Court File and Parties

Court File No.: Toronto Date: 2013-02-26 Ontario Court of Justice

Between: Her Majesty the Queen

— And —

Adam Wookey – And – Purepillz Corporation – And – Pure Principles Inc.

Before: Justice L. Chapin

Heard on: April 16, 17, 19, 20, June 7, 8 and September 20, 2012

Reasons for Judgment released: Tuesday, February 26, 2013

Revised Ruling: To include consistent reference to all three defendants

Counsel:

• E. Gilman, for the Crown
• R. Marzel, for the accused Adam Wookey, Purepillz Corporation and Pure Principles Inc.

Judgment

Justice Chapin:

[1] Motion for Directed Verdict

[1] This is a ruling on a motion for a directed verdict. The issue is whether or not the substance that Mr. Wookey and Purepillz Corporation and Pure Principles Inc. were selling is caught within the definition section of "drug" in section 2(b) of the Food and Drug Act. Drug is defined in that section as follows:

"drug" « drogue »

"drug" includes any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying organic functions in human beings or animals, or

(c) disinfection in premises in which food is manufactured, prepared or kept;

[2] Defence Position on Legislation

[2] Mr. Marzel indicated that he didn't contest that the Crown could likely prove that BZP is a substance that modifies bodily functions and could also likely establish that the defendants made claims in relation to "getting high". His focus is on how the legislation should be interpreted.

[3] Charges and Agreed Statements of Fact

[3] The defendants are charged with a number of offences pursuant to s. 31 of the Food and Drugs Act. Two agreed statements of fact were filed with the court. They read as follows:

ADAM WOOKEY

– and –

PUREPILLZ CORPORATION

– and –

PURE PRINCIPLES INC.

AGREED STATEMENT OF FACTS

1. Adam Wookey incorporated Purepillz Corporation (Ont Corp # 1742815) on August 8, 2007. Adam Lincoln Vance Wookey was the director, president and chief executive officer with an address of 119 Hazelton Ave, Toronto (M5R 2E4).

2. On January 17, 2008, Adam Wookey incorporated Pure Principles Incorporated (Ont Corp # 1757668) at 37A Hazelton Avenue, Toronto (M5R 2E3). Adam Wookey is the director and chief executive officer.

3. Between March 2008 and June 2010, Purepillz imported (and distributed in Canada) 1-Benzyl-Piperazine [BZP] from Stargate Enterprises, a company located in New Zealand. The products containing BZP were shipped from outside Canada by Stargate to Adam Wookey and Purepillz.

4. On August 7, 2008, Canadian Border Services Agency officers intercepted a shipment from China of capsules from "Stargate Enterprises/Stargate International." The shipment was consigned to "Pure Pillz Corp." at 1-110 Cumberland Street, suite 402, Toronto, Ontario, M5R 3V5. These capsules contained BZP, were packaged, and ready for sale and consumption.

5. Between March 2008 and January 2010, Purepillz Corporation had a retail location and sold 'Freq,' 'Peaq,' 'Rush,' 'Rush2,' 'Spun,' and 'Flow' (i.e., Purepillz capsules containing BZP) at 266 Adelaide Street West, Toronto.

6. Adam Wookey's Purepillz business card lists him to be a "distributor" for:

• STAR GATE
• HARM REDUCTION SOLUTIONS

7. Between March 2008 and January 2010, Purepillz sold (by way of on-line internet sales at www.Purepillz.ca) 'Freq,' 'Peaq,' 'Rush,' 'Rush2,' 'Spun,' and 'Flow.' The capsules contained BZP.

8. Between March 2008 and June 2010, from Toronto, Purepillz Corporation sold 'Freq,' 'Peaq,' 'Rush,' 'Rush2,' 'Spun,' and 'Flow.' These capsules contained BZP and were sold to both retail locations and individuals across Canada.

9. On January 12, 2010, Health Canada executed search warrants on three locations: (1) 266 Adelaide Street West, Toronto, Ontario; (2) 119 Hazelton Avenue, Toronto, Ontario; and, (3) 1-110 Cumberland Street, suite 402, Toronto, Ontario.

10. As a result of the aforementioned search warrants, Health Canada seized the following items from the 266 Adelaide Street West Purepillz retail location, inter alia:

