R. v. Wookey, 2013 ONCJ 825

COURT FILE No.: Toronto DATE: 2013-07-10 Citation: R. v. Wookey , 2013 ONCJ 825 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, February 26, 2013, May15 and 16, 2013. Reasons for Judgment released on July 10, 2013 E. Gilman ............................................................................................................. for the Crown T. Bryant . for the accused Adam Wookey, Purepillz Corporation and Pure Principles Inc. Chapin J.

Introduction [ 1 ] The defendants are charged with a number of offences pursuant to the Food and Drug Act . The original information contained 33 counts; however the Crown indicated at the outset of the proceedings that they would not be proceeding on counts 7, 14, 21, 28, 30, 31 and 32 and those charges were subsequently withdrawn on May 15, 2013. [ 2 ] The Crown alleges that the defendants were selling a drug, namely 1-(Phenylmethyl) Piperazine [also known as N- Benzylpiperazine or BZP]. The parties filed two agreed statements of fact that were marked as exhibits and the crown called four witnesses.

The defence did not call any evidence. At the end of the Crown case the defendants brought an application for a directed verdict. The issue was whether or not the substance that Mr. Wookey, Purepillz Corporation and Pure Principles Inc. were selling was caught within the definition

section of “drug” in

section 2(

b) of the Food and Drugs Act . I found that BZP was caught within the definition and the application was dismissed see R. v. Wookey , 2013 ONCJ 83 ; [2013] O.J. No. 867 (O.C.J.) . Subsequently there was a change in defendants’ counsel. The Information [ 3 ] The parties agree that the charges fall into six different categories. [ 4 ] Category 1 - Counts 1 – 6 – are allegations that the defendants, between March 2008 and June 2010, in Toronto, were selling a drug in dosage form for which no drug identification number (DIN) number was assigned contrary to

section C.01.014 of the Food and Drug Regulations thereby committing an offence contrary to

section 31 of the Food and Drugs Act. There are six counts as there are six different types of pills containing various amounts of BZP and two of the six pills also contained other substances, Piperazine and Flipperazine. The names and active ingredients of these pills were listed on the Purepillz website ( www.purepillz.ca ) as follows; • Freq (70 mg BZP) • Peaq (170 mg BZP) • Rush (105 mg BZP)

• Rush 2 (105 mg BZP) • Spun (45 mg BZP and 45 mg Piperazine blend), and • Flow (80 mg BZP and 40 mg Flipperazine). [ 5 ] Category 2 – Counts 8 – 13 allege that, between March 2008 and June 2010, in Toronto, the defendants were unlawfully selling, and advertising a new drug without the manufacturer of the drug filing a new drug submission or abbreviated new drug submission and without the Minister issuing to the manufacturer a notice of compliance contrary to

section C.08.002(1) of the Food and Drug Regulations and did thereby commit an offence contrary to

section 31 of the Food and Drugs Act. There are six counts as the charges relate to the six different pills referred to above. [ 6 ] Category 3 – Counts 15 – 20 allege that, between March 2008 and June 2010, in Toronto, the defendants were unlawfully selling and advertising a drug without a DIN on its label contrary to

section C.01.005 of the Food and Drug Regulations and section 9(1) of the Food and Drugs Act thereby committing an offence contrary to

section 31 of the Food and Drugs Act . As in the two previous categories there are six counts as they related to the aforementioned variation in amount, and in some cases combination of substances, in the pills. [ 7 ] Category 4 – Counts 22 – 27 allege that, between March 2008 and June 2010, in Toronto, the defendants were unlawfully selling a drug in dosage form without a label bearing a DIN number contrary to C.01.003 of the Food and Drugs Regulations and section 9(2) of the Food and Drugs Act thereby committing an offence contrary to

section 31 of the Food and Drugs Act. [ 8 ] Category 5 – Count 29 alleges that, between November 2007 and June 2010, in Toronto, the defendants imported drugs containing BZP for sale in violation of

section A.01.040 of the Food and Drugs Regulations thereby committing an offence contrary to

section 31 of the Food and Drugs Act . [ 9 ] Category 6 – Count 33 – alleges that, between March 2008 and November of 2010, in Toronto, the defendants advertised drugs to the general public as a treatment, preventative or cure for addiction contrary to

section 3 of the Food and Drugs Act thereby committing an offence contrary to

section 31 of the Food and Drugs Act . The Evidence [ 10 ] Two agreed statements of fact were filed with the court. They are reproduced here: 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 : a. Cash register with current receipts b. Notebook and promotional materials for Purepillz c. Wrappers and packaging for BZP products (approximately 1200 packaging cards for Rush, Flow, and Freq d.

