VOL. XXXVI, NO. 6                                                                  June 2003

- INTELLIGENCE ALERT -

"HOMEMADE" CHOCOLATES CONTAINING PSILOCYBIN MUSHROOMS
APPEARING ACROSS THE UNITED STATES

- RESPONSES REQUESTED -

Editor's Preface: In April and May 2003, the DEA Office of Forensic Sciences received multiple reports of homemade chocolates containing ground-up psilocybin mushroom parts. Three of the reports were from State and Local forensic laboratories and/or police departments in Ohio, Oregon, and Rhode Island. The fourth was reported by the DEA Mid-Atlantic Laboratory (Largo, Maryland), and was seized in Virginia. Additionally, a similar report concerning a seizure in Vail, Colorado was published in the National Drug Intelligence Center's (NDIC's) April 29, 2003 issue of the Narcotics Digest Weekly. The NDIC report also included a summary brief of a number of similar seizures dating back as far as two years.

In several cases, the seizures were multi-kilo. There were two common elements among most of the seizures: First, the chocolates all appeared to have been made from molds - in several cases, using candy molds, and in other cases apparently using ice-cube trays (and the seizure in Virginia was received in an ice-cube tray). In addition, in several cases, the chocolates were wrapped in colored foil.

The first report of these chocolates (from North Ridgefield, Ohio) in Microgram Bulletin was reported in the May 2003 issue. The other three referenced seizures (or sets of seizures) are reported below. The above referenced intelligence brief from the Narcotics Digest Weekly is also reproduced below.

RESPONSES REQUESTED: The widespread appearances, seizure amounts, and similarities of preparation (candy molds or ice cube trays) and sales packaging (wrapping in colored foil), suggest the possibility of a common source (or a loose confederation of sources) and a nationwide distribution network. The DEA Dangerous Drugs Strategic Intelligence Unit (NTSG) and the National Drug Intelligence Center (NDIC) are both interested in this issue. Subscribers are asked to forward details to NTSG by FAX to 202/307-7916, Attn: J. Hines; and to NDIC by email to < ronald.strong2@usdoj.gov >.

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IN PORTLAND, OREGON

Photo 1	Photo 2

Photo 3

Photo 4

Under magnification, grey flakes were visible throughout the chocolate matrix on all exhibits. Samples were analyzed as follows: The concoctions were crushed, soaked in dilute sulfuric acid, and washed with chloroform (to remove some of the fatty components). The acidic layer was isolated, basified with aqueous NaOH to pH 10, and extracted with chloroform. Analysis of the extract by GC/MS indicated caffeine (from the chocolate) and confirmed psilocin. UV spectrophotometry on the final chloroform extract displayed a broad absorption in the region consistent with psilocin/psilocybin, but it was too similar to the UV from a blank chocolate extract to be considered conclusive. A second analysis was conducted by particle-picking specks of the mushroom material from the concoctions (see Photo 4), adding fresh Weber's color test reagent to them, and noting a color change from red to blue upon addition of a drop of concentrated HCl (positive for psilocin). Quantitation was not performed on any of the exhibits.

[Editor's Notes: According to the submitter, the relative percentage of mushrooms varied significantly between seizures; this indicates poor "quality control" and the potential for overdosing. Additionally, the submitter indicated that a subsequent (fifth) case was seized from a UPS package; this confirms that any parcel delivery service may be utilized for shipment. The latter case was handled by the Portland Police Department (no further information).]

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IN SOUTH KINGSTOWN, RHODE ISLAND

The Drug Chemistry Section of the Rhode Island State Forensic Laboratory (Providence, Rhode Island) recently received a submission of two pieces of chocolate "candy" reported to contain psilocin (See Photos 5 and 6). The exhibits were seized in South Kingstown by the South Kingstown Police Department from an individual who was trying to sell them to students at a local public school. The chocolates weighed 16 grams each, and were individually wrapped in colored foil (see upper right quadrant of Photo 5). After cutting the pieces in half, visual inspection confirmed that small pieces of (presumed) mushroom pieces were mixed into the chocolate (see Photo 6). The mixtures were otherwise homogenous, suggesting that the mushroom pieces had been mixed with hot, liquified chocolate, and the resulting concoction allowed to harden in some type of mold (possibly an ice cube tray). Analysis of a 6% acetic acid/chloroform extract by GC/MS and UV confirmed psilocin (quantitation was not performed). This is the first time the laboratory has received a submission of this type.

Photo 5	Photo 6

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IN RICHMOND, VIRGINIA

 

Photo 7

The DEA Mid-Atlantic Laboratory (Largo, Maryland) recently received an unusual exhibit consisting of one 14-section plastic ice cube tray with each compartment containing a cube of hardened mixture of chocolate and plant material, suspected containing psilocybin mushrooms (see Photo 7). The exhibit (total net mass 354.2 grams) was seized from a residence in Richmond, Virginia by agents from the DEA Richmond District Office, and was ancillary to an MDMA seizure. Analysis by GC/MS confirmed psilocin (quantitation was not performed). The exhibit was unusual in that the relative percentage of mushroom material to chocolate was quite high, varying between 10 and 20 percent by volume, and the mushrooms were also "sandwiched" between two layers of chocolate, not evenly distributed. In addition, the chocolate was a much lighter color than "normal" chocolate (see Photo); it was unclear whether this was due to the method of preparation, or if a lighter colored variety of chocolate was used. This was the first submission of a chocolate/psilocybin mushroom concoction to the Mid-Atlantic Laboratory.

[Editor's Notes: According to the Case Agent, the perpetrators in this case were making the concoction themselves, not receiving it from an outside source. The mushrooms were allegedly provided by a relative in New England.]

* * * * *

IN VAIL, COLORADO

From the April 29, 2003 issue of the Narcotics Digest Weekly
(Reprinted with Permission)

Colorado: The Vail Police Department reports that local independent dealers increasingly are distributing chocolate-coated psilocybin mushrooms wrapped in multicolored foil--a practice that was first reported in the Vail area approximately 18 to 24 months ago. The chocolate-coated psilocybin mushrooms typically are distributed at area concerts and private parties for $10 per 1-inch cube. Police officials believe that distributors are supplied by psilocybin mushroom cultivators in Oregon and Washington who transport the drug via package delivery services.

NDIC Comment: Coating psilocybin mushrooms in chocolate provides traffickers with an effective method of concealment and enables abusers to ingest the drug in public settings. Law enforcement reporting indicates that chocolate-coated psilocybin mushroom distribution has recently increased in several areas of the United States, including Colorado, Georgia, North Carolina, Oregon, West Virginia, and Wisconsin. Moreover, law enforcement reporting indicates that Portland, Oregon, is one of the primary source areas for chocolate-coated psilocybin mushrooms. From September 2002 to April 2003, law enforcement authorities with the Portland Police Bureau, DEA, and the Portland Airport Interagency Narcotics Team (PAINT) seized over 250 pounds of chocolate-coated psilocybin mushrooms in nine incidents. The psilocybin mushrooms were being transported from Oregon to markets throughout the United States via package delivery services.

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- INTELLIGENCE BRIEF-

VERY LARGE ECSTASY LABORATORY SEIZED
IN BANGOR, PENNSYLVANIA

In early December 2002, agents from the Pennsylvania Office of Attorney General, Bureau of Narcotics Investigation (BNI), seized a very large MDMA production laboratory in Bangor, Pennsylvania (located about 90 miles north of Philadelphia). A supply and storage warehouse in nearby Roseto was also seized; this latter facility was acting as a front company to purchase precursor and essential chemicals - the nominal purpose of which was to create flavoring ingredients for fruit juices. Unusually, the laboratory was located within a 30,000 gallon steel drum that had been mostly buried underneath the very long driveway of the operator's rather isolated residence, and was further obscured from view and camouflaged with large boulders (see Photos 8 and 9).

