Time Sensitive Information - Canadian bill #C51

[Guest guest]

Please tell everyone you know especially if they buy from or live in

Canada. Without some of these food supplements, there could be an

increase in cancer patients.

 

Suzanne Stapler

 

 

 

Time Sensitive - This Bill may pass in the 1st half of May!

Canada's C-51 Bill

 

Big Pharma Pushing to Criminalize Foods and Supplements

 

Please read and tell your local healthfood stores and food coops, and

ESPECIALLY anyone you know in Canada who cares about this topic: If

this happens in Canada, it can easily happen here next.

 

 

For a brief update on what this law entails, go to:

 

www.naturalnews.com:80/023121.html

 

posted on Monday, April 28, 2008 by: Mike Adams

 

This is a hugely restrictive law that is impending passage in Canada.

I have been researching this Bill this morning and have talked with

several people in Canada who are on the front lines to fight this

Bill. In addition to getting information at:

http://www.naturalnews.com/023121.html, please go to www.stopc51.com.

While there, read the Bill and go to the " What You Can Do " section.

Go to the " Tell Others About It " section and then click on the Fact

Sheet.

 

 

 

This is a very time sensitive issue and it is important to take

action FAST!

 

 

 

Take Action Fast

 

The First Reading of Bill C-51 was on Wednesday, April 9th, 2008

The Second Reading is Scheduled for Monday, April 28th, 2008

There is one more Reading on May 7th- and if it passes, it will

become law!

 

 

It appears that the Canadian Government is trying to fast track this

bill before anyone has a chance to challenge it. Bills normally take

months to pass not weeks.

 

 

 

This morning I called 4 people in Canada - 2 in BC, 1 in Calgary and

another in Ontario - NONE of them knew about this. This information

is critical to get out. Contact as many Canadian citizens as possible

and have them contact the Minister of Health to voice their

disapproval. For more information call 888-878-3467 and ask for Tanza

Mendenhal. Emails can be sent to: minister_ministre and

calls can be made to: Media Relations - 613-957-2983.

 

An Important Notice Regarding Bill C-51

 

 

 

On April 8th, 2008, the Canadian Minister of Health introduced Bill C-

51 into the House of Commons. This Bill proposes significant changes

to the current Food and Drugs Act that will have wide-ranging

negative implications for Canadians.

 

Bill C-51 will:

 

· Remove democratic oversight, bypassing elected officials to

vote in laws and allow bureaucrats to adopt laws from other countries

without our consent.

 

· Remove 70% of Natural Health Products from Canadians and

many others will be available by prescription only.

 

· Restrict research and development of safe natural

alternatives in favor of high risk drugs.

 

· Punish Canadians with little or no opportunity for protection

or recourse for simply speaking about or giving a natural product

without the approval of government. More than 70% of people in

Canada use a Natural Health Product. The new law goes so far as to

warrant action against a person who would give another person

an " unapproved " amount of garlic on the recommendation that it would

improve that person's health.

 

Proposed New Enforcement Powers:

 

· Inspectors will enter private property without a warrant

 

· Inspectors will take your property at their discretion

 

· Inspectors will dispose of your property at will

 

· Inspectors will not reimburse you for your losses

 

· Inspectors will seize your bank accounts

 

· Inspectors will charge owners shipping and storage charges

for seized property

 

· Inspectors will be empowered to store your property

indefinitely

 

· Inspectors will levy fines of up to $5,000,000.00 and/or

seek 2 years in jail per incident

 

With your assets and money under their control will you be able to

defend yourself in Court?

 

 

Can you trust government with this new law and enforcement power?

 

Would our government really ever turn this law against us?

 

 

 

 

 

 

Will this new law be used to abuse and punish special interest

groups, minorities, religious groups or others?

· Why do bureaucrats want to bypass the Parliament and

Senate's approval to create new laws?

 

· Why do bureaucrats want seizure warrants without judge

approval ?

 

· With fines being increased a 1000 times, and seizing

authority without a warrant, is Bill C-51 meant to bankrupt and

silence its target audience?

 

 

 

Here's what you can do to protect your rights:

 

Educate Yourself

 

· Go to http://www.stopc51.com/

 

· Read a legal discussion on Bill C-51

 

· Read bill C-51 on www.parl.gc.ca

 

Tell others about it

 

· Talk to your local Press

 

· Contact your local MP Click Here

 

· Ask the leaders in your community to get involved

 

· Contact your MLA

 

· Tell your Friends

 

Get involved

 

· Print off this fact sheet and hand it out in your

neighborhood.

 

· Attend our rally at the Calgary Federal Court on May 9th

2008 . Call 1-888-878-3467 for Details

 

Federal Court Rally Information

Where: 635 8 Ave SW, Calgary, AB, Canada Federal Court (View

In Google Maps)

When: 11:45 AM Friday May 9th

 

This is a peaceful rally, after which a hearing will be held asking

the judge to place restraints on our governments ability to seize

property without a warrant. Taking place on the 4th floor at 1:00pm.

[Guest guest]

I read about some of this mng. from the Mercola email. I was shocked it was Canada as they seem liberal about many things. Scary stuff here!

 

Bonnie & CodyGas prices getting you down? Search AOL Autos for fuel-efficient used cars.

[Guest guest]

The bill was passed last week....

 

 

DRAFT DISCUSSION PAPER ON Bill C-51

 

 

Prepared by Shawn Buckley, president of the NHPPA on April 9, 2008.

 

 

 

Purpose of the Paper

 

 

 

Yesterday the Minister of Health introduced Bill C-51 into the House

of Commons. The Bill passed first reading. The following is a link

to a version of the Bill:

 

http://www2.parl.gc.ca/HousePublications/Publication.aspx?

DocId=3398126 &

 

 

 

Although this only occurred yesterday, upon our reading of the Bill

it became apparent that it may have wide ranging negative

implications for the Natural Health Product industry. We are of the

opinion that it would be prudent to draft an initial discussion paper

to be circulated to stakeholders and more importantly to other

stakeholder groups to begin discussion on the issues raised in this

Bill.

 

 

 

 

 

Need for a Broad Consensus

 

 

 

We feel that Bill C-51 has such broad implications for the Natural

Health Product Industry that it would be prudent for all of the

various stakeholder groups to collaborate to see if an industry

consensus can be reached in how to approach Bill C-51. If Bill C-51

poses a threat to the industry, unless there is consensus, efforts to

protect the industry will fail.

 

 

 

 

 

Discussion Paper Only

 

 

 

This is a discussion paper only and does not reflect the position of

the NHPPA or of the NHPPA advisory board. The thoughts and comments

are those of the author, Mr. Shawn Buckley and are intended to foster

discussion.

 

 

 

The NHPPA will formulate its position after industry feedback.

 

 

 

 

 

 

 

Invitation to Other Stakeholder Groups

 

 

 

We will be forwarding this discussion paper to other stakeholder

groups such as the CHFA and consumer groups.

 

 

 

We would like the other stakeholder groups to analyze the Bill. We

would then like to get representatives of the various groups together

to see if a consensus can be reached concerning Bill C-51. We

believe that it is important for the various stakeholder groups to

take a leading role with their members on this issue in the event

that their leadership is required to protect the industry.

 

 

 

 

 

Initial Points of Discussion

 

 

 

Scope of Discussion Points

 

 

 

Because we feel it is necessary to get this Discussion Paper out

immediately to stimulate examination and discussion on Bill C-51, I

will only focus on what I consider to be major points. I fully

expect that as others examine this Bill and take part in the

discussion that they will identify other significant issues.

 

 

 

Preamble to the Act

 

 

 

The preamble to the Act is not part of the Act and does not become

law if the Bill is passed. What the preamble does is explain why the

Bill is necessary.

 

 

 

The second last paragraph of the preamble reads:

 

 

 

" Whereas the Parliament of Canada recognizes that it is the

responsibility of regulated persons to ensure that only products that

meet legislative requirements are available to the public; "

 

 

 

My initial thoughts is that this is a classic case of what George

Orwell calls doublespeak. That is, a case of saying the opposite of

what you are doing.

 

 

 

What is communicated:

 

 

 

that it is the responsibility of " regulated persons " to ensure that

only products that meet the legislative requirements are available to

the public.

 

 

 

What the Act does:

 

 

 

the Act gives broad power and responsibility to Health Canada

inspectors to force " regulated persons " to take whatever measures the

inspectors deem necessary to ensure safety. For example, see section

23.8 of the Bill.

 

 

 

I am troubled by this due to the following scenario developing:

 

 

 

1) currently roughly 60% of natural health product license

applications are failing. The majority of these license applications

are for single ingredient products which are easier to licence then

multi-ingredient products. The percentage of failed license

applications is expected to increase as more multi-ingredient product

license applications are considered. My estimate is an overall

failure rate of 70%. This means that over 60% of the natural health

products on the market will fail the licensing process and will

become illegal. At that point the manufacturer can wilfully withdraw

them from the market or Health Canada can take enforcement action;

 

 

 

2) the NHPD has been given more resources to process license

applications which means that the majority of the products will

become illegal sooner rather than later;

 

 

 

3) Health Canada is currently going to universities to recruit

university graduates as inspectors because Health Canada anticipates

an increased need for enforcement, and

 

 

 

4) Bill C-51 gives inspectors new powers to force products off of

the market.

 

 

 

I am not aware of Health Canada having enforcement problems with

chemical drug pharmaceutical companies. My belief is that when

Health Canada asks a pharmaceutical company to take a product off of

the market, the pharmaceutical company does. I expect that this

occurs because pharmaceutical companies would face huge liability

issues if they failed to comply with a Health Canada request and then

someone was injured. If I am incorrect in this I am inviting

correction as it is important for us to determine " who " the new

enforcement powers are directed to.

 

 

 

If Health Canada is not having compliance problems with

pharmaceutical companies, then should we interpret the new powers in

Bill C-51 as necessary to force the natural health product industry

into compliance? I do not know the answer to this. I would ask you

to analyse this as you work through the Bill.

 

 

 

 

 

The Move to the term " Therapeutic Products "

 

 

 

Bill C-51 moves away from the use of the term " drug " and introduces

the term " therapeutic products " . Indeed even the name of the " Food

and Drugs Act " will be changed to " An Act respecting foods,

therapeutic products and cosmetics. "

 

 

 

The definition of " drug " remains unchanged but a new definition

of " therapeutic product " is added which includes drugs, medical

devices and cells, tissues or organs. However, the term " drug " is

replaced throughout the old Food and Drugs Act with the

term " therapeutic products " .

