Proposed Food and Drugs Act amendments say NHPs to be under the definition of ‘therapeutic product’

by | Jul 14, 2023 | Canadian Regulatory, Cosmetics, Natural Health Products, Research/Science/Technology

The proposed amendments to the Food and Drugs Act (FDA) in Bill C-47 mainly focus on encompassing Natural Health Products under the ‘therapeutic product’ definition, empowering the Minister of Health to have more authority to deal with therapeutic products that may pose serious health risks and prohibitions on animal testing for cosmetics.

As per the proposed amendments to the Food and Drugs Act (FDA) in Bill C-47, the following changes will be implemented in terms of NHPs and cosmetics:

NHPs:

  • The definition of a therapeutic product has been replaced by the following: ‘therapeutic product means a drug or device or any combination of drugs and devices’ thereby including NHPs. Consequently, all regulations pertaining to therapeutic products will also apply to NHPs, with the exception of a few sections.
  • The Minister will be empowered to order a person to provide information within their control, including any new information may raise questions about the product’s effect on health and safety for the purpose of assessing serious risks to health. Additionally, the Minister may require a therapeutic product authorization holder to compile information to assess the benefits, harms, and uncertainties of a product.
  • The Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or the safety of the public if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.
  • If it is deemed necessary to prevent harm to health, such as situations where the label fails to adequately reflect potential product risks, or when there are similar brand names or packaging that could result in errors in prescribing or dispensing, the Minister will now have the authority to instruct the import/sale authorization holder to revise the label of a therapeutic product to include new harm information or to change the brand name or packaging. Please re-check the labels of the products in your portfolio for the same.
  • If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to recall the product; or send the product, or cause it to be sent, to a place specified in the order.
  • The amendments include an increase in the level of fines and penalties for non-compliance to a maximum penalty of $5,000,000 or 2 years in prison to better reflect the serious nature of the offence.
  • A person who knowingly makes a false or misleading statement to the Minister of Health or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.
  • The incorporation by reference of technical and non-technical documents relating to therapeutic products into the Food and Drug Regulations will be permitted.
  • The Minister of Health will have an obligation to make any orders issued under these new powers publicly available.

Cosmetics:

  • No person shall sell a cosmetic unless the person can establish the safety of the cosmetic without conducting and relying on data derived from a test performed on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal, if the purpose of the test is to meet a requirement under a provision of FDA or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state.
  • No person shall make a claim on the label of or in an advertisement for a cosmetic that is likely to create an impression that the cosmetic was not tested on animals after the day on which this section comes into force unless the person has evidence that no such testing occurred after that day.

If you would like to know more about the proposed amendments, how it may impact your business, and more, please contact us.