Packet of 2 pills (Rush) under cash register. e. 25 x 2-packs (Flow) f. 12 x 2-packs (Peaq, white) g. 25 x 2-packs (Rush, orange) h. 28 x 2-packs (Spun, blue/white) i. 18 packs of Aroma (incense) j. 13 x 2-packs (Rush) k. 77 orange capsules (containing 88.2 mg/capsule of BZP) l. 44 orange capsules marked “Rush2” (containing 108.5 mg/capsule of BZP) m. 1 bag white capsules, 3 blister 4-packs n. invoice/shipping sticker in name of Purepillz o. 30 x 3-packs (Spun, blue/white) p. 1 x 3-pack (Flow, blue) q. 1 x 2-pack (Rush, orange) r. 1 x 2-pack (Rush2, orange) s. 4 x 2-pack (white); 2 x 2-pack (orange) t. 2 x 2-pack (blue/green); small ziplock w. 10 pink capsules u.

A sales receipt (in the name of Purepillz)

v. 1 box with: i. 4 bags of (Peaq, white) 2-packs (approx. total 350 packs); ii. bag of white capsules (500-600 Peaq); iii. bag of 222 blue capsules (containing 52.9 mg/capsule of BZP); iv. bag of orange capsules (664 Rush capsules containing 63.1 mg/capsule of BZP); v. bag of 30 x Aroma; and, vi. bag of approx 596 white (unlabelled) pills (containing 81.5 mg/capsule of BZP) w. Bag of light brown/beige pills containing 1267 capsules with BZP x. Box of labels and packaging for Purepillz BZP capsules y. A laptop computer z.

Shipping receipts aa. 5 bags containing BZP powder (raw materials for the production of capsules) bb. Bag of 7 tablets (on cash register) cc. Cash register receipts dd. Product/inventory list (55 copies) ee. Gram precision scale ff. Tanita digital scale gg. Bag of 1027 orange capsules labelled as Rush2 hh. UPS waybills ii. Bag of small plastic pouches jj. Boxes of labels for approx 2400 x Rush, Peaq, Freq, est. 2100 x Flow kk.

PC Green shopping bag containing finished product: i. 55 x 3-packs Flow ii. 56 x 2-pack Rush iii. 1 x 2-pack Perq ll. a beige brown Longo bag with finished product: i. 99 x 3-pack Flow ii. 61 x 2-pack Rush iii. 58 Rush2 2-pack (labels) mm. 8 loose blue pills nn. 615 blue capsules labelled Flow in a sealed plastic bag (6” x 8”) oo. Shipping receipts and documentation pp. Purepillz invoices qq. 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 : a.

Various documents bearing the name Purepillz. b. bottles and bags of pills – Blue Lagoon, Cherry Pop, Puff, Zonk, Empathy, Energy, Entropy

c. Letters and Pay Pal receipt addressed to Adam Wookey d. letter from Adam Wookey (representing Stargate) to Professor Alan Young e. 11 x 4-pack red (unlabelled) pills; 1 x 2-pack Rush2; unlabelled pills (blue/white, pink) f. Bag of BZP g. Various packaging materials (including for Flow, Freq, Rush), Purepillz pill labels, empty capsules h. Bag of clear capsules filled with beige powder i. Bag of white and purple capsules, 1 container of 4 “Spun” capsules j. A Purepillz banner (signage) k. 3 electronic digital weigh scales l.

Purepillz banner, hats, t-shirts, and other promotional material m. 451 sheets of stickers for Purepillz Sour & Rush n. Invoices and order forms in name of Purepillz o. 1 green tablet, 1 orange capsule, 1 white capsule p. Stargate document related to Purepillz q. Business cards r. Empty capsules s. Capsuling equipment t. Notebook of store locations u. 66 page paper “Assessment of Risks Associated with Piperazine Based Social Tonic (PBST) use v. packing slip from Capsuline to Adam Wookey – Dec 19, 2008 w.

UPS Store mailbox agreement for Purepillz signed by Adam Wookey x. 3 single packs (Peaq); 3 unlabelled purple/white capsules, 2 2-pack Meo pills y. 2 Spun capsules z. 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 : a. Various envelopes addressed to Adam Wookey b. 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 DIN for any of the Purepillz products that are the subject of these charges. Health Canada has never assigned a DIN 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 Psychelec [ sic ] 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 (45mg 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 le- gal 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 [ sic ] Peaq with a new blend of increased euphoric stimulation. • Maximum recommended serving: 2 capsules (105mg 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 average monthly gross revenue of $17,016.93. And, the second agreed statement of fact read as follows; 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. In addition to the agreed statements of fact the Crown called four witnesses who are employees of Health Canada. The Crown Evidence Viva Voce Evidence Ms. Christina Amin [ 11 ] 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. [ 12 ] Ms. Amin was asked to look into the Purepillz website as a result of a trade complaint. [ 13 ] 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 a DIN if they were to be sold in Canada and he would need to get an establishment licence (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. [ 14 ] Ms.

Amin followed up 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 she provided the requirements for the drug as well as some information to assist his application for both a DIN and an EL. She also provided several Health Canada websites specifically relating to DINs and EL applications. [ 15 ] 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. [ 16 ] 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 licensable activities and to reply by April 30, 2008. [ 17 ] 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. [ 18 ] 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. [ 19 ] On May 29 th , 2008 Ms. Amin, along with others from her office, met with Mr. Wookey and Mr. Bowden. 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 licensable 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. [ 20 ] On June 5 th , 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. [ 21 ] On July 8, 2008 Ms. Amin hand delivered a letter to the Purepillz retail location in Toronto which requested that the defendants stop selling the product.

