Towards a pathway for health products containing cannabidiol: How to get involved

We would like to hear from you. Information that you provide on this subject will help inform Health Canada's ongoing policy work.

Summary of questions for feedback on human use

Site licensing, good manufacturing practices and product quality

• What are your views regarding whether something like a Cannabis Drug Licence and specific physical and personal security controls are required for NHPCCs?
• Are additional raw material GMP standards or qualifications necessary for Cannabis Act licence holders supplying raw material for NHPCCs, to ensure that CBD being used as an ingredient in NHPCCs conforms with established standards for NHPs?
• Provide any comments related to the need for a certificate of analysis for CBD to support the quality of NHPCCs licensed as NHPs.

Packaging and labelling

• Given the potential for concurrent health product and prescription drug use, is there a need for NHPCCs to include a warning statement on the principle display panel to inform the consumer that they contain CBD?

Clinical trials

• Describe any barriers or concerns with clinical trials that you are currently facing for products containing CBD or that you anticipate might impact your ability to produce evidence to support the safety or efficacy of NHPCCs

Place of sale

• Where should NHPCCs be sold?
  • pharmacies
  • health food stores
  • online
  • locations consistent with that of other NHPs (pharmacies, health food stores)
  • other, please specify
• What retail considerations for NHPCCs would optimize consumer safety and prevent misuse of products?
  • limit NHPCC sales to behind the counter in pharmacies
  • allow general sales of NHPCCs for self-selection
  • require NHPCCs sales by health care providers (for example, pharmacists)

Advertising and promotion

• Are there any further considerations on advertising and promotion that Health Canada should contemplate?

Post-market safety monitoring of NHPCCs

• Are there any further considerations on vigilance that Health Canada should contemplate?

Other

• Are there additional comments or suggestions you would like to share that could help in developing the NHPCC pathway for human use?

Summary of questions for feedback on animal use

Establishment licensing, good manufacturing practices and product quality

• New products such as VDCCs would normally be considered "new drugs" (Part C, Division 8 of the FDR). All new drug submissions need to supply data that ensures a drug is safe, effective and high quality (chemistry and manufacturing). This data is then carefully reviewed. Would a more streamlined regulatory approach be appropriate? If so, how could a regulatory approach be streamlined? Note that the VHP notification program is not an appropriate option, as treatment, prevention and cure claims are not permitted.
• What are your views regarding whether something like a Cannabis Drug Licence and specific physical and personnel security controls being required for VDCCs?
• For evidence on manufacturing processes and quality control, what level of evidence/scientific review would you expect for a CBD product? For example, would a summary of the chemistry and manufacturing data be sufficient, or would data/scientific evidence in line with, Part C, Division 8 of the FDR be more appropriate? Should the regulatory pathway include the submission of a certificate of analysis (CoA) or should such information be made readily available upon request? Please provide any comments related to the need for a certificate of analysis for CBD to support the quality of VDCCs licensed as non-prescription drugs.
• One approach proposes that the GPP requirements under the CA would apply if you were producing the raw material CBD and the GMP requirements (FDA and FDR) would apply if you are sourcing the CBD as the medicinal ingredient from a licensed producer. If a company produces the CBD and makes the VDCC, both would apply. Do you have any comments or information to share about these important practices that are in place to ensure product quality?
• Are additional raw material GMP standards or qualifications necessary for Cannabis Act licence holders supplying raw material for VDCCs, to ensure that CBD being used as an ingredient in VDCCs conforms with established standards for veterinary drugs?

Packaging and labelling

• Given the potential for concurrent health product and prescription drug use, is there a need for VDCCs to include a warning statement on the principle display panel to inform the consumer that they contain CBD?

Experimental studies: Research using cannabis

• Describe any barriers or concerns with research/studies that you are currently facing for products containing CBD or that you anticipate might impact your ability to produce evidence to support the safety or efficacy of VDCCs

Place of sale

• Based on the SAC-HPCC's recommendations and the objectives of the CA, the place of sale is proposed to be a veterinary clinic. Currently, only prescription veterinary drugs are required to be sold pursuant to a prescription by a veterinarian through their clinic. Any non-prescription product can be sold in other retail locations, such as pet stores and front of counter at veterinary clinics. Do you agree or do you have other considerations or concerns for the sale of VDCCs in a pet store or at retail?

Advertising and promotion

• In contrast to natural health products containing CBD, what unique context or challenges should be considered for VDCCs?
• Are there any further considerations on advertising and promotion that Health Canada should contemplate?

Post-market safety monitoring of VDCCs

• As envisioned, VDCCs would have the same post-market requirements and obligations as other veterinary drugs. Do you agree or have a rationale to justify an alternate approach without compromising the importance of providing ongoing safety-related information throughout the product's lifecycle?
• Are there any further considerations on vigilance that Health Canada should contemplate?

Other

• Do you have or are you aware of scientific or clinical evidence, literature studies or other forms of quality information on the safety, efficacy and quality of cannabis (including CBD) for use in animals, for specific indications or uses at specific doses?
• Are there additional comments or suggestions you would like to share that could help in developing the regulatory pathway for VDCCs for animal use

Submissions should be sent to the Natural and Non-prescription Health Products Directorate before June 5, 2025. Please send your comments via the online feedback form or by email to nnhpd.consultation-dpsnso@hc-sc.gc.ca. In the subject line include the title "Notice to stakeholders: Health products containing CBD discussion paper".