Functional Foods and Natural Health Products Survey - 2011

Functional Foods and/or Natural Health Products - Question identifier:1. a.

Please indicate the types of functional foods intended for human consumption that your business unit, directly or indirectly, developed and/or produced in fiscal year 2011/2012.

Foods and beverages that are fortified with vitamins and/or minerals beyond mandatory requirements for the purpose of providing added health benefits.

• 1.: Yes
• 2.: No

Foods and beverages that have added active ingredients, excluding vitamins or minerals, that have been scientifically demonstrated to provide health benefits beyond their basic nutritional functions.

• 1.: Yes
• 2.: No

Foods and beverages specially enhanced to contain more of a functional component, through plant breeding techniques, genetic modification, processing, or special livestock feeding techniques, that have been scientifically demonstrated to provide health benefits beyond their basic nutritional functions.

• 1.: Yes
• 2.: No

Other, please specify

• 1.: Yes
• 2.: No

Functional Foods and/or Natural Health Products - Question identifier:1. b.

Please indicate the types of natural health products intended for human consumption that your business unit, directly or indirectly, developed and/or produced in fiscal year 2011/2012.

Natural health products that are extracted or purified from plants.

• 1.: Yes
• 2.: No

Natural health products that are ground, dried, powdered and pressed from plant materials.

• 1.: Yes
• 2.: No

Natural health products that are produced extracted or purified from animals or micro organisms.

• 1.: Yes
• 2.: No

Natural health products that are produced extracted or purified from marine sources.

• 1.: Yes
• 2.: No

Natural health products comprised solely of vitamins and minerals (sold in dosage form).

• 1.: Yes
• 2.: No

Other, please specify

• 1.: Yes
• 2.: No

Functional Foods and/or Natural Health Products - Question identifier:1. c.

Please indicate the health benefit(s) of the functional foods and/or natural health products developed or produced by your business unit in fiscal year 2011/2012.

A. Reduction of risk of disease.

• 1.: Yes
• 2.: No

B. Health and wellness promotion

• 1.: Yes
• 2.: No

C. Performance enhancement

• 1.: Yes
• 2.: No

D. Special populations

• 1.: Yes
• 2.: No

E. Supplements

• 1.: Yes
• 2.: No

F. Other, please specify

• 1.: Yes
• 2.: No

Functional Foods and/or Natural Health Products - Question identifier:1. d.

For your business unit's functional food and/or natural health product operations, in which of the following activities did your business unit engage directly in fiscal year 2011/2012?

Please check all that apply

A. Scientific research & development

B. Product development or scale up of new products

C. Extraction of bioactives or medicinal ingredients

D. Manufacturer of ingredients or raw materials to be used in functional foods or natural health products

E. Manufacturer of semi-finished functional foods and/or natural health products to be further processed before sales

F. Manufacturer of consumer-ready products to be sold without further processing

G. Wholesaler of products

H. Retailer of products

I. Other, please specify

Functional Foods and/or Natural Health Products - Question identifier:2. a.

Did your business unit provide services to other business units involved in the functional food and/or natural health product industry in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Functional Foods and/or Natural Health Products - Question identifier:2. b.

For what purpose(s) did your business unit provide these services to other business units during fiscal year 2011/2012, either in Canada or in foreign markets?

A. Scientific research & development

• 1: Canada
• 2: Foreign

B. Intellectual property

• 1: Canada
• 2: Foreign

C. Regulatory

• 1: Canada
• 2: Foreign

D. Clinical trials

• 1: Canada
• 2: Foreign

E. Custom manufacturing or production or formulation

• 1: Canada
• 2: Foreign

F. Extraction of bioactives or medicinal ingredients

• 1: Canada
• 2: Foreign

G. Technical or engineering or mechanical

• 1: Canada
• 2: Foreign

H. Quality control

• 1: Canada
• 2: Foreign

I. Sales or marketing or advertising

• 1: Canada
• 2: Foreign

J. Market research or business development

• 1: Canada
• 2: Foreign

K. Other, please specify

• 1: Canada
• 2: Foreign

Functional Foods and/or Natural Health Products - Question identifier:2. c.

What are your business unit's total revenues, in thousands of Canadian dollars ($'000), derived from these services, as listed in question 2b, which were provided to other business unit's involved in the functional food and natural health product industry during the fiscal year 2011/2012?