Photo 8	Photo 9

Safrole and sassafras oil were both recovered. Based on the various chemicals found at the site, the operator was apparently converting safrole to isosafrole, oxidizing isosafrole to the corresponding phenylacetone, and using methylamine (probably produced from acetamide) to produce MDMA via an aluminum amalgam reduction. A tableting press was also recovered (see Photo 10). Tablets purchased during the investigation and recovered at the laboratory site (approximately 4,000) weighed 290 - 295 milligrams each, and were brownish-white, plain (no logo), and unscored (see Photo 11; closeup photo not available). Analysis confirmed MDMA (quantitation not reported). Agents on-site estimated that the laboratory had been in operation for at least two years, and was capable of producing more than one million Ecstasy tablets per year - making it likely the largest MDMA laboratory ever seized in the eastern United States. The tablets were distributed throughout the (local) Lehigh Valley and also in several nearby states.

Photo 10	Photo 11

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- INTELLIGENCE BRIEF-

POLYDRUG SEIZURES, INCLUDING "ICE" METHAMPHETAMINE,
IN FORT LAUDERDALE, FLORIDA

 

Photo 12

The Broward Sheriff's Office Crime Laboratory (Fort Lauderdale, Florida) recently received a number of interesting exhibits from the Fort Lauderdale Police Department. Seized at a local residence were three bags of suspected "Ice" methamphetamine, total net mass 19.7 grams (see Photo 12). Analysis by GC/MSD and by chemical derivatization confirmed methamphetamine (not quantitated). Also seized at the location were 57 orange colored tablets with a "ying/yang" logo, total net mass 19.8 grams, suspected Ecstasy (see photo 13). Analysis, however, indicated not MDMA but rather 3,4-methylenedioxy-amphetamine (MDA) (not quantitated). Finally, 10 green tablets with an unidentified logo (possibly an animal head), were also seized, net mass not reported, suspected Ecstasy (see Photo 14). Analysis confirmed MDMA (not quantitated).

Also submitted as a result of an (unrelated) vehicle stop was a FedEx box containing three exhibits. The first was a bag of white crystalline material, net mass 672.7 grams, suspected "Ice" methamphetamine (photo not available). Analysis by GC/MSD and by chemical derivatization confirmed methamphetamine (not quantitated). The second was 48 boxes of 10 mL injectable vials, each labelled "Ketaphorte 1000 mg Anasthesia Injectable, Cosulte al Medico Veternario, ketamina base 100 mg" (photo not available). Analysis by GC/MSD and UV confirmed ketamine (not quantitated). The third was a red tablet with a "TP" logo, suspected Ecstasy (photo not available; net mass not reported). Analysis by GC/MSD and chemical derivatization indicated a mixture of methamphetamine, MDMA, and caffeine. This second set of seizures was notable because the "Ice" methamphetamine exhibit was the largest ever submitted to the Broward Sheriff's Office Crime Laboratory.

Photo 13	Photo 14

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- INTELLIGENCE BRIEF -

MDMA TABLETS WITH A "DOVE" LOGO IN REDDING, CALIFORNIA

 

Photo 15

The California Department of Justice, Bureau of Forensic Services, Redding Criminalistics Laboratory (Redding, California - approximately 150 miles north of Sacramento) recently received six light green pills (approximately 7 mm x 4-5 mm) with a dove logo, submitted as an unknown (see Photo 15). The pills were obtained in Redding by the Redding Police Department, as a result of a traffic stop; two baggies of cocaine were also seized. Analysis of the tablets by color testing and GC/MS confirmed MDMA (not quantitated). A tablet similar to this submission was found on the Internet (www.dancesafe.org/labtesting/), but this was the first time these type of pills have been submitted to the Redding Laboratory.

 

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- INTELLIGENCE BRIEF -

TABLETS CONTAINING MIXED PIPERAZINES IN ALGONA, IOWA

 

Photo 16

The Iowa Division of Criminal Investigation Criminalistics Laboratory (Des Moines, Iowa) recently received three pink tablets, composition unknown, total net mass 450 milligrams. The tablets measured 10 mm x 4 mm and had an indistinct logo (see Photo 16). The exhibits were seized in Algona by the Algona Police Department as a result of a vehicle stop to serve an arrest warrant for methamphetamine manufacture. Analysis by TLC and GC/MS indicated a mixture of benzylpiperazine (BZP), trifluromethylphenylpiperazine (TFMPP), and ortho-methoxyphenylpiperazine (OMPP) (quantitation not performed, but all three compounds showed strong peaks in the GC/MS run). The tablets appear to be quite similar in color and composition to mixed piperazine tablets previously reported in Microgram Bulletin. This is the first encounter of these federally controlled Schedule I substances in Iowa. BZP, TFMPP, and OMPP are not yet scheduled in Iowa; however, it is anticipated they will become Schedule I (Iowa) by next year.

 

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- INTELLIGENCE BRIEF -

COCAINE IN PLASTIC PLANTAINS IN STATEN ISLAND, NEW YORK

The DEA Northeast Laboratory (New York, New York) recently received an unusual submission of green plastic plantains containing suspected cocaine (see Photo 17). The plantains were seized by U.S. Coast Guard and the DEA-NY Task Force from a shipping container that was destined for New York City. Each plantain measured approximated 12.5 x 2.5 inches, and contained a cylinder of compressed powder within a balloon (see Photo 18). Analysis by GC/MS, FTIR, and GC confirmed 75 percent cocaine hydrochloride. In all, 702 plantains contained a total net mass of 90.05 kilograms. Although this laboratory has analyzed many cocaine samples from variety of smuggling techniques, this was the first encounter of this particular method of concealment.

 

Photo 17

Photo 18

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- INTELLIGENCE BRIEF -

"LIQUID HEROIN" IN RUM BOTTLES AT JFK AIRPORT, NEW YORK

 

Photo 19

The DEA Northeast Laboratory (New York, New York) recently received three "Havana Club" rum bottles containing a brown-colored liquid, that field-testing indicated contained heroin (see Photo 19). The bottles were seized by U.S. Customs at JFK International Airport in Queens, New York, from a passenger arriving from Cali, Colombia. Analysis by GC/MS, FTIR, and GC confirmed 319 milligrams heroin hydrochloride per milliliter. A total net mass of 702 grams of heroin hydrochloride was recovered from about 2.2 liters of liquid (suspected alcohol based, not further identified). Although this laboratory has analyzed many liquid cocaine samples, liquid heroin is very unusual. However, field intelligence suggests that this method of smuggling heroin may be encountered more frequently in the near future.

* * * * *

Photo 20

The DEA Southeast Laboratory (Miami, Florida) recently received a cocaine brick mold contaminated with white powder, plus two additional exhibits of white powder, one of which was recovered from the mold, suspected to be cocaine or a cocaine adulterant/diluent. The exhibit was seized from a private residence in Miami by personnel from the DEA Miami Field Division. A hydraulic press was also found at the residence, but was not submitted to the laboratory. At the time of seizure, the powder was being compressed into a brick. The mold inside dimensions were approximately 8 x 6 x 3 inches (see Photo 20). Analysis of the powder being pressed in the mold (total net mass 665.9 grams) by GC/FID and GC/MS confirmed 15 percent cocaine hydrochloride, cut with tetracaine and caffeine. Analysis of the second powder exhibit (total net mass 277.0 grams) identified it to be a mixture of tetracaine and caffeine. This was the first seizure of a cocaine brick mold to the Southeast Laboratory.

[Editor's Notes: According to the analyst, the evidence and related intelligence confirmed that the perpetrators were cutting higher purity cocaine and repressing it for sale. This would mimic analogous cocaine and heroin "pelleting" operations previously reported in Microgram Bulletin.]

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* * * * *

* * * * *

Selected Intelligence Brief

Information Bulletin: Salvia Divinorum.

National Drug Intelligence Center
319 Washington St., 5th Floor
Johnstown, PA 15901

[Unclassified; Reprinted With Permission]

[This Information Bulletin is an overview of the distribution and abuse of Salvia Divinorum, an herb that contains the hallucinogen Salvinorin A. It includes a discussion of the drug's background, abuse, availability, federal legislation, and outlook.]

* * * * *

The distribution and abuse of Salvia divinorum or S. divinorum, a plant that contains the hallucinogen Salvinorin A, are becoming an increasing concern for law enforcement officials in the Northeast, Midwest, and Pacific regions of the country. Neither Salvia divinorum nor Salvinorin A is federally regulated in the United States or controlled in any other country except Australia, which adopted controlling legislation in 2002. Thus, Salvia divinorum is openly distributed via Internet sites and "head shops" located in California, Hawaii, Missouri, New York, Washington, and Wisconsin.