• Cash register with current receipts
• Notebook and promotional materials for Purepillz
• Wrappers and packaging for BZP products (approximately 1200 packaging cards for Rush, Flow, and Freq)
• Packet of 2 pills (Rush) under cash register
• 25 x 2-packs (Flow)
• 12 x 2-packs (Peaq, white)
• 25 x 2-packs (Rush, orange)
• 28 x 2-packs (Spun, blue/white)
• 18 packs of Aroma (incense)
• 13 x 2-packs (Rush)
• 77 orange capsules (containing 88.2 mg/capsule of BZP)
• 44 orange capsules marked "Rush2" (containing 108.5 mg/capsule of BZP)
• 1 bag white capsules, 3 blister 4-packs
• Invoice/shipping sticker in name of Purepillz
• 30 x 3-packs (Spun, blue/white)
• 1 x 3-pack (Flow, blue)
• 1 x 2-pack (Rush, orange)
• 1 x 2-pack (Rush2, orange)
• 4 x 2-pack (white); 2 x 2-pack (orange)
• 2 x 2-pack (blue/green); small ziplock w. 10 pink capsules
• A sales receipt (in the name of Purepillz)
• 1 box with:
  • 4 bags of (Peaq, white) 2-packs (approx. total 350 packs)
  • Bag of white capsules (500-600 Peaq)
  • Bag of 222 blue capsules (containing 52.9 mg/capsule of BZP)
  • Bag of orange capsules (664 Rush capsules containing 63.1 mg/capsule of BZP)
  • Bag of 30 x Aroma
  • Bag of approx 596 white (unlabelled) pills (containing 81.5 mg/capsule of BZP)
• Bag of light brown/beige pills containing 1267 capsules with BZP
• Box of labels and packaging for Purepillz BZP capsules
• A laptop computer
• Shipping receipts
• 5 bags containing BZP powder (raw materials for the production of capsules)
• Bag of 7 tablets (on cash register)
• Cash register receipts
• Product/inventory list (55 copies)
• Gram precision scale
• Tanita digital scale
• Bag of 1027 orange capsules labelled as Rush2
• UPS waybills
• Bag of small plastic pouches
• Boxes of labels for approx 2400 x Rush, Peaq, Freq, est. 2100 x Flow
• PC Green shopping bag containing finished product:
  • 55 x 3-packs Flow
  • 56 x 2-pack Rush
  • 1 x 2-pack Perq
• A beige brown Longo bag with finished product:
  • 99 x 3-pack Flow
  • 61 x 2-pack Rush
  • 58 Rush2 2-pack (labels)
• 8 loose blue pills
• 615 blue capsules labelled Flow in a sealed plastic bag (6" x 8")
• Shipping receipts and documentation
• Purepillz invoices
• Sales receipts

11. As a result of the aforementioned search warrants, Health Canada seized the following items from Adam Wookey's residence at 119 Hazelton Avenue, inter alia:

• Various documents bearing the name Purepillz
• Bottles and bags of pills – Blue Lagoon, Cherry Pop, Puff, Zonk, Empathy, Energy, Entropy
• Letters and Pay Pal receipt addressed to Adam Wookey
• Letter from Adam Wookey (representing Stargate) to Professor Alan Young
• 11 x 4-pack red (unlabelled) pills; 1 x 2-pack Rush2; unlabelled pills (blue/white, pink)
• Bag of BZP
• Various packaging materials (including for Flow, Freq, Rush), Purepillz pill labels, empty capsules
• Bag of clear capsules filled with beige powder
• Bag of white and purple capsules, 1 container of 4 "Spun" capsules
• A Purepillz banner (signage)
• 3 electronic digital weigh scales
• Purepillz banner, hats, t-shirts, and other promotional material
• 451 sheets of stickers for Purepillz Sour & Rush
• Invoices and order forms in name of Purepillz
• 1 green tablet, 1 orange capsule, 1 white capsule
• Stargate document related to Purepillz
• Business cards
• Empty capsules
• Capsuling equipment
• Notebook of store locations
• 66 page paper "Assessment of Risks Associated with Piperazine Based Social Tonic (PBST) use"
• Packing slip from Capsuline to Adam Wookey – Dec 19, 2008
• UPS Store mailbox agreement for Purepillz signed by Adam Wookey
• 3 single packs (Peaq); 3 unlabelled purple/white capsules, 2 2-pack Meo pills
• 2 Spun capsules
• 2 pink capsules (unlabelled); 1 blistered capsule (unlabelled); 2 Peaq capsules

12. As a result of the aforementioned search warrants, Health Canada seized the following items from a post box rented by Purepillz at 1-110 Cumberland Street, suite 402, Toronto, Ontario, inter alia:

• Various envelopes addressed to Adam Wookey
• Various envelopes addressed to Purepillz

13. Neither Adam Wookey nor Purepillz Corporation nor Pure Principles Incorporated nor any other person affiliated with these persons have made an application to Health Canada for a drug identification number (DIN) for any of the Purepillz products that are the subject of these charges. Health Canada has never assigned a drug identification number for any of the Purepillz products that are subject to these charges.

14. Neither Adam Wookey nor Purepillz Corporation nor Pure Principles Incorporated nor any other person affiliated with these persons have filed with Health Canada a new drug submission, extraordinary drug submission, an abbreviated new drug submissions or an abbreviated extraordinary use new drug submission relating to any of the Purepillz products that are the subject of these charges. Health Canada has never assigned a notice of compliance in respect of any of the Purepillz products that are subject to these charges.

15. Between March 2008 and June 2010, the Purepillz' website (www.Purepillz.ca) was on-line. The site was utilized to complete sales of, and provided information regarding, 'Freq,' 'Peaq,' 'Rush,' 'Rush2,' 'Spun,' and 'Flow.' The following was on www.Purepillz.ca between March 2008 and June 2010, inter alia:

a. Description of BZP products for sale and their specific dose levels:

i. Peaq: Intensely Speedy and mildly Euphoric Effect

• 170 mg BZP/capsule
• Peaq is a high level energy pill with moderate but satisfying euphoric effects. Great for parties and clubbing and guaranteed to keep you going hard all night.
• No recommended dose.

ii. Tweq: Psychedelic sensual Party Biscuit

• 100 mg BZP/capsule
• Tweq is moderately speedy with stronger psychedelic/sensual effects. Great for those who don't want to the full intensity of Peaq but still want more stimulation (speedy/sensual/psychedelics) than Freq – a nice middle ground
• No recommended dose.

iii. Freq: Psychedelic Sensual Stimulation

• 70 mg BZP/capsule
• Freq provides a sensual buzz with more visuals and psychedelic effects as you increase the dosage. Great to just sit back, relax and enjoy the trip. Normally come in a pack of six tablets.
• No recommended dose.