Percentage of revenue from services for functional food

___.__%

Percentage of revenue from services for natural health products

___.__%

Functional Foods and/or Natural Health Products - Question identifier:3.

In fiscal year 2011/2012, how many functional food and/or natural health product related product lines did your business unit have in development and/or in production?

Functional food, Total products in development

__________ Number

Functional food, Products sold only to customers in Canada

__________ Number

Functional food, Products sold only to customers outside of Canada

__________ Number

Functional food, Products sold both to customers in Canada and outside of Canada

__________ Number

Functional food, Total Products sold

__________ Number

Natural health products, Total products in development

__________ Number

Natural health products, Products sold only to customers in Canada

__________ Number

Natural health products, Products sold only to customers outside of Canada

__________ Number

Natural health products, Products sold both to customers in Canada and outside of Canada

__________ Number

Natural health products, Total Products sold

__________ Number

Business unit activities - Question identifier:4.

Please provide your best estimate of your business unit's proportion of sales, in fiscal year 2011/2012, of functional foods, natural health products, or bioactive/medicinal ingredients through the following distribution channels:

Distribution methods

A. Direct selling

B. Internet sales or mail order

C. Wholesaler

D. Direct to retailer

E. Direct to other manufacturers

F. Multi-level marketing or network marketing

G. Broker or 3rd party distributor

H. Other, please specify

Business unit activities - Question identifier:5.

Please provide your best estimate of your business unit's proportion of sales, during fiscal year 2011/2012, of functional foods, natural health products, or bioactive/medicinal ingredients to the following customer types:

Customer Types

A. Direct to consumers

B. Health food store

C. Other retail (e.g. grocery store, mass merchandiser)

D. Pharmacy

E. Wholesaler

F. Private label

G. Other manufacturers

H. Other, please specify

Business unit activities - Question identifier:6. a.

From the ingredient list provided below, please indicate which source of the bioactive and/or medicinal ingredients was used in the production of your business unit's functional food and/or natural health products during fiscal year 2011/2012.

Sources of the bioactive and/or medicinal ingredients

A. Dairy products

• 1.: Yes
• 2.: No

B. Oil seeds

• 1.: Yes
• 2.: No

C. Meat and poultry or other animal products

• 1.: Yes
• 2.: No

D. Seafood or other marine species

• 1.: Yes
• 2.: No

E. Grains and cereals

• 1.: Yes
• 2.: No

F. Pulses or Legumes

• 1.: Yes
• 2.: No

G. Fruits

• 1.: Yes
• 2.: No

H. Vegetables

• 1.: Yes
• 2.: No

I. Floriculture, herbs and spices

• 1.: Yes
• 2.: No

J. Trees (bark, leaves, symbiotics (mushroom or other fungus))

• 1.: Yes
• 2.: No

K. Synthetics

• 1.: Yes
• 2.: No

L. Other, please specify

• 1.: Yes
• 2.: No

Business unit activities - Question identifier:6. b.

In fiscal year 2011/2012, for each of the following sources of the bioactive and/or medicinal ingredients used in your business unit's product(s), what was the country of origin?

A. Dairy products

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

B. Oil seeds

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

C. Meat and poultry or other animal products

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

D. Seafood or other marine species

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

E. Grains and cereals

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

F. Pulses or Legumes

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

G. Fruits

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

I. Floriculture, herbs and spices

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

J. Trees (bark, leaves, symbiotics (mushroom or other fungus))

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

K. Synthetics

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

L. Other, please specify

• 1: Canada
• 2: Foreign
• 3: Don't know
• 4: Not applicable

Business unit activities - Question identifier:6. c.

In fiscal year 2011/2012, for those sources of the bioactive and/or medicinal ingredients which were available both in Canada and in foreign market, how important were the following factors for importing?

A. Lower total cost

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

B. Higher quality

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

C. Year-round availability

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

D. Regulatory approval process reduced

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

E. Other, please specify

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

Business unit activities - Question identifier:6. d.

For each of the sources of the bioactive and/or medicinal ingredients imported, during fiscal year 2011/2012, what were the volumes imported?

Sources of the bioactive and/or medical ingredients

A. Dairy products

B. Oil seeds

C. Meat and poultry or other animal products

D. Seafood or other marine species

E. Grains and cereals

F. Pulses or Legumes

G. Fruits

H. Vegetables

I. Floriculture, herbs and spices

J. Trees (bark, leaves, symbiotics (mushroom or other fungus))

K. Synthetics

L. Other, please specify

Business unit characteristics - Question identifier:7.