Background

Salvia divinorum (pronounced SAL-vee-ah dee-vin-OR-um)--frequently referred to as "Ska Maria Pastora" and "Diviner's Sage"--is a perennial herb in the mint family that resembles sage. The plant is native to certain areas of the Sierra Mazateca region of Oaxaca, Mexico, but can be grown in any humid, semitropical climate as well as indoors. Within the United States, the plant primarily is cultivated in California and Hawaii. It grows in large clusters and reaches over 3 feet in height.

Salvinorin A is the active component of Salvia divinorum. Other plants with similar properties include Cannabis sativa, which contains tetrahydrocannabinol, the primary psychoactive compound in marijuana and Artemisia absinthium, known as wormwood and used to make absinthe. At this time there is no accepted medical use for Salvia divinorum; however, Mazatec Indians in Mexico use the plant in traditional healing ceremonies and to induce visions. The manner in which Salvia divinorum interacts with the brain to produce its hallucinogenic effect remains unclear.

Abuse

Abusers ingest Salvia divinorum using various methods of administration. Like tobacco, Salvia divinorum can be smoked or chewed. It also can be brewed and ingested as a tea. When converted into a liquid extract, Salvia divinorum also can be vaporized and inhaled. Immediately after ingesting the drug, abusers typically experience vivid hallucinations--including out-of-body experiences, sensations of traveling through time and space, and feelings of merging with inanimate objects. Some abusers experience intense synesthesia, an effect that causes the abusers' senses to become confused. For example, abusers may describe hearing colors or smelling sounds. The hallucinogenic effects generally last 1 hour or less unlike other hallucinogens like LSD and PCP. High doses of the drug can cause unconsciousness and short-term memory loss.

Salvia divinorum leaf. © Drugid

The long-term effects of Salvia divinorum abuse are unknown, as medical studies undertaken to examine the drug's physiological effects have focused only on short-term effects. However, information provided by abusers indicates that the negative long-term effects of Salvia divinorum may be similar to those produced by other hallucinogens such as LSD (lysergic acid diethylamide) including depression and schizophrenia. Some abusers also indicate that long-term abuse can cause hallucinogen persisting perception disorder, or "flashbacks". Numerous individuals report experiencing negative effects during their first experience with Salvia divinorum and indicate that they would not use it a second time. Some others report that the drug caused them to become introverted and sometimes unable to communicate clearly.

National surveys conducted to estimate rates of drug abuse do not include questions regarding abuse of Salvia divinorum. Thus, current levels of abuse are difficult to determine. Most likely, the abuser population is limited and primarily consists of young adults and adolescents who frequent "head shops" or have been influenced by Internet sites promoting the drug. The percentage of first-time users who become regular abusers of the substance also is difficult to determine; however, one Internet distributor indicated that only 1 in 10 customers places a repeat order for the drug.

Adolescent Abuse of Salvia Divinorum in St. Peters, Missouri Law enforcement officials in St. Peters, Missouri, indicate that Salvia divinorum abuse by young people in that area is extremely high. Abuse levels among youths are so high that St. Peters became the first community to enact a local ordinance designed to regulate the distribution of Salvia divinorum. The ordinance--enacted in January 2003--makes it unlawful "for any person to engage in the sale or distribution of Salvia divinorum a/k/a Salvinorin A, or any variation thereof, to an individual who is seventeen years of age or younger". The ordinance does not apply to the distribution of Salvia divinorum by a family member on private property. Violations of the city ordinance are punishable by a $25 fine for the first offense, $100 for the second offense, and $250 for the third and subsequent offenses. According to the city's Board of Aldermen, enactment of the ordinance was necessary due to high rates of abuse by adolescents and concerns that the herb poses a threat to the health, safety, and welfare of residents of St. Peters.

Availability

Salvia divinorum most often is distributed via the Internet and at some "head shops" in California, Hawaii, Missouri, New York, Washington, and Wisconsin. Prices for Salvia divinorum vary widely but are generally higher for plants grown in Hawaii and Sierra Mazateca (Central Mexico). An ounce of Salvia divinorum leaves sells for $15 to $120 while Salvia divinorum plants generally sell for $20 to $45 each. Liquid extract of Salvia divinorum--produced by crushing the leaves of the plants and using solvents to extract Salvinorin A--sells for $110 to $300 per ounce. Purchased primarily via the Internet, Salvia divinorum is transported to customers via package delivery services.

Salvia divinorum plants. © Drugid

The production, distribution, and abuse of Salvia divinorum or Salvinorin A currently are not federally regulated as the drug is not listed under Title 21 U.S. Code §812 of the Controlled Substances Act. However, HR 5607 (the Hallucinogen Control Act of 2002)--introduced in Congress on October 10, 2002--contains provisions to regulate Salvia divinorum and Salvinorin A. This bill was not acted upon when the 107th Congress adjourned, but is expected to be reintroduced during the current session. In response to the introduction of legislation on Salvia divinorum, a group has formed to lobby Congress to fight any attempts to regulate the use or availability of Salvia divinorum and Salvinorin A in the United States.

Outlook

Increasing numbers of young adults and adolescents most likely will experiment with Salvia divinorum as the drug currently is unregulated and readily available via the Internet and "head shops". Salvia divinorum most likely will not become widely abused at social events such as raves and dance parties. The drug often causes some individuals to become introverted, and abusers at such events tend to seek drugs that enhance social interaction such as MDMA (3,4-methylenedioxymethamphetamine, also known as ecstasy). Proposed federal legislation to control Salvia divinorum and Salvinorin A may impact its availability, as distributors may be hesitant to sell the drug openly.

Sources

• ABC News
  
• Drug Enforcement Administration
  
• Drugid
  
• Falkowski, Carol. Dangerous Drugs; An Easy-to-Use Reference for Parents and Professionals. Center
  City, Minnesota: Hazelden, 2003
  
• Los Angeles High Intensity Drug Trafficking Area
  
• Los Angeles Times
  
• Milwaukee Journal Sentinel
  
• The New York Times
  
• St. Peters (MO) Police Department

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CLARIFICATION OF LISTING OF "TETRAHYDROCANNABINOLS" IN SCHEDULE I AND EXEMPTION FROM CONTROL OF CERTAIN INDUSTRIAL PRODUCTS AND MATERIALS DERIVED FROM THE CANNABIS PLANT; FINAL RULES

[Reprinted from the Code of Federal Regulations, Friday, March 21, 2003, pps. 14114 - 14126]

[Note: Slightly Edited to Fit Microgram Bulletin Format]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-205F]

RIN 1117-AA55

Clarification of Listing of "Tetrahydrocannabinols" in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: The Drug Enforcement Administration (DEA) is revising the wording of the DEA regulations to clarify that the listing of "Tetrahydrocannabinols" (THC) in schedule I of the Controlled Substances Act (CSA) and DEA regulations refers to both natural and synthetic THC.

DATES: This final rule becomes effective on April 21, 2003.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537; Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and by What Authority Is It Being Issued?

This final rule clarifies that, under the CSA and DEA regulations, the listing of "Tetrahydrocannabinols" in schedule I refers to both natural and synthetic THC.
This rule is being issued pursuant to 21 U.S.C. 811, 812, and 871(b). Sections 811 and 812 authorize the Attorney General to establish the schedules in accordance with the CSA and to publish amendments to the schedules in the Code of Federal Regulations, part 1308 of title 21. Section 871(b) authorizes the Attorney General to promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient enforcement of his functions under the CSA. These functions vested in the Attorney General by the CSA have been delegated to the Administrator and Deputy Administrator of DEA. 21 U.S.C. 871(a); 28 CFR 0.100(b) and 0.104, appendix to subpart R, sec. 12.

Why Is There A Need To Clarify The Meaning of "Tetrahydrocannabinols"?

As DEA explained in its October 9, 2001 interpretive rule (66 FR 51530; hereafter "interpretive rule"), it is DEA's interpretation of the plain language of the CSA and DEA regulations that the listing of "Tetrahydrocannabinols" in schedule I refers to both natural and synthetic THC. Despite the wording of the statute, some members of the public were under the impression (prior to the publication of the interpretive rule) that the listing of "Tetrahydrocannabinols" in schedule I includes only synthetic THC--not natural THC. To eliminate any uncertainty, DEA is hereby revising the wording of its regulations to refer expressly to both natural and synthetic THC.