iv. Spun: Super-Psychedelic Stimulation

• 45 mg BZP/capsule & 45 mg Piperazine blend/capsule
• Great Psychedelic effect with a milder speedy feeling. A unique blend of four piperazines, organic compounds known for their "mildly hallucinogenic" and "euphoric" effects. There is no other psychedelic pill like this on the market…a unique mixture with high ingredient synergy for a great trip, with lots of laughs and smiles and less speedy than typical club pills.
• Maximum recommended serving: 2 capsules (45 mg BZP/capsule) with a maximum of 4 capsules over a 24 hours period.

v. Flow

• 80 mg BZP/capsule & 40 mg Flipperazine/capsule
• Moderate energy boost with a new blend of increased euphoric stimulation. This is a very popular product with a nice euphoric effect. If you like the effect of rush you will like this product as it is similar but with a new blend of piperazines to create a unique new buzz. This product produces an effect similar to Rush2 but at a slightly milder serving.
• Maximum recommended serving: 2 capsules (80 mg BZP/capsule) with a maximum of 4 capsules over a 24 hours period.

vi. Rush: E-sensory Stimulation

• 105 mg BZP/capsule
• A higher than average speedy effect with a strong euphoric feeling which becomes psychedelic at higher doses. Give you an extreme rush and leaves you saying 'whoa'. The closest legal experience to MDMA/Ecstasy of any pill on the market. Excellent for clubbing, partying and dancing.
• Maximum recommended serving: 2 capsules (105 mg BZP/capsule) with a maximum of 4 capsules over a 24 hours period.

vii. Rush2

• 105 mg BZP/capsule
• Lower energy boost then Peaq with a new blend of increased euphoric stimulation.
• Maximum recommended serving: 2 capsules (105 mg BZP/capsule) with a maximum of 4 capsules over a 24 hours period.

b. Pricing of BZP capsules:

i. By unit:

• Tweq: $30 per 2-capsule pack
• Peaq: $20 per 2-capsule pack
• Freq: $10 per 2-capsule pack
• Spun: $20 per 2-capsule pack
• Flow: $25 per 3-capsule pack
• Rush: $20 per 2-capsule pack
• Rush2: $20 per 2-capsule pack

ii. Bulk/wholesale pricing:

• Rush: 6 x 2-capsule packs for $100
• Rush2: 13 x 2-capsule packs for $200

iii. Examples of monthly discounts and special pricing:

• Peaq: 25 x 2 pill packs for $350 (30% off $500)
• Peaq: 15 x 2 pill packs for $240 (20% off $300)
• Spun: 25 x 2 pill packs for $350 (30% off $500)
• Flow: 25 x 3 pill packs for $450 (28% off $625)
• Rush2: 25 x 2 pill packs for $350 (30% off $500)
• Rush: 25 x 2 pill packs for $350 (30% off $500)

c. The effects of BZP:

BZP is a stimulant similar to speed or an amphetamine, yet more euphoric. The higher the level of BZP, the more "speedy" the pill will be.

d. Verbiage from Purepillz.ca:

i. Home page:

Purepillz is a Canadian retailer and independent direct seller of "Social Tonics." The term "Social Tonic" was first coined by Stargate international to describe a range of products they developed and brought to market as safer legal alternative to more dangerous street drugs. Many competitors have since tried to ride on Stargate's coat tails and capitalize on the demand for the products they pioneered and carefully formulated. However, none of these other companies have kept the same social conscience, or commitment to consistently create products that are both safer and of the highest quality.

ii. "Company Info":

Purepillz is a solutions provider in the area of drug harm reduction. We sell retail products which act as the most practical alternatives with the least potential for harm. If you have a retail outlet or a venue through which you would like to sell our products please contact info@Purepillz.ca

We believe that by providing products which offer a low potential for abuse and harm we can contribute to a realistic, socially responsible, evidence based future for drug policy in Canada.

We bring the new breed of club pills and cutting edge products to Canadian adults over 18 years of age, and remain committed to promoting them as the most viable and least harmful alternatives available on the market.

iii. On a page titled "Store Locations – Store locations by Province":

Please note, all store locations are no longer listed because of the potential for Government theft

Please contact us via email, to contact an independent direct seller in your area

iv. "Principles":

Purepillz corporation and its affiliates are dedicated to providing the highest quality recreational pills available on the market today. We believe that the existence of illegal drugs, the drug trafficking market, and rampant drug abuse cannot be dealt with through conventional means. The battle against illegal drugs and drug trafficking must take place on an individual level as the current laws and legislation are inherently flawed, unsuccessful, and outdated. The nature of the problem is this: there is an enormously profitable market that will always exist for both regulated and banned substances. No amount of prosecutions, raids, or drug busts are capable of eradicating the harsh reality of the human condition.

Due to the value and profitability of illegal narcotics, people will take great risks to purchase and sell these substances. The cycle of abuse is one that only serves to create a dangerous situation in which dealers resort to violence and crime, drug abusers are ignored and imprisoned, and large quantities of taxpayer dollars are spent in an exhaustive effort to win the never-ending "War on Drugs". This current paradigm makes the trafficking of narcotics so unnaturally profitable that it inevitably corrupts good individuals, drawing them into a life of crime and potential imprisonment.

