Product No. 2002-L0424-003
`
`I N F O R M A T I O N
`
`BULLETIN
`
`AUGUST 2002
`
`U. S.
`
` D E P A R T M E N T O F J U S T I C E
`
`©Porrata Consulting
`
`Introduction
`
`Because the criminal penalties associated with
`GHB (gamma-hydroxybutyrate) have been made more
`stringent and law enforcement pressure has rendered
`GHB more difficult to obtain, the distribution and
`abuse of GHB analogs have become an increasing
`concern. GHB analogs, which include GBL, BD,
`GHV, and GVL, are drugs that possess chemical
`structures that closely resemble GHB. The ingestion of
`any of these analogs produces physiological effects
`similar to the effects associated with GHB abuse—
`relaxation, mild euphoria, and drowsiness. Abusers
`who emerge from a deep sleep or coma caused by
`GHB analogs may become easily agitated and ex-
`tremely combative. GHB analogs are of particular
`concern because they contribute to increasing numbers
`of auto accidents, sexual assaults, and deaths.
`
`While federal law prohibits the sale of analogs
`for human consumption, GHB analogs are available
`legally as industrial solvents used to produce polyure-
`thane, pesticides, elastic fibers, pharmaceuticals,
`coatings on metal or plastic, and other products.
`These analogs also are sold illicitly as supplements
`
`for bodybuilding, fat loss, reversal of baldness,
`improved eyesight, and to combat aging, depression,
`drug addiction, and insomnia. GBL and BD are sold
`as “fish tank cleaner,” “ink stain remover,” “ink
`cartridge cleaner,” and “nail enamel remover” for
`approximately $100 per bottle—much more expen-
`sive than comparable products. Law enforcement’s
`efforts to identify the abuse of GHB analogs are
`hampered by the fact that routine toxicological
`screens do not detect the presence of these analogs. In
`addition, distributors continually develop new ana-
`logs to avoid law enforcement detection.
`
`Analogs
`
`GHB analogs often are abused in place of
`GHB or are used to produce GHB. Common GHB
`analogs include GBL, BD, GHV, and GVL. (See
`Table 1 on page 2.) Both GBL and BD metabolize
`into GHB upon ingestion. GBL is the most com-
`mon precursor used in the production of GHB.
`GVL is abused in place of GHB because it me-
`tabolizes into GHV, which produces physiological
`effects similar to GHB.
`
`JAZZ EXHIBIT 2008
`Par Pharm., Inc. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case CBM2014-00151
`
`Page 1 of 8
`
`