Why Should Natural THC Be Considered a Controlled Substance?

There are several reasons why natural THC should be considered a controlled substance. First, as explained in the interpretive rule, it is evident from the plain language of the CSA that Congress intended all THC--natural or synthetic--to be a schedule I controlled substance. Congress did so by listing "Tetrahydrocannabinols" in schedule I of the CSA--without limiting "Tetrahydrocannabinols" to either natural or synthetic form. 21 U.S.C. 812(c), Schedule I(c)(17). The basic dictionary definition of the word "tetrahydrocannabinols" refers collectively to a category of chemicals--regardless of whether such chemicals occur in nature or are synthesized in the laboratory.\1\

[\1\ For example, Merriam - Webster's Collegiate Dictionary (10th ed. 1999) defines "THC" as "a physiologically active chemical C21H30O2 from hemp plant resin that is the chief intoxicant in marijuana--called also tetrahydrocannabinol;" this definition does not mention synthetic THC.]

Second, every molecule of THC has identical physical and chemical properties and produces identical psychoactive effects, regardless of whether it was formed in nature or by laboratory synthesis.\2\ Likewise, a product that contains THC in a given formulation will cause the same reaction to the human who ingests it regardless of whether the THC is natural or synthetic. Indeed, some researchers are currently investigating the possibility of using natural THC (extracted from cannabis plants) in drug products.\3\

[\2\ In this context, "every molecule of THC" refers to every molecule of the same isomer of THC. For example, all molecules of \9\-(trans)-THC are identical, regardless of whether they are natural or synthetic.
It should also be noted that "Tetrahydrocannabinols" refers to a class of substances which includes \9\-(trans)-THC, its isomers, and other related substances. Collectively, this class will be referred to in this document as "THC," unless otherwise indicated.

\3\ At present, Marinol[reg] is the only THC-containing drug product that has been approved for marketing by FDA. Marinol[reg] contains synthetic dronabinol (an isomer of THC) in sesame oil and encapsulated in soft gelatin capsules. This product has been approved for the treatment of nausea and vomiting associated with cancer chemotherapy as well as the treatment of anorexia associated with weight loss in patients with AIDS. See 64 FR 35928 (1999) (DEA final order transferring Marinol[reg] from schedule II to schedule III).]

Third, regardless of its source, THC meets the criteria for classification in schedule I of the CSA. It is an hallucinogenic substance with a high potential for abuse and no currently accepted medical use.\4\ See 21 U.S.C. 812(b)(1). Thus, for purposes of CSA scheduling, there is no basis for distinguishing natural THC from synthetic THC.

[\4\ There are no FDA-approved drug products that consist solely of THC. However, as stated in the preceding footnote, the FDA has approved a drug product (Marinol[reg]), which contains synthetic THC with other ingredients in a specified product formulation.]

Fourth, to ignore the foregoing considerations and to treat natural THC as a noncontrolled substance would provide a loophole in the law that might be exploited by drug traffickers. If natural THC were a noncontrolled substance, those portions of the cannabis plant that are excluded from the CSA definition of marijuana (the stalks and sterilized seeds of the plant) would be legal, noncontrolled substances--regardless of their THC content. As a result, it would be legal to import into the United States, and to possess, unlimited quantities of cannabis stalks and sterilized seeds--again, regardless of their THC content. Anyone could then obtain this raw cannabis plant material to produce an extract of THC--all without legal consequence. This would give drug traffickers an essentially limitless supply of raw plant material from which they could produce large quantities of a highly potent extract that would be considered a noncontrolled substance and, therefore, entirely beyond the reach of law enforcement. To provide such a safe harbor to drug traffickers would be plainly at odds with the purpose and structure of the CSA.\5\

[\5\ As one United States Court of Appeals has stated, "a reading of the [CSA] and its legislative history makes it apparent that Congress, in legislating against drug use, intended to encompass every act and activity which could lead to proliferation of drug traffic. Nothing in the statute indicates any congressional intent to limit the reach of this legislation, which is described in its title as ‘Comprehensive.'" United States v. Everett, 700 F.2d 900, 907 (3d Cir. 1983) (internal citations omitted).]

Does This Rule Change the Legal Status of "Hemp" Products?

This rule does not change the legal status of so-called "hemp" products (products made from portions of the cannabis plant that are excluded from the CSA definition of marijuana). Rather, this rule clarifies provisions of the law and regulations that have been in effect since 1971. For the reasons provided in the interpretive rule, it is DEA's view that the CSA and DEA regulations have always (since their enactment more than 30 years ago) declared any product that contains any amount of tetrahydrocannabinols to be a schedule I controlled substance. This interpretation holds regardless of whether the product in question is made from "hemp" or any other material.
Nor does this rule add to, or subtract from, the exemptions issued by DEA in the October 9, 2001 interim rule. Every type of "hemp" product that was exempted from control under that interim rule will remain exempted following the finalization of this rule. Thus, given DEA's interpretation of current law (expressed in the interpretive rule), this rule does not change the legal status of any "hemp" product.

What Is the Difference Between This Final Rule and the Previously-Issued Interpretive Rule?

This final rule is a legislative rule. It is important to understand the difference between a legislative rule and an interpretive rule, such as the interpretive rule on THC that DEA issued on October 9, 2001. The following is a brief explanation of the difference between legislative rules and interpretive rules.
Under the Administrative Procedure Act (APA), agencies may issue interpretive rules to advise the public of how the agency interprets a particular provision of a statute or regulation which the agency administers.\6\ By definition, interpretive rules are simply the agency's announcement of how it interprets existing law. Interpretive rules are not new laws and are not binding on the courts. Even though courts often defer to an agency's interpretive rule, they are always free to choose otherwise.

[\6\ See Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, 99 (1995).]

Legislative rules, on the other hand, have the full force of law and are binding on all persons, and on the courts, to the same extent as a congressional statute.\7\ Because of this crucial difference, the APA requires agencies to engage in notice-and-comment proceedings before a legislative rule takes effect.\8\ By the same reasoning, since interpretive rules do not have the full force of law and are not binding on the courts, the APA expressly allows agencies to issue interpretive rules without engaging in notice-and-comment. 5 U.S.C. 553(b)(A), (d)(2).

[\7\ National Latino Media Coalition v. F.C.C., 816 F.2d 785, 788 (D.C. Cir. 1987).

\8\ Syncor Int'l Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 1997) ("it is because the agency is engaged in lawmaking [when it issues a legislative rule] that the APA requires it to comply with notice and comment").]

Consistent with these APA principles, DEA published the interpretive rule in October 2001 without notice and comment, whereas the legislative rule that is being finalized in this document has gone through notice and comment. As a result, this final rule will have the full force of law and be binding on the courts--just as with all the other DEA regulations that have gone through notice and comment.\9\ In contrast, the interpretive rule was not binding on the courts. The practical effect of this distinction can be seen by considering the following hypothetical scenarios. If, prior to the publication of this final rule, a federal prosecution was commenced based solely on DEA's interpretive rule, the presiding court would have been free to choose between applying DEA's interpretation or its own interpretation of the law. But once this rule becomes final, if a person were to refuse to abide by the regulation and a federal prosecution were commenced, the court would be required to apply the new regulation.\10\

[\9\ The DEA regulations are published in Title 21 of the Code of Federal Regulations, Part 1300.
\10\ Legislative regulations are controlling on the courts unless they are "arbitrary, capricious, or manifestly contrary to the statute." Chevron, U.S.A. v. Natural Resources Defense Council, 467 U.S. 837, 844 (1984).]

Comments That DEA Received in Response to the Proposed Rule

Following publication of the proposed rule, DEA received comments from thousands of individuals and groups. The comments were in the form of original letters, form letters, petitions, and a cookbook. Those who submitted comments included companies that manufacture and distribute various "hemp" products, associations that represent such manufacturers and distributors, domestic and Canadian government officials, and individuals. These commenters expressed criticisms on a variety of issues. In accordance with the APA, DEA carefully considered all of the comments it received.