On the other side of the coin, drug abusers have virtually no alternative other than to submit themselves to a dangerous process of purchasing substances which are (for the purpose of profit) of the lowest potential quality. Dangerous mixtures of narcotics are not quality-controlled and there is virtually no way of ensuring against them being extremely harmful or ultimately fatal. Rather than attempting to approach this crisis with an iron fist and without compassion, rather than being responsible for making criminals and corpses, we believe that society must begin to take a progressive and realistic perspective in our endeavors to alter the landscape of drug trafficking. We cannot turn our backs on those who are caught up in this struggle; instead we must challenge the old methods and find innovative new perspectives and alternatives.

There are several aspects to our approach that require the integration of different methods in order to find a more humane and effective way of deflating the current crisis. The problem must be dealt with on many different levels: intelligent and informed law enforcement, proper social and medical services to help abusers and potential abusers, the spreading of general information and awareness (paying special attention to the more vulnerable subcultures often riddled with recreational use), youth, and more generally anyone who might be faced with a decision to use.

There must be the creation of an alternate accessible market of safer and regulated alternative substances in an effort to derail the illegal market of banned substances, while providing the general public who will inevitably choose to use with an option that offers a significantly reduced potential for harm. The approach cannot simply be reactionary, we must spread awareness and provide safer, regulated, and well-tested alternatives to the harmful and dangerous illegal drugs circulating in our society today.

Purepillz is dedicated to spreading awareness about harmful drugs and their effects in order to improve the public's general understanding of how they can stay healthy and safe. More importantly, in the absence of abstinence, it is imperative that individuals are given a choice to use safer alternatives, rather than their more harmful counterparts. All of our products are of the highest quality and have been specifically designed to have a significantly reduced potential for harm and addiction. Furthermore, none of the ingredients in any of our products have a history of seriously harmful or fatal effects when taken in accordance with the directions, cautions and recommended dose. Ultimately, Purepillz is dedicated to providing the most respected and highest quality brands with the best reported user experiences to ensure that you can have a realistic alternative to harmful illegal drugs.

v. "Disclaimer – Terms":

Disclaimer of Liability

…We do not recommend the use of the products on this site by anyone with a mental illness, psychological or medical condition. Products on this site are not suitable for use by pregnant or lactating mothers. Do not use products on this site if you have high blood pressure, heart or thyroid disease or if you are taking any other prescription drug…

Warning

DO NOT underestimate the powerful effects of these products. DO NOT exceed the stated dose on the packet. These products may cause increased heart rate and short term insomnia. Many products listed contain PHENYLALANINE.

16. Capsules seized from both 266 Adelaide Street West and 110 Hazelton Avenue during the execution of the January 12, 2010 search warrants were packaged, labelled, and ready for sale and consumption. Capsules that were labelled 'Freq,' 'Peaq,' 'Rush,' 'Rush2,' 'Spun,' and 'Flow' contained BZP.

17. Adam Wookey, Purepillz Corporation, and Pure Principles Inc. maintained bank accounts with the Royal Bank of Canada (RBC). A production order was obtained for these accounts. Deposits into the Purepillz Corporation account with RBC (account #06702-1135607), from May 2009 to April 2010, establish an average monthly gross revenue of $17,016.93.

And

The products sold on www.Purepillz.ca were represented for recreational purposes - this was the general and overarching theme of the website's claims in relation to the products that form the substance of these charges. The specific claims of the site's individual product descriptions (of the products that form the substance of these charges) were recreational in nature only.

Crown Evidence – Viva Voce Evidence

Ms. Christina Amin

[4] Ms. Amin has been employed as a compliance officer at the Health Canada - Health Products and Food Branch Inspectorate since January of 2007. Compliance officers deal with human drugs, natural health products, veterinary products and enforce the sections of the Food and Drug Act and regulations that relate to those products.

[5] Ms. Amin was asked to look into the Purepillz website as a result of a trade complaint.

[6] Ms. Amin's first direct communication with Mr. Wookey was on April 3, 2008 over the telephone. He advised her that he was the Manager of Purepillz and she advised him that a complaint had been made with respect to Purepillz products. She told him that the products Freq, Peaq, Rush and Spun required drug identification numbers (hereinafter referred to as DIN) if they were to be sold in Canada and he would need to get an establishment licence (hereinafter referred to as EL) in order to fabricate, distribute, package and label these products. Mr. Wookey responded by saying that he only imported and distributed the products. Ms. Amin informed him that Health Canada was requesting that he stop selling all four products and cease all licensable activities unit the appropriate licenses were obtained.

[7] Ms. Amin followed up this conversation by sending a letter on April 7, 2008 which noted that a search had been conducted in Health Canada records for both a DIN and an EL. In that letter she explained that the products being sold by Purepillz were considered to be drugs under the definition in the Food and Drugs Act and provided the requirements for the drug as well as some information to assist his application for both a DIN and EL. She also provided several Health Canada websites specifically relating to drug identification numbers and establishment licence applications.

[8] Ms. Amin received a response from Mr. Wookey on April 17, 2008. In this letter he indicated that he understood the need for regulation of these types of products. He also advised her that New Zealand had provided for a new class of drugs for recreational purposes that could be regulated and requested a face to face meeting with Health Canada and another gentleman named Matt Bowden.

[9] Ms. Amin responded by sending an email message on April 25, 2008 declining the invitation for the meeting as her office was not involved in legislative changes and, she was aware that Mr. Bowden was already scheduled to meet with other public health officials and members of parliament to discuss drug policy in Canada. Her email also included a request, once again, for him to stop the sale of Freq, Peaq, Rush and Spun and associated bulk products and to cease to conduct any licenceable activities and to reply by April 30, 2008.

