Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both Canadian consumers, merchants, and brands as well as U.S. suppliers.
Natural health products (NHPs) will be subject to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) authority as of June 22, 2023. This is so because natural health products are now included in the amended definition of “therapeutic product” in the Food and Drug Act.
The following major provisions of the Food and Drugs Act apply to natural health products right away:
- Order a recall of NHPs that present a serious or imminent risk of injury to human health.
- If necessary, require a label change or package modification to prevent serious injury to health.
- Impose higher fines and penalties for non-compliance
- Order a person to provide information to determine if a product presents a serious risk of injury to human health.
- Disclose confidential business information where the product may present a serious risk of injury to human health or for the protection or promotion of human health or the public’s safety.
- Incorporate by reference, and
- Prohibit false or misleading statements or information made to the Minister.
After supporting rules are released, the remaining powers will take effect through an Order in Council. There would be consultation before any enabling regulations.
In our blog, we explore the implications of the therapeutic product changes for NHPs under the Protecting Canadians from Unsafe Drugs Act.
What is the definition of a therapeutic product?
A Natural Health Product is excluded from the definition of a therapeutic product, a drug, a medical device, or a combination of both. The Natural Health Products Regulations will still apply to these.
What new powers will the Minister have to oversee the changes?
Now, the Health Minister will be able to learn more about the product. This can be accomplished in one of two ways: either by asking individuals to disclose information to assess serious health concerns or by requiring the holder of a therapeutic product authorization to gather data, carry out new tests or research, or keep track of experience. The Minister of Health may order a therapeutic product authorization holder to evaluate a product’s advantages, disadvantages, and uncertainties.
How can the Minister disclose related therapeutic product safety confidential information?
To assess whether a therapeutic product poses a substantial danger of harm to human health, the Minister of Health will now have the ability to divulge private company information regarding a therapeutic product.
Furthermore, the disclosure is made for a reason related to the protection or promotion of human health or the public’s safety. In that case, the Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or performs functions related to those two things.
Clinical Trials information to be made available to the public?
This new section now requires holders of therapeutic product authorizations to ensure that the information needed about any clinical study is made public at the time and in the way specified by regulations. This might be achieved by mandating those trials registered on well-known, openly available clinical trial registries.
Will companies be required to modify or replace labels or packaging?
Sometimes, the approved label may not appropriately reflect the medicinal product’s risk. Additionally, brand names with similar appearances, sounds, or packaging may harm consumers’ health and result in incorrect prescriptions and dispensed medications.
The Minister of Health will now have the authority to order an authorization holder to update a medicinal product’s label to add new harmful information, change the brand name, or alter the packaging where it is determined that changes are required to prevent harm to health.
What are the consequences if you fail to comply?
To appropriately reflect the seriousness of the offense, fines and punishments for individuals who violate the Act will be enhanced, with the highest possible fine or sentence now being $5,000,000 or two years in jail. In addition, the court may impose a larger punishment or up to five years in prison on someone who intentionally violates the Act or its regulations, poses a substantial risk of injury, or makes false or misleading statements to the Minister of Health. Additionally, a court can issue an injunction ordering someone to stop doing something connected to the conduct of an infraction at the Minister of Health’s request.
The federal government can act more forcefully against those who endanger Canadians’ safety by strengthening the Minister of Health’s capacity to enforce the Act’s provisions. The sanctions have increased in line with those imposed by other Canadian laws, including the Safe Food for Canadians Act and the Canadian Consumer Product Safety Act.
Any orders issued under this new authority must be made public by the Minister of Health.
Incorporate by Reference:
This makes it possible for technical and non-technical papers on therapeutic items to be incorporated by reference into the Food and Drug Regulations.
These papers can currently be added to the regulations by amending the regulations. Incorporating by reference is a quicker and less time-consuming procedure that doesn’t involve changing the regulations. Appropriate scientific oversight and public accessibility will continue to be a part of the incorporation-by-reference process. This strategy will lessen red tape and enable the government to concentrate resources where they will have the biggest positive impact on Canadians’ health and safety.
How Quality Smart Solutions can help
At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.