17 Phytochemical Related Regulation

Question 1

What regulates the food and drug act?

Answer 1

Health Canada and Health Protection and Foods Branch (HPFB)

Question 2

Branches of the HPFB

Answer 2

TPP - Therapeutic Products Programme (drugs)
FD - Food Directorate (food)
NHPD - Natural Health Products Directorate (between food and drugs)

Question 3

Factors increasing NHP use

Answer 3

• promotion of healthy living benefits
• preventative medicine
• self medication
• aging population

Others

• enhancing performance
• less costly than prescription

Question 4

PSCH

Answer 4

Parliamentary Standing Committee on Health

• legislation and regulations of NHPs in Canada
• elected MPs
• receive testimony from representatives/stake holders(med schools and companies)

Question 5

Contents of Parliamentary Report

Answer 5

NHP

• product and site licensing
• labeling
• type of claims
• standards of evidence for claims
• adverse events reporting
• role of health care practitioner
• distribution and licensing mechanisms
• description of NHP industry infrastructure

Question 6

Most pivotal recommendation on the Parliamentary Report

Answer 6

third category distinct from foods and drugs

- regulate stricter than foods, less than drugs

Question 7

Result of the Parliamentary Report

Answer 7

Federal Minister of Health in 1999 accepted all 53 recommendations
- Natural Health Products Department (NHPD) was formed

Question 8

When looking products, the NHPD considered?

Answer 8

saftey
effectiveness for intended use
quality (bioactivity)
when extracted (expiry date)

Question 9

NHPD regulatory components

Answer 9

1. product labeling
2. product licensing
3. site licensing
4. GMPs (good manufacturing practices)
5. Reporting on adverse events

ammendments to Food and Drug Act Regulations

Question 10

NHP commonly expressed concerns

Answer 10

1. NHP access
2. NHP cost
   - licenses
   - taxes on products formally sold as food
3. GMPs
4. Claims Restriction/Schedule A
5. Standards of evidence to make a claim
6. adverse reaction reporting

Question 11

schedule A

Answer 11

List of diseases you are not allowed to advertise about

- serious health issues should be diagnosed and treated by medical practitioner

Question 12

Definition of NHPs (2 parts)

Answer 12

functional component
- disease risk reduction, prevention, treatment, restoration etc 
substance component
- inclusion and exclusion lists
- active component vs non active

Question 13

Considered a natural health product (inclusion list)?

Answer 13

Anything natural or synthetically derived

- phytochemical, micronutrients, probiotics etc

Question 14

Not considered a natural health product? (exclusion list)

Answer 14

antibiotics
injected substances
tobacco
etc

Question 15

NHPs come in what forms

Answer 15

capsule
pill
tablet
liquid
gums/bars that aren't considered conventional foods

Question 16

Where do the NHP regulation fit?

Answer 16

under the Food and Drug act