[10] On April 30, 2008 Ms. Amin received an email message from Mr. Wookey indicating that he had passed on her request to his legal department and referred her to a CBC report concerning the legality of these products.

[11] On May 8, 2008 Ms. Amin responded and advised Mr. Wookey that there must have been some sort of misunderstanding in the CBC report as BZP and TFNP are considered to be new drugs in Canada and they are subject to regulation and require DINs. Once again, she made a request that he stop the sale of these products and obtain the necessary DIN and EL. She also proposed a face-to-face meeting.

[12] On May 29th, 2008 Ms. Amin, along with others from her office, met with Mr. Wookey and Mr. Powden. The representatives from Health Canada wanted to approach the meeting as an educational session. They went over the Food and Drug Act and highlighted certain areas regarding enforcement and provided him with a formal letter asking Mr. Wookey to stop selling the substance and to stop all licenceable activities. Mr. Wookey said that he would have his lawyers look at the letter. Ms. Amin could not recall if there was any discussion during the meeting as to whether or not recreational drugs fall within the scope of the definition of drug in the Food and Drug Act. Ms. Amin also followed up by sending a second letter on May 29, 2008 to the same effect and asked for a response by June 5, 2008.

[13] On June 5th, 2008 Ms. Amin spoke to Mr. Wookey. He advised her that he would stop importing the product but did not say that he would stop sales of it. He was asked to provide a written confirmation that he would stop selling the product; however, he failed to do so.

[14] On July 8, 2008 Ms. Amin hand delivered a letter to the Purepillz retail location in Toronto asking Mr. Wookey to stop selling the product. The letter also indicated that if he did not comply Health Canada may take further action pursuant to their compliance policy 0001. Mr. Wookey did not respond to this letter.

[15] Ms. Amin sent another letter by registered mail on September 12, 2008 specifically requesting that he stop selling the product, particularly from the Purepillz website. There was no response to this letter either. The letter indicated that if it was not signed and received by September 19, 2008 Health Canada may take further compliance action in accordance with their compliance and enforcement policy 0001.

Dr. Collette Strnad

[16] Dr. Strnad has worked for Health Canada as a Senior Scientific Advisor regarding drug safety issues for the last thirteen years. Prior to that she worked for Heath Canada for ten years reviewing drugs that affect the central nervous system. Her academic credentials include a PhD in pharmacology from the University of Alberta. Dr. Strnad also serves on an expert working group on standards for drug research and development, regularly speaks at conferences on drug safety issues and has co-authored several white papers on drug safety issues that have been published in the "American Heart Journal". Dr. Strnad was qualified as an expert in the area of regulatory pharmacology and specifically, the pharmacology of BZP and its effect on the human central nervous system.

[17] In the spring of 2010 Dr. Strnad was asked by a Senior Medical Advisor of Risk Management at Health Canada to prepare a document that discusses the basis upon which BZP qualifies as a drug. Dr. Strnad was instructed to discuss its pharmacodynamics and focus on clinical and non-clinical dynamics that demonstrate the pharmacodynamic effects of BZP. She explained that "pharmacodynamics" is the effect of a drug on an intact animal or human tissue or cell, and the effect of the drug on living systems involving changes at molecular levels or changes to intact organ.

[18] Dr. Strnad conducted a review of all available scientific literature and various websites on the internet, on-clinical studies (laboratory studies involving rats and monkeys) and clinical studies involving humans. Her conclusions after reviewing the material were as follows:

• BZP has an effect on the brain. It is perceived by experienced drug users as having an exciting effect, similar to amphetamine. In drug naive individuals there are also subjective effects such as changes in mood and perception.

• BZP is readily absorbed in the human body and peaks after 1 hour of ingestion and has a half-life of 5½ hours.

• BZP inhibits 3 enzymes in the liver which could have implications for interactions with other drugs.

• BZP elevates the heart rate and blood pressure, increases pupil size and causes flushing of the skin and sweating.

• BZP can cause severe anxiety, panic attacks, hallucinations, severe headaches in some individuals.

• BZP would have abuse liability - in other words would be an addictive substance.

• BZP was found to be a substitute for amphetamine.

• BZP in combination with alcohol in test subjects caused severe adverse reactions such as anxiety, agitation, hallucinations, panic attack and severe headache.

[19] Dr. Strnad advised that the amount of BZP used in the clinical trials was between 100 and 300 milligrams. The recommended dosage on the Purepillz website was from 80 to 420 mg per day and between 45 and 200 mg per dose.

[20] In cross-examination Dr. Strnad said that in order for a new drug to be approved the applicant must show that it is safe, effective and of good quality. She explained that it would not be likely that a recreational drug would be approved by health Canada as most have considerable abuse liability and toxicity to the cardiovascular system.

Eric Ornsby

[21] Mr. Ornsby is employed by Health Canada and is the Manager of the Therapeutic Products Directorate (hereinafter referred to as the TPD). He has worked there for 30 years and has been the manager for 12 years. His responsibilities include participation in advisory committees, specialized reviews and the reconsideration process (when a drug is refused the sponsor has a right to appeal that decision). The TPD also has a classification area that classifies products according to the appropriate regulatory framework.

