8 regulation of miscellaneous products

Question 1

what is the summary of this lecture?

Answer 1

-veterinary pharmaceuticals
-natural health products
-cosmetics
-medical devices
-novel foods
-food additives

Question 2

what is the evidence needed for veterinary pharmaceuticals?

Answer 2

a veterinary drug is approved for sale in Canada is the manufacturer has supplied evidence that the drug:
-is safe for the animals being treated
-is effective treating the condition for which it is marketed
-is manufactured according to strict specifications
-will not pose demonstrable health hazard to humans eating food products from treated animals

Question 3

what are the regulatory agencies of veterinary pharmaceuticals?

Answer 3

Veterinary Drugs Directorate (VDD), Health Canada
-food and drugs act and regulations

Question 4

what is extra-label drug use (ELDU) in animals (“off-label use”)?

Answer 4

-the use or intended use of a drug approved by Health Canada in an animal in a manner not in accordance with the label or package insert
-it also includes the use of all unapproved drugs, including unapproved bulk active pharmaceutical ingredients (APIs) and compounded drugs
-VDD acknowledges that ELDU is an important tool in the practice of veterinary medicine

Question 5

what are the decisions to use ELDU?

Answer 5

-a potential lack of efficacy of approved products
-lack of approved products to address specific needs
-economic considerations

Question 6

what are the possible human health risks relating to ELDU in animals?

Answer 6

-development of antimicrobial resistance (AMR)
-presence of drug residue in foods derived from treated animals and in the environment

Question 7

what is antimicrobial resistance (AMR)?

Answer 7

-antimicrobials are the most effective treatment for infectious diseases
-AMR is a natural microbial survival mechanism; however, the overuse and misuses of antimicrobials has increased the rate of resistance development and spread
-many available antimicrobials are now less effective for treating disease
-AMR is an emerging global health issue

Question 8

how many people in canada have AMR?

Answer 8

-there has been an 8-fold increase in the rate of methicillin resistance Staphylococcus aureus (MRSA) infections among hospitalized patients in canada from 1995-2012
-each year in canada, more than 18,000 hospitalized patients acquire infections that are resistant to antimicrobials

Question 9

what are the categories of antimicrobials?

Answer 9

-the antimicrobials in Category 1: essential for the treatment of serious bacterial infections and there are limited or no availability of alternative antimicrobials in case of resistance to these antimicrobials
-Health Canada is recommending against Category 1 antimicrobials use in an ELDU manner

Question 10

what are maximum residue limits (MRLs)?

Answer 10

-level of residue that could safely remain in the tissue or food product derived from a food-producing animal that has been treated with a veterinary drug
-no adverse health effects if ingested daily by humans over a lifetime
-veterinary Drugs Directorate (HC) conducts extensive reviews of data submitted by manufacturers to determine whether these veterinary drug residues are at safe levels for human consumption

Question 11

what is the list of MRLs for veterinary drugs in foods?

Answer 11

Question 12

what does it mean when there is no MRL required?

Answer 12

-low toxicity drug, poorly absorbed or bioavailable, rapidly metabolized or eliminated, likely infrequently used, etc
-no need to routinely monitor the residues of these veterinary drugs in specific foods

Question 13

what is the health risk assessment process to establish MRLs?

Answer 13

metabolism studies of veterinary drugs conducted in the food-producing animals (e.g. swine, chickens, cows, etc) are reviewed
-concentration and half-life of a drug and its metabolites

comparative metabolism studies conducted in laboratory test animals are reviewed
-similar metabolism pattern?

toxicity of the substance is determined by toxicity/carcinogenicity (cancer) testing
-used to determine Acceptable Daily Intake (ADI)

Question 14

what else is involved in the health risk assessment process to establish MRLs?

Answer 14

-a marker residue is identified for the purpose of drug analysis, and an analytical method is developed
-withdrawal period: residue depletion data for the marker residue in the target tissue (highest concentration)

Question 15

what are do the labels contain on veterinary drugs (MRLs)?