 

 

 

Natural Health Products remain " drugs " under the Act. The only

change is that now all drugs are referred to as " therapeutic

products " in the Act instead of as drugs.

 

 

 

I have found this to be a very interesting change, and perhaps the

most significant of all of the changes. I think this is perhaps the

most significant of all changes as I asked myself the following

questions:

 

 

 

1) why is a language change away from the word " drug " and to the

term " therapeutic product " important to Health Canada , and

 

 

 

2) what part of the industry is this change for?

 

 

 

We think and communicate in language. The terms we use to define and

refer to things affect how we think about them. That is why

advertising firms exist.

 

 

 

The term " drug " in the Food and Drugs Act is not substance specific

in that any substance is considered a " drug " if sold or manufactured

for a therapeutic purpose. However, many people think of the

word " drug " as referring to chemical drugs as opposed to plants sold

for therapeutic purposes.

 

 

 

There is no confusion in the public's mind concerning pharmaceutical

drugs. When the public thinks of pharmaceutical drugs they are

comfortable with the word " drug " .

 

 

 

There is confusion when the word " drug " is applied to natural health

products.

 

 

 

Because there was no confusion concerning pharmaceutical drugs and

the word " drug " , is the change of terminology directed at the Natural

Health Product industry or are there other reasons?

 

 

 

The change certainly affects the dynamics of the debate over

regulating NHPs as foods or as a third category separate from drugs.

Let's use the NHPPA's position on regulatory change as an example.

The NHPPA Advisory Board has given the NHPPA the goal of obtaining a

regulatory environment where:

 

 

 

(1) NHPs are presumed to be safe. A NHP cannot be taken

off of the market unless the Government can prove that it is unsafe;

 

 

 

(2) there are different claims structures so that:

 

 

 

a) manufacturers do not have to make claims;

 

b) manufacturers can make limited claims, such as structure

function claims with a low evidence threshold, and

 

c) manufacturers can make specific health claims if they can meet

a higher evidence threshold;

 

 

 

(3) NHPs are not regulated as drugs. They are either

regulated as food or as a third category separate from drugs and food;

 

 

 

(4) there are Good Manufacturing Processes that are

appropriate for the low risk profile of NHPs, and

 

 

 

(5) there is a conflict resolution mechanism to settle

disputes between the Government and industry members.

 

 

 

The last time consumers and the industry rebelled against Health

Canada enforcement actions against NHPs, the rallying cry was " don't

treat our foods as drugs " . That rallying cry created the most

successful petition drive in Canadian history. It was a large factor

leading then Minister of Health Allan Rock to refer the issue to the

Standing Committee on Health. The result was the 53 Recommendations

which the industry would still like to see implemented.

 

 

 

Would the rallying cry have been successful with the new

term: " don't treat our foods as therapeutic products " ? Or to be

more accurate: " don't treat or natural health products as

therapeutic products " ?

 

 

 

My point in all of this is simply to communicate that terms and

language are important as they determine the parameters of how we

think and can affect debate. The change in terms is being introduced

deliberately by Health Canada and we need to consider what the

implications for the industry are.

 

 

 

 

 

Expanded Definition of " Sell "

 

 

 

The old definition of " sell " is:

 

 

 

" 'sell' includes offer for sale, expose for sale, have in possession

for sale and distribute, whether or not the distribution is made for

consideration. "

 

 

 

The new definition of " sell " is "

 

 

 

" 'sell' includes offer for sale, expose for sale or have in

possession for sale or distribute to one or more persons, whether or

not the distribution is made for consideration and in relation to a

device, includes lease, offer for lease, expose for lease or have in

possession for lease. "

 

 

 

(emphasis added).

 

 

 

The lease provision is not going to affect the NHP industry.

 

 

 

The change that is interesting is the new if you distribute to " one

or more persons " you can be prosecuted for selling under the Act.

Under the old definition, although you did not have to get paid if

you gave product away, it is fair to say that the definition

of " sell " , especially when considered in the context of the Act as a

whole, would be considered to be referring to a commercial venture.

So for example a manufacturer giving out free samples would be

selling.

 

 

 

Now the term " selling " will apply to a single isolated giving of a

therapeutic product. So if I give my child a natural health product

I am now selling under the Act and can be prosecuted. I doubt that

the intention is to prosecute parents for giving their children NHPs,

although that could happen under the new definition. Rather, as a

lawyer who defends people and companies charged with violating the

Act and Regulations, I see this as an open door to prosecute natural

health practitioners, including naturopathic and homeopathic doctors.

 

 

 

Changes to legislation are supposed to solve a problem. When we

analyse this change to the definition of " sell " we need to ask, what

is the problem that Health Canada feels needs to be addressed by

significantly widening the scope of selling under the Act?

 

 

 

It is going to be vital to obtain the input of natural health

practitioners concerning this change.

 

 

 

 

 

Introduction of the term " Controlled Activity "

 

 

 

The Bill creates the following term:

 

 

 

" 'controlled activity' means

 

 

 

(a) in relation to a therapeutic product manufacturing,

collecting, processing, preserving, labelling, packaging, importing

for sale, distributing, wholesaling or testing, and

 

(b) in relation to a designated therapeutic product

manufacturing collecting, processing, preserving, labelling,

packaging, importing, distributing or testing.

 

 

 

My initial thoughts on the introduction of this term is that it is

again directed at natural health practitioners such as naturopathic

and homeopathic doctors.

 

 

 

The Bill introduces the following section:

 

 

 

" 13. No person shall conduct a controlled activity unless they are

authorized by an establishment license to do so. "

 

 

 

The change from our current regulatory scheme is the expansion of the

site licence requirements. Section 27 of the Natural Health Products

Regulations does not include: collecting, processing, preserving.

Section 27 already includes manufacturing. By adding processing and

preserving Health Canada is targeting something other than

manufacturing.

 

 

 

 

 

Allowing Trade Agreements to become law without Parliamentary

Approval – and the Sharing of Confidential Information with Foreign

Governments and Agencies.

 

 

 

The following term is added to the Act:

 

 

 

" 'government' means any of the following or their institutions, as

applicable:

 

(a) the federal government;

 

(b) a corporation named in Schedule III to 10 of the

Financial Administration Act,

 

© a provincial government or a public body established

under an Act of the legislature of a province,

 

(d) an aboriginal government as defined in subsection 13

(3) of the Access to Information Act,

 

(e) a government of a foreign state or of a subdivision

of a foreign state, or

 

(f) an international organization of states.

 

 

 

(emphasis added).

 

 

 

Defining " government " to include foreign states or international

organizations of states such as the United Nations, is important

because of a change to section 30 of the Act. Bill C-51 adds the

following to the regulation making power of the federal government:

 

 

 

" 30(7) A regulation may incorporate by reference documents produced

by a person or body other than the Minister of the Canadian Food

Inspection Agency including

 

(a) an organization established for the purpose of writing

standards, including an organization accredited by the Standards

Council of Canada;

 

(b) an industrial or trade organization; or

 

© a government. "

 

 

 

This addition allows the federal government to make documents

prepared by foreign governments or bodies law in Canada by simply

passing a regulation incorporating the document. So for example, the

CODEX treaty could become law without Parliamentary approval by

simply passing a regulation saying it is now part of our regulations.

 

 

 

Just so that everyone understands what this means I will explain the

difference between Acts and Regulations. Acts are documents

introduced into either the House of Commons or the Senate. They must

pass three readings in both before they can become law. This process

ensures that Canadians and their representatives become aware of

proposed changes, have them debated in Parliament, and have time to

contest them.

 

 

 

Regulations on the other hand are simply published in the Canada

Gazette twice and then can be signed into law. Parliament does not

vote on regulations.

 

 

 

This change to allow the federal cabinet to incorporate documents

from foreign governments or organizations as law by referring to them

in regulations will remove Parliamentary scrutiny on issues that

could fundamentally change the ground rules for our industry.

 

 

 

Because these changes were not made by accident, the questions are

raised:

 

 

 

what purpose is served by removing Parliamentary scrutiny to the

adoption of documents from foreign governments and institutions into

Canadian Law, and

 

 

 

does the federal cabinet already have specific foreign documents in

mind?

 

 

 

There are also significant confidentiality issues associated with the

new term of " government " in the Act. Bill C-51 also gives the

Minister authority to disclose personal and business information

without consent to a person or " government " that carries out

functions relating to the protection or promotion of human health

(see sections 20.9, 21 and 21.1). There are some safeguards, but at

the same time the Minister has new power to share personal and

confidential business information with a wide range of bodies, both

Canadian and foreign, without consent.

 

 

 

 

 

Product Monographs are " Deemed " to be part of your Label

 

 

 

Bill C-51 adds:

 

 

 

2.1 For the purposes of this Act,

 

a) a product monograph of a therapeutic product is deemed to be a

label even if it is not attached or included in or does not accompany

the therapeutic product;

 

 

 

Approaching this from a defence counsel perspective, my immediate

concern is that this will subject companies to misrepresentation and

fraud charges.

 

 

 

I will need input from industry stakeholders concerning the

implications when manufacturers disagree with the Health Canada

monographs.

 

 

 

It would also be helpful to get feed-back as to why Health Canada

wants this change. Put another way, what is broken that this is

intended to fix?

 

 

 

 

 

A New Purpose of The Act

 

 

 

The Food and Drugs Act (i.e. the Food and Therapeutic Products Act)

is given a new purpose which is:

 

 

 

2.3 The purpose of this Act is to protect and promote the health and

safety of the public and encourage accurate and consistent product

representation by prohibiting and regulating certain activities in

relation to foods, therapeutic products and cosmetics.

 

 

 

(emphasis added).

 

 

 

 

 

Section 3 Prohibiting Schedule A Claims is Removed

 

 

 

Section 3 of the Act which prohibited Schedule A claims is removed.

I expect that this is in response to the CanWest lawsuit to have s. 3

declared unconstitutional.

 

 

 

 

 

New Restrictions on the Importation and Transportation of Food

 

 

 

Section 4 of the Act is amended to include restrictions on

the " import for sale " of foods that are poisonous, unfit, injurious

or adulterated. I do not see a difficulty with this.