[22] Mr. Ornsby advised the court that the Food and Drug Act was first created in 1920 and that since that time there have been modifications. The Act is designed to protect the health and safety of Canadians regarding products they consume or use on their body or use in a therapeutic manner. The Act protects the public by giving authority to define regulatory frameworks for certain products that are captured in the Act such as cosmetics, drugs, foods and devices.

[23] His office receives 40 to 50 applications per year. The majority are from manufacturers who are trying to determine the regulatory framework their product would fall under to get their product to market. His office also gets requests from inspectors at the border if there is a shipment of a product that they don't know about to obtain a classification.

[24] Mr. Ornsby testified that Section 2 of the Act defines what a drug is.

"drug" includes any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying organic functions in human beings or animals, or

(c) disinfection in premises in which food is manufactured, prepared or

[25] Mr. Ornsby's evidence was that 80 percent of drugs would fit into category (a) and (b) of the definition. Examples of drugs that fit category (b) would be oral contraceptives, colon cleansers and caffeine if the manufacturers are making claims about warding off fatigue. Caffeine also qualifies as a food if it is in liquid form. Caffeine could also qualify as a "natural health product" as it is a substance that occurs in nature. The "natural health product" category is a subset of the "drug" category. When caffeine is found in energy drinks it is categorized as a natural health product.

[26] Mr. Ornsby explained that drugs that have been approved by Health Canada have drug identification numbers and natural health products that have been similarly approved have natural product numbers. Examples of products with NPN's would be "Red Bull" energy drinks and "Wake-Ups" pills.

[27] In October of 2007 Mr. Ornsby testified that the TPD received a request for an inspector at the New Brunswick border regarding a quantity of white pills that were detained at the border. Their lab analysis had determined that the pills contained BZP. His team looked into this substance and determined that it would act similar to an amphetamine and that it was a controlled substance in the United States of America. The conclusion of the TPD was that it was an unapproved drug.

[28] In Mr. Ornsby's opinion BZP is a synthetic compound that is captured under the Food and Drug regulations. There are two frameworks under the Food and Drug Regulations in order to gain approval to sell. Older drugs that have been on the market through other vendors just go through a DIN application as they have already been assessed for safety and efficacy long ago. Aspirin would be an example of an older drug that has proven to be safe and effective.

[29] A new synthetic product would go through division 8 of the Food and Drug Regulations. In 2008 the TPD received two DIN applications for BZP which indicated that the drug could be used for "stress management".

[30] Mr. Ornsby explained the procedure required for a sponsor who wanted to sell a new synthetic product. The sponsor would have to complete a new drug submission form in order for the Minister to assess the safety and effectiveness of the drug. The applicant would have to show that a well-designed clinical trial had been conducted which confirmed that the drug did what it was claiming to do. Studies involving animals would also be required to determine whether or not there was long-term toxicity or was cancer causing.

Jocelyn Kula

[31] Jocelyn Kula is a manager of the Regulatory Policy Division within the Office of Controlled Substances at Health Canada. Her duties are to supervise staff that interpret and analyze the regulatory framework for controlled drugs and substances in Canada. This includes precursor chemicals. Her office is responsible for developing and amending regulations under the Controlled Drugs and Substances Act (hereinafter referred to as the CDSA).

[32] Ms. Kula holds a Bachelor of Science degree from McGill University with a double major in microbiology and immunology.

[33] Ms. Kula testified that the legislated framework for controlled substances in Canada is the CDSA. The CDSA is the means by which Canada honours its obligations under the three United Nations Drug Control Conventions. The three U.N. conventions form the basis for the current global drug control system. As Canada is a signatory to those conventions there is a requirement to have a comprehensive legislative framework for controlled drugs and substances in effect.

[34] The purpose of the CDSA is to control substances that can alter mental processes and may produce harm to health or society when diverted or misused. Prior to the CDSA, which came into force in 1997 the Narcotics Control Act and the Food and Drugs Act Parts III and IV was the legislative framework.

[35] The CDSA has a number of schedules which list substances. In deciding which schedule to place a drug in Ms. Kula's group looks at six different factors as follows:

• The chemical and pharmacological similarities with other substances already listed in the schedules
• The use of the substance (medical or therapeutic)
• The international requirements and trends in scheduling
• Potential for abuse and/or addiction both physical and psychological
• The extent of the actual abuse in Canada and internationally
• Risk to public health and safety

[36] There are eight schedules; five contain a list of substances that are loosely organized around chemical structure. Schedule 1 contains opiate narcotics, schedule II contains cannabis and the majority of schedule III substances are stimulants.

[37] Ms. Kula explained that there is no definition for the word drug in the CDSA as it pertains to substances whether they are narcotics or industrial substances. She noted that many substances in the CDSA are also regulated under the Food and Drug Act or its regulations.

[38] When a new substance comes to the attention of Health Canada it collects any information about all of the different factors and summarizes it all in a single document that sets out options for senior management to consider. Once a decision is made by senior management that the substance should be listed in the CDSA her office goes through the process of determining which schedule it should be placed in.

[39] Once a substance is listed in the CDSA any activities with that substance are illegal unless there is a specific exception for its use created in the legislation. Codeine is an examples of a substance that is listed but can be used for certain purposes in accordance with the regulations.

[40] Ms. Kula's office was responsible for the scheduling assessment that was carried out for BZP and the subsequent move to regulate it under the CDSA and its regulations. She referred to the Regulatory Impact Analysis Statement for BZP which was made public on April 11, 2012 when it was published in the Canada Gazette, Part 11.