What was the structure of your business unit in fiscal year 2011/2012?

Structure

• a.: Private corporation
• b.: Publicly traded corporation
• c.: Sole proprietorship
• d.: Unincorporated partnership
• e.: Cooperative
• f.: Other, please specify

Business unit characteristics - Question identifier:8.

Was your business unit's head office located in Canada in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Business unit characteristics - Question identifier:9.

Was your business unit a subsidiary of a Multi-National Enterprise (MNE) in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Business practices - Question identifier:10.

Did your business unit contract out functional food and/or natural health product related activities in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Business practices - Question identifier:11.

For what purpose (s) did your business unit contract out functional food and/or natural health product related activities, either in Canada or in foreign markets in fiscal year 2011/2012?

Purposes

A. Scientific research & development

• 1: Canada
• 2: Foreign
• 3: Not applicable

B. Intellectual property

• 1: Canada
• 2: Foreign
• 3: Not applicable

C. Regulatory

• 1: Canada
• 2: Foreign
• 3: Not applicable

D. Clinical trials

• 1: Canada
• 2: Foreign
• 3: Not applicable

E. Custom manufacturing or production or formulation

• 1: Canada
• 2: Foreign
• 3: Not applicable

F. Extraction of bioactives or medicinal ingredients

• 1: Canada
• 2: Foreign
• 3: Not applicable

G. Technical or engineering or mechanical

• 1: Canada
• 2: Foreign
• 3: Not applicable

H. Quality control

• 1: Canada
• 2: Foreign
• 3: Not applicable

I. Sales or marketing or advertising

• 1: Canada
• 2: Foreign
• 3: Not applicable

J. Market research or business development

• 1: Canada
• 2: Foreign
• 3: Not applicable

K. Other, please specify

• 1: Canada
• 2: Foreign
• 3: Not applicable

Business practices - Question identifier:12. a.

In fiscal year 2011/2012, was your business unit involved in functional food and/or natural health product related cooperative/collaborative arrangements with other business units or organizations?

(Please include both those inside and outside of Canada.)

• 1.: Yes
• 2.: No

Business practices - Question identifier:12. b.

In fiscal year 2011/2012, how many cooperative/collaborative arrangements did your business unit have with other business units or organizations?

__________ Number

Business practices - Question identifier:12. c.

In fiscal year 2011/2012, how many of these cooperative/collaborative arrangements involved more than one other partner?

__________ Number

Business practices - Question identifier:13.

Please indicate which of the following types of collaborative partners your business unit collaborated with during the previous 3 fiscal years (2009/2010, 2010/2011 and 2011/2012).

Partner Types

• a.: Other business units in Canada
• b.: Other business units outside Canada
• c.: University in Canada
• d.: University outside Canada
• e.: Federal government agency or laboratory
• f.: Provincial government agency or laboratory
• g.: Other, please specify

Business practices - Question identifier:14.

Please rate the level of importance that each of the following reasons had on your business unit's decision to cooperate/collaborate with partners during the previous 3 fiscal years (2009/2010, 2010/2011 and 2011/2012).

Reasons for cooperative/collaborative arrangements

A. Access to outside scientific expertise or knowledge

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

B. Conduct research and development

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

C. Access to bioactive or medicinal ingredients

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

D. Access to marine or terrestrial biomass

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

E. Access to production or manufacturing facilities

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

F. Access to extraction facilities or technologies

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

G. Access to marketing or distribution channels

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

H. Access to partner's intellectual property

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

I. Access to capital

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

J. Access to regulatory affairs expertise

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

K. Other, please specify

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

Intellectual property - Question identifier:15.

Did your business unit grant any functional food and/or natural health product licensing agreement(s) in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Intellectual property - Question identifier:16.

How much revenue, in thousands of Canadian dollars ($'000), did your functional food and/or natural health product related intellectual property (IP) licensing agreement(s) generate in fiscal year 2011/2012?

$ _________,000

Intellectual property - Question identifier:17.

Did your business unit acquire any functional food and/or natural health product licensing agreement(s) in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Intellectual property - Question identifier:18.

Did your business unit develop trade secrets in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Intellectual property - Question identifier:19.