 

 

 

This is part of a general change in the Act towards prohibiting

importation and shipping.

 

 

 

Sections 5.1 to 5.4 are added which place restrictions on " prescribed

food " . A prescribed food will be a food put on a list by the federal

cabinet. These sections prevent the importation from another country

and the shipping across provincial borders of a prescribed food

unless they have a " registration or a license " . These foods can only

be sent to registered establishments.

 

 

 

It is not clear to me at this point what danger or purpose these new

provisions are directed to addressing. What foods currently need

these types of restrictions?

 

 

 

Bill C-51 represents a tightening of restrictions and the increasing

of Health Canada powers in all areas covered by the Act.

 

 

 

 

 

Importing is added to prohibitions in the former sections 8 and 9.

 

 

 

The new sections 8 and 9 are similar in nature to the old ones except

that the prohibitions are expanded to include importing and conveying

for sale.

 

 

 

 

 

Is Health Canada Approval now required for clinical trials involving

food?

 

 

 

Prior to the creation of the NHPD universities did not get Health

Canada approval to do nutrition research. So for example, if a

university wanted to run a clinical trial to better understand the

effect limes have on scurvy, they did not get Health Canada

approval. Even with the creation of the NHPD, it is not clear to me

that Health Canada approval would be necessary to study the effect of

limes on scurvy.

 

 

 

It has also been the case that some clinical trial businesses did not

feel they needed Health Canada approval for natural health products

that had been in the food chain for a long period of time.

 

 

 

The new Act adds a definition of " clinical trial " as well as a

prohibition on conducting a clinical trial for a therapeutic product

without Health Canada authorization.

 

 

 

As I read the new provisions, I think that a study of limes for

scurvy would now require Health Canada approval.

 

 

 

I would like input as to whether the current regime needs to be

widened?

 

 

 

 

 

The need for pre-market approval becomes part of the Act as opposed

to part of the Regulations – And the Criteria Changes.

 

 

 

The new section 12 provides:

 

 

 

12(1) No person shall advertise, sell or import for sale a

therapeutic product that does not have a market authorization or is

not a designated therapeutic product.

 

 

 

The Act does not currently require Health Canada pre-approval for the

sale of drugs. For there to be a pre-approval requirement, it has to

be added in the Regulations. So for example, the NHP Regulations

require pre-approval.

 

 

 

This change will mean that there is a blanket need for pre-approval

and any exception needs to be added to the Regulations.

 

 

 

What has changed is that the Act will now presume that

all " therapeutic products " are dangerous and need pre-approval unless

specifically exempted.

 

 

 

Again part of the general tightening in Bill C-51.

 

 

 

Concerning the criteria change: section 18.7 will only enable Health

Canada to issue market authorization if satisfied " that the benefits

that are associated with the therapeutic product outweigh the

risks. " Risks are not defined and so it is unclear if Health Canada

will continue to use risk factors such the risk people will not

seek " proper " (i.e. read mainstream medical) treatment if they take

an NHP.

 

 

 

This criteria change is legislating an efficacy requirement. The

NHPD will have to have evidence of efficacy before they can determine

that the benefits outweigh any risks.

 

 

 

This balancing is appropriate for chemical drugs that carry a high

risk profile. The industry will have to discuss whether it is

appropriate for the NHP industry which has never caused a single

death in Canadian history. In any event, if Bill C-51 passes, the

goal posts for the NHP industry will change which should require re-

licensing of NHPs.

 

 

 

 

 

After the Act is changed to require NHPs to demonstrate their

benefits outweigh their risks, NHPs can only be exempted from this

requirement if the federal cabinet is satisfied that their nature is

such that a risk assessment is not necessary

 

 

 

I have just discussed how the Act will now require proof of efficacy

before a product can be licensed unless it is specifically exempted.

It needs to be appreciated, however, that there are limits on

exempting products from this requirement. The new subsection 30(1.1)

contains this limit as follows:

 

 

 

30 (1.1) a regulation may be made under paragraph (1)(d) [the section

governing the designation of therapeutic products] only if the

Governor in Council is satisfied that the therapeutic product is one

that by its nature does not need to be the subject of an assessment

of its benefits and risks.

 

 

 

This means that the federal cabinet could only exempt NHPs or a class

of NHPs from the new proof of efficacy requirement " if " they are

satisfied that " by its nature " it does not need to be subject to a

benefit and risk analysis. This is very vague and there is no

mechanism in place for making submissions to the cabinet.

 

 

 

If Bill C-51 passes, those in the industry such as our advisory board

who would like to see NHPs to be presumed safe until proven to be

dangerous will be disappointed. It would require a change to the new

Act as opposed to a change to the regulations.

 

 

 

 

 

" Import for sale " is added to the old drug provisions.

 

 

 

The old drug provisions of the Act which are now the " therapeutic

product " provisions now include a prohibition for importing for sale

although this addition is not highlighted in the proposed Bill as

other changes are.

 

 

 

 

 

A Prohibition against selling prescription " therapeutic products "

without a prescription is added to the Act.

 

 

 

The Regulations currently provide that prescription drugs (that is

those listed in Schedule F of the Regulations) are only available by

those authorized to write prescriptions. This is now being put as

part of the Act as opposed to the Regulations.

 

 

 

There are other changes and it is not clear to me yet whether or not

it will now be Health Canada as opposed to the provinces who will be

determining who is eligible to write prescriptions, although I view

that as an area of provincial jurisdiction.

 

 

 

Why the prescription drug issue is important to the NHP industry is

that Health Canada currently has a policy that if you can extract a

prescription drug substance from a plant or animal, then that plant

or animal can only be sold by prescription. So for example, green

and black tea contain a prescription substance but Health Canada has

not yet started attacking NHPs with tea as an ingredient.

 

 

 

Again part of the general tightening in Bill C-51.

 

 

 

 

 

Inspection and Seizure Powers are Increased

 

 

 

The inspection and seizure powers found in s. 23 of the Act are

increased to:

 

 

 

· give inspectors authority to enter private property to

prevent non-compliance with the Act or Regulations;

 

 

 

· enter conveyances for the purposes of inspections;

 

 

 

· enter places where even a document relating to the Act and

Regulations may be located. Currently inspectors are restricted to

places where articles to which the Act or regulations apply are

manufactured, prepared, preserved, packaged or stored. Note that

document is defined in Bill C-51 to include information that can be

read by a computer or device so if your blackberry is in your car the

car can be searched;

 

 

 

· take samples free of charge. This is interesting for two

reasons. First, there is no limit to the value of the samples.

Second, although the current wording of the section does not state

that Health Canada should pay for samples they take, it was clearly

the intention of the government that they do pay for them. Prior to

the current wording the Act specifically set out that Health Canada

had to pay fair value for samples they took. When the new wording

was introduced the Minister made it clear that although the wording

changed that the samples were to be paid for. This can be found in

the Hansard for April 21, 1953 where the Minister is asked:

 

 

 

Q. In the matter of taking samples, the section says that the

inspector may take samples and examine them. No provision is made in

section 21 for leaving the sample. Later on in the bill we are going

to come to the point of a court case on the analysis of a sample.

 

A. When an inspector takes the sample he pays for it, of course.

 

 

 

There is a general principle that the government cannot take property

without compensating the owner. Is it necessary to abandon that

principle in this case?

 

 

 

· seize and detain for any time anything connected to the Act

and Regulations, such as your products and equipment. This is a

significant change. Currently, an inspector can only seize if

he/she " believes on reasonable grounds " the article is connected to a

violation of the Act or Regulations. Now an inspector can seize all

of your property without the pre-condition that he/she believes it is

connected to a violation of the Act.

 

 

 

The addition of " for any time " is also a change. Previously articles

could only be held for such time " as may be necessary " and in

connection with a violation. So for example, if your property was

seized for a labelling problem and you printed correct labels, the

property should be released. Now the property can be held for any

time and for any reason. This raises a question as to why such new

broad and sweeping seizure powers are necessary?

 

 

 

Keep in mind that Health Canada always has access to the search

warrant provisions found in the Criminal Code. These provisions have

been used by Health Canada and seem to work adequately for other

federal regulatory bodies. What is going to occur that requires

seizure without a warrant, without any reason, without reporting back

to a Court or Justice, and without any time constraints?

 

 

 

· enter on and pass through or over private property without

any liability and without the owner of the property having the right

to object;

 

 

 

· charge the owner for storage of seized property. Now not

only can Health Canada seize property for any length of time, but the

new s. 23.3 gives them the right to charge you for the moving and

storage. I am aware of one company that has had product seized for 5

years. Under this new provision they would be liable for ongoing

storage costs. This is unprecedented. Usually the government can

only seize private property for violations and it is very unusual for

their to be fees for the storage of what is then considered to be

evidence;

 

 

 

· if inspectors believe on reasonable grounds the seized

property could be injurious to human health they can dispose of it at

the expense of the owner or direct the owner to dispose of it.

Currently inspectors have to either obtain the owner's consent or

apply to a Court to have product destroyed. This protects the

property owner by ensuring that an impartial Judge will make the

decision. It is difficult to understand why it is in anyone's

interest to take away the current safeguards;

 

 

 

· property is immediately forfeited after 60 days unless an

owner is identified. No application to a Court is necessary. I find

this interesting as I was involved in a case in which product was

seized but for prosecution purposes Health Canada was going to have

difficulty proving ownership. Now if in doubt Health Canada can

simply seize enough of your property that you will go bankrupt if you

do not claim it and hence solve the proof of ownership issue. It is

highly unusual for their to be forfeiture without a Court order. The

costs of destruction can be charged to the owner or person entitled

to possession.

 

 

 

 

 

Inspectors are given apparently unlimited powers to direct your

actions and do " anything " for even the slightest suspected violation

of the Act or Regulations

 

 

 

The new section 23.8 gives inspectors extremely broad powers. If the

inspector believes on reasonable grounds there is a contravention of

the Act or Regulations they can direct you to:

 

 

 

a) stop doing something that is in contravention of the Act or

the regulations or cause it to be stopped; or

 

 

 

b) take a measure that is necessary to identify or respond to a

risk of injury to health that is related to the activity that is the

subject of the contravention.