The letter also indicated that if the defendants did not comply with Health Canada’s direction to stop selling the pills that further action would be taken pursuant to their compliance policy 0001. The defendants did not respond to this letter. [ 22 ] 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

[ 23 ] 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. [ 24 ] 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 organs. [ 25 ] 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 [1] ) 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 ex- citing 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 5½ hour half-life. • 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, it 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 [ 26 ] 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. [ 27 ] 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 [ 28 ] Mr.

Ornsby is employed by Health Canada and is the Manager of the Therapeutic Products Directorate (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. [ 29 ] Mr.

Ornsby advised the court that the Food and Drugs 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, 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 by the Act such as cosmetics, drugs, foods and devices. [ 30 ] 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 receives requests from inspectors at the border if there is a shipment of a product that they don’t know about to obtain a classification [ 31 ] 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 [ 32 ] 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.

[ 33 ] Mr. Ornsby explained that drugs that have been approved by Health Canada have DINs and natural health products that have been similarly approved have natural product numbers (NPN). Examples of products with NPN’s would be “Red Bull” energy drinks and “Wake-Ups” pills. [ 34 ] 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. [ 35 ] In Mr. Ornsby’s opinion BZP is a synthetic compound that is captured under the Food and Drugs Regulations. The Food and Drugs Regulations provides two ways by which an applicant may obtain approval to sell a drug. 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. [ 36 ] The second avenue of obtaining approval is to apply for a DIN through division 8 of the Food and Drug Regulations . In 2008 the TPD received two DIN applications for BZP, a synthetic product, which indicated that the drug could be used for “stress management”. [ 37 ] Mr. Ornsby explained that the procedure 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 the drug could cause long-term toxicity or cancer. Jocelyn Kula [ 38 ] Jocelyn Kula is the 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 (CDSA). [ 39 ] Ms. Kula holds a Bachelor of Science degree from McGill University with a double major in microbiology and immunology. [ 40 ] 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. [2] 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. [ 41 ] 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 contained the legislative framework. [ 42 ] 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, and • The extent of the actual abuse in Canada and internationally • Risk to public health and safety [3] [ 43 ] 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. [ 44 ] 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 Drugs Act or its regulations. [ 45 ] When a new substance comes to the attention of Health Canada it collects information regarding the enumerated factors above 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. [ 46 ] 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 example of a substance that is listed but can be used for certain purposes in accordance with the regulations. [ 47 ] 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.

[ 48 ] Ms. Kula’s office first became aware of BZP through the Canada Border Services Agency indicated that they 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. [ 49 ] 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. [ 50 ] 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 Crown [ 51 ] The Crown submits that the first group of charges, counts 2 – 6, which deal with selling a drug in dosage form for which there is no DIN number assigned are made out in the agreed statement of fact (ASF). In paragraphs 1 and 2 the ASF indicate that Mr. Wookey was the president, director and chief executive officer of Purepillz Corporation (Purepillz) and that he was also the director and chief executive officer of Pure Principles Incorporated (Pure Principles).

Paragraphs 7 and 8 of the ASF state that between March 2008 and January 2010, Purepillz and Pure Principle sold capsules containing BZP (by way of on-line internet sales at www.Purepillz.ca) with the names ‘Freq,’ ‘Peaq,’ ‘Rush,’ ‘Rush2,’ ‘Spun,’ and ‘Flow.’ [ 52 ] The Crown submits that the relevant legislation is C.01.014. For ease of reference I have set it out here as follows: C.01.014.

(1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to

section C.01.014.6. [ 53 ] Given that the ASF also indicates that the drug was being sold in dosage form in paragraph 15 the Crown submits that I can make a finding that the Crown has proved beyond a reasonable doubt that the defendants committed the offences in counts 1 – 6 and that given that no due diligence defence has been offered they should be found guilty of the offences. [ 54 ] The Crown referred to the punishment

section relating to these offences can be found in s. 31 of the Food and Drugs Act which reads as follows; 31. Subject to

section 31.1, every person who contravenes any of the provisions of this Act or of the regulations made under this

Part is guilty of an offence and liable (

a) on

summary conviction for a first offence to a fine not exceeding five hundred dollars or to imprisonment for a term not exceeding three months or to both and, for a subsequent offence, to a fine not exceeding one thousand dollars or to imprisonment for a term not exceeding six months or to both; and (

b) on conviction on indictment to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding three years or to both. [ 55 ] With respect to counts 8 – 12 that relate to the selling and advertising of a new drug the Crown referred to regulation is found in C.08.002 which states that: “

(1) No person shall sell or advertise a new drug unless (

a) the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister;…” [ 56 ] The Crown submits that this group of offences has also been proven by the facts admitted in the ASF, paragraphs 1,2,7 and 8 which indicate that Adam Wookey was the director, CEO and, president of the two defendant corporations and that all of the defendants did advertise and sell Freq, Peaq, Rush, Rush2, Spun and Flow, that contained BZP.