[41] Ms. Kula's office first became aware of BZP through the Canada Border Services Agency indicated that there were seeing a significant increase in the importation of it. In 2006 only five samples of seized controlled substances were found to contain BZP, but over 2,100 samples were found to contain BZP in 2009.

[42] Health Canada had some international discussions regarding the drug and initiated a scheduling assessment. Health Canada was aware that the United States had used their emergency scheduling power to add BZP to their list of substances under the Controlled Substances Act and was aware that New Zealand and the European Monitoring Centre for Drugs and Drugs of abuse had also concluded that BZP should be a controlled substance.

[43] Health Canada concluded that BZP was very similar to amphetamine and it was eventually included in schedule three of the Controlled Drugs and Substances Act on March 30, 2012.

Position of the Parties

Defence

[44] Mr. Marzel, on behalf of the defendants, submits that the Food and Drug Act does not apply to BZP as the legislation was never meant to apply to a "recreational substance". Mr. Marzel points to the history of the definitions of a drug in the Food and Drug Act over time. In 1920 the Food and Drug Act defined "drug" as "all medicines for internal or external use for man or animal". The definition changed in 1927 to "includes all medicine for internal or external use for man or animal, and any substance or mixture of substances intended to be used for the treatment, mitigation or prevention of disease in man or animal". In 1953 the last amendment was made to the definition of drug which now reads "includes any substance or mixture of substances manufactured, sold or represented for use in: (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal, (ii) restoring, correcting or modifying organic functions in man or animal, or (iii) disinfection in premises in which food is manufactured, prepared or kept, or for the control of vermin in such premises.

[45] Mr. Marzel argued that the addition of the Controlled Drugs section of the FDA in 1961 is further evidence of the government's intent to keep rules and regulations regarding recreational substances separate. Schedule G of the 1961 legislation referred to amphetamine, barbiturates and methamphetamine. The Minister of National Health and Welfare was concerned about amphetamine tablets nicknamed "goofballs" in the May 30, 1961 Hansard. The Minister speaks of the medical benefits of amphetamine and the fact that it should be controlled through the FDA and not the narcotic legislation because it would be inappropriate to stigmatize amphetamines.

[46] In terms of statutory interpretation Mr. Marzel submits that a purposive analysis should be undertaken. That is, approaching the interpretation of statutes by looking at the object and purpose of the legislation to give it the interpretation that best meets the goals and objects. See Chapter 8 of Sullivan on the Construction of Statutes, Ruth Sullivan, 5th edition 2008 LexisNexis Canada.

[47] Mr. Marzel noted that there have not been any cases that have considered the definition of drug in this context. However, he argued that some comments in obiter in Hitzig v. Canada, [2003] O.J. No. 3873 (O.C.A.) for authority that BZP should not be considered to be caught in the definition of drug in the Food and Drug Act. That case dealt with the issue of medical marijuana and at pars. 24 and 25 of that decision the court found that marijuana was a drug as defined by s. 2 of the Food and Drugs Act, R.S.C. 1985, c. F. 27 ("FDA") and a substance as defined by the CDSA. The court said "insofar as marihuana is said to have medicinal value, it qualifies as a drug under the FDA."

[48] Mr. Marzel also referred to R. v. Synergy Group of Canada Inc. [2006] A.J. No. 964. That case involved a similar prosecution of a company for failing to obtain a drug identification number. The company involved was selling a vitamin supplement used to treat depression and bipolar disorder. Health Canada ordered to the company to apply for a drug identification number; however, in order for the company to get a D.I.N. the product would have to undergo extensive testing which would take several years and would involve considerable cost.

[49] The company tried many times to contact Health Canada to make a case for continuing to sell their product without the necessity of obtaining a D.I.N. but there was no response. Representatives from the company met with a number of members of Parliament to discuss a private members bill that would allow an amendment to the FDA to permit the sale of the supplement as a food and not as a drug. In April 2003 the defendants wrote to Health Canada that they had serious concerns that if they stopped supplying the supplement to customers many would be at risk of serious harm or suicide. This warning had been sent to Health Canada in writing previously several times with no response.

[50] The judge hearing the case determined that Synergy Group of Canada Inc. could avail themselves of the defence of necessity given the significant harm that could occur to thousands of individuals who were taking the supplement through a support program if they could no longer have access to the supplement. The Court also found that the company had exercised due diligence given that it took all reasonable care that could have been expected of a reasonable person to comply with the requirements of Health Canada.

[51] Further, Mr. Marzel argues that alcohol and tobacco modify organic function yet Health Canada does not require those that sell alcohol and tobacco to obtain drug identification numbers and therefore, BZP should not be caught within the definition of drug in section 2 of the Act. Therefore, the requirement for a D.I.N. and licence establishment does not apply to him.

Crown

[52] Mr. Gilman, on behalf of the Crown, submits that the defence has failed to characterize the purpose of the Act and that the legislation's purpose is to protect Canadians from things that they may ingest or devices they may use.

[53] Mr. Gilman provided amendments that were made to the FDA in 1939 that were not referred to by counsel for the defendants. This amendment added among other things a definition of medicine as "any substance or mixture of substances that may be used in restoring, correcting or modifying organic functions". He submits that the comments of the Minister of Pensions and National Health show clearly that the government was intending to cover any substances that had either medicinal or non-medicinal characteristics. At page 332 of the January 26, 1939 Hansard the Minister states the following:

It is the intention to extend the definition of drugs to include certain substances for which no medicinal claims are made but which may be injurious to human health.