 

 

 

This means that if an inspector who does not understand the NHP

industry, and who is not qualified to make health decisions tells a

manufacturer to stop selling an essential product, or tells a natural

health practitioner not to provide a product their patients rely

upon, that the manufacturer or natural health practitioner is

committing an offence if they do not comply.

 

 

 

The new section 24 also gives Health Canada the authority to require

a product recall. Currently Health Canada cannot require a recall.

 

 

 

I am of the opinion that the recall provision is directed at the NHP

industry. As discussed above, I do not think there is a problem with

the chemical pharmaceutical industry recalling when Health Canada

asks them to recall.

 

 

 

There are problems in the NHP industry with companies refusing to

recall. This is because often it is dangerous for a NHP company to

issue a recall. The most obvious example is that of Truehope

Nutritional Support. The Alberta Court found that Truehope would

have caused suicides and hospitalizations if they had listened to

Health Canada 's demand to take the product off of the market. The

decision can be found at: http://www2.albertacourts.ab.ca/jdb%5C2003-

%5Cpc%5Ccriminal%5C2006%5C2006abpc0196.pdf

 

 

 

When a NHP manufacturer asks me whether they should follow a Health

Canada demand for a recall, I have to first get information from them

as to whether or not any Canadians rely upon the product for their

health. If they do then I have to advise them about the Criminal

Code criminal negligence provisions which would make them liable to

criminal prosecution if they removed a product from the market that

people relied upon, and for which there were not obvious alternatives.

 

 

 

When Health Canada inspectors demand that NHPs be recalled or

removed, they are in effect making decisions that affect people's

health. In determining whether these inspectors should be given

blanket power to recall and seize products, we need to consider

whether we want untrained persons making health decisions. Currently

to force a recall Health Canada would need to seek an injunction in

Court. Under this procedure the Court would consider the risk of

removing the NHP before making an order. In assessing these new

powers, we need to consider whether we want to remove the Court's

oversight which is currently required.

 

 

 

Bill C-51 adds the right to apply to a Court for an injunction. This

right already exists under the Federal Court Act and so this is not a

significant change except that it may enable provincial superior

courts to consider injunction applications.

 

 

 

 

 

You are now told where to keep your documents, which includes

computer records

 

 

 

The new section 25 and 26 require you to keep your documents " in

Canada at a prescribed place " . Remember documents is defined to

include electronic documents and would also cover your web-sites.

 

 

 

Again part of the general tightening in Bill C-51.

 

 

 

 

 

Expanded powers to make regulations

 

 

 

For the purpose of this discussion paper I am not going to go into

the specifics of the expanded powers except to comment that the

Minister's powers to make regulations is expanded.

 

 

 

 

 

The new offence of not listening to an inspector

 

 

 

Section 31 is amended to make it an offence not to do something that

the Minister or an inspector directs you to do. Similarly it is an

offence to do something the Minister or an inspector tells you not to

do.

 

 

 

As discussed above, this is particularly problematic for natural

health practitioners who would be violating the new Act if they

failed to take health decision advice from an inspector.

 

 

 

 

 

An incredible increase in penalties for violating the Act or

Regulations along with New Offences.

 

 

 

There are two types of offences under the Act: indictable offences

and summary conviction offences. Indictable offences are considered

more serious than summary conviction offences.

 

 

 

The current penalties are:

 

 

 

· for summary conviction offences a fine of up to $500 and/or

imprisonment of up to 3 months for a first offence, and a fine of up

to $1,000 and/or up to 6 months incarceration for subsequent

offences, and

 

 

 

· for indictable offences a fine of up to $5,000 and/or

imprisonment for up to 3 years.

 

 

 

The new penalties are:

 

 

 

· for summary conviction offences a fine of up to $250,000

and/or imprisonment of up to 6 months for a first offence, and a

fine of up to $500,000 and/or up to 18 months of incarceration for

subsequent offences, and

 

 

 

· For indictable offences a fine of up to $5,000,000 and/or

imprisonment of up to 2 years.

 

 

 

This is not a doubling or tripling of fines. In the case of

indictable offences the fine is increased by a multiple of 1000

times. In the case of summary conviction offences the fine is

increased by a multiple of 500 times.

 

 

 

This raises the question as to why it is necessary to raise the

primary penalty by multiples of 500 and 1000. This is probably

unprecedented in Canadian history.

 

 

 

Again, we need to ask who the changes are directed towards and

whether they will be beneficial for the industry.

 

 

 

There are also new offences for wilfully or recklessly violating the

Act or Regulations or not listening to the Minister or an inspector.

The penalties for these new wilful or reckless offences are higher.

They are:

 

 

 

· For summary conviction offences a fine of up to $500,000

and/or imprisonment for up to 18 months for a first offence, and a

fine of up to $1,000,000 and/or imprisonment of up to two years for

subsequent offences, and

 

 

 

· for indictable offences " a fine the amount of which is at

the discretion of the court or to imprisonment for a term of not more

than five years or to both " .

 

 

 

Please note that in all of my years defending companies in Court, I

have never seen Health Canada charge only one offence. In one case

there were 73 charges. Under ten would be an exception. So when

considering whether a company could survive sentencing, do not

calculate a single fine for a single offence. Rather assume multiple

fines for multiple offences.

 

 

 

These are penalties that few manufacturers or natural health

practitioners could survive. Small and medium manufacturers along

with natural health practitioners now face bankruptcy for violations

of the Act or Regulations.

 

 

s and officers of corporations are now also personally

responsible for violations of the Act and Regulations and so are also

facing personal bankruptcy if there is any violation of the Act or

Regulations.

 

 

 

 

 

Need for input

 

 

 

This draft document is admittedly only a cursory consideration of

Bill C-51. However, because the Bill presents significant changes

that may be extremely damaging to the NHP industry, we felt that it

was necessary to prepare an initial discussion document to get the

various stakeholders aware of the issues presented by the Bill.

 

 

 

It is essential that stakeholders and stakeholder groups take the

time to examine Bill C-51 and to draw their own conclusions.

 

 

 

We will be inviting the various stakeholder groups to discuss the

issues to see if there is consensus on how the industry should

proceed and how they can take a leadership role in protecting the

industry.

 

 

 

I anticipate that my very quick analysis will contain errors and that

some of you will correct them. I thank you in advance for your

input. I am also looking forward to issues that I missed or avoided

being brought forward.

 

 

 

For those of you who would like to send their comments by email,

probably the best email address to use is

shawn. Please restrict your use of this email

address to your comments on this Discussion Paper.

 

 

 

Shawn Buckley

 

 

 

oleander soup , " suzannestapler " <scupe1

wrote:

>

> Please tell everyone you know especially if they buy from or live

in

> Canada. Without some of these food supplements, there could be an

> increase in cancer patients.

>

> Suzanne Stapler

>

>

>

> Time Sensitive - This Bill may pass in the 1st half of May!

> Canada's C-51 Bill

>

> Big Pharma Pushing to Criminalize Foods and Supplements

>

> Please read and tell your local healthfood stores and food coops,

and

> ESPECIALLY anyone you know in Canada who cares about this topic: If

> this happens in Canada, it can easily happen here next.

>

>

> For a brief update on what this law entails, go to:

>

> www.naturalnews.com:80/023121.html

>

> posted on Monday, April 28, 2008 by: Mike Adams

>

> This is a hugely restrictive law that is impending passage in

Canada.

> I have been researching this Bill this morning and have talked with

> several people in Canada who are on the front lines to fight this

> Bill. In addition to getting information at:

> http://www.naturalnews.com/023121.html, please go to

www.stopc51.com.

> While there, read the Bill and go to the " What You Can Do " section.

> Go to the " Tell Others About It " section and then click on the Fact

> Sheet.

>

>

>

> This is a very time sensitive issue and it is important to take

> action FAST!

>

>

>

> Take Action Fast

>

> The First Reading of Bill C-51 was on Wednesday, April 9th, 2008

> The Second Reading is Scheduled for Monday, April 28th, 2008

> There is one more Reading on May 7th- and if it passes, it will

> become law!

>

>

> It appears that the Canadian Government is trying to fast track

this

> bill before anyone has a chance to challenge it. Bills normally

take

> months to pass not weeks.

>

>

>

> This morning I called 4 people in Canada - 2 in BC, 1 in Calgary

and

> another in Ontario - NONE of them knew about this. This information

> is critical to get out. Contact as many Canadian citizens as

possible

> and have them contact the Minister of Health to voice their

> disapproval. For more information call 888-878-3467 and ask for

Tanza

> Mendenhal. Emails can be sent to: minister_ministre and

> calls can be made to: Media Relations - 613-957-2983.

>

> An Important Notice Regarding Bill C-51

>

>

>

> On April 8th, 2008, the Canadian Minister of Health introduced Bill

C-

> 51 into the House of Commons. This Bill proposes significant

changes

> to the current Food and Drugs Act that will have wide-ranging

> negative implications for Canadians.

>

> Bill C-51 will:

>

> · Remove democratic oversight, bypassing elected officials to

> vote in laws and allow bureaucrats to adopt laws from other

countries

> without our consent.

>

> · Remove 70% of Natural Health Products from Canadians and

> many others will be available by prescription only.

>

> · Restrict research and development of safe natural

> alternatives in favor of high risk drugs.

>

> · Punish Canadians with little or no opportunity for

protection

> or recourse for simply speaking about or giving a natural product

> without the approval of government. More than 70% of people in

> Canada use a Natural Health Product. The new law goes so far as to

> warrant action against a person who would give another person

> an " unapproved " amount of garlic on the recommendation that it

would

> improve that person's health.

>

> Proposed New Enforcement Powers:

>

> · Inspectors will enter private property without a warrant

>

> · Inspectors will take your property at their discretion

>

> · Inspectors will dispose of your property at will

>

> · Inspectors will not reimburse you for your losses

>

> · Inspectors will seize your bank accounts

>

> · Inspectors will charge owners shipping and storage

charges

> for seized property

>

> · Inspectors will be empowered to store your property

> indefinitely

>

> · Inspectors will levy fines of up to $5,000,000.00 and/or

> seek 2 years in jail per incident

>

> With your assets and money under their control will you be able to

> defend yourself in Court?

>

>

> Can you trust government with this new law and enforcement power?

>

> Would our government really ever turn this law against us?

