Vol. 146, No. 21 — October 10, 2012

Registration

SOR/2012-176 September 20, 2012

CONTROLLED DRUGS AND SUBSTANCES ACT

Order Amending Schedule I to the Controlled Drugs and Substances Act (MDPV)

P.C. 2012-1077 September 20, 2012

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 60 of the Controlled Drugs and Substances Act (see footnote a), deeming that it is necessary in the public interest, makes the annexed Order Amending Schedule I to the Controlled Drugs and Substances Act (MDPV).

ORDER AMENDING SCHEDULE I TO THE CONTROLLED DRUGS AND SUBSTANCES ACT (MDPV)

AMENDMENT

1. Schedule I to the Controlled Drugs and Substances Act (see footnote 1) is amended by adding the following after item 17:

17.1 Methylenedioxypyrovalerone (MDPV), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order or the Regulations.)

Issue and objectives

Methylenedioxypyrovalerone, also known as MDPV, is a synthetic drug used recreationally for its mind-altering effects and is a key ingredient in products known as “bath salts.” These products are not genuine bath salts intended for use in bathing but are rather the street name for drugs that typically contain one or more synthetic stimulants.

“Bath salts” are available for purchase on the Internet and may be found in alternative lifestyle stores. Examples of product names include “MITSEEZ,” “MOJO Novelty Bath Salts,” “Ivory Snow,” “Purple Wave,” and “Vanilla Sky.” These products are typically labelled “not for human consumption” and may also be labelled “plant food” in an attempt to circumvent regulatory control.

The use of MDPV poses a potential risk to the health and safety of Canadians. MDPV is a central nervous system stimulant. The use of MDPV has been associated with severe panic attacks and anxiety, as well as hallucinations and psychosis. Adverse physical effects associated with the use of stimulants can include palpitations, irregular or abnormal heartbeat, heart attack or cardiovascular collapse.

Canadian reports of incidents involving “bath salts” have originated primarily from eastern provinces, including New Brunswick and Nova Scotia. On May 18, 2012, health officials in northern Nova Scotia issued a warning about “bath salts,” including reports of a significant number of emergency room visits. There have also been reports of “bath salts” being mixed with other drugs such as cannabis.

From January 2010 to June 30, 2012, Health Canada’s Drug Analysis Service (DAS) reported 549 exhibits of suspected controlled substances seized by law enforcement agencies and suspected to be “bath salts.” Of these exhibits, 498 were found to contain MDPV and 17 were found to contain mephedrone, a substance that is already controlled under the Controlled Drugs and Substances Act (CDSA). The remaining 34 were found to contain other illegal substances such as methylone, flephedrone and ethylcathinone.

The objective of this regulatory amendment is to protect the health and safety of Canadians from the potential risks posed by the use of MDPV. Regulating MDPV as a controlled substance under the CDSA clearly communicates that it is unsafe and illegal, and allows law enforcement to take action against suspected illegal activities involving the substance. This regulatory amendment responds to the concerns expressed by health officials, particularly in Nova Scotia, about the health and safety risks associated with the use of MDPV, and by law enforcement and the Canada Border Services Agency about the substance’s growing popularity and availability in Canada. A secondary objective of this regulatory amendment is to enable access to MDPV for authorized scientific and research purposes, by adding the substance to the Schedule to Part J of the Food and Drug Regulations (FDR).

Description

The CDSA provides a legislative framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual or to society when diverted or misused.

Scheduling under the CDSA is a three-step process in that substances are first assessed to determine whether or not they should be regulated under the CDSA and then into which Schedule they best fit. Finally, depending on whether they have a legitimate use (i.e. scientific, medical or industrial), a decision must be made regarding the regulation to which the substances should be subject.

Health Canada considers several factors in determining whether the scheduling of a substance under the CDSA is warranted. These include

• Overall risk to public health and safety posed by the substance;
• Chemical and pharmacological similarity to other substances already regulated under the CDSA;
• Legitimate uses of the substance;
• Potential for abuse and risk of addiction associated with the substance;
• Extent of actual abuse of the substance in Canada and internationally; and
• International requirements and trends in international control.

