©BRIGHTSTRS EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
NUTR 3330 Final Exam Questions With
Verified Answers
What is the food and drug act and who regulates it? - Answers✔- all products intended for
human consumption are regulated historically as a FOOD or drigs
- regulated by a branch of health canada: Health protection and foods branch (HPFB)
> evaluates and monitors safety and effectiveness of food and drugs
3 branches of HPFB - Answers✔1. TTP; therapeutic products programme (drugs)
> formerly drug directorate
2. FD; food directorate (food)
3. NNHPD; natural and non prescription health products directorate (b/w drugs and food)
what is the newest branch of HPFB and how did it come about? - Answers✔- NNHPD
- helpful to understand the history of this exciting regulatory development in canada
what are the numerous aspects of NHP? - Answers✔- product and site licenses
- labeling
- type of claims
- standards of evidence for claims
- adverse events reporting
- role of the healthcare practitioner
- distribution and licencing mechanisms
- description of the NHP industry infrastructure
5 NHPD regulatory components? - Answers✔1. product labelling
1
, ©BRIGHTSTRS EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
2. product licensing
3. site licensing
4. GMPs
5. reporting on adverse events
most common expressed concerns about regulations? - Answers✔- NHP access
- NHP cost
- GMPs
- Claims/schedule A
NHP access concern? - Answers✔concern that regulatory framework would restrict people's
access to NHPs
NHP cost cancern? - Answers✔- cost of product licenses
- addition of taxes to NHPs that used to be sold as foods
- manufacturers... capital expenditures to meet requirements of new regulations
GMP concern? - Answers✔- manufacturers felt it was too strict especially with product testing
- at same time, recognize the need
- industry, consumers & healthy care professionals will work with NHPD to make new GMP
Claims/schedule A concern? - Answers✔- many felt if there is evidence ti support a claim then
should be allowed
- suggestion that HC should develop policy guidelines differentiating types of claims
what is schedule A? - Answers✔- part of food and drug act
- not allowed to advertise food/drugs as products to cure any diseases
commonly expressed concern for schedule A? - Answers✔- what is the standard for evidence
needed to make a claim
- how it it going to exist (framework)
- adverse reaction reporting
- labeling
- capacity vs. workload
2
, ©BRIGHTSTRS EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
concerns about natural health products? - Answers✔- definition needs to draw a line between
NHPs and food and between NHPs and drugs
- def needs to be flexible to accomodate future products
the definition of NHP has two part? - Answers✔- Function component
- Substance component
what is the function component of the definition of NHPs? - Answers✔- they are intended for
health use
- they allow for health claims
what is the structure component of the definition of NHPs? - Answers✔- inclusion and exclusion
list
form of administration of NHPs? - Answers✔- capsule
- pill
- tablet
- does not include conventional foods
regulatory framework for NHPs? - Answers✔- NHP licenses (product & site)
- GMPs
- labelling and packaging
- adverse reaction report and analysis
where do the NHP regulations fit? - Answers✔- under the food and drugs act
- stand alone regulations
- must recognize existing food & drug regulations
- make necessary reg. amendments
- ensure food and drug reg. won't apply to NHPs
regulation of NHPs is in revision? - Answers✔- NHPD has changed its name to NNHPD
- started to include the oversight of non-prescription and disinfectant drugs
NHPs now under consumer health product framework? - Answers✔- natural health products
- cosmetics
3
ALL RIGHTS RESERVED.
NUTR 3330 Final Exam Questions With
Verified Answers
What is the food and drug act and who regulates it? - Answers✔- all products intended for
human consumption are regulated historically as a FOOD or drigs
- regulated by a branch of health canada: Health protection and foods branch (HPFB)
> evaluates and monitors safety and effectiveness of food and drugs
3 branches of HPFB - Answers✔1. TTP; therapeutic products programme (drugs)
> formerly drug directorate
2. FD; food directorate (food)
3. NNHPD; natural and non prescription health products directorate (b/w drugs and food)
what is the newest branch of HPFB and how did it come about? - Answers✔- NNHPD
- helpful to understand the history of this exciting regulatory development in canada
what are the numerous aspects of NHP? - Answers✔- product and site licenses
- labeling
- type of claims
- standards of evidence for claims
- adverse events reporting
- role of the healthcare practitioner
- distribution and licencing mechanisms
- description of the NHP industry infrastructure
5 NHPD regulatory components? - Answers✔1. product labelling
1
, ©BRIGHTSTRS EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
2. product licensing
3. site licensing
4. GMPs
5. reporting on adverse events
most common expressed concerns about regulations? - Answers✔- NHP access
- NHP cost
- GMPs
- Claims/schedule A
NHP access concern? - Answers✔concern that regulatory framework would restrict people's
access to NHPs
NHP cost cancern? - Answers✔- cost of product licenses
- addition of taxes to NHPs that used to be sold as foods
- manufacturers... capital expenditures to meet requirements of new regulations
GMP concern? - Answers✔- manufacturers felt it was too strict especially with product testing
- at same time, recognize the need
- industry, consumers & healthy care professionals will work with NHPD to make new GMP
Claims/schedule A concern? - Answers✔- many felt if there is evidence ti support a claim then
should be allowed
- suggestion that HC should develop policy guidelines differentiating types of claims
what is schedule A? - Answers✔- part of food and drug act
- not allowed to advertise food/drugs as products to cure any diseases
commonly expressed concern for schedule A? - Answers✔- what is the standard for evidence
needed to make a claim
- how it it going to exist (framework)
- adverse reaction reporting
- labeling
- capacity vs. workload
2
, ©BRIGHTSTRS EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
concerns about natural health products? - Answers✔- definition needs to draw a line between
NHPs and food and between NHPs and drugs
- def needs to be flexible to accomodate future products
the definition of NHP has two part? - Answers✔- Function component
- Substance component
what is the function component of the definition of NHPs? - Answers✔- they are intended for
health use
- they allow for health claims
what is the structure component of the definition of NHPs? - Answers✔- inclusion and exclusion
list
form of administration of NHPs? - Answers✔- capsule
- pill
- tablet
- does not include conventional foods
regulatory framework for NHPs? - Answers✔- NHP licenses (product & site)
- GMPs
- labelling and packaging
- adverse reaction report and analysis
where do the NHP regulations fit? - Answers✔- under the food and drugs act
- stand alone regulations
- must recognize existing food & drug regulations
- make necessary reg. amendments
- ensure food and drug reg. won't apply to NHPs
regulation of NHPs is in revision? - Answers✔- NHPD has changed its name to NNHPD
- started to include the oversight of non-prescription and disinfectant drugs
NHPs now under consumer health product framework? - Answers✔- natural health products
- cosmetics
3