Will this new law be used to abuse and punish special interest

> groups, minorities, religious groups or others?

> · Why do bureaucrats want to bypass the Parliament and

> Senate's approval to create new laws?

>

> · Why do bureaucrats want seizure warrants without judge

> approval ?

>

> · With fines being increased a 1000 times, and seizing

> authority without a warrant, is Bill C-51 meant to bankrupt and

> silence its target audience?

>

>

>

> Here's what you can do to protect your rights:

>

> Educate Yourself

>

> · Go to http://www.stopc51.com/

>

> · Read a legal discussion on Bill C-51

>

> · Read bill C-51 on www.parl.gc.ca

>

> Tell others about it

>

> · Talk to your local Press

>

> · Contact your local MP Click Here

>

> · Ask the leaders in your community to get involved

>

> · Contact your MLA

>

> · Tell your Friends

>

> Get involved

>

> · Print off this fact sheet and hand it out in your

> neighborhood.

>

> · Attend our rally at the Calgary Federal Court on May 9th

> 2008 . Call 1-888-878-3467 for Details

>

> Federal Court Rally Information

> Where: 635 8 Ave SW, Calgary, AB, Canada Federal Court (View

> In Google Maps)

> When: 11:45 AM Friday May 9th

>

> This is a peaceful rally, after which a hearing will be held

asking

> the judge to place restraints on our governments ability to seize

> property without a warrant. Taking place on the 4th floor at 1:00pm.

>

[Guest guest]

Here is the latest action alert from IAHF on C-51. If you are interested in helping to fight it, I implore you to sign up for John Hamell's newsletter as he is/has been on the front lines of this fight against CODEX for ove 10 years.

 

He is working with all of the best health freedom advocates in North America to stop it, and needs all of our help.

 

C-51 is very dangerous not only for Canada, but also for t U.S. and Mexico thanks to North American harmonization treaties.

 

Elaine

 

 

International Advocates for Health Freedom

TRUEHOPE ATTACKED IN NATIONAL POST, PHARMA IS DESPERATE!

http://www2.parl.gc.ca/HousePublications/Publication.aspx?Pub=projected & Language=E & Mode=1 & Parl=39 & Ses=2

Your ongoing efforts are needed for a huge SURGE to " persuade " the Conservatives to stop C-51 from passing second reading and to cancel C-52 and the Drug Sub Class Natural Health Product regulations immediately. (See WHAT TO DO- Below.)

THINGS ARE HEATING UP AS THE CONSERVATIVES & BIG PHARMA GETTING DESPERATE!

The National Post published an article yesterday in an attempt to smear Truehope and the Strauss Herb Company which are (naturally) being accused of being " quack companies " desperate to kill C-51 http://www.nationalpost.com/news/canada/story.html?id=590205

The article asserts (falsely) that Truehope is attempting to " hide " their affiliation with http://www.stopc51.com/ but that is patently absurd and totally exposes the National Posts pro Pharma bias. If you go to http://www.healthcanadaexposed.com/c51/contact.asp right there Truehope clearly identifies themselves as having built the site by giving this email address: support along with their tollfree number. The National Post would have readers believe that the national campaign against C-51 is being pushed by " fake grass roots " or " astroturf " when nothing could be further from the truth, but this is how they're trying to spin it.

Additionally, this entire section of the Stopc51 site details Health Canada's witch hunt against Truehope's product Empower Plus which has helped thousands of people with bipolar illness http://www.healthcanadaexposed.com/pages/default_hce.asp

This page provides details about how Truehope beat Health Canada in court and about how Health Canada murdered several of their customers by driving them to suicide.

I am disgusted with the National Post a newspaper. Not only do they engage in these lies about Truehope, but they also quote Terry Polevoy, (the widely discredited pimple doctor from Ontario) who fancies himself to be the heir to also widely discredited so called " quackbuster " Dr.Stephen Barrett in the USA.

(The two work closely together as " attack dogs " on behalf of big pharma, engaging in numerous frivolous lawsuits against alternative practitioners and the natural products industry on both sides of the border. I urge you to write a letter to the editor to complain http://www.nationalpost.com/contact/letters.html?name=Letters & Subject=Letter+to+the+Editor...

You'll find plenty of juicy (albeit totally true) dirt on Polevoy and Barrett at http://www.quackpotwatch.org/opinionpieces/stalkerpolevoy.htm where Tim Bolen rakes them and all the other so called quackbusters over the coals. I am going to call Tim in a minute to ask his help in sounding this alarm.

WHAT TO DO:

Contact your MP via http://www2.parl.gc.ca/Parlinfo/Lists/Members.aspx?Parliament=0d5d5236-70f0-4a7e-8c96-68f985128af9 & Current=True

Tell them you oppose C-51 which is scheduled for debate today and that you want it killed. Tell them the bill threatens to give Health Canada Police State Powers which they would use against the Natural Products Industry. Request that they watch these videos of MP James Lunney discussing his concerns about the bill: http://www.youtube.com/results?search_query=James+Lunney%2CC-51 & search_type= & aq=f

Let them know that we are tracking all MPs on this issue via this database http://www.healthcanadaexposed.com/c51WhatMPsSaid/index.html and that any who vote the wrong way on it will be driven from office. Let them know we will be handing this issue on a silver platter to their competitor prior to the next election if they mess with us because Health Canada has killed entirely too many Natural Health Products consumers already and we're not going to take it anymore.

Call everyone you know and urge them to take immediate action!! Forward this alert after removing the unsub link at the bottom!

Donations to IAHF assist us in bringing you this timely information. If C-51 isn't killed in Canada, its draconian measures will come south to the USA via FDA's Trilateral Cooperation Charter.

Please send a donation to: IAHF 556 Boundary Bay Rd., Point Roberts WA 98281 USA or via paypal at http://www.iahf.com/index1.htmlFor Health Freedom, John C. Hammell, President International Advocates for Health Freedom 556 Boundary Bay Road Point Roberts, WA 98281-8702 USA http://www.iahf.com/ jham 800-333-2553 N.America 360-945-0352 World

 

 

 

 

Can Health Canada be Trusted With the Police State Powers Sought For In Bill C-51? -Causing Deaths Through Enforcement Actions-Filing of Falsified Court Documents

-Attempting to Bankrupt Businesses-Falsified Charges-Enforcing Regulations Against Constitutional Rights Review the Damning Evidence (Click Here)

 

 

 

Bill C-51 Will:

 

Allow Government agents to:

 

 

-Enter private property without a warrant

Section 23 (4)

 

 

-Confiscate your property at their discretion, at your cost

Section 23.3 a

 

 

-Dispose of your property at their discretion, at your cost

Section 23.3 c

 

 

-Seize your bank accounts without a warrant

Section 23 (2) (d)

 

 

-Charge you for shipping and storage of your property

Section 23.3a-b

 

 

-Store your property Indefinitely without paying you for damages

Section 23 (2) (d)

 

 

-Levy fines of up to $5,000,000.00 / 2 years in jail per offence.

Section 31.1

 

 

 

 

 

Introduce new legislation that will:

 

 

-Allow laws to be created in Canada, behind closed doors, with the assistance of foreign governments, industrial and trade organizations

Section 30.7

 

 

-Allow " Crack house style " of enforcement on natural health providers

Section 23.1

 

 

-Allow enforcement to be considered on more than 70% of Canadians who use NHP's

Health Canada Reference

 

 

 

-Allow the minister, based on opinion, to shut down research without any scientific reason or evidence of risk or harm

Section 18.5

 

 

-Allow the minister, based on opinion, to allow or disallow market authorizations for Natural Health Products

 

 

On Thu, Jun 19, 2008 at 8:43 AM, anqele <anqele wrote:

The bill was passed last week....DRAFT DISCUSSION PAPER ON Bill C-51Prepared by Shawn Buckley, president of the NHPPA on April 9, 2008.

Purpose of the PaperYesterday the Minister of Health introduced Bill C-51 into the Houseof Commons. The Bill passed first reading. The following is a linkto a version of the Bill:

http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3398126 & Although this only occurred yesterday, upon our reading of the Bill

it became apparent that it may have wide ranging negativeimplications for the Natural Health Product industry. We are of theopinion that it would be prudent to draft an initial discussion paperto be circulated to stakeholders and more importantly to other

stakeholder groups to begin discussion on the issues raised in thisBill.Need for a Broad ConsensusWe feel that Bill C-51 has such broad implications for the NaturalHealth Product Industry that it would be prudent for all of the

various stakeholder groups to collaborate to see if an industryconsensus can be reached in how to approach Bill C-51. If Bill C-51poses a threat to the industry, unless there is consensus, efforts toprotect the industry will fail.

Discussion Paper OnlyThis is a discussion paper only and does not reflect the position ofthe NHPPA or of the NHPPA advisory board. The thoughts and commentsare those of the author, Mr. Shawn Buckley and are intended to foster

discussion.The NHPPA will formulate its position after industry feedback.Invitation to Other Stakeholder GroupsWe will be forwarding this discussion paper to other stakeholder

groups such as the CHFA and consumer groups.We would like the other stakeholder groups to analyze the Bill. Wewould then like to get representatives of the various groups togetherto see if a consensus can be reached concerning Bill C-51. We

believe that it is important for the various stakeholder groups totake a leading role with their members on this issue in the eventthat their leadership is required to protect the industry.