Answer 15

-must include WARNING statements that highlight the human safety related issues on its use
-withdrawal periods for tissues or withholding times for milk
-in a food producing animal, the specified withdrawal period of the withholding time must be observed before the animal is slaughtered or the milk is harvested for use as food to allow the residues to deplete below the MRL

Question 16

what are the adverse veterinary drug reactions?

Answer 16

-any unwanted or harmful event that occurs that administration of a veterinary drug (according to the label and/or off-label)

all suspected adverse effects should be reported, essentially:
-unexpected (not consistent with product information or labelling)
-serious, whether expected or not (even if listed, need to report)

-anyone can report suspected veterinary drugs adverse reactions to Health Canada
-according to the Food and Drug Regulations (canada), reporting is mandatory for manufacturers

Question 17

what is the job of the veterinary pharmacovigilance program?

Answer 17

to monitor:
-the safety and efficacy of veterinary drugs used in animals
-the safety of humans handling these products (animals can’t give themselves drugs)
-the safety of consuming food derived from treated animals (helps determine maximum residue limit)

Question 18

what is the regulatory agency of natural health products (NHP)?

Answer 18

-regulatory agency: Natural and non-prescription Health Products Directorate, Health Canada
-Natural Health Products regulations

Question 19

what are considered natural health products?

Answer 19

-vitamins and minerals
-herbal remedies
-homeopathic medicines
-traditional medicines such as traditional Chinese medicines
-probiotics
-other products, such as amino acids and essential fatty acids

Question 20

how do you buy natural health products?

Answer 20

-must be safe to use as over-the-counter products without a prescription
-if prescription is needed, the product should be regulated as drugs under the Food and Drug regulation

Question 21

what is the natural health products regulation in Canada?

Answer 21

-natural health products regulations
-product must have a product license (e.g. Natural Product Number-NPN)
-Canadian sites that manufacture, package, label and import must have site licenses
-specific labelling and packaging requirements must be met (cant make absurd claims)

Question 22

what are the labelling requirements in Canada?

Answer 22

-product name
-product license number
-quantity of the product in the bottle
-complete list of medicinal and non-medicinal ingredients
-recommended use (purpose or health claim, route of administration and dose)
-warnings, possible adverse reactions associated with the product
-storage conditions (if any)

Question 23

what must the manufacturer do when producing natural health products?

Answer 23

-good manufacturing practices (GMP) must be followed
-the manufacturer must provide full details on what the exact ingredients are, where they come from (source), the composition of any excipients (not active ingredients)
-proper safety and efficacy evidence must be provided

Question 24

what are the evidence requirements for safety and efficacy of natural health products? (claims)

Answer 24

depends on the proposed health claim of the product and its overall risks
-treatment claims: treatment or partial treatment and mitigation of a disease
-cure claims: describe a therapeutic effect that results in the elimination of a disease
-risk reduction claims: altering a major risk factor(s) for a disease or health-related condition
-prevention claims: significantly reduce the incidence of the disease
-general health maintenance: restoration, correction, or modification of a structure or physiological function in the human body
-antioxidant claims: antioxidant properties

Question 25

what are more evidence requirements for safety and efficacy?

Answer 25

-clinical trial data -references to published studies, journals, pharmacopoeias and traditional resources

Question 26

how does adverse reaction reporting work for natural health products?

Answer 26

-product license holders are required to monitor all adverse reactions related to their product -must report serious adverse reactions to Health Canada

Question 27

what is the regulatory agency of cosmetics?

Answer 27

-regulatory agency: healthy environments and consumer safety branch -mandate to protect health by minimizing risks associated with the use of cosmetics -defines and communicates requirements for manufacture, labelling, safe and evaluates compliance Canada: cosmetic regulations under the Food and Drugs Act -notification is a mandatory requirement (within 10 days of first sale), but not testing (put on market, notify Health Canada)

Question 28

what is the definition of a cosmetic?

Answer 28

"any substance or mixture of substances, manufactured, sold or represented for use inn cleansing, improving or altering the complexation, skin, hair, or teeth and includes deodorants and perfumes" Food and Drugs Act, Canada -cosmetic products are required to have mandatory ingredient labelling as per the cosmetic regulations -labelling should follow the international nomenclature for cosmetic ingredients (INCI) system

Question 29

what is an example of the quick INCI guide?

