Chapter 15 - Regulation of NHPs

Question 1

When was the Food and Drug Act first passed?

Answer 1

1920

Question 2

What was the Food and Drug Act originally concerned with?

Answer 2

Food, drugs, therapeutic devices, and cosmetics.

Question 3

Food and Drug Act update in 1985 was to…

Answer 3

Ensure product safety. Ingredients must be disclosed. Drugs must be effective. Cannot advertise cure for serious diseases to the general public. And controlled substances like amphetamines.

Question 4

Schedule A Diseases

Answer 4

Serious ones like cancer.

Question 5

When did the Natural Health Products Regulations of the Food and Drug Act come into effect?

Answer 5

2004

Question 6

What does the Natural Health Products Regulations of the Food and Drug Act cover?

Answer 6

All NHPs: vitamins and minerals, herbal medicines, homeopathic treatments, traditional medicines, probiotics, amino acids and fatty acids.

Question 7

What is a Site Licence?

Answer 7

A licence that all sites that manufacture, package, label and import must have.

Question 8

Getting a site licence requires…

Answer 8

Specific labelling and packaging requirements, safety and efficacy evidence, maintaining proper distribution records, having procedures for handling/storage/delivery and procedures for product recalls, a good manufacturing process, and must report serious adverse reactions to Health Canada.

Question 9

Site licencing requirements do not apply to…

Answer 9

Practitioners who compound products on an individual basis and retailers.

Question 10

What is a Product Licence?

Answer 10

A licence for a Natural Health Product.

Question 11

How do you get a NHP licensed?

Answer 11

You must tell Health Canada: medical ingredients, non-medical ingredients, source, dose, potency, and recommended uses.

Question 12

What is an exemption number?

Answer 12

A number given to unevaluated products.

Question 13

What does an exemption number look like?

Answer 13

EN-XXXXXX

Question 14

What does a Natural Product Number look like?

Answer 14

NPN-XXXXXX

Question 15

What does a Homeopathic Medicine Number look like?

Answer 15

DIN-HM-XXXXXX

Question 16

What must labels on NHPs look like?

Answer 16

Must include product name, product licence number, quantity, recommended use, cautionary statements, and special storage needs.

Question 17

Who provides the evidence for safety and efficacy?

Answer 17

The applicant.

Question 18

What might evidence for safety and efficacy of a NHP to quality for a NPN consist of?

Answer 18

Clinical trials, references to published studies, pharmacopoeias, and traditional resources.

Question 19

Bill C-51

Answer 19

A proposed amendment to the Food and Drugs Act that was tabled and never passed.

Question 20

What would Bill C-51 have done?

Answer 20

Protected and promoted health and safety. Encouraged accurate and consistent product representation. And adding prohibitions on giving false or misleading information.

Question 21

What was the public reaction to Bill C-51?

Answer 21

Lots of people protested arguing it would be too much regulation.

Question 22

What’s wrong with claims that Bill C-51 was funded and pushed by “big pharma”?

Answer 22

Big pharma also sells NHPs and gain from the current system’s lack of regulation.