The Crown referred to the definition of “new drug” which is found in regulation C.08.001(

a) as follows: For the purposes of the Act and this Division, “new drug” means (

a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;…” [ 57 ] The Crown submits that BZP fits within this definition given that it the evidence shows that this drug had not been properly tested and that it had been flagged for possible scheduling in the Controlled Drugs and Substances Act. The Crown points to the evidence of Ms.

Amin that Mr. Wookey had been warned about the illegality of his actions several times as well as the evidence of Dr. Strnad regarding the dangers of consumption of BZP and that it had not been approved for use in Canada. The Crown submitted that paragraph 4 of the ASF sets out that the defendants “had not filed a new drug submission, extraordinary drug submission, abbreviated new drug submissions or an abbreviated extraordinary use new drug submission.” [ 58 ] The Crown also pointed out that Ms. Amin put Mr. Wookey on notice that BZP was considered to be a new drug in her letter of May 8, 2008.

Given this the Crown submits that the Crown has proven these offences beyond a reasonable doubt and as no defence evidence has been called the defendants are guilty. [ 59 ] With respect to counts 15 – 20 the Crown submits that this group of charges refer to the selling and advertising of a drug without a DIN. The regulation is s. 2.0105 and reads as follows; C.01.005.

(1) The principal display panel of both the inner and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned by the Director for that drug pursuant to subsection C.01.014.2(1), preceded by the

words “Drug Identification Number” or “Drogue : identification numérique” or both, or the letters “DIN”. [ 60 ] The Crown submits that the actus reus of these offence have been proven beyond a reasonable doubt given that the evidence is that the products did not have DINs and that as no defence evidence has been called to establish due diligence the defendants should be found guilty of these offences as well.

In response to my question regarding whether or not the Kienapple principle should be applied given that this group of charges is so similar to counts 1 – 6 the Crown submitted that although the offences are similar there are slight differences and that there could be situations where a defendant could be offending one provision and not the other.

Further the Crown submits that Parliament has declared that these are different offences that ought to be enforced and that each offence protects the public in different ways. [ 61 ] The Crown relies again on the ASF for the proof of Counts 22 – 27 given that it was admitted that Mr. Wookey was the controlling mind of the two defendant corporations and that the defendants did sell various pills without a DIN. The Crown also points out that Mr. Wookey never advised Ms. Amin that he was not in a position to make any decisions.

The Crown makes the same submissions as to whether or not these charges ought to be staying having regard to the principle in Kienapple . Given the admissions the Crown submits that the actus reus has been proven beyond a reasonable doubt and as no defence evidence has been called the defendants are guilty of these offences. [ 62 ] Count 29 refers to the offence of importing a drug into Canada in violation of

section A.01.040 of the Food and Drugs Act Regulations which states; A.01.040. Subject to

section A.01.044, no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations. [ 63 ] The Crown relies again on the ASF for proof of the actus reus of this offence as it was admitted that the defendants imported BZP into Canada from Stargate Enterprises at paragraphs 3 and 4. Ms. Amin testified that Mr. Wookey told her that he would stop importing the product but never did. [ 64 ] The last count involved relates to the advertising of drugs to the general public as a treatment, prevention or cure for addiction referred to in

Schedule A as defined in the Food and Drugs Act . The Crown again relies on the ASF which lists all of the claims made on the website Purepillz.ca. The website makes a number of claims that the products are safer legal alternatives to dangerous street drugs. The Crown submits that this proves the actus reus of the offence and as there was no evidence called by the defendants they should be found guilty of this offence as well. Position of the Defence [ 65 ] Mr. Bryant made submissions on behalf of the defendants.

He pointed out that the name of the Corporation that all charges against the Corporation Pure Principles Incorporated should be dismissed because the name of the company was misspelled on the information as “Pure Principals Inc.”. Mr. Bryant also submitted that there was no evidence that there was any action taken by Pure Principles and urged that all charges against that defendant be dismissed. [ 66 ] Mr.

Bryant submitted that the charges before the court are very similar and they are just repeated six times in each of the first four groups of charges; therefore, the Kienapple principle should apply. [ 67 ] With respect to group one, charges 1 – 6 Mr. Bryant submits that the ASF, which was carefully drafted, did not set out that Purepillz and Adam Wookey did certain things in certain paragraphs. For instance paragraphs 3 – 5, 7 – 8, 9, and 15 relate only to Purepillz and not the other defendants. He also points out that paragraph 1 of the ASF says that Mr.

Wookey “was” the director, president and chief executive officer” and doesn’t say he “is” or that he was the director etc. at the relevant time of the offences. [ 68 ] Mr. Bryant points to the second paragraph 2 of the ASF which says that “Adam Wookey is the director and chief executive officer” to show that there is a difference in the use of the present tense and past tense. This is important as in paragraph three it is Purepillz that was importing the BZP and selling it through a retail location and on the internet. Mr. Bryant submits that the website belongs to Purepillz and not Mr. Wookey. Further Mr.