Answer 29

dont need to memorize

Question 30

what is the cosmetic ingredient hotlist (health canada)?

Answer 30

-communicates to manufacturers and others that certain substances may be prohibited or restricted for use in cosmetics -a science-based document that is reviewed and updated periodically (i.e. when new scientific data becomes available) -prohibited ingredients (should not be present in cosmetic products sold in Canada) -restricted ingredients (are permitted under certain conditions, e.g. concentration)

Question 31

what is the cosmetic-drug interface?

Answer 31

-these are products that may share the characteristics of both "cosmetics" and "drug" -examples: acne therapy, anti-perspirants, anti-dandruff products, fluoride-containing anti-caries products, medicated skin products, diaper rash products, antiseptic skin cleansers, sunburn protectants, skin whiteners, and tooth whiteners

Question 32

a product at the cosmetic-drug interface (PCDI) can be regulated by:

Answer 32

-the cosmetic regulations -the food and drug regulations -the natural health products regulations

Question 33

the distinction between drugs and cosmetics is based on:

Answer 33

-representations made about the products: what is the proposed claim? -the composition of the product: ingredient and/or concentration may make the product unsuitable for classification as a cosmetic or as a drug -level of action: does the product exert solely a superficial effect?

Question 34

what is the representations made about the product (drugs vs cosmetics)?

Answer 34

what is the proposed claim? -if it is used for treating, diagnosing, preventing or curing disease; or restoring, correcting or modifying organic functions in human beings=drug

Question 35

what is the composition of the product (drug vs cosmetics)?

Answer 35

ingredient and/or concentration may make the product unsuitable for classification as a cosmetic or as a drug -some ingredients are inherently drugs. For example, corticosteroids are internationally recognized as drugs (

Question 36

what is the level of action (drug vs cosmetics)?

Answer 36

does the product exert solely a superficial effect? -cosmetics exhibit a lack of percutaneous absorption and should not have to be absorbed systematically to achieve the effect

Question 37

what is the graph of cosmetic-drug interface?

Answer 37

Question 38

what are some graphs of product type and if they are cosmetic, drug and NHP?

Answer 38

Question 39

what are medical devices?

Answer 39

-instrument, apparatus, machine, in vitro reagent, etc -intended for use in the diagnosis or in the treatment or prevention of disease -intended to affect the structure or function of the body, and which does not achieve its purpose through chemical action or dependence on metabolism

Question 40

medical devices: premarket approval application requires nonclinical laboratory studies:

Answer 40

-toxicological (ex: implant material doesn't release any toxins) -microbiological (no bacteria or fungi) -immunobiological (doesn't cause an immune reaction) -biocompatibility -stress (put at varying temperatures and make sure still functions the same) -wear -shelf life -potentially other lab or animal tests

Question 41

what are some examples of medica devices?

Answer 41

-hip implants -pacemakers -synthetic skin -artificial heart valves -test kits for diagnosis -contraceptive devices -medical laboratory diagnostic instruments

Question 42

what is the MDD?

Answer 42

medical devices directorate, Health Canada -reviewing scientific information to assess the safety, effectiveness and quality of medical devices -assessing the potential benefits and risks of a medical device reviewing applications for investigational testing authorizations (ITAs) for medical devices ensure that: -studies are well designed -participants will not be exposed to undue risk (patients aren't healthy)

Question 43

what does the MDD actually do?

Answer 43

-monitoring the evolving safety of medical devices in development and already on the market -making unlicensed medical devices available to health care professionals for patients when conventional therapies have failed, aren't suitable or are not available -providing canadians with the science-based medical information they need to make informed choices

Question 44

how are medical devices classified?

Answer 44

risk-based classification system: -in vitro diagnostic devices (IVDDs) -non-in vitro diagnostic devices (non-IVDDs)

Question 45

how are IVDDs categorized?

Answer 45

grouped into four classes, with class IV being the highest risk

Question 46

what is class I of IVDDs?

