17 Phytochemical Related Regulation Flashcards Preview

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Flashcards in 17 Phytochemical Related Regulation Deck (16):
1

What regulates the food and drug act?

Health Canada and Health Protection and Foods Branch (HPFB)

2

Branches of the HPFB

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

3

Factors increasing NHP use

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

Others
- enhancing performance
- less costly than prescription

4

PSCH

Parliamentary Standing Committee on Health
- legislation and regulations of NHPs in Canada
-elected MPs
- receive testimony from representatives/stake holders(med schools and companies)

5

Contents of Parliamentary Report

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

6

Most pivotal recommendation on the Parliamentary Report

third category distinct from foods and drugs
- regulate stricter than foods, less than drugs

7

Result of the Parliamentary Report

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

8

When looking products, the NHPD considered?

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

9

NHPD regulatory components

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

10

NHP commonly expressed concerns

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

11

schedule A

List of diseases you are not allowed to advertise about
- serious health issues should be diagnosed and treated by medical practitioner

12

Definition of NHPs (2 parts)

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

13

Considered a natural health product (inclusion list)?

Anything natural or synthetically derived
- phytochemical, micronutrients, probiotics etc

14

Not considered a natural health product? (exclusion list)

antibiotics
injected substances
tobacco
etc

15

NHPs come in what forms

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

16

Where do the NHP regulation fit?

under the Food and Drug act