Bryant submits that there is no evidence of who authored the statements on the website. [ 69 ] Mr. Bryant submits that the evidence of Ms. Amin is the only evidence suggesting that Adam Wookey was the operating mind of the corporate defendants is the evidence of Ms. Amin that he was a manager. Mr. Bryant also submits that there is no evidence that anyone purchased anything directly from Mr. Wookey and no evidence that he sold them in dosage form. [ 70 ] Mr.

Bryant referred to the definition of manufacturer under s. 2 of the Food and Drugs Act Regulations which reads as follows; “manufacturer” “manufacturer” or “distributor” means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; (fabricant or distributeur) and submitted that the Crown’s suggestion that Mr. Wookey fell within this definition is incorrect as there was no evidence that Mr. Wookey said that “Purepillz was his mark.

In his submission the Crown would have to have evidence that somebody other than Purepillz was involved in controlling the use of the Purepillz name, and that it was that person that was selling a drug. [ 71 ] With respect to the second group of charges, counts 8 – 13 Mr. Bryant submits that the same arguments apply but concedes that these offences relate to different delicts. In Mr. Bryant’s submission there is no evidence that Mr. Wookey or Pure Principles sold or advertised the drugs. He further submits that the period of time referred to, between March 2008 and June 2010, predates to time period when Dr.

Strnad was asked to prepare a document that discusses the basis upon which BZP qualifies as a new drug. Her report is dated June 21, 2010; therefore, prior to that time Health Canada was uncertain as to whether or not the substance is a new drug. Mr. Bryant

referred to the decision in R. v. M.B.P. (SCC), [1994] S.C.J. No. 27 (S.C.C.). That case involved sexual assaultallegations with respect to a young girl. The Crown wanted to recall the mother of the sexual assault victim regarding the timing of theoffence after the defence announced that they were going to call alibi evidence. The Crown also applied to amend the information toextend the time frame in accordance with the mother’s correction as to the time. The trial judge allowed the Crown to re-open its caseand amend the information.

Ultimately the Supreme Court of Canada held that it was unfair to the accused to allow the crown to do thisgiven that the defendant had announced his intention to call evidence. [72] Mr. Bryant submits that the decision not to call evidence was based on the erroneous time period set out in the information. TheCrown did not make an application to amend the time frame in the information and in Mr. Bryant’s submission that was fatal to theCrown’s case [73] In looking at the third group of charges, counts 15 – 20, Mr.

Bryant relies on his prior submissions but also submits theKienapple principle should apply given that the offences related to the same time frame, the same defendants and the same phrase “didunlawfully sell and advertise”. The only thing that is different is that these offences refer to a lack of a DIN. Given this, in his submissionthe charges should be stayed pursuant to Kienapple if the defendants are found guilty of these offences. Further, Mr.

Bryant submits thatthese offences as drafted in the information do not conform with the legislation as the charges do not refer to the words “in dosage form”. [74] The fourth group of charges Mr. Bryant submits that the same considerations apply to these charges. Mr. Bryant submits thatthe fact that various documents and promotional materials bearing the name Purepillz being found in Mr. Wookey’s residence do notprove the actus reus of the charges as there could be other reasons for the materials being there. [75] With respect to the importing charge, count 29, Mr. Bryant refers again to Dr.

Strnad’s report which, in his submission, showsthat Health Canada was not sure if the substance, BZP, was a new drug during the time frame (November 2007 to June 2010) referred toin the information. Mr. Bryant submits that there is evidence of Purepillz importing a drug but not Mr. Wookey or Pure Principles. [76] The final count relates to advertising a drug to the general public as a treatment, preventative or cure for addiction. In Mr.Bryant’s submission there is no claim in the ASF that this drug was a treatment for addiction.

He submits that it is not described as beinga cure for any addiction, nor is it described as being preventative. In Mr. Bryant’s view the claim would have to be one that referred to aclaim that the substance assists a person in getting away from an addiction. Further he submits that there is no evidence that he is theauthor of the ASF. Crowns Response to the Defence Submissions [77] With respect to the spelling of Pure Principles the Crown concedes that there was a significant typographical error on theinformation. The Crown essentially conceded that the evidence against Pure Principles is weak and that Mr.

Wookey and Purepillzappear to be the main players. [78] The Crown submits that the submission made by Mr. Bryant regarding the omission of the words “in dosage form” in thecharges in group three, counts 15 – 20 should not concern me given that the defendants had enough information to understand what thecharge against them was particularly as the regulation was specified in the counts. [79] Regarding the defence submission that there were no health claims on the Purepillz website the Crown referred to a portion of theASF that I have reproduced here for ease of reference.

More importantly, in the absence of abstinence, it is imperative that individuals are given a choice to use safer alternatives, rather thantheir more harmful counterparts. All of our products are of the highest quality and have been specifically designed to have a significantlyreduced potential for harm and addiction.