Answer 46

general in vitro diagnostic laboratory equipment and general diagnostic reagents. Example: microbiological growth media

Question 46

what is class II of IVDDs?

Answer 46

-low public health risk or a moderate individual risk -examples: infectious agents that are not know to be easily propagated in the canadian population or are normally self-limiting (malaria, salmonella, etc)

Question 47

what is class III of IVDDs?

Answer 47

moderate public health risk or high individual risk -examples: erroneous result would put the patient in an imminent life-threatening situation (cases of suspected meningitis or septicaemia; cancer or prenatal screening)

Question 48

what is class IV of IVDDs?

Answer 48

high public health risk to the community in general -examples: donor screening or for the diagnosis of life-threatening diseases (HIV, hepatitis)

Question 49

how are non-IVDDs classified?

Answer 49

-invasive devices: contact with the surface of the eye, or which penetrates inside the body (in whole or in part). Examples: intravascular catheter, surgical glove, dental cement, etc -non-invasive devices: contact with injured skin. Examples: gauze bandage, oxygen mask, etc -active devices: requires a source of energy. Examples: computed tomography x-ray screening, air conduction hearing-aid, powered toothbrush, etc -special rules: disinfecting or sterilized blood, tissues or organs (transfusion or transplantation), disinfecting or sterilized a medical device. Examples: ultraviolet sterilizer, autoclave, etc

Question 50

what is the regulatory agency of novel foods?

Answer 50

-regulatory agency: health products and food branch, Health Canada -novel food regulations under Food and Drugs Act

Question 51

what are novel foods?

Answer 51

-products that have never been used as food -food which result from a process that has not previously been used for food -foods that have been modified by genetic manipulations (GMOs)

Question 52

what are GMOs?

Answer 52

genetically modified (GM) food comes from an organism (plant, animal or microorganism) modified by: -conventional breeding techniques: cross-breeding or mutagenesis -modern biotechnology techniques, such as genetic engineering -gene editing

Question 53

GM has been used to produce crops that are better at:

Answer 53

-resisting disease -resisting pests that destroy crops -tolerating the herbicides used to kill weeds -delaying the ripening process to allow them to be transported long distances -surviving drought conditions where water is scarce

Question 54

how do novel foods become registered?

Answer 54

-regulations require notification to Health Canada by company wanting to sell novel foods, including biotech products -Health Canada conducts safety assessment of all products to demonstrate novel food is safe and nutritious for human use -CFIA (canadian food inspection agency) shares responsibility for regulation of biotech products, including plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics -for genetic modified crops, CFIA assesses potential risk of adverse environmental effects

Question 55

what is the regulatory agency of food additives? what are they?

Answer 55

-regulatory agency: health products and food branch, Health Canada -food and drugs act -substances that are used in food to maintain its nutritive quality, enhance its keeping quality, make it attractive or to air in its processing, packaging or storage are all considered to be food addivitives -anything that comes into contact with food

Question 56

according to the Food and Drugs Act, food additives do not include:

Answer 56

-food ingredients such as salt, sugar, starch -vitamins, minerals, amino acids -spices, seasonings, flavoring preparations -agricultural chemicals -veterinary drugs -food packaging materials (secondary packaging)

Question 57

what are some examples of food additives?

Answer 57

-colouring agents to give appetizing appearance -anticaking agents that keep powders such as salt free-running -preservatives that prevent or delay undesirable spoilage in food -certain sweeteners that do not add the caloric value of the foods

Question 58

what must happen to new food additives?

Answer 58

-all permitted food additives and their conditions of use are listed in the lists of permitted food -for new food additives, a scientific assessment must be completed (science support the submission); Health Canada will issue a Notice of Proposal to the public for consideration prior to make any modifications the above list

Question 59

what are food colors? (food additives)

Answer 59

-food colors are regulated in canada as food additives -in the past, Health Canada allowed manufacturers to just use the word "color" for declaring added food colors -they must be declared by their specific common name in the list of ingredients (2021) (ex: must state red 40, due to allergies)