Did your business unit register any trademarks in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Intellectual property - Question identifier:20.

Did your business unit have functional food and/or natural health product related patents or pending patents in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Intellectual property - Question identifier:21.

Please indicate the number of functional food and/or natural health product related patents and pending patents your business unit has worldwide.

• 1: _________ Number of existing patents
• 2: _________ Number of pending patents

Raising capital - Question identifier:22.

Did your business unit attempt to raise capital specifically for functional food and/or natural health product related purposes in fiscal year 2010/2011 and/or 2011/2012?

• 1.: Yes
• 2.: No

Raising capital - Question identifier:23.

Was your business unit successful in raising any capital specifically for functional food and/or natural health product related purposes in fiscal year 2010/2011 and/or 2011/2012?

• 1.: Yes
• 2.: No

Raising capital - Question identifier:24.

Please indicate your business unit's targeted amount of capital and actual amount of capital raised for the fiscal year(s) 2010/2011 and/or 2011/2012, in thousands of Canadian dollars ($'000).

Target amount in 2010/2011

$ _________,000

Amount raised in 2010/2011

$ _________,000

Target amount in 2011/2012

$ _________,000

Amount raised in 2011/2012

$ _________,000

Raising capital - Question identifier:25.

Please indicate which of the following sources contributed capital to your business unit, and provide a percentage distribution of total capital raised from each source, during fiscal year 2011/2012.

Source

A. Canadian based venture capital

___.__%

B. American based venture capital

___.__%

C. Other foreign based venture capital

___.__%

D. Conventional funds (i.e. banks, credit union, Initial Public Offering (IPO), Secondary Public Offering (SPO))

___.__%

E. Angel investors or family members

___.__%

F. Government(s) (i.e. Business Development Corporation (BDC), Farm Credit Canada (FCC), Export Development Corporation (EDC), Industrial Research Assistance Program (IRAP))

___.__%

G. Partner(s) from strategic alliance(s)

___.__%

H. Other, please specify

Raising capital - Question identifier:26.

What were the reasons your business unit raised or attempted to raise capital for functional foods and/or natural health products related purposes in fiscal year 2010/2011 and/or 2011/2012?

Reasons

• a.: Scientific research & development purposes
• b.: Develop or expand production and manufacturing capability
• c.: Commercialize current research & development projects
• d.: Clinical or regulatory expenses
• e.: To expand in existing or enter into new markets
• f.: Repay current investors
• g.: Other, please specify

Raising capital - Question identifier:27.

Please rate the level of importance of each of the following barriers to the production and/or development of functional foods and/or natural health products for your business unit in fiscal year 2011/2012.

Barriers

A. Access to capital

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

B. Access to technology

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

C. Access to bioactive or medicinal ingredients

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

D. Cost of bioactive or medicinal ingredients

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

E. Access to human resources and adequate skills

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

F. Access to information

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

G. Domestic market too small

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

H. Lack of domestic distribution and marketing channels

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

I. Lack of access to international markets

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

J. Lack of international market distribution and marketing channels

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

K. Lack of public awareness or acceptance

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

L. Regulatory requirements in Canada

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

M. Labeling requirements in Canada

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

N. Regulatory requirements in international markets

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

O. Labeling requirements in international markets

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

P. International harmonization

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

Q. Patent rights held by others

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

R. Protecting intellectual property

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

S. Lack of quality assurance or control

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

T. Access to an establishment with good manufacturing practices (GMP)

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

U. Access to an establishment with a site license

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

V. Approval time for acquiring a site license

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

W. Other, please specify

• 1: Very unimportant
• 2: Unimportant
• 3: Neither important or unimportant
• 4: Important
• 5: Very important

Human resources - Question identifier:28.

How many employees (include permanent, seasonal, casual and contract) did your business unit employ in fiscal year 2011/2012?
(Please report highest employment level for fiscal year 2011/2012).

__________ Number

Human resources - Question identifier:29.

How many of your business unit's employees (include permanent, seasonal, casual and contract), devoted all or any portion of their time to functional food and/or natural health product related activities, or tasks associated (such as administrative or secretarial) with the running of the functional food and/or natural health product portion of this business in fiscal year 2011/2012?

__________ Number

Human resources - Question identifier:30.

Did your business unit have unfilled functional food and/or natural health product related positions in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Human resources - Question identifier:31.

For those unfulfilled positions in your business unit, what type of competencies were needed?