The Crown submits that this statement is more than enough to make out the actus reus of the offence with respect to claiming that thereis a preventative aspect for addiction. [80] The Crown conceded that if I find the defendants guilty of counts 15 – 20 and counts 22 – 27 that those charges should be stayed. [81] The Crown takes issue with the defence characterization of Dr. Strnad’s report as the lynchpin of the government’s case. TheCrown argues that

section 2 of the Food and Drugs Act characterizes any substance that modifies organic functioning of a person as asubstance. The Crown also points to the evidence of Mr. Ormsby who testified that there were two DIN applications for BZP in 2008.Mr. Ormsby also testified about an issue in October of 2007 when some pills were seized at the border and he was called upon to make adetermination as to whether or not this was a drug. Mr. Ormsby’s evidence was that it wasn’t even a close call. Finally, Ms. Amin’sevidence was that she advised Mr.

Wookey time after time that this substance was a new drug well before June of 2010. [82] The Crown also takes issue with the defence submission that there is no evidence that Mr. Wookey is the directing mind ofPurepillz Corporation. In addition the ASF the Crown submits that there is other evidence from the witnesses that were called. Ms.Amin’s evidence was that Mr. Wookey was the only person she dealt with who was associated with Purepillz with the one exception ofthe clerk, Jason Spanton, who was at the Adelaide location on July 9, 2008. Mr. Spanton was not surprised when Ms. Amin handed himthe letter.

The evidence that Mr. Wookey undertook to Ms. Amin that he would stop importing the drug is further evidence, in theCrown’s submission, that he was the directing mind of the corporation. There is also the evidence that Mr. Wookey’s address is thesame as the address of Purepillz Corporation, which can been seen in exhibit 8, the letter from Ms. Amin dated September 12, 2008 toMr. Wookey at 119 Hazelton Avenue. [83] With respect to what is located at Mr. Wookey’s residence the Crown submits that this is not just a letter or two or a t-shirt.

TheASF shows that there were hundreds of sheets of sticker, banners, business cards, notebooks of store locations, packing slips, emptycapsules etc. Therefore, the conclusion to be draw is that Mr. Wookey is not an employee. The Crown relies on the decision in in R. v.

Brown [2007] O.J. No. 1580 (S.C.J.) where Justice Hill discusses how to approach circumstantial evidence at paras. 41 – 42 as follows; 41 Circumstantial evidence is "evidence that tends to prove a factual matter by proving other events or circumstances from which theoccurrence of the matter at issue can be reasonably inferred": R. v. Cinous (2002), 2002 SCC 29 , 162 C.C.C. (3d) 129 (S.C.C.)at 172. Put differently but to the same end, "Circumstantial evidence is evidence of a basic fact or facts from which the jury is asked toinfer a further fact or facts": Shepherd v. The Queen (1990), 170 C.L.R. 573 (H.C.

Aust.) at 579. Accordingly, circumstantial evidencefrequently involves proof of a primary fact or facts and the drawing of an intermediate factual conclusion or inference for considerationwith the whole of the evidence to determine whether guilt has been established beyond a reasonable doubt. 42 Circumstantial inferences are ones which "can be reasonably and logically drawn from a fact or group of facts established by theevidence": R. v. Morrissey (1995), (ON CA), 97 C.C.C. (3d) 193 (Ont. C.A.) at 209. Most cases "will involvehiatuses in the evidence which can be filled only by inference": Lameman v.

Canada (Attorney General), 2006 ABCA 392 ,[2006] A.J. No. 1603 (C.A.) at para. 87. "The process of drawing inferences from evidence is not, however, the same as speculating evenwhere the circumstances permit an educated guess": U.S.A. v. Huynh (2005), (ON CA), 200 C.C.C. (3d) 305 (Ont.C.A.) at 307. The same point is made in C.P.R. Co. v. Murray, (SCC), [1932] S.C.R. 112 at 117 in adopting thefollowing dicta from Jones v. Great Western Railway Co. (1930), 47 T.L.R. 39 at 45: The dividing line between conjecture and inference is often a very difficult one to draw.

A conjecture may be plausible but it is of nolegal value, for its essence is that it is a mere guess. An inference in the legal sense, on the other hand, is a deduction from the evidence,and if it is reasonable deduction it may have the validity of legal proof. The attribution of an occurrence to a cause is, I take it, always amatter of inference. The cogency of a legal inference of causation may vary in degree between practical certainty and reasonableprobability.

Where the coincidence of cause and effect is not a matter of actual observation there is necessarily a hiatus in the directevidence, but this may be legitimately bridged by an inference from the facts actually observed and proved. Indeed, as Lord Shaw said inMarshall v. Owners of SS. Wild Rose [26 T.L.R. 608; [1910] A.C. 486, at 494.]: "The facts in every case may leave here and there ahiatus which only inference can fill." [84] The Crown also relies on the Ontario Court of Appeal decision in R. v. Pham (ON CA), [2005] O.J. No. 5127at para. 22 22 That Mr.

Nguyen left the unit and returned with the drugs in question (or that someone else brought them in), and therefore that thecocaine was not in Ms. Pham's possession on March 5th, is an argument raised by defence counsel, not on the basis of any evidence butmerely as a speculative consideration. In R. v. Jenner (2005), 2005 MBCA 44 , 195 C.C.C. (3d) 364 (Man.