Most of the comments that DEA received relate to both the proposed rule (DEA 205; 66 FR 51535) and the interim rule (DEA 206; 66 FR 51539), which were published together (along with the interpretive rule) in the October 9, 2001 Federal Register. Those comments that pertain primarily to DEA 205 are addressed in this final rule. Those comments that pertain primarily to DEA 206 are addressed in the final DEA 206 rule, which appears in a separate Federal Register document that immediately follows this document. Both DEA 205 and DEA 206 contain a summary of the pertinent comments, along with an explanation of how DEA considered them in deciding to finalize the rules.

The number of individuals and groups that participated in the comment process far exceeded the number of different issues raised. Many of the comments were similar to one another, partly because many persons submitted form letters or signed petitions written by groups which themselves submitted lengthy comments. In this document, together with the final rule finalizing the DEA 206 interim rule, DEA has addressed the major issues raised by the commenters. Some of these issues have already been addressed in the text that precedes this section. The remaining issues are addressed below and in the DEA 206 final rule.

Comments Expressing Legal Disagreement With the Proposed Rule

Many commenters disagreed with DEA's legal interpretation of those provisions of the CSA and DEA regulations that are relevant to the proposed rule. Specifically, these commenters disagreed with DEA's view that, under the plain language of the CSA, "any material, compound, mixture, or preparation, which contains any quantity of * * * Tetrahydrocannabinols (THC)" is a schedule I controlled substance. 21 U.S.C. 812(c), schedule I(c)(17); 21 CFR 1308.11(d)(27). These commenters asserted that THC content is irrelevant when it comes to products made from portions of the cannabis plant that are excluded from the definition of marijuana. According to these commenters, DEA should allow the CSA definition of marijuana to dictate which portions of the cannabis plant are controlled substances. DEA addressed this issue in detail in the legal analysis contained in the interpretive rule. Nonetheless, many commenters asserted that their point of view is the correct reading of the law and should be substituted for that of DEA. DEA reexamined this issue in view of the comments. While recognizing that many proponents of "hemp" products are steadfast in their view that natural THC content is irrelevant in deciding what is a controlled substance, DEA continues to believe that its interpretation follows directly from the plain language of the CSA and the DEA regulations and is consistent with the legislative history of the statute and regulations. Moreover, DEA believes that the analysis contained in the interpretive rule refutes all of the contrary legal arguments expressed in the comments. As the agency responsible for administering the CSA, it is DEA's obligation to ensure that the regulations clearly reflect what the agency believes are the purpose and intent of the Act.

Comments as to Whether This Rule Constitutes a Rescheduling Action

Some commenters expressed the view that this rule is a rescheduling action within the meaning of 21 U.S.C. 811 and that DEA should have gone through the procedures set forth in that section prior to issuing this rule.\11\ These comments appear to be based on a misunderstanding of the nature of the procedures under section 811. By its express terms, section 811 applies only where DEA seeks to add a substance to a schedule or remove one from a schedule. For example, if DEA were seeking to move a controlled substance from schedule II to schedule III, the agency would be required to follow the procedures set forth in section 811. The final rule being published today, however, does not change the schedule of THC or any other controlled substance. To the contrary, when this final rule becomes effective, on April 21, 2003, THC will remain in the same schedule in which it has been since the enactment of the CSA in 1970: Schedule I.

[\11\ Under 21 U.S.C. 811, to change the schedule of a controlled substance, DEA must first request from the Secretary of Health and Human Services a scientific and medical evaluation and scheduling recommendation and follow additional procedures set forth in section 811. However, as discussed above, section 811 is inapplicable where, as in this final rule, DEA is not changing the schedule of a controlled substance.]

Nor would engaging in the rescheduling procedures set forth in section 811 be consistent with the purpose of this rule. Section 811 sets forth the procedures to determine whether a particular substance meets the criteria for placement in a particular schedule. The purpose of this rule is not to determine whether THC meets the criteria for classification in schedule I; rather, this rule serves to clarify that the longstanding placement of THC in schedule I includes both natural and synthetic THC. There is no question about whether THC meets the criteria for placement in schedule I.\12\ Even those commenters who suggested that this rule should be issued under section 811 do not dispute that all THC (natural or synthetic) meets the criteria for placement in schedule I. As discussed above, the chemical THC has the identical physical and chemical properties, and produces the same psychoactive effects, regardless of whether it is natural or synthetic. For these reasons, section 811 is inapplicable to this rule.

[\12\ The criteria for placement in schedule I are: "no currently accepted medical use in treatment in the United States," "a lack of accepted safety for use * * * under medical supervision," and "a high potential for abuse." 21 U.S.C. 812(b)(1).]

Comments Regarding Poppy Seeds

Some of the commenters asserted that DEA should not take literally the plain language of the CSA: that "any material, compound, mixture, or preparation, which contains any quantity of * * * Tetrahydrocannabinols [THC]" is a schedule I controlled substance. To read this provision literally, some commenters said, would mean that poppy seeds must be considered controlled substances if they contain trace amounts of opiates (such as morphine, codeine, or thebaine). This concern is unfounded because, under the CSA and DEA regulations, substances that contain opiates are controlled differently than substances that contain schedule I hallucinogens (such as THC). It is true that poppy seeds are excluded from the definition of opium poppy (21 U.S.C. 802(19)) just as sterilized cannabis seeds are excluded from the definition of marijuana. However, while it is the case that "any material, compound, mixture, or preparation, which contains any quantity of" an hallucinogenic controlled substance is a controlled substance (21 U.S.C. 812(c), schedule I (c); 21 CFR 1308.11(d)), it is not the case that any material, compound, mixture, or preparation which contains any quantity of an opiate is a controlled substance. Rather, naturally-occurring opiates found in substances of vegetable origin are subject to control under the CSA only if they are extracted from the substances of vegetable origin. 21 U.S.C. 812(c), schedule II(a); 21 CFR 1308.12(b)).\13\

[\13\ Plant materials that are the source of narcotics, such as opium poppy, poppy straw, and opium, are specifically listed in schedule II. However, as stated above, the listing of opium poppy does not include poppy seeds, since the seeds are excluded from the definition of opium poppy.]

Comments Regarding the Single Convention on Narcotic Drugs

Several commenters asserted that the proposed rule is impermissible in view of a certain provision of the Single Convention on Narcotic Drugs, 1961 ("Single Convention"). The Single Convention, which the United States ratified in 1967, was designed to establish effective control over international and domestic traffic in controlled substances, and parties to the Convention are required to implement certain minimum measures. Article 28 of the Single Convention imposes on parties certain restrictions on the cultivation of the cannabis plant. However, paragraph 2 of Article 28 states that the Single Convention does not apply "to the cultivation of the cannabis plant exclusively for industrial purposes (fibre [sic] and seed) or horticultural purposes." Several commenters asserted that this provision means that the United States is prohibited from imposing any restrictions on "hemp." This assertion is incorrect.

The Single Convention sets minimum standards of drug control measures that the parties must apply--not maximum measures. Parties are free to impose whatever additional measures they believe are necessary to prevent the misuse, and illicit traffic in, controlled substances. Indeed, various provisions of the CSA go beyond the minimum measures required by the Single Convention. Congress's decision under the CSA to control anything that contains "any quantity" of THC is the decisive factor for purposes of this rule, regardless of whether a less restrictive rule would be permissible under the Single Convention.\14\

[\14\ To fully address the distinctions between the control of cannabis under the Single Convention and the control of marijuana and THC under CSA would require a lengthy discussion. Such a discussion is unnecessary here because this rule is based on how THC is controlled under the CSA. Thus, there is no need to address here whether the reference in the Single Convention (Article 28, paragraph 2) to cannabis grown for "industrial" or "horticultural" purposes includes cannabis grown to make foods or beverages, or whether such reference is limited to non-human-consumption items such as rope, paper, textiles, industrial solvents, and birdseed.
A full analysis of the international drug control treaties would also require discussion of the Convention on Psychotropic Substances, 1971 (Psychotropic Convention). THC is a substance listed in the schedules of the Psychotropic Convention. Accordingly, the United States, as a party to the Psychotropic Convention, has certain obligations thereunder with respect to the control of THC. However, it is unnecessary to examine the scope of those obligations in this document because Congress stated expressly in United States domestic law that anything that contains "any quantity" of THC is a schedule I controlled substance, unless listed in another schedule or expressly exempted. Adherence to this rule and the corresponding provisions of the CSA ensures that the United States meets its obligations under the Psychotropic Convention with respect to THC.]