`
`GHB Analogs—GBL, BD, GHV, and GVL
`
`Table 1. GHB Analogs
`/emaNlacimehC
`rofrosrucerP
`emaNevitanretlA
`fonoitcudorP
`enotcalorytub-ammag
`ordyh-idenonaruf
`enonarufordyhid
`loidenatub-4,1
`locylgenelyhtemartet
`B-locus
`locylgenelytub
`etarelavyxordyh-ammag
`BHG-lyhtem
`enotcalorelav-ammag
`edilonatnep-4
`
`BHG
`
`LBG
`
`*
`
`VHG
`
`golanA
`
`LBG
`
`DB
`
`VHG
`
`LVG
`
`sezilobateM
`otnI
`
`BHG
`
`BHG
`
`*
`
`VHG
`
`and drowsiness. Such effects are similar to those
`associated with GHB abuse and may resemble the
`results of alcohol intoxication. GHB analogs also
`may increase libido, suggestibility, passivity, and
`cause amnesia—traits that make users vulnerable to
`sexual assault and other criminal acts. Users awak-
`ening or emerging from a coma may exhibit ex-
`treme combativeness, a condition which is also
`observed among those in withdrawal from addiction
`to GHB and its analogs. GHB analogs are known to
`produce side effects such as topical irritation to the
`skin and eyes, nausea, vomiting, incontinence, loss
`of consciousness, seizures, liver damage, kidney
`failure, respiratory depression, and even death. GHB
`analogs are physically addictive, causing addicts to
`experience severe withdrawal symptoms if they
`miss a dose or attempt to stop using the drug.
`
`Some GHB analog abusers begin consuming
`dietary supplements believing the claims made by
`manufacturers, and then find themselves addicted
`to the product. GHB analogs typically are abused
`in place of GHB by users who want to experience
`the effects associated with GHB and who find the
`analogs more widely available or easily obtained.
`Often users are unaware that they are consuming
`an analog and mistakenly believe that the sub-
`stance they are ingesting is GHB. Many users mix
`the analogs with flavored beverages to mitigate
`their salty flavor and unappealing odor. Some
`users, however, simply ingest the drugs straight or
`mixed with water. It is often difficult or impossible
`to detect the presence of GBL, BD, GHV, or GVL
`when they are mixed with other liquids because all
`these analogs are clear and colorless. A quick test
`that indicates the possible presence of GHB ana-
`logs or GHB in a clear liquid involves shaking the
`liquid. If it becomes cloudy, GHB analogs or GHB
`may be present.
`
`Because GHB analogs either are metabolized
`into GHB by the human body or produce similar
`physiological effects when ingested, healthcare
`providers often are unable to distinguish between
`the abuse of GHB and GHB analogs. Thus, the
`rising abuse of GHB, evidenced by the increase in
`
`*GHV is not used as a precursor and is not metabolized into
`another drug.
`Abuse
`
`GHB analogs are distributed as liquids and
`consumed orally. When ingested, these analogs
`produce effects such as relaxation, mild euphoria,
`
`Man Drugs Wife and Babysitter With BD
`In March 2002 a South Dakota man was arrested
`for possession of BD and the distribution of BD to
`a minor. The man had purchased a dietary supple-
`ment containing BD from a Canadian company
`over the Internet. The man’s wife believes that her
`husband drugged both her and their babysitter
`with the substance. The man allegedly experi-
`mented with the product on himself in order to
`determine the dosage, in relation to body weight,
`that would achieve the desired effects. On several
`occasions, after consuming mixed drinks her
`husband prepared, the wife fell into a deep sleep
`and vaguely recalled her husband’s having sexu-
`ally abused her. One evening, when both the
`husband and wife had separate plans to be out of
`the house, the wife returned home and found the
`husband at home with the babysitter who said she
`felt drowsy. The babysitter claimed that the hus-
`band had given her something for a headache and
`said she recalled him rubbing her back and touch-
`ing her breasts. The wife immediately took the
`babysitter to the hospital and notified authorities.
`
`Source: Sioux Falls Police Department.
`
`2
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 2 of 8
`
`Page 2 of 8
`
`

`
`Table 2. Emergency Department Mentions for
`GHB and GBL in 22 Major U.S. Cities, 1994–2000
`raeY
`latoT
`
`4991
`
`5991
`
`6991
`
`7991
`
`8991
`
`9991
`
`0002
`
`65
`
`541
`
`836
`
`267
`
`282,1
`
`871,3
`
`969,4
`
`Source: Substance Abuse and Mental Health Services Administra-
`tion, Drug Abuse Warning Network (DAWN).
`
`DAWN emergency department mentions, reflects
`increased GHB analog use as well.
`
`Distribution
`
`GHB analogs are readily available, and various
`methods are used to distribute these drugs. Because
`of legislation (see page 5), GHB analogs are legally
`available only in products not intended for human
`consumption. Abusers and distributors may obtain
`commercial products such as chemical solvents
`legally and then illegally consume or distribute them.
`
`BD Ingredient in Sleep Aid
`On January 27, 2000, a Utah man died from taking
`Zen, a product containing sucol-B, an alternative
`name for 1,4-butanediol. The man initially purchased
`the product in July 1999 as a sleep aid from a local
`health food store and was unaware that the product
`contained a GHB analog. He realized he had become
`addicted to the substance and was trying to wean
`himself from it before his death. In April 2002 the
`man’s widow reached an undisclosed settlement in a
`case filed in civil court holding the store responsible in
`the wrongful death of her husband, claiming they failed
`to warn consumers that the product contained an
`active ingredient that is processed by the body into
`GHB.
`
`Sources: G. Erick Nielson and Associates (plaintiff’s legal
`representative); Associated Press.
`
`National Drug Intelligence Center
`
`Illegal distribution of GHB analogs often occurs at
`raves, concerts, nightclubs, health clubs, gyms, and
`on college campuses. At these venues GHB analogs
`usually are sold for $10 to $20 per capful (approxi-
`mately 1 teaspoonful). When distributors sell these
`drugs, they may fail to specify which analog they are
`selling, or they may misrepresent the analog as GHB.
`
`GHB analogs also are distributed at disrepu-
`table stores that sell health food and nutritional
`supplements. The analogs also may be marketed on
`the Internet and then shipped to purchasers via
`package delivery services. Typically, analogs are
`marketed as dietary supplements, sleep aids, and
`cleaning products. They are packaged in bottles
`containing 4 to 20 ounces and sold for $40 to $100
`each. The products that are distributed as dietary
`supplements usually contain GVL as the active
`ingredient, while the cleaning supplies usually
`contain GBL or BD. The concentration of the analog
`varies; therefore, the size of a dose may range from
`one-half teaspoon to one-half ounce, and the number
`of doses per bottle may range from 24 to 48.
`
`Individuals who illegally produce GHB analogs
`for human consumption often list alternative chemi-
`cal names to disguise the ingredients. Most users
`recognize the analog by the brand name or through
`advertisements that tout the product as a replacement
`for a similar product that has been removed from the
`market. Products that contained BD or GBL such as
`RenewTrient II, Serenity, Inner-G, Soma Solution,
`and Blue Nitro are no longer sold, primarily because
`of law enforcement pressure, but comparable
`products with similar brand names are available.
`
`GHB analogs often are sold with disclaimers
`that they are not for human consumption; however,
`many of the products have labels implying that the
`product may be ingested. One product marketed as an
`industrial solvent has a label that states “Warning!
`Accidental ingestion of [product] will produce GHB
`in your body. If you ingest some by mistake, don’t
`take alcohol or any other drug!” Another product
`label states “Warning: Accidental ingestion may
`cause… euphoria…increases tactile sensitivity….”
`
`3
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 3 of 8
`
`Page 3 of 8
`
`