Initial Points of DiscussionScope of Discussion PointsBecause we feel it is necessary to get this Discussion Paper outimmediately to stimulate examination and discussion on Bill C-51, I

will only focus on what I consider to be major points. I fullyexpect that as others examine this Bill and take part in thediscussion that they will identify other significant issues.Preamble to the Act

The preamble to the Act is not part of the Act and does not becomelaw if the Bill is passed. What the preamble does is explain why theBill is necessary.The second last paragraph of the preamble reads:

" Whereas the Parliament of Canada recognizes that it is theresponsibility of regulated persons to ensure that only products thatmeet legislative requirements are available to the public; "

My initial thoughts is that this is a classic case of what GeorgeOrwell calls doublespeak. That is, a case of saying the opposite ofwhat you are doing.What is communicated:

that it is the responsibility of " regulated persons " to ensure thatonly products that meet the legislative requirements are available tothe public.What the Act does:the Act gives broad power and responsibility to Health Canada

inspectors to force " regulated persons " to take whatever measures theinspectors deem necessary to ensure safety. For example, see section23.8 of the Bill.I am troubled by this due to the following scenario developing:

1) currently roughly 60% of natural health product licenseapplications are failing. The majority of these license applicationsare for single ingredient products which are easier to licence then

multi-ingredient products. The percentage of failed licenseapplications is expected to increase as more multi-ingredient productlicense applications are considered. My estimate is an overallfailure rate of 70%. This means that over 60% of the natural health

products on the market will fail the licensing process and willbecome illegal. At that point the manufacturer can wilfully withdrawthem from the market or Health Canada can take enforcement action;

2) the NHPD has been given more resources to process licenseapplications which means that the majority of the products willbecome illegal sooner rather than later;3) Health Canada is currently going to universities to recruit

university graduates as inspectors because Health Canada anticipatesan increased need for enforcement, and4) Bill C-51 gives inspectors new powers to force products off ofthe market.

I am not aware of Health Canada having enforcement problems withchemical drug pharmaceutical companies. My belief is that whenHealth Canada asks a pharmaceutical company to take a product off ofthe market, the pharmaceutical company does. I expect that this

occurs because pharmaceutical companies would face huge liabilityissues if they failed to comply with a Health Canada request and thensomeone was injured. If I am incorrect in this I am invitingcorrection as it is important for us to determine " who " the new

enforcement powers are directed to.If Health Canada is not having compliance problems withpharmaceutical companies, then should we interpret the new powers inBill C-51 as necessary to force the natural health product industry

into compliance? I do not know the answer to this. I would ask youto analyse this as you work through the Bill.The Move to the term " Therapeutic Products " Bill C-51 moves away from the use of the term " drug " and introduces

the term " therapeutic products " . Indeed even the name of the " Foodand Drugs Act " will be changed to " An Act respecting foods,therapeutic products and cosmetics. " The definition of " drug " remains unchanged but a new definition

of " therapeutic product " is added which includes drugs, medicaldevices and cells, tissues or organs. However, the term " drug " isreplaced throughout the old Food and Drugs Act with theterm " therapeutic products " .

Natural Health Products remain " drugs " under the Act. The onlychange is that now all drugs are referred to as " therapeuticproducts " in the Act instead of as drugs.I have found this to be a very interesting change, and perhaps the

most significant of all of the changes. I think this is perhaps themost significant of all changes as I asked myself the followingquestions:1) why is a language change away from the word " drug " and to the

term " therapeutic product " important to Health Canada , and2) what part of the industry is this change for?We think and communicate in language. The terms we use to define and

refer to things affect how we think about them. That is whyadvertising firms exist.The term " drug " in the Food and Drugs Act is not substance specificin that any substance is considered a " drug " if sold or manufactured

for a therapeutic purpose. However, many people think of theword " drug " as referring to chemical drugs as opposed to plants soldfor therapeutic purposes.There is no confusion in the public's mind concerning pharmaceutical

drugs. When the public thinks of pharmaceutical drugs they arecomfortable with the word " drug " .There is confusion when the word " drug " is applied to natural healthproducts.

Because there was no confusion concerning pharmaceutical drugs andthe word " drug " , is the change of terminology directed at the NaturalHealth Product industry or are there other reasons?

The change certainly affects the dynamics of the debate overregulating NHPs as foods or as a third category separate from drugs.Let's use the NHPPA's position on regulatory change as an example.

The NHPPA Advisory Board has given the NHPPA the goal of obtaining aregulatory environment where:(1) NHPs are presumed to be safe. A NHP cannot be takenoff of the market unless the Government can prove that it is unsafe;

(2) there are different claims structures so that:a) manufacturers do not have to make claims;b) manufacturers can make limited claims, such as structurefunction claims with a low evidence threshold, and

c) manufacturers can make specific health claims if they can meeta higher evidence threshold;(3) NHPs are not regulated as drugs. They are eitherregulated as food or as a third category separate from drugs and food;

(4) there are Good Manufacturing Processes that areappropriate for the low risk profile of NHPs, and(5) there is a conflict resolution mechanism to settledisputes between the Government and industry members.

The last time consumers and the industry rebelled against HealthCanada enforcement actions against NHPs, the rallying cry was " don'ttreat our foods as drugs " . That rallying cry created the most

successful petition drive in Canadian history. It was a large factorleading then Minister of Health Allan Rock to refer the issue to theStanding Committee on Health. The result was the 53 Recommendationswhich the industry would still like to see implemented.

Would the rallying cry have been successful with the newterm: " don't treat our foods as therapeutic products " ? Or to bemore accurate: " don't treat or natural health products as

therapeutic products " ?My point in all of this is simply to communicate that terms andlanguage are important as they determine the parameters of how wethink and can affect debate. The change in terms is being introduced

deliberately by Health Canada and we need to consider what theimplications for the industry are.Expanded Definition of " Sell " The old definition of " sell " is:

" 'sell' includes offer for sale, expose for sale, have in possessionfor sale and distribute, whether or not the distribution is made forconsideration. " The new definition of " sell " is "

" 'sell' includes offer for sale, expose for sale or have inpossession for sale or distribute to one or more persons, whether ornot the distribution is made for consideration and in relation to a

device, includes lease, offer for lease, expose for lease or have inpossession for lease. " (emphasis added).The lease provision is not going to affect the NHP industry.

The change that is interesting is the new if you distribute to " oneor more persons " you can be prosecuted for selling under the Act.Under the old definition, although you did not have to get paid if

you gave product away, it is fair to say that the definitionof " sell " , especially when considered in the context of the Act as awhole, would be considered to be referring to a commercial venture.So for example a manufacturer giving out free samples would be

selling.Now the term " selling " will apply to a single isolated giving of atherapeutic product. So if I give my child a natural health productI am now selling under the Act and can be prosecuted. I doubt that

the intention is to prosecute parents for giving their children NHPs,although that could happen under the new definition. Rather, as alawyer who defends people and companies charged with violating theAct and Regulations, I see this as an open door to prosecute natural

health practitioners, including naturopathic and homeopathic doctors.Changes to legislation are supposed to solve a problem. When weanalyse this change to the definition of " sell " we need to ask, what

is the problem that Health Canada feels needs to be addressed bysignificantly widening the scope of selling under the Act?It is going to be vital to obtain the input of natural healthpractitioners concerning this change.

Introduction of the term " Controlled Activity " The Bill creates the following term: " 'controlled activity' means(a) in relation to a therapeutic product manufacturing,

collecting, processing, preserving, labelling, packaging, importingfor sale, distributing, wholesaling or testing, and(b) in relation to a designated therapeutic productmanufacturing collecting, processing, preserving, labelling,

packaging, importing, distributing or testing.My initial thoughts on the introduction of this term is that it isagain directed at natural health practitioners such as naturopathicand homeopathic doctors.

The Bill introduces the following section: " 13. No person shall conduct a controlled activity unless they areauthorized by an establishment license to do so. " The change from our current regulatory scheme is the expansion of the

site licence requirements. Section 27 of the Natural Health ProductsRegulations does not include: collecting, processing, preserving.Section 27 already includes manufacturing. By adding processing andpreserving Health Canada is targeting something other than

manufacturing.Allowing Trade Agreements to become law without ParliamentaryApproval – and the Sharing of Confidential Information with ForeignGovernments and Agencies.The following term is added to the Act:

" 'government' means any of the following or their institutions, asapplicable:(a) the federal government;(b) a corporation named in Schedule III to 10 of the

Financial Administration Act,© a provincial government or a public body establishedunder an Act of the legislature of a province,(d) an aboriginal government as defined in subsection 13

(3) of the Access to Information Act,(e) a government of a foreign state or of a subdivisionof a foreign state, or(f) an international organization of states.

(emphasis added).Defining " government " to include foreign states or internationalorganizations of states such as the United Nations, is importantbecause of a change to section 30 of the Act. Bill C-51 adds the

following to the regulation making power of the federal government: " 30(7) A regulation may incorporate by reference documents producedby a person or body other than the Minister of the Canadian Food

Inspection Agency including(a) an organization established for the purpose of writingstandards, including an organization accredited by the StandardsCouncil of Canada;(b) an industrial or trade organization; or

© a government. " This addition allows the federal government to make documentsprepared by foreign governments or bodies law in Canada by simplypassing a regulation incorporating the document. So for example, the

CODEX treaty could become law without Parliamentary approval bysimply passing a regulation saying it is now part of our regulations.Just so that everyone understands what this means I will explain the

difference between Acts and Regulations. Acts are documentsintroduced into either the House of Commons or the Senate. They mustpass three readings in both before they can become law. This processensures that Canadians and their representatives become aware of

proposed changes, have them debated in Parliament, and have time tocontest them.Regulations on the other hand are simply published in the CanadaGazette twice and then can be signed into law. Parliament does not

vote on regulations.This change to allow the federal cabinet to incorporate documentsfrom foreign governments or organizations as law by referring to themin regulations will remove Parliamentary scrutiny on issues that

could fundamentally change the ground rules for our industry.Because these changes were not made by accident, the questions areraised:what purpose is served by removing Parliamentary scrutiny to the

adoption of documents from foreign governments and institutions intoCanadian Law, anddoes the federal cabinet already have specific foreign documents inmind?There are also significant confidentiality issues associated with the

new term of " government " in the Act. Bill C-51 also gives theMinister authority to disclose personal and business informationwithout consent to a person or " government " that carries outfunctions relating to the protection or promotion of human health

(see sections 20.9, 21 and 21.1). There are some safeguards, but atthe same time the Minister has new power to share personal andconfidential business information with a wide range of bodies, bothCanadian and foreign, without consent.

Product Monographs are " Deemed " to be part of your LabelBill C-51 adds: 2.1 For the purposes of this Act,a) a product monograph of a therapeutic product is deemed to be a

label even if it is not attached or included in or does not accompanythe therapeutic product;Approaching this from a defence counsel perspective, my immediateconcern is that this will subject companies to misrepresentation and

fraud charges.I will need input from industry stakeholders concerning theimplications when manufacturers disagree with the Health Canadamonographs.It would also be helpful to get feed-back as to why Health Canada

wants this change. Put another way, what is broken that this isintended to fix?A New Purpose of The ActThe Food and Drugs Act (i.e. the Food and Therapeutic Products Act)is given a new purpose which is:

2.3 The purpose of this Act is to protect and promote the health andsafety of the public and encourage accurate and consistent productrepresentation by prohibiting and regulating certain activities in

relation to foods, therapeutic products and cosmetics. (emphasis added).Section 3 Prohibiting Schedule A Claims is RemovedSection 3 of the Act which prohibited Schedule A claims is removed.

