NUTR 3330 NEW FINAL EXAM WITH COMPLETE
SOLUTIONS 100% VERIFIED
what is the food and drug act and who regulates it? - ANSWER - 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 - ANSWER 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? - ANSWER - NNHPD
- helpful to understand the history of this exciting regulatory development in canada
what are the numerous aspects of NHP? - ANSWER - 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? - ANSWER 1. product labelling
2. product licensing
3. site licensing
4. GMPs
5. reporting on adverse events
most common expressed concerns about regulations? - ANSWER - NHP access
- NHP cost
- GMPs
- Claims/schedule A
NHP access concern? - ANSWER concern that regulatory framework would restrict
people's access to NHPs
NHP cost cancern? - ANSWER - 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? - ANSWER - 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? - ANSWER - 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? - ANSWER - part of food and drug act
, - not allowed to advertise food/drugs as products to cure any diseases
commonly expressed concern for schedule A? - ANSWER - 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
concerns about natural health products? - ANSWER - 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? - ANSWER - Function component
- Substance component
what is the function component of the definition of NHPs? - ANSWER - they are intended
for health use
- they allow for health claims
what is the structure component of the definition of NHPs? - ANSWER - inclusion and
exclusion list
form of administration of NHPs? - ANSWER - capsule
- pill
- tablet
- does not include conventional foods
regulatory framework for NHPs? - ANSWER - NHP licenses (product & site)
SOLUTIONS 100% VERIFIED
what is the food and drug act and who regulates it? - ANSWER - 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 - ANSWER 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? - ANSWER - NNHPD
- helpful to understand the history of this exciting regulatory development in canada
what are the numerous aspects of NHP? - ANSWER - 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? - ANSWER 1. product labelling
2. product licensing
3. site licensing
4. GMPs
5. reporting on adverse events
most common expressed concerns about regulations? - ANSWER - NHP access
- NHP cost
- GMPs
- Claims/schedule A
NHP access concern? - ANSWER concern that regulatory framework would restrict
people's access to NHPs
NHP cost cancern? - ANSWER - 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? - ANSWER - 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? - ANSWER - 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? - ANSWER - part of food and drug act
, - not allowed to advertise food/drugs as products to cure any diseases
commonly expressed concern for schedule A? - ANSWER - 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
concerns about natural health products? - ANSWER - 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? - ANSWER - Function component
- Substance component
what is the function component of the definition of NHPs? - ANSWER - they are intended
for health use
- they allow for health claims
what is the structure component of the definition of NHPs? - ANSWER - inclusion and
exclusion list
form of administration of NHPs? - ANSWER - capsule
- pill
- tablet
- does not include conventional foods
regulatory framework for NHPs? - ANSWER - NHP licenses (product & site)