`
`GHB Analogs—GBL, BD, GHV, and GVL
`
`GHB Kits
`Between March 22, 1999, and January 20, 2000,
`two brothers operating from Mississippi and South
`Carolina marketed “GHB kits” on the Internet dis-
`guised as computer-cleaning solvents. The kits
`included instructions for producing GHB from GBL
`and contained enough GBL and sodium hydroxide
`(the chemical used to convert GBL to GHB) to make
`15 to 20 doses of GHB; the kits were sold for $55.
`New Jersey Statewide Narcotics Task Force investi-
`gators made nine undercover purchases by commu-
`nicating via web sites and an e-mail account. Police
`seized a 55-gallon drum of GBL and 10 pounds of
`sodium hydroxide from a home owned by the broth-
`ers in Mount Pleasant, South Carolina. On March
`23, 2002, a New Jersey court sentenced the broth-
`ers to 4 years in prison under a plea agreement.
`
`Source: Associated Press.
`
`Many of the products are marketed as “Great House-
`hold Bargains” (GHB) in order to increase their
`exposure to individuals seeking GHB analogs.
`
`In addition to the distribution methods discussed
`previously, supplies, kits, and recipes for producing
`GHB using the GHB analog GBL are marketed and
`sold on the Internet.
`
`Tests for GHB Analogs
`
`Seized GHB analogs frequently are not identified
`because detection of such analogs requires specific
`field and laboratory testing. Three different color
`tests—cobalt nitrate, Marquis reagent, and Mandelin
`reagent—are useful for detecting the presence of GHB
`analogs. (Contact forensic laboratories to obtain
`specific instructions regarding utilizing these test kits.)
`Both the Marquis reagent and the Mandelin reagent
`tests are available commercially.
`
`Routine toxicological screens do not detect
`GHB or GHB analogs; thus, law enforcement
`officers and medical personnel must order specific
`blood and urine tests when they suspect GHB
`analog abuse. Federal, state, and local forensic
`
`4
`
`laboratories may not routinely test for GHB in
`blood or urine. The most common urine tests
`screen only for the “NIDA-5,” five of the most
`commonly abused categories of drugs—amphet-
`amines (amphetamines, methamphetamine),
`cocaine (powdered cocaine, crack), cannabinoids
`(marijuana, hash), opiates (heroin, opium, codeine,
`morphine), and phencyclidine (PCP). GHB in the
`blood or urine can result from the ingestion of
`GHB, GBL, or BD. To yield a reliable result, tests
`for GHB and GHB analogs must be performed not
`long after ingestion. Urine tests for GHB and GHB
`analogs must be performed within 12 hours after
`ingestion, and blood tests must be performed
`within 5 hours.
`
`GHB Factor in Auto Fatality
`On November 21, 2000, a Florida woman under the
`influence of GHB crashed head-on into another car,
`killing a passenger in the other vehicle. Hours before
`the incident, the woman had been arrested after
`passing out at a red light. A Breathalyzer test failed to
`detect alcohol; however, the woman admitted to
`having drunk from a bottle that contained GHB. She
`posted bond and was released. Two weeks before the
`fatal collision, the driver had been ticketed for careless
`driving; police did not detain her because the officer at
`the scene did not smell alcohol and did not know to
`test for GHB.
`
`Source: Florida Department of Law Enforcement; St. Petersburg
`Times.
`
`Because GHB analogs produce effects similar
`to GHB, driving under the influence of the analogs
`is just as dangerous as driving under the influence
`of GHB. As a result, some agencies have adopted
`aggressive strategies for identifying drivers who
`may have consumed GHB. The Pinellas-Pasco
`Medical Examiner’s Office in Florida conducts
`GHB tests on drivers who are suspected of driving
`under the influence (DUI). In 2000 GHB was
`detected in approximately 8 percent of the
`suspected DUI cases that the office examined.
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 4 of 8
`
`Page 4 of 8
`
`