C.A.) at paragraph16, this type of approach was dealt with as follows: The accused's argument is found not on attempting to rebut the evidence tendered by the crown, but on raising questions andissues that although valid in a rhetorical sort of way add nothing to the issues that the trial judge had to address, and the manner in whichhe did so. Such a manner of attack was dealt with by this court in R. v. Drury (L.W.) et al. (2000), 150 Man. R. (2d) 64, 2000 MBCA100.

Huband J.A. addressed the issue as follows (at paragraph 92): This is a question that only the accused Drury could answer, but he elected not to testify. Raising the question and invitingthe court to speculate as to the answer does nothing to overcome the body of evidence which overwhelmingly points to guilt. [85] In the Crown’s submission there is no other evidence that anybody else made a single decision for this company and that Mr.Wookey cannot isolate himself from prosecution by printing off a business card that indicates that he is a manager.

The Crown submitsthat there is only one rational inference that can be made on an assessment of the evidence before the court and that is that Mr. Wookeyran the company Analysis Has the Crown proven the Actus Reus of the Offences Beyond a Reasonable Doubt [86] This issue in this case is whether or not the Crown has proven the actus reus of these regulatory offences beyond a reasonable doubt.The defence has called no evidence of due diligence. In R. v. Sault Ste.

Marie, (1978) (SCC), 40 C.C.C.(2d) 353(S.C.C.) the Supreme Court of Canada set out the approach regarding strict liability offences such as these at page 374 as follows: Offences in which there is no necessity for the prosecution to prove the existence of mens rea; the doing of the prohibited act prima facieimports the offence, leaving it open to the accused to avoid liability by proving that he took all reasonable care. This involvesconsideration of what a reasonable man would have done in the circumstances.

The defence will be available if the accused reasonablybelieved in a mistaken set of facts which, if true, would render the act or omission innocent, or if he took all reasonable steps to avoid theparticular event. These offences may properly be called offences of strict liability. Mr. Justice Estey so referred to them in Hickey's case. At page 373 of the decision the Court explained why it was necessary to relieve the Crown of the burden of proving mens rea in casessuch as this one.

In a normal case, the accused alone will have knowledge of what he has done to avoid the breach and it is not improper to expect him tocome forward with the evidence of due diligence. This is particularly so when it is alleged, for example, that pollution was caused by theactivities of a large and complex corporation.

Equally, there is nothing wrong with rejecting absolute liability and admitting the defenceof reasonable care. [87] Both the Crown and defence take the position that there is not sufficient evidence before the court to find that the defendant PurePrinciples committed the actus reus of the offences it is charged with beyond a reasonable doubt. I agree and those charges aredismissed. As the Crown and Defence categorized the charges into different groups it would be useful for me to take this approach as

well. Group 1 – counts 1 – 6 – selling the six varieties of BZP between March 2008 and June 2010 in dosage form for which no DIN hasbeen assigned contrary to

section C.01.014 of the Food and Drugs Regulations thereby committing an offence contrary to section31 of the Food and Drugs Act [88] In my view the actus reus of these offences has been proven beyond a reasonable doubt. The ASF clearly indicates that Mr. Wookeywas the president, director and chief executive officer of Purepillz Corporation. In addition to this paragraphs 7 and 8 of the ASF indicatethat Purepillz was selling the six varieties of BZP by way of internet sales as well as retail locations.

The defence submission that thepast tense in paragraph 1 is significant is answered in my view by the evidence of Ms. Amin who had dealings with him from April in2008 to September of 2008. I found her evidence to be straight forward and have no reason to disbelieve it. [89] Ms. Amin only dealt with Mr. Wookey in terms of matters that required decisions. The fact that he told her he was a manager doesnot, in my view, tend to show that he was not the controlling mind. Mr. Wookey made admissions to her that, in my view, prove that hewas the person who was in control. In April of 2008 during a telephone call Ms.

Amin told him that the products needed drugidentification numbers and advised him that he would need an establishment licence. He responded by saying that he only imported anddistributed the products. This is an important admission as it shows that he is in control of the product. He controls where it comes fromand where it goes. [90] In April 17, 2008 he sent a letter to Ms. Amin he wanted to meet with her regarding the regulation of these types of products. Heis the one making decisions regarding attempts to get the government to allow the sale of these types of products.

On May 29, 2008during the meeting with Health Canada Mr. Wookey told Ms. Amin that he would have his lawyers look over the formal letter that wasprovided to him asking him to stop selling the substance. This is not an action of a mere employee. On June 5, 2008 it was Mr. Wookeywho advised Ms. Amin that he would stop importing the drug. He didn’t indicate that there was any need to check with someone else.This again is the action of someone in control of Purepillz Corporation. [91] With respect to the material that was found at Mr.

Wookey’s residence (also the address of Purepillz Corporation) listed at para.11 is indicative of someone who is in charge of this company. I do not accept the defence submission that Mr. Wookey does not fallwithin the definition of a manufacturer under s. 2 of the Food and Drug Act as the evidence clearly shows, in my view, that Mr. Wookeywas the only person in a position to make decisions regarding the company he created. The only rational inference that I can make, and Ifind as a fact that Mr. Wookey was that controlling mind of Purepillz Corporation.

