other punishment authorized by this section. This same penalty applies if you employ, hire or use a person 14 years of age or younger to knowingly provide or distribute a controlled substance or analog.
Subsection (e) states that the above penalties shall not be suspended and probation shall not be granted. Any Schedule-I, Schedule-II or analog conviction requires a mandatory minimum term of imprisonment for which early parole is disallowed.
Husbands of pregnant women beware! Subsection (f) makes it a specific crime for any person to knowingly or intentionally provide or distribute a controlled substance or analog to a pregnant individual. Men, make your pregnant wife feed herself! And yes, pickles and ice cream both contain GHB and/or GHB analogs. Maybe its a blessing in disguise. No more midnight runs to the all-night food store!
21 USC § 843(b) makes it unlawful for any person to knowingly or intentionally use any communication facility to commit a drug-related felony act, or to cause or facilitate the commission of any scheduled-substance felony crime. Each such act is a separate offense under this subsection. All public and private instrumentalities used or useful in the transmission of writing, signs, signals, pictures, or sounds of all kinds are communication facilities, including mail, telephone, wire, radio, and all other means of communication.
The advertising of GHB-containing foods is separately illegal. 21 USC § 843(c) makes it unlawful for any person to knowingly place an advertisement in any newspaper, magazine, handbill or other publication, that seeks or offers to receive, buy or distribute a Schedule I controlled substance. No more McDonalds commercials on television. No more pizza coupons in the mail. No more Jenny Craig weight-loss radio spots. No more supermarket flyers in newspapers.
In respect of constitutional rights to free speech, subsection (c) does exempt material which merely advocates the use of a similar material, which advocates a position or practice, and does not attempt to propose or facilitate an actual transaction in a Schedule I controlled substance. So its OK to talk about eating meat, but not OK to talk about selling or buying it.
The penalties for violating these subsections are a term of imprisonment of not more than 4 years, a fine of not more than $30,000, or both. Do it twice, double the penalty.
Unfortunately for US citizens, Congress has determined that the emergency scheduling of GHB is not subject to judicial review [21 USC § 811(h)(6)]. This means that Congress is not checked or balanced by the courts on this issue. If this provision stands, HR 2130 can only be undone by Congress repealing it.
Legal action to block the Attorney General from scheduling GHB is also fundamentally futile. HR 2130 paragraph (a)(2) states that if the final order is not issued within 60 days, GHB will become Schedule-I as if the Attorney General had issued a final order. Congress has anticipated and eliminated every possible legal contingency.
So it looks to be like citizens have two simple choices: 1) write to your Senator and/ or Congressperson, or 2) lay low, keep a low profile, and cross your fingers. Theres not much else you can do.
This emergency scheduling of GHB is complicated by a separate provision of HR 2130 which independently establishes Schedule-III status for GHB that may be contained in FDA-approved brands of GHB. This means that GHB will be unique in having dual status as a Schedule-I and Schedule-III substance. Exactly how a substance can be Schedule I (no medical uses) and Schedule III (definite medical uses) at the same time will probably remain a legislative mystery.
The provision of the Controlled Substances Act which authorizes the Attorney General to temporarily place a substance in the Schedule-I category specifies that 1) it must be an imminent hazard to public safety, 2) it must not be listed in any other schedule, and 3) it must not be approved as a new drug (or exempted as an investigational drug) by the FDA. Although GHB is not an imminent hazard to public safety, HR 2130 finds that GHB is an imminent hazard, so no hearings or consultations with experts are required. However, HR 2130 does contain a provision for Schedule-III status for GHB (Section 4), so GHB could be considered to be listed in another schedule. Furthermore, GHB is in the final stages of being investigated as a new drug, so an IND exemption must exist for it to be legally studied in FDA-approved trials. So it is not clear to me that the Attorney General actually has the authority to execute the Congressional order in HR 2130. However, as far as scheduling is concerned, it really doesnt matter. If the Attorney General doesnt have the authority, Congress has provided a back-up clause that schedules it without the Attorney Generals participation.
One of the consequences of HR 2130 is that pre-existing prescription use of GHB will have to cease or become illegal. Narcoleptic patients using GHB to overcome their disabilities, but not within FDA-approved studies, will now be in violation of Federal law.
The situation with GHB will be somewhat analogous to what is happening in several states with medical marijuana. Several Western states have passed laws that allow for marijuana to be used medically, and Federal law prohibits any such medical use. The jurisdictional conflict between Federal safety and public health powers and states rights to regulate medicine and pharmacy is the same in both cases. While there is reasonable evidence that marijuana has legitimate medical uses, there is overwhelming evidence that GHB has multiple legitimate medical uses. Narcoleptic patients distressed by the prospect of resuming their full disability might want to join legal forces with marijuana proponents in a mutual effort to put limits on Federal powers to arbitrarily decide what is medically legitimate and what is not. The fact that foods are now being criminalized by the Federal Controlled Substances Act may make the Federal case against marijuana that much more difficult to defend before reviewing justices.
One of the requirements of law is that it must be focussed on what it is intended to accomplish (i.e., that it not be overly broad). This is obviously violated by HR 2130. Whether or not the Federal government does or does not have the direct or indirect authority to regulate the medical legitimacy issue, they certainly do not have any authority to directly criminalize healthy foods or to indirectly starve the American public to death.
The Ninth Amendment states, the enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people. The Tenth Amendment states, the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.
The Constitution specifically grants the Federal government the power to provide for the general Welfare and to regulate Commerce among the several states. These powers are the basis of both the Food Drug and Cosmetics Act and the Controlled Substances Act. However, the power to regulate the practices of medicine and pharmacy are considered powers that are reserved to the states, and the many unenumerated rights to life, liberty and the pursuit of happiness are reserved to the people.
So does the Federal government have the legitimate power to place GHB in Schedule I, with all its extensive ramifications? If the only consequence were an increase in public safety, then the answer would probably be yes. But that is far from reality. The elimination of medical uses of GHB will severely injure patients who would otherwise enjoy the clinical benefits of GHB. According to Orphan Medical (the company conducting FDA-sanctioned studies of GHB), narcoleptic patients receive an approximate 70% reduction in their disability from GHB. The corollary of this statistic is that narcoleptic patients deprived of GHB by HR 2130 would experience a three-fold increase in their disability. Such a result can hardly be described as providing for the general welfare. And it can certainly be described as interference in the practice of medicine.
Federal interference in the use of safe and nutritious foods by citizens cannot be justified on any general welfare grounds.
HR 2130 is an eggregious violation of the US Constitution and common law.