Midterm 3 (lecture 15) Flashcards
Regulation of natural health products and supplemented foods
Food and drug act
- all products intended for human consumption are regulated historically as a FOOD or DRUG
Regulated by health Canada
Regulated by the HPFB; Health Protection and Foods Branch
- evaluates and monitors safety and effectiveness of food and drugs (and ensuring high quality)
Branches of HPFB
TPP: Therapeutic Products Programme
- formerly drug directorate
- drugs, medicinal devices, biological products
FD; Food Directorate
- foods; recognizes that food is fundamental to health
NNHPD; Natural and Non Prescription Health Products Directorate
- newest branch
- in between food and drugs
Contents of parliamentary report
Components of NHP regulations
- product licensing
- site licensing
- product labeling
- good manufacturing processes
- health claims (standards of evidence for claims
- adverse events reporting
Most pivotal recommendation was that NHPs comprise a legislated and official third category
Government response: announced creation of the office of natural health products; now the NNHPD
NNHPD mission
To ensure that all Canadians have ready access to natural health products that are safe, effective, and of high quality while respecting freedom of choice…
Indetifies key ideas
- accessible
- safety
-efficacy
- high quality
Most commonly expressed concerns
NHP access and NHP cost
- both linked (if somethings too expensive, then it’s not accessible)
Good manufacturing process
- manufacturers felt they were too strict, especially with product testing
Claims/schedule A
- precludes ads of products that exert effects associated with a list of specific diseases (hypertension, obesity, heart disease etc)
- enacted to prevent claims directed to the general public regarding serious health issues
Implications of schedule A
- holds up advancement of health claim policy advancement in Canada ; can’t make claims about foods and CVD risk etc
- currently amended to allow for claims
Most commonly expressed concerns 2
Claims/standard of evidence
- clear guidelines wanted
NNHPD developing a framework
Labeling
- public wants more but challenge to fit everything on label
Capacity vs workload
- public concerned not enough staff to process applications
NNHPD response
What are natural health products? (Definition)
Definition of NHP has two parts:
- function component and substance component
function component (health aspect)
— relates to the function (intent) of the NHP
— the function of the NHP is for health
— allows for full range of health claims relating the NHP to health (nutrient function, therapeutic, disease risk reduction)
substance component (the actual list)
— inclusion list:
- plant or plant material, algae,fungus, animal material
- an extract or isolate of above
- a vitamin
- an amino acid
- an essential fatty acid
- a synthetic dupe of b or E
- a mineral
- a probiotic
Also an exclusion list
Natural health products definition - form of administration
Forms of administration is relevant to NHPs
NHPs are typically in a medicinal form such as: capsule, pill, tablet
NHP definition is NOT intended to include conventional foods
Regulatory framework for NHPs review
Contents of document
- NHP license (product and site license)
- good manufacturing processes (GMP)
- labeling and packaging
- adverse reaction report and analysis
Where do the NHP regs fit
Under the food and drugs act
- adopted as stand alone regulations
- NHPR (natural health product regulations)
LNHPD: licensed NHP database
Inventory of all NHPs that have received a license from health Canada
All licensed NHPs have a natural product number (NPN) or homeopathic medicine number (DIN-HM) on label
Medicinal and non medicinal ingredients
Products dosage form
Products recommended use
Risk information