As there was no evidence of due diligence called Mr.Wookey and Purepillz Corporation are found guilty of these counts. Group 2 –Counts 8 – 13 – selling the six varieties of BZP between March 2008 and June 2010 without the manufacturer of thedrug filing with the Minister a new drug submission contrary to

section C.08.002(1) of the Food and Drugs Regulations therebycommitting an offence contrary to

section 31 of the Food and Drugs Act [92] The determination of whether or not the Crown has established the actus reus of these offences turns on my finding as to whenHealth Canada determined that BZP was a new drug within the relevant time frame given my decision with respect to counts 1 - 6. In myview there is ample evidence, which I accept, that Health Canada viewed BZP as a drug during the timeframe between March 2008 andJune 2010. I find as a fact that Health Canada did consider BZP to be a new drug between March 2008 and June 2010. [93] Ms. Amin’s evidence referred to BZP as a drug.

The correspondence dated April 7, 2008 refers to “Sale of Drug Products”, heremail of April 25, 2008 set out that “.. as it currently stands, the products that Purepillz sells are regulated as drug products under theFood and Drugs Act and Regulations”. In Ms. Amin’s email of May 8th, 2008 she yet again, sets out that the position of Health Canadais that the products sold by Purepillz are drugs subject to regulation.

Once more in her correspondence of May 29, 2008 she states thatthese products are considered to be drugs and again in her hand delivered letter dated July 8, 2008. [94] In addition to this there is clear evidence from Mr. Ornsby that as far back as October of 2007 his department, the TherapeuticProducts Directorate, had reached the conclusion that BZP was a drug that was subject to regulation. He testified that there were twoapplications in 2008 for DINs for BZP claiming that they were beneficial for stress management.

These applications were denied.Therefore, the submission of the defendants that Health Canada didn’t determine that BZP was a new drug until June of 2010 fails. Thecrown has proven the actus reus of these offences beyond a reasonable doubt and as there has been no evidence of due diligence calledthe defendants Adam Wookey and Purepillz Corporation are guilty of these offences. Group 3 – counts 15 – 20- unlawfully selling and advertising the six varieties of BZP between March 2008 and June 2010 withouta drug identification number contrary to

section C.01.005 of the Food and Drugs Act Regulations and thereby committing anoffence contrary to sections 9(1) and 31 of the Food and Drugs Act [95] In my view the actus reus of these charges have been proven beyond a reasonable doubt given my findings regarding Group 1together with the admission in paragraph 13 of the ASF. I disagree with the defence submission that the charges are not sufficientlyparticularized given that the words “in dosage form” are missing.

The counts are quite detailed and the case to meet would have beenmade abundantly clear to the defendants. [96] However, the Crown has conceded that these offences should be stayed in accordance with the rule against multiple convictionsgiven that they involve the same delict as those in counts 1 – 6: see R. v. Kienapple (SCC), [1975] 1 S.C.R. 729 (S.C.C.)at page 10. I will stay these charges. Group 4 – counts 22 – 27- unlawfully selling the six varieties of BZP between March 2008 and June 2010 in dosage form withouta label bearing a DIN contrary to

section C.01.003 of the Food and Drugs Regulations and thereby committing an offencecontrary to sections 9(2) and 31 of the Food and Drugs Act [97] It follows that given my previous findings with respect to groups 1 and 2 of the charges that the actus reus of these charges hasalso been proven beyond a reasonable doubt. As the defendants have not called evidence of due diligence Adam Wookey and Purepillz

Corporation are guilty of these offences as well. Again, the crown concedes that these charges should be stayed given that they involve the same delict as counts 1 – 6. These charges are also stayed. The Importing Charge – Count 29 – importing drugs as defined in the Food and Drugs Act – BZP – between November 2007 and June 2010 contrary to

section A.01.040 of the Food and Drugs Regulations and thereby committing an offence contrary to

section 31 of the Food and Drugs Act [ 98 ] In my view the Crown has proven the actus reus of this offence beyond a reasonable doubt. Paragraph 3 of the ASF states that Purepillz imported BZP from Stargate Enterprises in New Zealand and that the product was shipped to Adam Wookey and Purepillz. Mr. Wookey also told Ms. Amin that he would stop importing the drug. In addition to this I have made a finding that Health Canada was of the view that BZP was a new drug. As there was no evidence called regarding due diligence the defendants Adam Wookey and Purepillz Corporation are guilty of this offence.

Count 33 – Advertising a drug to the general public as a treatment, preventative or cure for addiction between March 2008 and November 2010 contrary to

section 3 of the Food and Drugs Act and thereby committing an offence contrary to

section 31 of the Food and Drugs Act. [ 99 ] Finally, with respect to count 33 I also find that the Crown has proven the actus reus beyond a reasonable doubt. The ASF refers to the claims found on the Purepillz website which makes the claim that, 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 .

In other words, the defendants our saying take our drug to avoid the potential for harm and addiction. Again, the defendants have chosen not to call any evidence of due diligence and are guilty of this count as well. Released: July 10, 2013 Signed: “Justice Chapin”