[54] The Crown submits that this is clear evidence of the intention of Parliament in terms of the applicability of the FDA which is to protect Canadians from substances that could be harmful to them and that I should not be tempted to read in the word "health" as Mr. Marzel suggests.

[55] The Crown also submits that I must look at the plain and ordinary words found within the definition of drugs in section 2 (b). The Canadian Oxford dictionary defines restore as "bring back to original state, to bring back to good health, i.e., to cure. It also defines it as "to bring into good state, and to bring into generation". The Crown further submits that the term "organic function" is not defined but each word is individually. Organic is "related to organs" and "function is defined as an activity proper to a person or institution. In short the Crown submits that it is clear that BZP modifies organic function and that it is a drug for the purposes of the FDA.

[56] With respect to alcohol the Crown submits that it is treated as both a food and a drug depending on its use and that the government has decided to deal with it in two different ways. As a food, alcohol is governed by the regulations of the FDA.

[57] The Crown also submits that although Mr. Marzel states that the defendants are not making a health claim the website uses language that tells readers that the Purepillz products are safer and are of a higher quality than others. The company website also talks about its commitment to promoting the drugs "as the most viable and least harmful alternatives available on the market".

Analysis

[58] Statutory interpretation with a purposive analysis is discussed in Ruth Sullivan, Sullivan on the Construction of Statutes, and states that "today purposive analysis is a regular part of interpretation, to be relied on in every case, not just those in which there is ambiguity or absurdity". Later at page 260 in her continued discussion of purposive analysis she sets out the following, "First, there is the remedial construction rule found in the Interpretation Acts of all Canadian jurisdictions. Starting with the first statute on interpretation enacted by the Parliament of Canada in 1849, every federal, provincial and territorial Interpretation Act has included a provision that directs Courts to give every enactment "such fair, large and liberal construction and interpretation which best ensures the attainment of its objects". Although this provision was ignored by Courts for more than a century, in recent years it is often invoked to justify adopting an outcome that promotes the legislature's purpose". I agree that a purposive analysis should be undertaken.

[59] The question then is what is the purpose of the Food and Drug Act? When one reviews the Act, it becomes abundantly clear that the Food and Drug Act is public welfare legislation designed to protect Canadians by enforcing certain standards and regulations regarding foods, drugs, devices etc. I heard evidence from Mr. Ornsby, the Manager of the Therapeutic Products Directorate who explained that the Act was first created in 1920 and that the purpose of the Act is to protect the health and safety of Canadians regarding products they consume or use on their body or use in a therapeutic manner. I accept his evidence.

[60] The Courts have consistently determined that social welfare legislation should be "liberally construed so as to advance the benevolent purpose of the legislation". Therefore, in determining whether or not BZP falls within the definition of "drug" in the Food and Drug Act the definition should be liberally construed to ensure that the purpose of the Act, protecting Canadians from purchasing and consuming a potential harmful substance, is fulfilled.

[61] Health Canada's view certainly is that BZP falls within the definition of drug and given that there is a Therapeutic Products Directorate set up to consider applications for substances to approve drugs. In fact there were two applications in 2008 for DINs which were denied. Further, Dr. Strnad's evidence was that BZP modifies organic functions in humans as it has an effect on the brain, liver, heart and blood pressure.

[62] With respect to Mr. Marzel's reference to the Hitzig, supra decision, the comment that was made with respect to marijuana being a drug as defined by the Food and Drug Act in so far as it has medicinal value has to be considered in the context of the discussion. The Supreme Court was discussing the legislative context of the applicants' argument regarding the constitutional validity of the regulations relating to medical marijuana. The court goes on to discuss the process necessary to have a drug approved under the Food and Drug Act and comments that private industry has not attempted to have this done given the cost. It was not a discussion as to whether or not a substance had to have medicinal value to be considered a drug with respect to that legislation. The comment has no bearing on this case.

[63] The Synergy Group case, supra, also does not assist me. That case involved a consideration of the defences of necessity and due diligence to a charge of not obtaining a DIN number. There was no discussion about the definition of the word "drug" in the legislation.

[64] Mr. Marzel's argument that parliament did not intend to regulate recreational substances through the Food and Drug Act, is answered by an excerpt from parliamentary discussions submitted by the Crown. In the January 26, 1939 Hansard the Minister states the following, "It is the intention to extend the definition of drugs to include certain substances for which no medicinal claims are made but which may be injurious to human health". In my view that comment makes it clear that substances like BZP are caught within this category. It also makes sense to have a process for those employed with Health Canada to test a substance to ensure it doesn't get to market if it could be injurious to health of Canadians and to later list it on a schedule contained within the CDSA.

[65] The motion for a directed verdict is dismissed.

Released: February 26, 2013

Signed: "Justice Chapin"

Footnotes

[1] Dr. Strnad testified that historical experience has shown that laboratory results from studies involving monkeys and rats have to found to accurately predict abuse liability in humans. Transcript April 19, 2012, p. 25, l. 18

[2] The 1961 Single Convention on Narcotic Drugs, the 1971 Single Convention on Psychotropic Substances and the 1988 Convention on Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances

[3] This refers to any knowledge that government might have about health risks associated with the use of the substance in terms of association with crime.

[4] 5th edition 2008, LexisNexis Canada Inc., at page 257

[5] The quote within the quote is from the Interpretation Act, R.S.C. 1985

[6] Supra note 4 at Page 260

[7] Supra note 4 at page 486