I expect that this is in response to the CanWest lawsuit to have s. 3declared unconstitutional.New Restrictions on the Importation and Transportation of FoodSection 4 of the Act is amended to include restrictions on

the " import for sale " of foods that are poisonous, unfit, injuriousor adulterated. I do not see a difficulty with this.This is part of a general change in the Act towards prohibitingimportation and shipping.

Sections 5.1 to 5.4 are added which place restrictions on " prescribedfood " . A prescribed food will be a food put on a list by the federalcabinet. These sections prevent the importation from another country

and the shipping across provincial borders of a prescribed foodunless they have a " registration or a license " . These foods can onlybe sent to registered establishments.It is not clear to me at this point what danger or purpose these new

provisions are directed to addressing. What foods currently needthese types of restrictions?Bill C-51 represents a tightening of restrictions and the increasingof Health Canada powers in all areas covered by the Act.

Importing is added to prohibitions in the former sections 8 and 9.The new sections 8 and 9 are similar in nature to the old ones exceptthat the prohibitions are expanded to include importing and conveying

for sale.Is Health Canada Approval now required for clinical trials involvingfood?Prior to the creation of the NHPD universities did not get HealthCanada approval to do nutrition research. So for example, if a

university wanted to run a clinical trial to better understand theeffect limes have on scurvy, they did not get Health Canadaapproval. Even with the creation of the NHPD, it is not clear to methat Health Canada approval would be necessary to study the effect of

limes on scurvy.It has also been the case that some clinical trial businesses did notfeel they needed Health Canada approval for natural health productsthat had been in the food chain for a long period of time.

The new Act adds a definition of " clinical trial " as well as aprohibition on conducting a clinical trial for a therapeutic productwithout Health Canada authorization.As I read the new provisions, I think that a study of limes for

scurvy would now require Health Canada approval.I would like input as to whether the current regime needs to bewidened?The need for pre-market approval becomes part of the Act as opposed

to part of the Regulations – And the Criteria Changes.The new section 12 provides:12(1) No person shall advertise, sell or import for sale atherapeutic product that does not have a market authorization or is

not a designated therapeutic product.The Act does not currently require Health Canada pre-approval for thesale of drugs. For there to be a pre-approval requirement, it has tobe added in the Regulations. So for example, the NHP Regulations

require pre-approval.This change will mean that there is a blanket need for pre-approvaland any exception needs to be added to the Regulations.What has changed is that the Act will now presume that

all " therapeutic products " are dangerous and need pre-approval unlessspecifically exempted.Again part of the general tightening in Bill C-51.Concerning the criteria change: section 18.7 will only enable Health

Canada to issue market authorization if satisfied " that the benefitsthat are associated with the therapeutic product outweigh therisks. " Risks are not defined and so it is unclear if Health Canadawill continue to use risk factors such the risk people will not

seek " proper " (i.e. read mainstream medical) treatment if they takean NHP.This criteria change is legislating an efficacy requirement. TheNHPD will have to have evidence of efficacy before they can determine

that the benefits outweigh any risks.This balancing is appropriate for chemical drugs that carry a highrisk profile. The industry will have to discuss whether it isappropriate for the NHP industry which has never caused a single

death in Canadian history. In any event, if Bill C-51 passes, thegoal posts for the NHP industry will change which should require re-licensing of NHPs.After the Act is changed to require NHPs to demonstrate their

benefits outweigh their risks, NHPs can only be exempted from thisrequirement if the federal cabinet is satisfied that their nature issuch that a risk assessment is not necessaryI have just discussed how the Act will now require proof of efficacy

before a product can be licensed unless it is specifically exempted.It needs to be appreciated, however, that there are limits onexempting products from this requirement. The new subsection 30(1.1)contains this limit as follows:

30 (1.1) a regulation may be made under paragraph (1)(d) [the sectiongoverning the designation of therapeutic products] only if theGovernor in Council is satisfied that the therapeutic product is one

that by its nature does not need to be the subject of an assessmentof its benefits and risks.This means that the federal cabinet could only exempt NHPs or a classof NHPs from the new proof of efficacy requirement " if " they are

satisfied that " by its nature " it does not need to be subject to abenefit and risk analysis. This is very vague and there is nomechanism in place for making submissions to the cabinet.If Bill C-51 passes, those in the industry such as our advisory board

who would like to see NHPs to be presumed safe until proven to bedangerous will be disappointed. It would require a change to the newAct as opposed to a change to the regulations. " Import for sale " is added to the old drug provisions.

The old drug provisions of the Act which are now the " therapeuticproduct " provisions now include a prohibition for importing for salealthough this addition is not highlighted in the proposed Bill as

other changes are.A Prohibition against selling prescription " therapeutic products " without a prescription is added to the Act.The Regulations currently provide that prescription drugs (that is

those listed in Schedule F of the Regulations) are only available bythose authorized to write prescriptions. This is now being put aspart of the Act as opposed to the Regulations.There are other changes and it is not clear to me yet whether or not

it will now be Health Canada as opposed to the provinces who will bedetermining who is eligible to write prescriptions, although I viewthat as an area of provincial jurisdiction.Why the prescription drug issue is important to the NHP industry is

that Health Canada currently has a policy that if you can extract aprescription drug substance from a plant or animal, then that plantor animal can only be sold by prescription. So for example, greenand black tea contain a prescription substance but Health Canada has

not yet started attacking NHPs with tea as an ingredient.Again part of the general tightening in Bill C-51.Inspection and Seizure Powers are IncreasedThe inspection and seizure powers found in s. 23 of the Act are

increased to:· give inspectors authority to enter private property toprevent non-compliance with the Act or Regulations;· enter conveyances for the purposes of inspections;

· enter places where even a document relating to the Act andRegulations may be located. Currently inspectors are restricted toplaces where articles to which the Act or regulations apply are

manufactured, prepared, preserved, packaged or stored. Note thatdocument is defined in Bill C-51 to include information that can beread by a computer or device so if your blackberry is in your car thecar can be searched;

· take samples free of charge. This is interesting for tworeasons. First, there is no limit to the value of the samples.Second, although the current wording of the section does not statethat Health Canada should pay for samples they take, it was clearly

the intention of the government that they do pay for them. Prior tothe current wording the Act specifically set out that Health Canadahad to pay fair value for samples they took. When the new wordingwas introduced the Minister made it clear that although the wording

changed that the samples were to be paid for. This can be found inthe Hansard for April 21, 1953 where the Minister is asked:Q. In the matter of taking samples, the section says that theinspector may take samples and examine them. No provision is made in

section 21 for leaving the sample. Later on in the bill we are goingto come to the point of a court case on the analysis of a sample.A. When an inspector takes the sample he pays for it, of course.

There is a general principle that the government cannot take propertywithout compensating the owner. Is it necessary to abandon thatprinciple in this case?· seize and detain for any time anything connected to the Act

and Regulations, such as your products and equipment. This is asignificant change. Currently, an inspector can only seize ifhe/she " believes on reasonable grounds " the article is connected to aviolation of the Act or Regulations. Now an inspector can seize all

of your property without the pre-condition that he/she believes it isconnected to a violation of the Act.The addition of " for any time " is also a change. Previously articlescould only be held for such time " as may be necessary " and in

connection with a violation. So for example, if your property wasseized for a labelling problem and you printed correct labels, theproperty should be released. Now the property can be held for anytime and for any reason. This raises a question as to why such new

broad and sweeping seizure powers are necessary?Keep in mind that Health Canada always has access to the searchwarrant provisions found in the Criminal Code. These provisions havebeen used by Health Canada and seem to work adequately for other

federal regulatory bodies. What is going to occur that requiresseizure without a warrant, without any reason, without reporting backto a Court or Justice, and without any time constraints?· enter on and pass through or over private property without

any liability and without the owner of the property having the rightto object;· charge the owner for storage of seized property. Now notonly can Health Canada seize property for any length of time, but the

new s. 23.3 gives them the right to charge you for the moving andstorage. I am aware of one company that has had product seized for 5years. Under this new provision they would be liable for ongoingstorage costs. This is unprecedented. Usually the government can

only seize private property for violations and it is very unusual fortheir to be fees for the storage of what is then considered to beevidence;· if inspectors believe on reasonable grounds the seized

property could be injurious to human health they can dispose of it atthe expense of the owner or direct the owner to dispose of it.Currently inspectors have to either obtain the owner's consent orapply to a Court to have product destroyed. This protects the

property owner by ensuring that an impartial Judge will make thedecision. It is difficult to understand why it is in anyone'sinterest to take away the current safeguards;· property is immediately forfeited after 60 days unless an

owner is identified. No application to a Court is necessary. I findthis interesting as I was involved in a case in which product wasseized but for prosecution purposes Health Canada was going to havedifficulty proving ownership. Now if in doubt Health Canada can

simply seize enough of your property that you will go bankrupt if youdo not claim it and hence solve the proof of ownership issue. It ishighly unusual for their to be forfeiture without a Court order. Thecosts of destruction can be charged to the owner or person entitled

to possession.Inspectors are given apparently unlimited powers to direct youractions and do " anything " for even the slightest suspected violationof the Act or Regulations

The new section 23.8 gives inspectors extremely broad powers. If theinspector believes on reasonable grounds there is a contravention ofthe Act or Regulations they can direct you to:a) stop doing something that is in contravention of the Act or

the regulations or cause it to be stopped; orb) take a measure that is necessary to identify or respond to arisk of injury to health that is related to the activity that is thesubject of the contravention.

