Natural Health Products Exempt from Drug Rules

Summary#

This bill changes the Food and Drugs Act so that natural health products (NHPs) are not treated as “therapeutic products,” except for nicotine replacement therapies. That means NHPs would not be subject to the same post‑market monitoring and enforcement tools as drugs and medical devices. The bill also repeals two specific provisions and pauses certain prosecutions related to NHPs during a set time window.

• Redefines “therapeutic product” to exclude NHPs, except nicotine products used for nicotine replacement therapy (Bill, amendment to s.2).
• Repeals section 21.321 and subsection 21.8(2) of the Food and Drugs Act (Bill, repeals).
• Bars starting or continuing proceedings for offences under sections 31.2 or 31.4 that involve NHPs during a period tied to Budget Implementation Act, 2023, No. 1, section 500 (Transitional Provision).
• Practical effect: NHPs would not be under the same federal monitoring regime as drugs and devices (Bill Summary).

What it means for you#

• Households

  • Natural health products (vitamins, herbal remedies, probiotics, etc.) would not be monitored under the same federal rules used for drugs and medical devices. This could change how recalls, label changes, or safety notices are handled for these products (Bill, amendment to s.2; Bill Summary).
  • Nicotine replacement products (like certain gums or patches) remain covered by the therapeutic product rules if they contain nicotine or its salts and are used for cessation (Bill, amendment to s.2).

• Workers and patients in health care institutions

  • Subsection 21.8(2) of the Act would be repealed. This changes how the adverse reaction reporting section operates in law. Institutions may see changes in what must be reported to Health Canada related to NHPs once guidance is updated (Bill, repeal of s.21.8(2)). Data on exact operational change is not specified in the bill text.

• Businesses (manufacturers, importers, distributors, and retailers of NHPs)

  • Your products would not fall under the “therapeutic product” monitoring and enforcement scheme, except for nicotine replacement therapies (Bill, amendment to s.2).
  • Any proceedings for alleged offences under s.31.2 or s.31.4 related to NHPs that occurred after section 500 of the Budget Implementation Act, 2023, No. 1 came into force and before this bill takes effect could not be started or continued (Transitional Provision). This affects enforcement exposure for that period.

• Regulators (Health Canada) and enforcement partners

  • Tools that apply to “therapeutic products” would no longer apply to NHPs, except for nicotine replacement therapies. This narrows which powers can be used for NHP oversight (Bill, amendment to s.2; Bill Summary).
  • Section 21.321 is repealed; any authority that section provided would no longer be available (Bill, repeal of s.21.321).

Expenses#

Estimated net cost: Data unavailable.

• No appropriations are included in the bill text. Data on administrative savings or costs for Health Canada, hospitals, or industry is unavailable.
• No fiscal note identified. Data unavailable.

Proponents' View#

• Keeps NHPs under their own regulatory framework rather than the drug/device framework, which supporters say better matches product risk and avoids applying drug‑level monitoring to low‑risk products (Bill, amendment to s.2; Bill Summary).
• Avoids exposing NHP companies to offence provisions designed for drugs and devices, by excluding NHPs from “therapeutic product” rules and pausing certain prosecutions for a defined period (Bill, amendment to s.2; Transitional Provision referencing s.31.2 and s.31.4).
• Provides clarity by carving out an explicit exception for nicotine replacement therapies, ensuring those remain under stricter oversight (Bill, amendment to s.2).
• Reduces compliance burden by removing provisions that would otherwise apply to NHPs, through repeal of s.21.321 and s.21.8(2) (Bill, repeals). Extent of burden reduction depends on how those sections were being applied. Data unavailable.

Opponents' View#

• Weakens consumer protection by removing NHPs from the “therapeutic product” monitoring regime used for drugs and devices, potentially reducing the federal tools available for recalls, label changes, testing orders, or risk communications for NHPs (Bill, amendment to s.2; Bill Summary).
• Repeal of subsection 21.8(2) may reduce adverse reaction information captured for NHPs, limiting early detection of safety issues. The precise change depends on how the subsection currently operates (Bill, repeal of s.21.8(2)).
• Repeal of section 21.321 removes an enforcement or oversight tool; opponents warn this narrows Health Canada’s options for addressing NHP safety or compliance issues (Bill, repeal of s.21.321).
• Transitional pause on proceedings under s.31.2 and s.31.4 for NHP‑related offences during the specified window may reduce accountability and deterrence for violations that occurred in that period (Transitional Provision).