`
`Legislation
`
`Outlook
`
`National Drug Intelligence Center
`
`On February 18, 2000, the “Hillory J. Farias
`and Samantha Reid Date-Rape Prohibition Act of
`1999” (Public Law 106-172) was signed into law,
`legislating GHB as a Schedule I controlled sub-
`stance. GBL was also regulated under this law as a
`List I controlled chemical. Illicit use of GHB
`analogs may now be prosecuted as Schedule I
`substances under 21 U.S. Code § 813.
`
`GHB analogs are treated as controlled sub-
`stances under Federal law only if intended for
`human consumption. According to 21 U.S.C. § 813,
`“a controlled substance analog(ue) shall, to the
`extent intended for human consumption, be treated,
`for the purposes of any Federal law as a controlled
`substance in Schedule I.” Thus, authorities can
`prosecute drug offenses involving GHB analogs in
`the same manner as offenses involving GHB. (See
`21 U.S.C. § 802(32) for the definition of a con-
`trolled substance analog(ue).)
`
`Deterring the distribution and abuse of GHB
`analogs poses unique challenges. Some analogs
`have legitimate purposes and are legally available.
`Distributors of illicit GHB analogs will continue to
`develop new products to disguise their activities,
`and illicit producers will continue to develop new
`GHB analogs for the same reasons. Web sites
`advertising these products will continue to be
`deceptive and ever-changing. Distributors will
`develop new disguises for GHB analogs in addi-
`tion to marketing them as cleaning fluids and
`dietary supplements. Sharing current information
`and associated trends relating to GHB analogs
`among medical personnel, law enforcement officers,
`and laboratory personnel is essential to stemming
`the distribution and abuse of these analogs.
`
`5
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 5 of 8
`
`Page 5 of 8
`
`

`
`GHB Analogs—GBL, BD, GHV, and GVL
`
`Sources
`
`Annals of Emergency Medicine
`Associated Press
`Broward County (FL) Commission on Substance Abuse
`Emedicine, www.emedicine.com
`Florida Department of Law Enforcement
`G. Erick Nielson and Associates
`Hazeldon Foundation
`Journal of Medicinal Chemistry
`Journal of the Clandestine Laboratory Investigating Chemists Association
`Missouri State Highway Patrol
`Neuropharmacology
`New England Journal of Medicine
`Pennsylvania Attorney General, Bureau of Narcotics Investigation and Drug Control
`Porrata Consulting, Inc.
`Sioux Falls Police Department
`St. Petersburg Times
`U.S. Code Title 21, Food and Drugs
`U.S. Department of Health and Human Services
`Food and Drug Administration
`National Institutes of Health
`National Institute on Drug Abuse
`Community Epidemiology Work Group
`Substance Abuse and Mental Health Services Administration
`Drug Abuse Warning Network
`U.S. Department of Justice
`Drug Enforcement Administration
`Philadelphia Division
`St. Louis Division
`United Nations Office for Drug Control and Crime Prevention
`WebMD Medical News, onhealth.webmd.com
`
`6
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 6 of 8
`
`Page 6 of 8
`
`

`
`This page intentionally left blank.
`
`National Drug Intelligence Center
`
`7
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 7 of 8
`
`Page 7 of 8
`
`

`
`GHB Analogs—GBL, BD, GHV, and GVL
`
`032803
`
`319 Washington Street 5th Floor, Johnstown, PA 15901-1622 • (814) 532-4601
`NDIC publications are available on the following web sites:
`http://ndicosa
`LEO
`home.leo.gov/lesig/ndic
`ndic.riss.net
`INTERNET
`www.usdoj.gov/ndic
`
`ADNET
`RISS
`
`This document may contain dated information. It has been made available to provide access to historical materials.
`
`ARCHIVED
`
`Page 8 of 8
`
`Page 8 of 8