Comments Regarding Trade Agreements

Some commenters expressed the view that the proposed rule violates certain obligations of the North American Free Trade Agreement (NAFTA) and the World Trade Organization (WTO) agreements. Many of these same commenters expressed these assertions to DEA before the proposed rule was published in October 2001. As a result, both before and after publication of the proposed rule, DEA sought the input of the Department of State and other components of the Executive Branch with the relevant expertise and responsibility for such matters and concluded that the proposed rule--which simply clarifies longstanding federal law with respect to schedule I hallucinogenic controlled substances--does not violate NAFTA or the WTO agreements.
One of the bases for these treaty claims asserted by commenters is the contention that the proposed rule provides more favorable treatment to United States and foreign, non-Canadian investors and their investments than to Canadian "hemp" investors and their investments in the United States. In reality, the rule applies to and treats all "hemp" industry investors and their investments the same--i.e., regardless of nationality of ownership. No company (whether Canadian-owned, foreign but non-Canadian-owned, or United States-owned) can manufacture, distribute or market products used, or intended for use, for human consumption that contain any amount of THC. DEA has made no exception to this rule for any United States company or any foreign company.

Comments Requesting an Extension of the Comment Period

Some commenters asked DEA to extend the comment period. DEA did not do so for the following reasons. In the notice of the proposed rule, DEA provided a 60-day comment period from the date of the publication in the Federal Register, which allowed ample time for any interested persons to express their opinions.
DEA considered all comments that were postmarked within the comment period, even where the agency did not receive the comments until several months after the comment period closed.\15\ It is evident from the number and variety of comments that were submitted, and the detailed nature of such comments, that a wide range of viewpoints was expressed to the agency during the comment period. Nearly all of the types of comments that were submitted during the comment period were repeated many times over by a number of commenters, which further indicates that interested parties have had sufficient opportunity to express their comments.

[\15\ At the time the comment period closed, postal deliveries to DEA and other agencies were delayed after the widely-reported incidents of anthrax being sent through the mail. Because of this, although the proposed rule indicated that DEA would only consider comments received on or before December 10, 2001, the agency considered all comments postmarked by that date, even if they arrived late.]

DEA provided the public with advance notice of the rules. In the year preceding the October 9, 2001 publication of the rules, DEA announced twice in the Federal Register that the agency would be issuing the proposed rule, along with the interpretive rule and the interim rule, and described the nature of the rules. See Department of Justice Unified Agenda, 66 FR 25624 (May 14, 2001), 65 FR 74024 (November 30, 2000). It is evident from the comments submitted on the proposed rule that the advance notice gave interested persons ample time to assemble and articulate their thoughts and opinions. Some of those persons who requested an extension of the comment period themselves submitted lengthy comments, indicating that they have already fully expressed their views. In light of these considerations, extending the comment period was unnecessary.

Comments Regarding Economic Impact of the Proposed Rule

Many commenters expressed concern about how the proposed rule might impact economically various businesses that deal in "hemp" products. These economic considerations are addressed in the next section of this document (regulatory certifications).

Regulatory Certifications

Certain provisions of Federal law and executive orders (specified below) require agencies to assess how their rules might impact the economy, small businesses, and the states. (Hereafter in this document, these provisions will be referred to collectively as the "certification provisions.") DEA has conducted these certifications. However, before discussing the economics, the nature of this rule should be reiterated. This rule revises the wording of the DEA regulations to clarify for the public the agency's understanding of longstanding federal law. In other words, through this rule, DEA is implementing what it believes to be the mandate of Congress under the CSA. (This mandate is that every substance containing THC be listed in schedule I, unless the substance is specifically exempted from control or listed in another schedule.) Regardless of how this rule might impact the economy, small businesses, or the states, DEA must carry out the mandate.
It is also critical to bear in mind that only a very narrow category of "hemp" products will be prohibited under the rules that DEA is publishing today. As a result of the exemptions issued by DEA under the interim rule, all "hemp" products that do not cause THC to enter the human body are entirely exempted from control, regardless of their THC content. Thus, items such as "hemp" clothing, industrial solvents, personal care products, and animal feed mixtures are considered noncontrolled substances (not subject to any of the CSA requirements) regardless of their THC content. This rule therefore causes no economic impact whatsoever on such exempted products.
It also must be considered that when Congress enacted the CSA, it created a system of controls that was comprehensive in scope to protect the general welfare of the American people within the context of the Act.\16\ Incidental restrictions on economic activity resulting from enforcement of the CSA have never been viewed as a proper basis to cease such enforcement. The certification provisions are no exception to this principle.

[\16\ See 21 U.S.C. 801(2).]

Moreover, one of the chief aims of the certification provisions is to ensure that agencies consider the potential economic ramifications of imposing new regulations. This rule, however, does not create any new category of regulation governing the handling of controlled substances. Rather, the rule merely helps to clarify what products are, or are not, subject to what DEA believes are preexisting CSA requirements.
DEA recognizes, however, that some members of the public disagree with DEA's interpretation of the law with respect to THC. As a result, some companies may be continuing to market in the United States "hemp" food and beverage products that contain THC. Accordingly, for purposes of calculating the economic impact of these rules, DEA has assumed THC-containing "hemp" foods and beverages are lawful products until this rule becomes final.
In the regulatory certifications that accompanied the proposed rule, DEA explained in detail its analysis of the economic activity relating to "hemp" food and beverage products (referred to therein and hereafter in this document as "edible `hemp' products"). 66 FR at 51536-51537. In that analysis, using conservative assumptions (erring on the side of inclusiveness), DEA estimated that the total sales of edible "hemp" products in the United States is no more than $20 million per year with no more than 500 persons employed in connection with these products. In the publication of the proposed rule, DEA urged any manufacture or distributor of "hemp" products to submit during the comment period any data on this economic activity that might warrant adjustments to these estimates. The comments that DEA received suggest that the agency might have overestimated the amount of economic activity tied to edible "hemp" products. The highest estimate submitted by representatives of businesses that produce and distribute edible "hemp" products was that the total sales of such products in the United States is approximately $6 million.
It also must be noted that not every such edible product marketed as a "hemp" product is necessarily prohibited under the rule being finalized today. As DEA stated repeatedly in the text accompanying the proposed rule and the interim rule, if a product says "hemp" on the label but contains no THC (or any other controlled substance), it is not a controlled substance and, therefore, not affected by this rule. At least one "hemp" food company claims that its products are THC-free.\17\ If this is correct, such products are not controlled substances and not prohibited by the CSA. Thus, even if the edible "hemp" products business is a $6 million industry in the United States, some of that business might be able to continue under this final rule.

[\17\ On January 28, 2002, a company that sells "hemp" food products issued the following statement on its website (http://www.thehempnut.com): It is the position of HempNut, Inc. and the Hemp Food Association (HFA) that this Rule [published by DEA on October 9, 2001] is merely a clarification and confirmation of the basis under which DEA, US Customs, and all responsible hempseed importers have already been operating under for quite some time, namely, that hempseed products may not contain tetrahydrocannabinol (THC). A survey of hempseed importers revealed that all were in full compliance with the Rule, and have
no THC in their products.]

The one other category of products that might be impacted economically by this rule is that in which pure cannabis seeds are sold as birdseed. (As set forth in the interim rule, which is being finalized today, DEA is exempting animal feed mixtures containing sterilized cannabis seeds with other ingredients, but not pure sterilized cannabis seeds.) In the regulatory certifications attached to the proposed rule, DEA estimated that no more than $77,000 worth of birdseed that contains cannabis seeds is imported into the United States for sale in this country. It appears likely that most of this birdseed is sold in a mixture that is exempted under the interim rule. Accordingly, the total amount of pure "hempseeds" sold as birdseed in this country is probably much less than $77,000.