This means that if an inspector who does not understand the NHPindustry, and who is not qualified to make health decisions tells amanufacturer to stop selling an essential product, or tells a natural

health practitioner not to provide a product their patients relyupon, that the manufacturer or natural health practitioner iscommitting an offence if they do not comply.The new section 24 also gives Health Canada the authority to require

a product recall. Currently Health Canada cannot require a recall.I am of the opinion that the recall provision is directed at the NHPindustry. As discussed above, I do not think there is a problem with

the chemical pharmaceutical industry recalling when Health Canadaasks them to recall.There are problems in the NHP industry with companies refusing torecall. This is because often it is dangerous for a NHP company to

issue a recall. The most obvious example is that of TruehopeNutritional Support. The Alberta Court found that Truehope wouldhave caused suicides and hospitalizations if they had listened toHealth Canada 's demand to take the product off of the market. The

decision can be found at: http://www2.albertacourts.ab.ca/jdb%5C2003-%5Cpc%5Ccriminal%5C2006%5C2006abpc0196.pdf

When a NHP manufacturer asks me whether they should follow a HealthCanada demand for a recall, I have to first get information from themas to whether or not any Canadians rely upon the product for their

health. If they do then I have to advise them about the CriminalCode criminal negligence provisions which would make them liable tocriminal prosecution if they removed a product from the market thatpeople relied upon, and for which there were not obvious alternatives.

When Health Canada inspectors demand that NHPs be recalled orremoved, they are in effect making decisions that affect people'shealth. In determining whether these inspectors should be givenblanket power to recall and seize products, we need to consider

whether we want untrained persons making health decisions. Currentlyto force a recall Health Canada would need to seek an injunction inCourt. Under this procedure the Court would consider the risk ofremoving the NHP before making an order. In assessing these new

powers, we need to consider whether we want to remove the Court'soversight which is currently required.Bill C-51 adds the right to apply to a Court for an injunction. Thisright already exists under the Federal Court Act and so this is not a

significant change except that it may enable provincial superiorcourts to consider injunction applications.You are now told where to keep your documents, which includescomputer records

The new section 25 and 26 require you to keep your documents " inCanada at a prescribed place " . Remember documents is defined toinclude electronic documents and would also cover your web-sites.

Again part of the general tightening in Bill C-51.Expanded powers to make regulationsFor the purpose of this discussion paper I am not going to go intothe specifics of the expanded powers except to comment that the

Minister's powers to make regulations is expanded.The new offence of not listening to an inspectorSection 31 is amended to make it an offence not to do something thatthe Minister or an inspector directs you to do. Similarly it is an

offence to do something the Minister or an inspector tells you not todo.As discussed above, this is particularly problematic for naturalhealth practitioners who would be violating the new Act if they

failed to take health decision advice from an inspector.An incredible increase in penalties for violating the Act orRegulations along with New Offences.There are two types of offences under the Act: indictable offences

and summary conviction offences. Indictable offences are consideredmore serious than summary conviction offences.The current penalties are:· for summary conviction offences a fine of up to $500 and/or

imprisonment of up to 3 months for a first offence, and a fine of upto $1,000 and/or up to 6 months incarceration for subsequentoffences, and· for indictable offences a fine of up to $5,000 and/or

imprisonment for up to 3 years.The new penalties are:· for summary conviction offences a fine of up to $250,000and/or imprisonment of up to 6 months for a first offence, and a

fine of up to $500,000 and/or up to 18 months of incarceration forsubsequent offences, and· For indictable offences a fine of up to $5,000,000 and/orimprisonment of up to 2 years.

This is not a doubling or tripling of fines. In the case ofindictable offences the fine is increased by a multiple of 1000times. In the case of summary conviction offences the fine isincreased by a multiple of 500 times.

This raises the question as to why it is necessary to raise theprimary penalty by multiples of 500 and 1000. This is probablyunprecedented in Canadian history.Again, we need to ask who the changes are directed towards and

whether they will be beneficial for the industry.There are also new offences for wilfully or recklessly violating theAct or Regulations or not listening to the Minister or an inspector.The penalties for these new wilful or reckless offences are higher.

They are:· For summary conviction offences a fine of up to $500,000and/or imprisonment for up to 18 months for a first offence, and afine of up to $1,000,000 and/or imprisonment of up to two years for

subsequent offences, and· for indictable offences " a fine the amount of which is atthe discretion of the court or to imprisonment for a term of not morethan five years or to both " .

Please note that in all of my years defending companies in Court, Ihave never seen Health Canada charge only one offence. In one casethere were 73 charges. Under ten would be an exception. So when

considering whether a company could survive sentencing, do notcalculate a single fine for a single offence. Rather assume multiplefines for multiple offences.These are penalties that few manufacturers or natural health

practitioners could survive. Small and medium manufacturers alongwith natural health practitioners now face bankruptcy for violationsof the Act or Regulations.Directors and officers of corporations are now also personally

responsible for violations of the Act and Regulations and so are alsofacing personal bankruptcy if there is any violation of the Act orRegulations.Need for inputThis draft document is admittedly only a cursory consideration of

Bill C-51. However, because the Bill presents significant changesthat may be extremely damaging to the NHP industry, we felt that itwas necessary to prepare an initial discussion document to get thevarious stakeholders aware of the issues presented by the Bill.

It is essential that stakeholders and stakeholder groups take thetime to examine Bill C-51 and to draw their own conclusions.We will be inviting the various stakeholder groups to discuss the

issues to see if there is consensus on how the industry shouldproceed and how they can take a leadership role in protecting theindustry.I anticipate that my very quick analysis will contain errors and that

some of you will correct them. I thank you in advance for yourinput. I am also looking forward to issues that I missed or avoidedbeing brought forward.For those of you who would like to send their comments by email,

probably the best email address to use isshawn. Please restrict your use of this emailaddress to your comments on this Discussion Paper.

Shawn Buckleyoleander soup , " suzannestapler " <scupe1wrote:>> Please tell everyone you know especially if they buy from or live

in> Canada. Without some of these food supplements, there could be an> increase in cancer patients.>> Suzanne Stapler>>>> Time Sensitive - This Bill may pass in the 1st half of May!

> Canada's C-51 Bill>> Big Pharma Pushing to Criminalize Foods and Supplements>> Please read and tell your local healthfood stores and food coops,and> ESPECIALLY anyone you know in Canada who cares about this topic: If

> this happens in Canada, it can easily happen here next.>>> For a brief update on what this law entails, go to:>> www.naturalnews.com:80/023121.html

>> posted on Monday, April 28, 2008 by: Mike Adams>> This is a hugely restrictive law that is impending passage inCanada.> I have been researching this Bill this morning and have talked with

> several people in Canada who are on the front lines to fight this> Bill. In addition to getting information at:> http://www.naturalnews.com/023121.html, please go to

www.stopc51.com.> While there, read the Bill and go to the " What You Can Do " section.> Go to the " Tell Others About It " section and then click on the Fact

> Sheet.>>>> This is a very time sensitive issue and it is important to take> action FAST!>>>> Take Action Fast>> The First Reading of Bill C-51 was on Wednesday, April 9th, 2008

> The Second Reading is Scheduled for Monday, April 28th, 2008> There is one more Reading on May 7th- and if it passes, it will> become law!>>> It appears that the Canadian Government is trying to fast track

this> bill before anyone has a chance to challenge it. Bills normallytake> months to pass not weeks.>>>> This morning I called 4 people in Canada - 2 in BC, 1 in Calgaryand

> another in Ontario - NONE of them knew about this. This information> is critical to get out. Contact as many Canadian citizens aspossible> and have them contact the Minister of Health to voice their

> disapproval. For more information call 888-878-3467 and ask forTanza> Mendenhal. Emails can be sent to: minister_ministre and> calls can be made to: Media Relations - 613-957-2983.>> An Important Notice Regarding Bill C-51

>>>> On April 8th, 2008, the Canadian Minister of Health introduced BillC-> 51 into the House of Commons. This Bill proposes significantchanges> to the current Food and Drugs Act that will have wide-ranging

> negative implications for Canadians.>> Bill C-51 will:>> · Remove democratic oversight, bypassing elected officials to> vote in laws and allow bureaucrats to adopt laws from other

countries> without our consent.>> · Remove 70% of Natural Health Products from Canadians and> many others will be available by prescription only.>> · Restrict research and development of safe natural

> alternatives in favor of high risk drugs.>> · Punish Canadians with little or no opportunity forprotection> or recourse for simply speaking about or giving a natural product> without the approval of government. More than 70% of people in

> Canada use a Natural Health Product. The new law goes so far as to> warrant action against a person who would give another person> an " unapproved " amount of garlic on the recommendation that it

would> improve that person's health.>> Proposed New Enforcement Powers:>> · Inspectors will enter private property without a warrant>> · Inspectors will take your property at their discretion

>> · Inspectors will dispose of your property at will>> · Inspectors will not reimburse you for your losses>> · Inspectors will seize your bank accounts>

> · Inspectors will charge owners shipping and storagecharges> for seized property>> · Inspectors will be empowered to store your property> indefinitely>> · Inspectors will levy fines of up to $5,000,000.00 and/or

> seek 2 years in jail per incident>> With your assets and money under their control will you be able to> defend yourself in Court?>>> Can you trust government with this new law and enforcement power?

>> Would our government really ever turn this law against us?>>>>>>> Will this new law be used to abuse and punish special interest> groups, minorities, religious groups or others?

> · Why do bureaucrats want to bypass the Parliament and> Senate's approval to create new laws?>> · Why do bureaucrats want seizure warrants without judge> approval ?

>> · With fines being increased a 1000 times, and seizing> authority without a warrant, is Bill C-51 meant to bankrupt and> silence its target audience?>>>> Here's what you can do to protect your rights:

>> Educate Yourself>> · Go to http://www.stopc51.com/>> · Read a legal discussion on Bill C-51>> · Read bill C-51 on www.parl.gc.ca

>> Tell others about it>> · Talk to your local Press>> · Contact your local MP Click Here>> · Ask the leaders in your community to get involved

>> · Contact your MLA>> · Tell your Friends>> Get involved>> · Print off this fact sheet and hand it out in your> neighborhood.>

> · Attend our rally at the Calgary Federal Court on May 9th> 2008 . Call 1-888-878-3467 for Details>> Federal Court Rally Information> Where: 635 8 Ave SW, Calgary, AB, Canada Federal Court (View

> In Google Maps)> When: 11:45 AM Friday May 9th>> This is a peaceful rally, after which a hearing will be heldasking> the judge to place restraints on our governments ability to seize

> property without a warrant. Taking place on the 4th floor at 1:00pm.>---