Phytoregulations

Question 1

Who regulates Phytochemicals in Canada? What is the name of the act?

Answer 1

• Regulated by Health Canada in the Food and Drug Act

- Evaluates and monitors safety and effectiveness of foods and drugs

Question 2

What are the branch(es) under Health Canada that deals with the various foods?

Answer 2

Health Protection and Foods Branch

1. Therapeutic Products Programme (TPP)
   - Formly known as Drug Directorate
   - Deals with drugs, medicinal devices, biological products
2. Food Directorate (FD)
   - Regulates foods with the goal of improving health of Canadians through science-based policies
3. Natural and Non-Prescription Health Products Directorate (NNHPD)
   - Newest branch
   - In between foods and drugs
   - Take into consideration existing FDA regulations, but make amendments where appropriate
   - Also regulates clinical trials after NHPs!

Question 3

What is the history of how NNHPD came to be?

Answer 3

• Due to increasing concern over unregulated NHPs in Canada, the Federal Government formed a Standing Committee to investigate the matter
• Report was published with 53 recommendations in a parliamentary report
• Government accepted all 53 recommendations and Office of Natural Health Products was created
• Later changed name: ONHP ⟶ Natural Health Product Directorate ⟶ Natural and Non-prescriptive Health Product Directorate (NNHPD)
• Broadened products to all self-care (cosmetics, NHPs, non-prescriptive drugs, disinfectant products)
• In the future, may regulate self-care products using risk-based regulation
• Health Canada may go from regulating all NHPs to only regulating those who make high risk claims
• May be unreasonable especially for products that rely on long history of use (eg. herbal remedies)

Question 4

What were the key recommendations in the parliamentary report?

Answer 4

• Establishment of a new regulatory authority specifically for NHPs
• Have a third category to distinguish NHP from foods and drugs
• Rationale: NHPs share properties of both foods and drugs, yet are dissimilar to both

Question 5

What are the NNHPD Regulatory Components?

Answer 5

1. Licensing
   - Product (to get NHP #)
   - Site
2. Product labelling + packaging
3. GMPs (Good Manufacturing Processes)
4. Reporting on adverse events

Question 6

What were the 8 common concerns from the public about NNHPD?

Answer 6

1. NHP Access
   - Regulatory framework would restrict people’s access to NHPs
2. NHP Cost
   - High cost of product licenses for manufacturers (can small businesses afford it?)
3. GMPs
   - Manufacturers felt they were too strict
   - Guidelines are still being developed
4. Claims
   - Many felt that if there is evidence to support a claim, even for a Schedule A disease, then it should be allowed
   - Suggestion that HC develop policy guidelines differentiating types of claims (symptoms vs. cure)
5. Standards of Evidence
   - Majority agreed that standards of evidence should be based on safety and use
   - Public wants clear guidelines on how the standards will e applied
6. Adverse Reaction Reporting
   - Public felt that consumers should be able to report adverse effects to government
   - Via direct method such as a 1-800 #
   - Outreach program will be needed to educate on what adverse effects are
7. Labelling
   - Public wants more rather than less
   - NNHPD needs to consider what information is required on product
   - Challenges to fit everything in 2 languages
8. Capacity vs. Workload
   - Public concerned that NNHPD would not have enough staff to process all applications
   - Don’t want long delays
   - Solution ⟶ monograph system (document of reference on all different NHPs; you don’t need applications for the health claim of an ingredient, just refer to monographs)

Question 7

What is Schedule A? Discuss the rationale.

Answer 7

• Subsection 3(1) of the Food and Drugs Act
• List of diseases and disorders for which you are not allowed to advertise product effects for (eg. arthritis, asthma, liver disease, obesity, hypertension)
• Rationale: prevent claims directed to public about health issues that should be treated with medical professional rather than marketer

Question 8

What are the implications of Schedule A?

Answer 8

• Holds up advancement of health claim policy advancement in Canada
• We do want to make health claims for NHPs!
• Was amended to allow for claims so it’s OK now!

Question 9

The definition of Natural Health Products must ____ yet ___.

Answer 9

Draw a line between NHPs and foods/drugs

Yet be flexible to accomodate future products

Question 10

What are the 2 components of the NHP definition?

Answer 10

1. Function
   - Refers to intent of NHP (health and self-care)
   - Definition allows for full range of health claims
2. Substance
   - Refers to actual content of NHP and what classifies a NHP
   - Inclusion list (eg. plant materials, vitamins, minerals, probiotics)
   - Exclusion list (eg. antibiotics, injections, Tobacco)
   - Consider form of administration; typically capsule, pill, tablet, liquid, gum, or bar
   - NHPs do NOT include conventional foods or products in food medium that might fall under definition
   - Eg. OJ with phytosterols is a FOOD but phytosterol pill is NHP
   - There is a limit of amount of vitamins/minerals you can put in a “food”