Regulatory Flexibility Act

For the reasons provided above, the Acting Administrator hereby certifies that this rule will not have a significant impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 605(b)). The economic activity that would be disallowed under this rule is already illegal under DEA's interpretation of existing law. Even if one were to assume that such economic activity were legal under current law, the prohibition on such activity resulting from this rule (summarized above) would not constitute significant impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act. Therefore, a final regulatory flexibility analysis is not required for this rule.

Executive Order 12866

This rule has been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, 1(b), Principles of Regulation. This rule has been determined to be a "significant regulatory action" under Executive Order 12866, 3(f). Accordingly, this rule has been reviewed by the Office of Management and Budget for purposes of Executive Order 12866.

Executive Order 13132

This rule does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rule does not have federalism implications warranting the application of Executive Order 13132.

Executive Order 12988--Civil Justice Reform

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year. Therefore, no actions are necessary under the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

For the reasons provided above, this rule is not likely to result in any of the following: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. The economic activity disallowed under this rule is already illegal under DEA's interpretation of existing law. Even if one were to assume that such economic activity were legal under current law, the prohibition on such activity resulting from this rule would not render the rule a major rule under the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. Therefore, the provisions of SBREFA relating to major rules are inapplicable to this rule. However, a copy of this rule has been sent to the Office of Advocacy, Small Business Administration. Further, a copy of this final rule will be submitted to each House of the Congress and to the Comptroller General in accordance with SBREFA (5 U.S.C. 801).

Paperwork Reduction Act of 1995

This rule does not involve collection of information within the meaning of the Paperwork Reduction Act of 1995.

List of Subjects in 21 CFR Part 1308

Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs.

Final Rule

Pursuant to the authority vested in the Attorney General under sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)), delegated to the Administrator and Deputy Administrator pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, appendix to subpart R, sec. 12, the Acting Administrator hereby orders that Title 21 of the Code of Federal Regulations, part 1308, be amended as follows:

PART 1308--[AMENDED]

1. The authority citation for part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

2. Section 1308.11(d)(27) is revised to read as follows:

Sec. 1308.11 Schedule I.

* * * * *
(d) * * *
(27) Tetrahydrocannabinols--7370
Meaning tetrahydrocannabinols naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following:
1 cis or trans tetrahydrocannabinol, and their optical isomers
6 cis or trans tetrahydrocannabinol, and their optical isomers
3, 4 cis or trans tetrahydrocannabinol, and its optical isomers

(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)

* * * * *

Dated: March 18, 2003.
John B. Brown III,
Acting Administrator.
[FR Doc. 03-6804 Filed 3-20-03; 8:45 am]

BILLING CODE 4410-09-P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-206F]

RIN 1117-AA55

Exemption From Control of Certain Industrial Products and Materials Derived From the Cannabis Plant

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: The Drug Enforcement Administration (DEA) is adopting as final an interim rule exempting from control (i.e., exempting from all provisions of the Controlled Substances Act (CSA)) certain items derived from the cannabis plant and containing tetrahydrocannabinols (THC). Specifically, the interim rule exempted THC-containing industrial products, processed plant materials used to make such products, and animal feed mixtures, provided they are not used, or intended for use, for human consumption (and therefore cannot cause THC to enter the human body).

DATES: This final rule becomes effective on April 21, 2003.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537; Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and by What Authority Is It Being Issued?

This final rule revises the DEA regulations to add a provision exempting from CSA control certain THC-containing industrial products, processed plant materials used to make such products, and animal feed mixtures, provided such products, materials, and feed mixtures are made from those portions of the cannabis plant that are excluded from the definition of marijuana and are not used, or intended for use, for human consumption. Among the types of industrial products that are exempted as a result of this final rule are: (i) Paper, rope, and clothing made from cannabis stalks; (ii) processed cannabis plant materials used for industrial purposes, such as fiber retted from cannabis stalks for use in manufacturing textiles or rope; (iii) animal feed mixtures that contain sterilized cannabis seeds and other ingredients (not derived from the cannabis plant) in a formulation designed, marketed, and distributed for animal (nonhuman) consumption; and (iv) personal care products that contain oil from sterilized cannabis seeds, such as shampoos, soaps, and body lotions (provided that using such personal care products does not cause THC to enter the human body).
This rule is being issued pursuant to 21 U.S.C. 811, 812, and 871(b). Sections 811 and 812 authorize the Attorney General to establish the schedules in accordance with the CSA and to publish amendments to the schedules in the Code of Federal Regulations, part 1308 of Title 21. Section 871(b) authorizes the Attorney General to promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient enforcement of his functions under the CSA. In addition, the Attorney General is authorized to exempt, by regulation, any compound, mixture, or preparation containing any controlled substance from the application of all or any part of the CSA if he finds such compound, mixture, or preparation meets the requirements of section 811(g)(3). These functions vested in the Attorney General by the CSA have been delegated to the Administrator and Deputy Administrator of DEA. 21 U.S.C. 871(a); 28 CFR 0.100(b) and 0.104, appendix to subpart R, sec. 12.

Why Is DEA Exempting From Control Certain THC-Containing Substances Not Intended for Human Consumption?

Without the exemptions made by the interim rule, which are adopted as final in this rule, a wide variety of legitimate industrial products derived from portions of the cannabis plant would be considered schedule I controlled substances. For example, paper, rope, and clothing (made using fiber from cannabis stalks) and industrial solvents, lubricants, and bird seed mixtures (made using sterilized cannabis seeds or oil from such seeds) would, in the absence of the interim rule, be considered schedule I controlled substances if they contained THC. If such products were considered schedule I controlled substances, their use would be severely restricted.\1\ Under the interim rule, however, which DEA is adopting as final here, DEA exempted such legitimate industrial products from control, provided they are not used, or intended for use, for human consumption. As explained below, DEA believes this approach protects the public welfare within the meaning of the CSA while striking a fair balance between the plain language of the Act and the intent of Congress under prior marijuana legislation.

[\1\ The CSA and DEA regulations permit industrial use of schedule I controlled substances, but only under strictly regulated conditions.]

THC is an hallucinogenic substance with a high potential for abuse. Congress recognized this fact by placing it in schedule I of the CSA. Because of this, there are only two ways that THC may lawfully enter a person's body: (1) If the THC is contained in a drug product that has been approved by the Food and Drug Administration (FDA) as being safe and effective for human use; \2\ or (2) if an experimental drug containing THC is provided to a research subject in clinical research that has been approved by FDA and conducted by a researcher registered with DEA.\3\ Disallowing human consumption of schedule I controlled substances except in the foregoing limited circumstances is an absolute necessity to conform with the CSA and protect the public welfare within the meaning of the Act.\4\

[\2\ 21 U.S.C. 331, 355, 811(b), 812(b). At present, Marinol[reg] is the only THC-containing drug product that has been approved for marketing by FDA. Marinol[reg] is the brand name of a product containing synthetic dronabinol (a form of THC) in sesame oil and encapsulated in soft gelatin capsules that has been approved for the treatment of nausea and vomiting associated with cancer chemotherapy as well as the treatment of anorexia associated with weight loss in patients with AIDS. Because Marinol[reg] is the only THC-containing drug approved by FDA, it is the only THC-containing substance listed in a schedule other than schedule I. DEA recently transferred Marinol[reg] from schedule II to schedule III, thereby lessening the CSA regulatory requirements governing its use as medicine. See 64 FR 35928 (1999).

\3\ 21 U.S.C. 823(f); 21 CFR 5.10(a)(9), 1301.18, 1301.32.

\4\ In enacting the CSA, Congress stated: "The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people." 21 U.S.C. 801(2).]

Where, however, a schedule I controlled substance is contained in a product not used for human consumption, the CSA provides DEA with discretionary authority to issue regulations exempting such product from control.\5\ DEA has carefully considered whether it is appropriate to exercise this discretionary authority when it comes to industrial "hemp" products (i.e., products made from portions of the cannabis plant excluded from the CSA definition of marijuana). The text of the CSA and its legislative history make no mention of industrial uses of the cannabis plant. However, DEA has taken into account that, under prior legislation (the Marihuana Tax Act of 1937), Congress intended to permit the use of certain cannabis-derived industrial products. The Senate Report accompanying the 1937 Act stated:

[\5\ See 21 U.S.C. 811(g)(3); see also 21 U.S.C. 871(b) (providing discretionary authority to DEA Administrator to "promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under [the CSA].").]

