Summary#

This bill changes how Canada regulates most natural health products (NHPs) under the Food and Drugs Act. It removes NHPs from the definition of “therapeutic product,” so they are not monitored like prescription and over‑the‑counter drugs. It keeps specific safety recall powers for NHPs and carves out an exception for nicotine NHPs used in nicotine replacement therapy, which remain regulated as therapeutic products (Bill: definition; application clause).

• Most NHPs would no longer be treated as “therapeutic products,” reducing the drug‑style monitoring that applies to them (Bill: definition).
• Health Canada’s recall powers, related duties, and penalties would still apply to NHPs (Bill: application of ss. 21.3–21.303; new regulation‑making powers in s. 30(1.2)(f.01)–(f.02)).
• NHPs with nicotine used for nicotine replacement therapy would remain regulated as therapeutic products (Bill: definition).
• Two existing provisions, section 21.321 and subsection 21.8(2), would be repealed (Bill: repeals).
• Prosecutors could not start or continue certain offences against NHPs for conduct between the effective date of Budget Implementation Act, 2023, No. 1, section 500, and this bill’s coming‑into‑force date (Bill: Transitional Provision).

What it means for you#

• Households

  • Most vitamins, minerals, herbal remedies, and similar NHPs would be monitored under a lighter regime than drugs. Health Canada could still recall an unsafe NHP and set penalties for not following a recall (Bill: application of ss. 21.3–21.303; s. 30(1.2)(f.01)–(f.02)).
  • If you use nicotine replacement therapy that is sold as an NHP, it would still be regulated like a therapeutic product, with full drug‑style monitoring (Bill: definition).
  • Timing: Changes take effect on the day the Act comes into force (the date of Royal Assent), which is not specified in the bill text (Bill: general structure).

• Workers and health care providers

  • Duties tied specifically to NHPs under the provisions being repealed would end. Other recall‑related duties for NHPs would remain, per sections 21.3–21.303 (Bill: repeals; application clause).
  • Institutions should review updated Health Canada guidance once issued to confirm any changes to reporting or compliance steps for NHPs. Exact changes depend on how existing duties map to provisions kept or repealed (Bill: repeals; application clause).

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

  • Most NHPs would no longer be subject to the full therapeutic‑product monitoring regime. Compliance obligations linked only to “therapeutic products” would no longer apply to NHPs, unless the bill explicitly preserves them (Bill: definition; application clause).
  • You would still be subject to recall orders, related obligations, and penalties for non‑compliance with recall duties, once regulations are made under s. 30(1.2)(f.01)–(f.02) (Bill: s. 30(1.2)(f.01)–(f.02)).
  • NHPs containing nicotine for nicotine replacement therapy would continue under the therapeutic‑product rules (Bill: definition).
  • Transitional clause: No new or ongoing proceedings for offences under ss. 31.2 or 31.4 may proceed for NHP‑related conduct during the specified past window, which could resolve certain pending matters (Bill: Transitional Provision).

• Local and provincial/territorial governments

  • Potential adjustments to enforcement coordination on NHP recalls, as federal recall powers for NHPs remain while other drug‑style tools may no longer apply to NHPs (Bill: application clause).

Expenses#

Estimated net cost: Data unavailable.

• No appropriation is included in the bill text (Data unavailable).
• The bill creates or maintains federal regulatory powers (recalls and penalties) for NHPs but removes broader therapeutic‑product monitoring from NHPs. Administrative costs or savings to Health Canada are not quantified in public documents (Data unavailable).
• Any industry compliance cost changes are not quantified in the bill or official non‑partisan analyses (Data unavailable).

Proponents' View#

• The bill restores a tailored approach by excluding most NHPs from “therapeutic product” status, so lower‑risk products are not regulated like drugs (Bill: definition; Summary).
• It preserves key safety tools for NHPs by applying recall provisions (ss. 21.3–21.303) and by authorizing regulations for NHP recalls and penalties, keeping the ability to act on unsafe products (Bill: application clause; s. 30(1.2)(f.01)–(f.02)).
• It targets higher‑risk cases by keeping nicotine NHPs used in nicotine replacement therapy under the full therapeutic‑product regime (Bill: definition).
• The transitional clause prevents prosecutions for certain NHP offences during a defined past period, which proponents may view as legal clarity and fairness after earlier amendments in Budget Implementation Act, 2023, No. 1 (Bill: Transitional Provision).
• By repealing section 21.321 and subsection 21.8(2), the bill removes parts of the drug‑style monitoring that were extended to NHPs, aligning oversight with product risk while retaining recalls (Bill: repeals; Summary).

Opponents' View#

• Removing NHPs from “therapeutic product” status could weaken consumer protections that apply to drugs, because only a subset of monitoring tools would continue to apply to NHPs. For example, powers outside ss. 21.3–21.303 (such as certain drug‑specific post‑market tools) would no longer cover NHPs unless separately provided (Bill: definition; application clause).
• Repealing section 21.321 and subsection 21.8(2) may eliminate specific safety or reporting tools currently in law; without those, oversight of NHPs could be narrower. The exact impact depends on the content of the repealed provisions in the current Act (Bill: repeals).
• Safety enforcement would rely heavily on recalls and related penalties. Other interventions used for drugs, such as certain mandatory label changes or other orders outside ss. 21.3–21.303, may not be available for NHPs (Bill: application clause).
• The effectiveness of the recall regime for NHPs will depend on new regulations under s. 30(1.2)(f.01)–(f.02). Until regulations are made and in force, penalties and detailed procedures may be limited (Bill: s. 30(1.2)(f.01)–(f.02)).
• The transitional clause halts certain prosecutions for past NHP‑related conduct during a specified window, which could reduce accountability for violations in that period (Bill: Transitional Provision).