This regulatory initiative adds MDPV to Schedule I to the CDSA, which means that all activities including possession, trafficking, production, distribution, import and export are illegal unless authorized by regulation. The penalties associated with illegal activities involving substances listed in Schedule I are the highest imposed by the CDSA. Examples of other substances listed in Schedule I include heroin and cocaine. Adding MDPV to the Schedule to Part J of the FDR provides a means by which authorized scientific and research activities involving this substance can be carried out in Canada.

Rationale

In response to evidence that increasing volumes of this substance are being imported into Canada and to concerns expressed by health officials and law enforcement, Health Canada undertook an analysis and determined that MDPV should be regulated as a controlled substance under the Controlled Drugs and Substances Act (CDSA).

Although MDPV is not listed under any of the United Nations drug control conventions, scheduling the substance under the CDSA is consistent with actions taken by a number of countries, including the United States, Australia, Denmark, Sweden and the United Kingdom.

Health Canada is adding MDPV to Schedule I to the CDSA because of the health and safety risks posed by this emerging drug, and reports of its cocaine and amphetamine-like effects. Proceeding in this way will also align the scheduling of MDPV with the rescheduling of amphetamines, which are also stimulants, from Schedule III to Schedule I under the Safe Streets and Communities Act, which will come into force on November 6, 2012. Adding MDPV to the Schedule to Part J of the FDR provides an appropriate mechanism for controlled access to this substance for authorized scientific and research purposes.

Consultation

Health Canada published a Notice to interested parties in the Canada Gazette, Part Ⅰ, on June 9, 2012, seeking stakeholder input on its intent to add MDPV to Schedule I to the CDSA. In particular, the Notice sought to determine the presence of any legitimate activity involving this substance.

During the 30-day comment period following publication, 11 submissions were received. While no submissions presented evidence of MDPV being used for any industrial purpose, limited use of MDPV for scientific and research purposes was subsequently identified.

Of the 11 submissions, 5 were supportive of Health Canada’s proposal, 4 expressed reservations, 1 contained an offer of assistance to Health Canada in its work on “bath salts” and 1 was an inquiry about the comment submission process.

The reservations included assertions that there is insufficient evidence to support scheduling of MDPV under the CDSA and that reducing access to MDPV would lead to increased use of other, potentially more harmful drugs. Health Canada considers, however, that the growing evidence of health and safety risks associated with this substance warrants the control measures associated with Schedule I to the CDSA.

Some submissions focused on drug control policy issues that are beyond the scope of this regulatory amendment, such as issues pertaining to the effectiveness of criminal sanctions in combating illicit drug use.

Law enforcement organizations, including the Royal Canadian Mounted Police and the Canadian Association of Chiefs of Police, as well as the Canada Border Services Agency, have indicated their support for this regulatory amendment.

Implementation, enforcement and service standards

The addition of “methylenedioxypyrovalerone (MDPV), namely 3,4-methylenedioxypyrovalerone and its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues” to Schedule I to the CDSA and to the Schedule to Part J of the FDR will come into force upon registration.

Since all activities with MDPV, including possession, trafficking, production, distribution, import and export will be illegal upon registration of this regulatory amendment unless authorized by regulation, Health Canada advises persons in possession of this substance or any controlled substance to seek legal advice if they have questions about compliance.

Health Canada will contact parties known to be involved in activities with MDPV for scientific and research purposes and assess applications for authorization of these activities according to the regulations. In addition, Health Canada will notify all stakeholders (e.g. law enforcement, provincial/territorial ministries of health, provincial/territorial licensing authorities for medicine and pharmacy and the research community) of this regulatory amendment and provide relevant links on the Department’s Web site.

Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA or its regulations. Criminal prosecution for offences under the CDSA or in relation to a contravention of the CDSA may involve the application of a fine and/or a term of imprisonment. This is the responsibility of the criminal justice system.

Health Canada will be responsible for assessing any incoming requests for permission to conduct research involving MDPV and for monitoring compliance with Part J of the FDR.

Contact

Nathan Isotalo
Regulatory Policy Division
Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Telephone: 613-941-1511
Fax: 613-946-4224
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@ hc-sc.gc.ca

Footnote a
 S.C. 1996, c. 19

Footnote 1
 S.C. 1996, c. 19