Until 1963 the major psychedelic drugs were regulated by the Federal Food, Drug, and Cosmetics Act of 1938, under which any drug not formally disapproved as unsafe by the Federal Drug Administration (FDA) was classified as a New Drug and could be marketed commercially to physicians, with a few restrictions that were net rigorously enforced. In effect, any physician could easily obtain supplies of LSD from the Sandoz company in New Jersey.

The fifst important amendments to this law were passed in 1962, after the thalidomide disaster, and went into effect in 1963. They restricted all drug experimentation considerably. Now the FDA had to approve each New Drug Application in writing, and evidence of effectiveness as well as safety had to be presented if a drug were to be freely available to physicians. Before approval it was an Investigational New Drug; this meant that it could be used only in research and not in general medical practice, and a special exemption had to be obtained for each research project. The requirements for an exemption included filing a detailed plan of investigation with the FDA and informed consent from all experimental subjects. LSD and other psychedelic drugs were soon reclassified as Investigational New Drugs, and from 1963 on they were supplied only to researchers in federal and state agencies or working on grants from federal and state agencies. This law did not at first affect research greatly or prevent LSD use from spreading. Researchers who had LSD on hand in 1963 continued to use it legally until 1965, when they had to turn it in to the government. Even in early 1966 there were still more than seventy LSD projects in progress in the United States.

Soon afterward the law began to respond to the sensational publicity and aura of cultural rebellion surrounding psychedelic drugs, as well as to reports of psychotic reactions and accidents. The first federal criminal sanctions were introduced by the Drug Abuse Control Amendments of 1965, which went into effect February 1, 1966. Unlawful manufacture and sale of "dangerous drugs" including amphetamines, barbiturates, and hallucinogens (psychedelics) became a misdemeanor; there was no penalty for unlawful possession. Enforcement was entrusted to the Department of Health, Education, and Welfare (HEW) rather than the Bureau of Narcotics. In May 1966, Sandoz withdrew its New Drug Application and took its LSD off the market. Meanwhile the states were passing their first laws against psychedelic drugs; possession of LSD was made a crime in the statutes that went into effect in California and New York, two centers of psychedelic culture, in 1966. In 1968, despite medical and scientific opposition, the Drug Abuse Control Amendments were modified to make possession of psychedelic drugs a misdemeanor and sale a felony. In the same year the Bureau of Narcotics and Dangerous Drugs was created in the Department of Justice by merging the Bureau of Narcotics with the Bureau of Drug Abuse Control of HEW; enforcement of the laws on psychedelic drugs was now entrusted to the same agency as enforcement of the narcotics laws.

Finally, the Comprehensive Drug Abuse Prevention and Control Act of 1970 consolidated and rationalized federal drug law. In the section designated the Controlled Substances Act, psychoactive drugs are divided into five classes or schedules. Most of the better-known psychedelic drugs (hallucinogens) are placed in Schedule I, defined as having a high potential for abuse, no current medical use, and a lack of safety for use under medical supervision. They are not available on prescription and can be obtained for research only by a special order form. Penalties for Schedule I hallucinogens, including marihuana, are less than those for Schedule I narcotics like heroin or even Schedule II narcotics like morphine with some medical uses: the upper limit is five years and a fine of $15,000 for manufacture, sale, distribution, importing, or exporting. Possession for personal use brings a penalty of up to one year in jail and a fine of $5000; first offenders may be put on probation and have their convictions expunged from the record. The law is enforced by the Drug Enforcement Administration (formerly the Bureau of Narcotics and Dangerous Drugs), an agency of the Department of Justice; the Attorney General is empowered to add drugs to the list of controlled substances or change their schedules; he can seek the recommendations but need not obtain the formal approval of a scientific advisory committee and the Secretary of Health, Education, and Welfare. Since 1970 most states have adopted a Uniform Controlled Substances Act using the federal classification system, but each imposes its own penalties. Often they are quite severe; for example, in New York possession with intent to sell LSD is a felony bringing one to seven years in prison, and sale of five milligrams or more brings six years to life in prison. In most states simple possession is a misdemeanor.

The regulations covering experimental and therapeutic research have also been tightened since 1965. In the fall of 1967 a Psychotomimetics Advisory Committee was established by the Food and Drug Administration and the National Institute of Mental Health (NIMH) conjointly to process all research applications. Since then Sandoz, still the only authorized manufacturer of LSD in the country, has supplied it only to the NIMH. The procedure for conducting experiments with psychedelic drugs is now as follows. An application for an Investigational Exemption for a New Drug must be approved by the Psychotomimetics Advisory Committee, which is now formed by the Food and Drug Administration and the National Institute on Drug Abuse, a branch of the NIMH. Then the Director of the Drug Enforcement Administration must issue a certificate of registration, and the drug is supplied by the National Institute on Drug Abuse. The Investigational New Drug (IND) regulations have been considerably strengthened since 1962. Among other requirements, all subjects must be given physical examinations, informed written consent (defined strictly) must be guaranteed, and a review committee from the research institution where the application is made must approve it. For Schedule I drugs, the IND plan must be accepted by the Psychotomimetics Advisory Committee before any investigation can start. The research protocol must be registered yearly with the Drug Enforcement Administration, which reviews it for safeguards against diversion of the drug and which investigates the sponsors (see Scigliano 1968; Asher 1975).

The main obstacle to psychedelic research, however, is not the rules alone but lack of money and trained personnel for work in a field that has become disreputable. Especially since the 1967 scare about chromosome damage from LSD, the government has been reluctant to approve projects, and physicians and psychiatrists who want to do psychedelic research have to face their colleagues' and the public's disapproval and mistrust (Dahlberg et al. 1968). The last intramural NIMH project using LSD on human subjects ended in 1968, and the last extramural grant was terminated in 1974, after $4,000,000 had been spent on thirty studies over a period of twenty years. The National Cancer Institute and the National Institute on Alcohol Abuse and Alcoholism have also stopped all grants. Half a dozen institutions still have authorized experiments using LSD, DPT, or MDA on human subjects, but most are in abeyance because of the money shortage (Asher 1975). The psychedelic drugs supplied by the National Institute on Drug Abuse are administered mainly to animals in pharmacological experiments. The rest of the world has taken its cue from the United States. Some projects continue in Europe, Latin America, and Canada, but few studies based on new work with human beings are being published.

Of the drugs discussed in the first chapter, the following are explicitly placed in Schedule I of the Controlled Substances Act: MDA, MMDA, PMA, TMA, bufotenine, DET, DMT, 2,5-DMA, DOB, DOM, ibogaine, LSD, marihuana, tetrahydrocannabinols, mescaline, peyote, psilocin, psilocybin, JB-318, and JB-336. Lysergic acid amide and PCP are less severely restricted, because they have accepted medical uses. Possession of plant materials like psilocybin mushrooms, morning-glory seeds, and San Pedro cactus (but not peyote) is probably legal if it is not for purposes of use as a drug; psilocybin mushroom spores are now being sold through the mail. Unscheduled drugs mentioned in chapter 1 include nitrous oxide, ketamine, harmala alkaloids, nutmeg, scopolamine, fly agaric, 5-Me0-DMT, DPT, DOET, and presumably dozens of other psychedelic methoxyamphetamines and tryptamines not named in the law. There are no criminal penalties for manufacture and possession of these drugs, usually because they have not appeared in any quantity on the nonmedical drug market. In an attempt to forestall further restrictive legislation, the Church of the Tree of Life, a San Francisco organization incorporated in 1971, has granted the status of sacrament to a long list of legal psychedelic and other substances.