The [cannabis] plant * * * has many industrial uses. From the mature stalks, fiber is produced which in turn is manufactured into twine, and other fiber products. From the seeds, oil is extracted which is used in the manufacture of such products as paint, varnish, linoleum, and soap. From hempseed cake, the residue of the seed after the oil has been extracted, cattle feed and fertilizer are manufactured. In addition, the seed is used as a special feed for pigeons.
S. Rep. No. 900, 75th Cong., 1st Sess., at 2-3 (1937). DEA recognizes that the intent of Congress in 1937 to allow the foregoing industrial "hemp" products is no longer controlling because the CSA (enacted in 1970) repealed and superseded the 1937 Marihuana Tax Act. DEA further recognizes that the allowance that Congress made for such products under the now-rescinded Marihuana Tax Act was based on a 1937 assumption (now refuted) that such products contained none of the psychoactive drug now known as THC. (In contrast, when Congress enacted the CSA in 1970, it expressly declared that anything containing THC is a schedule I controlled substance.) \6\ Still, for the reasons provided below, DEA believes it is an appropriate exercise of the Administrator's discretionary authority under the CSA to issue an exemption allowing the legitimate industrial uses of "hemp" that were allowed under the 1937 Act. At the same time, DEA has been careful to ensure that this exemption comports with the CSA by maintaining the rule that no humans may lawfully take THC into their bodies except when they are (i) using an FDA-approved drug product or (ii) the subjects of FDA-authorized research.

[\6\ A detailed comparison of the 1937 Marihuana Tax Act and the CSA is provided in the October 9, 2001 interpretive rule. 66 FR at 51530-51531.]

DEA may not arbitrarily exempt a controlled substance from application of the CSA. Rather, such an exemption must be based on a provision of the CSA. As cited above, the exemption of certain "hemp" products under this final rule is issued pursuant to two CSA provisions: 21 U.S.C. 811(g)(3)(B) and 871(b).
Pursuant to 811(g)(3)(B), the Administrator of DEA may exempt from control "[a] compound, mixture, or preparation which contains any controlled substance, which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse." This provision, which was added to the CSA in 1984, was aimed primarily at analytic standards and preparations which are not for use in humans and pose no significant abuse threat by nature of their formulation. It bears emphasis, however, that Congress did not mandate that DEA exempt from control all mixtures and preparations that DEA determines meet the criteria of section 811(g)(3)(B). Rather, as the word "may" in the first line of section 811(g)(3) indicates, Congress gave DEA discretionary authority to issue such exemptions.
The DEA regulation that implements section 811(g)(3)(B) is 21 CFR 1308.23. Section 1308.23(a) provides that the Administrator may exempt from control a chemical preparation or mixture containing a controlled substance that is "intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or other animal" if it is packaged in such a form or concentration, or with adulterants or denaturants, so that the presence of the controlled substance does not present any significant potential for abuse.
DEA believes that industrial "hemp" products such as paper, clothing, and rope, when used for legitimate industrial purposes (not for human consumption) meet the criteria of section 811(g)(3)(B) and Sec. 1308.23. Legitimate use of such products cannot result in THC entering the human body. Moreover, allowing these products to be exempted from CSA control in no way hinders the efficient enforcement of the CSA. Accordingly, DEA believes that these types of industrial products should be exempted from application of the CSA, provided they are not used, or intended for use, for human consumption. For the same reasons, processed cannabis plant materials that cannot readily be converted into any form that can be used for human consumption, and which are used in the production of such legitimate industrial products, are being exempted from control under this final rule.
The use of sterilized cannabis seeds \7\ that contain THC in animal feed fails to meet the criteria of section 811(g)(3)(B) and section 1308.23 because this involves the use of a controlled substance (THC) in animals.\8\ Nonetheless, pursuant to 21 U.S.C. 871(b), DEA believes it is appropriate to exempt from application of the CSA animal feed mixtures containing such seeds, provided the seeds are mixed with other ingredients that are not derived from the cannabis plant in a formulation designed, marketed and distributed for animal consumption (not for use in humans). Section 871(b) authorizes the Attorney General to promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient enforcement of his functions under the CSA. It should be underscored that section 871(b) is not a catchall provision that can be used to justify any exemption. For the following reasons, however, DEA believes that the use of sterilized cannabis seeds in animal feed mixtures is a unique situation that warrants an exemption pursuant to section 871(b).

[\7\ Unless otherwise indicated, all references in this document to "cannabis seeds" or " `hemp' seeds" refer to sterilized seeds (incapable of germination). In contrast to sterilized cannabis seeds, unsterilized cannabis seeds fit within the CSA definition of marijuana and are not exempted from control under this interim rule.

\8\ If, however, the "hemp" seeds used in animal feed are sterilized cannabis seeds that contain no THC, such seeds are not a controlled substance. Under such circumstances, there is no need to exempt such seeds from control.]

As stated above and in the interpretive rule, the legislative history of the 1937 Marihuana Tax Act reveals that Congress expressly contemplated allowing "hemp" animal feed. The 1937 Congress categorized such use of "hemp" as a legitimate "industrial" use. It is true that the intent of the 1937 Congress is no longer controlling since the CSA repealed the 1937 Act and declared anything containing THC to be a schedule I controlled substance. However, because neither the text nor the legislative history of the CSA addresses the legality of using sterilized cannabis seeds in animal feed, or the possibility that such seeds might contain THC, what was viewed under the 1937 Act as "legitimate industrial use" of such seeds in animal feed continued uninterrupted following the enactment of the CSA in 1970.
The historical lack of federal regulation of some THC-containing products (whether based on differences between prior law and the CSA, lack of awareness of the THC content of such product, or other considerations) does not--by itself--justify exempting such product from control under the CSA. DEA remains obligated to apply the provisions of the CSA to all controlled substances absent a statutory basis to exempt a particular substance from control. However, with respect to animal feed mixtures containing sterilized cannabis seeds, additional factors (combined with Congress' express desire under prior legislation to allow such products) justify an exemption pursuant to section 871(b). The presence of a controlled substance in animal feed poses less potential for abuse than in a product intended for human use and does not entail the administration of THC to humans. Moreover, when sterilized cannabis seeds are mixed with other animal feed ingredients and not designed, marketed, or distributed for human use, there is minimal risk that they will be converted into a product used for human consumption. Therefore, such legitimate use in animal feed mixtures poses no significant danger to the public welfare. Accordingly, given the unique circumstances and history surrounding the use of sterilized cannabis seeds in animal feed, DEA believes that it comports with the CSA to continue to treat such activity as a legitimate industrial use--not subject to CSA control--provided the foregoing conditions are met.

How Is "Human Consumption" Defined Under This Rule?

Under this final rule, a material, compound, mixture, or preparation containing THC will be considered "used for human consumption" (and therefore not exempted from control) if it is: (I) Ingested orally or (ii) applied by any means such that THC enters the human body. A material, compound, mixture, or preparation containing THC will be considered "intended for use for human consumption" and, therefore, not exempted from control if it is: (i) Designed by the manufacturer for human consumption; (ii) marketed for human consumption; or (iii) distributed, exported, or imported with the intent that it be used for human consumption.
In any legal proceeding arising under the CSA, the burden of going forward with the evidence that a material, compound, mixture, or preparation containing THC is exempt from control pursuant to this rule shall be upon the person claiming such exemption. 21 U.S.C. 885(a)(1). In order to meet this burden with respect to a product or processed plant material that has not been expressly exempted from control by the Administrator pursuant to 21 CFR 1308.23 (as explained below under the heading "What Is the Control Status of Personal Care Products Made from 'Hemp'?"), the person claiming the exemption must present rigorous scientific evidence, including well-documented scientific studies by experts trained and qualified to evaluate the effects of drugs on humans.

How Are "Processed Plant Material" and "Animal Feed Mixture" Defined Under This Rule?

Under this final rule, any portion of the cannabis plant excluded from the CSA definition of marijuana will be considered "processed plant material" if it has been subject to industrial processes, or mixed with other ingredients, such that it cannot readily be converted