Competencies

• a.: Scientific research & development
• b.: Intellectual property
• c.: Regulatory
• d.: Clinical trials
• e.: Manufacturing or production
• f.: Technical or engineering
• g.: Quality control
• h.: Sales or marketing or advertising
• i.: Market research
• j.: Management or finance
• k.: Business development
• l.: Other, please specify

Human resources - Question identifier:32.

Did your business unit experience any difficulty in filling vacant functional food and/or natural health product related positions in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Human resources - Question identifier:33.

Which of the following obstacles have impacted your business unit's efforts to fill your functional food and/or natural health product positions in fiscal year 2011/2012?

Obstacles

• a.: Compensation requirements by candidates too high
• b.: Candidates unwilling to relocate
• c.: Candidates lack of expertise
• d.: Capital / resources insufficient to attract candidates
• e.: Competition for qualified candidates
• f.: Lack of qualified candidates
• g.: Access to training
• h.: Lack of business predictability
• i.: Other, please specify

Human resources - Question identifier:34.

How many new positions with any type of functional food and/or natural health product responsibilities did your business unit create in fiscal year 2011/2012?

__________ Number

Regulations - Question identifier:35.

Did your business unit have any contact with either Health Canada or the Canadian Food Inspection Agency in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Regulations - Question identifier:36.

Which specific regulatory contact has your business unit experienced in fiscal year 2011/2012 regarding a functional food and/or natural health product?

Contact types

A. Novel food designation

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

B. Submission for health claim on food

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

C. Site license for natural health products

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

D. Product license for natural health products

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

E. Health claim for natural health products

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

F. Clinical trial approval

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

G. Labeling and advertising

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

H. Export of food and/or natural health products

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

I. Import of food and/or natural health products

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

J. Other, please specify

• 1: Health Canada - Food Directorate
• 2: Health Canada - Natural Health Products Directorate
• 3: Canadian Food Inspection Agency
• 4: Not applicable

Regulations - Question identifier:37. a.

Please rate the level of agreement to the following statements as they relate to your business unit's experience with Health Canada's Food Directorate.

Experiences with Health Canada's Food Directorate

A. I was able to identify the regulatory requirements needed

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

B. The guidance documents were easy to understand and follow

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

C. I was able to communicate with an individual regulator to obtain information prior to submission

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

D. I was able to provide all supporting data required in the initial application

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

E. I was able to request an update on the status of my submission

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

F. I was aware of the time required to obtain regulatory approval for my product

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

Regulations - Question identifier:37. b.

Please rate the level of agreement to the following statements as they relate to your business unit's experience with Health Canada's Natural Health Products Directorate.

Experiences with Health Canada's Natural Health Products Directorate

A. I was able to identify the regulatory requirements needed

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

B. The guidance documents were easy to understand and follow

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

C. I was able to communicate with an individual regulator to obtain information prior to submission

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

D. I was able to provide all supporting data required in the initial application

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

E. I was able to request an update on the status of my submission

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

F. I was aware of the time required to obtain regulatory approval for my product

• 1: Low
• 2: Medium
• 3: High
• 4: Not applicable

Regulations - Question identifier:38.

Did any of the following categories of claims increase your product sales in Canada in fiscal year 2011/2012?

Claims categories

A. Any of the approved Canadian health claims for a natural health product

• 1: Yes
• 2: No
• 3: Not applicable

B. Any of the seven approved Canadian health claims for food products

• 1: Yes
• 2: No
• 3: Not applicable

C. Any approved Canadian function claims for food - these include nutrient function claims (formerly called biological role claims) and other function claims.

• 1: Yes
• 2: No
• 3: Not applicable

D. Any approved US health claims (i.e. although the claim is not on your product, your product benefits incrementally from consumer awareness of a claim made on a product similar to yours that is sold in the US)

• 1: Yes
• 2: No
• 3: Not applicable

E. Any approved health claims in countries other than the US (i.e. although the claim is not on your product, your product benefits incrementally from consumer awareness of a claim made on a product similar to yours that is sold in a country other than the US)

• 1: Yes
• 2: No
• 3: Not applicable

Regulations - Question identifier:39.

Did any of the following categories of claims increase your product sales in international markets in fiscal year 2011/2012?

Claim categories

A. Any of the approved Canadian health claims for a natural health product

• 1: Yes
• 2: No
• 3: Not applicable

B. Any of the seven approved Canadian health claims for food products

• 1: Yes
• 2: No
• 3: Not applicable

C. Any approved Canadian function claims for food - these include nutrient function claims (formerly called biological role claims) and other function claims.

• 1: Yes
• 2: No
• 3: Not applicable

D. Any approved US health claims (i.e. although the claim is not on your product, your product benefits incrementally from consumer awareness of a claim made on a product similar to yours that is sold in the US)

• 1: Yes
• 2: No
• 3: Not applicable

E. Any approved health claims in countries other than the US (i.e. although the claim is not on your product, your product benefits incrementally from consumer awareness of a claim made on a product similar to yours that is sold in a country other than the US)

• 1: Yes
• 2: No
• 3: Not applicable

Financial information - Question identifier:40.

Please indicate your business unit's total revenue and scientific R&D expenditures in thousands of Canadian dollars ($'000) in the table below with a percentage breakdown by functional food and natural health product for fiscal years 2010/2011 and 2011/2012.

Total business unit revenues (from all sources) in fiscal year 2010/2011.

$ _________,000

Percentage of revenues from functional food products in fiscal year 2010/2011.

___.__%

Percentage of revenues from natural health products in fiscal year 2010/2011.

___.__%

Total business unit revenues (from all sources) in fiscal year 2011/2012.

$ _________,000

Percentage of revenues from functional food products in fiscal year 2011/2012.

___.__%

Percentage of revenues from natural health products in fiscal year 2011/2012.

___.__%

Total R&D expenditures in fiscal year 2010/2011.

$ _________,000

Percentage of total expenditures on functional food research and development in fiscal year 2010/2011.

___.__%

Percentage of total expenditures on natural health product research and development in fiscal year 2010/2011.

___.__%

Total R&D expenditures in fiscal year 2011/2012.

$ _________,000

Percentage of total expenditures on functional food research and development in fiscal year 2011/2012.

___.__%

Percentage of total expenditures on natural health product research and development in fiscal year 2011/2012.

___.__%

Financial information - Question identifier:41.

Did your business unit export any functional foods and/or natural health products in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Financial information - Question identifier:42.

Please indicate your business unit's total export revenues for fiscal year 2011/2012 in the first line, followed by export revenues of functional foods, and of natural health products separately.

Total export revenues of the business unit's operations.

$ _________,000

Value of export revenues of functional foods.

$ _________,000

Percentage of value of export revenues of functional foods from the USA.

___.__%

Percentage of value of export revenues of functional foods from the European Union.

___.__%

Percentage of value of export revenues of functional foods from Japan.

___.__%

Percentage of value of export revenues of functional foods from China.

___.__%

Percentage of value of export revenues of functional foods from other countries.

___.__%

Value of export revenues of natural health products.

$ _________,000

Percentage of value of export revenues of natural health product from the USA.

___.__%

Percentage of value of export revenues of natural health product from the European Union.

___.__%

Percentage of value of export revenues of natural health product from Japan.

___.__%

Percentage of value of export revenues of natural health product from China.

___.__%

Percentage of value of export revenues of natural health product from other countries.

___.__%

Financial information - Question identifier:43.

Did your business unit import any functional foods and/or natural health products in fiscal year 2011/2012?

• 1.: Yes
• 2.: No

Financial information - Question identifier:44.

Please indicate your business unit's total import expenditures for fiscal year 2011/2012 in the first line, followed by import expenditures of functional foods, and of natural health products separately.

Total import expenditures of the business unit's operations

$ _________,000

Value of import expenditures of functional foods

$ _________,000

Percentage of value of import expenditures of functional foods from the USA.

___.__%

Percentage of value of import expenditures of functional foods from the European Union.

___.__%

Percentage of value of import expenditures of functional foods from Japan.

___.__%

Percentage of value of import expenditures of functional foods from China.

___.__%

Percentage of value of import expenditures of functional foods from other countries.

___.__%

Value of import expenditures of natural health products.

$ _________,000

Percentage of value of import expenditures of natural health products from the USA.

___.__%

Percentage of value of import expenditures of natural health products from the European Union.

___.__%

Percentage of value of import expenditures of natural health products from Japan.

___.__%

Percentage of value of import expenditures of natural health products from China.

___.__%

Percentage of value of import expenditures of natural health products from other countries.

___.__%