In 2016 Health Canada began a consultation on an innovative and progressive concept to regulate cosmetics, OTC drugs and Natural Health Products. If brought to life, the idea would regulate these three categories on a continuum of risk, as opposed to three separate categories as they currently are regulated. This concept makes sense, and is consistent with how governments regulate everything from consumer products to serious prescription drugs. The consultation has however ignited a firestorm of controversy and underscores the challenge for a government agency to bring in sweeping change.
So far, the most forceful opposition to the Consumer Product Framework has come from the natural health community. While they have several concerns with this proposal, an important one is that Canada’s current Natural Health regulations are working just fine. When Canada’s rules for this new category came into force in 2004, they were completely unworkable. Companies were forced to apply for approval for their Natural Health remedies, only to find their applications languish in file boxes in Ottawa for years. To their credit, Health Canada has made enormous improvements to the system and it now works [...] Learn more
Recently, there has been increased activity from Health Canada and the Canadian Border Services Agency (CBSA) in relation to cosmetics being imported into Canada. The CBSA has authority under the Customs Act to detain goods that are suspected to contravene Health Canada legislation. If Health Canada is alerted by the CBSA of an import that does not meet regulations, they may request that the CBSA further detains or rejects the products. Health Canada inspectors have the authority to open, test, seize, or sample any goods detained by the CBSA.
After seizure, Health Canada will determine whether the goods are admissible into Canada. If the products are found to contravene any respective legislation, the importer will be subject to penalties. Failing to comply with the Food & Drugs Act, Cosmetic Regulations, or the Customs Act may result in penalties ranging from administrative, to fines, to imprisonment.
For cosmetic products, these contraventions are often claims on the product packaging or the company’s website that refer to changing the structure or function of the skin, or are therapeutic in [...] Learn more
Health Canada is holding consultations on a very progressive new system to regulate Personal Care Products. After consultation in Fall 2016 on the proposed risk based regulatory framework for personal care products, Health Canada has refined the proposal which is now available for comment. If you are a consumer, member of an industry or consumer association, a healthcare professional, an academic/regulator, or an Indigenous Canadian, you will have the opportunity to submit comments until May 5th, 2017.
Read the 2016 consultation report here.
Personal care products include toothpastes, sunscreens, dietary supplements, over the counter medications, and cosmetics. Under the current regulatory system, a sunscreen designed to prevent skin cancer may be regulated as a drug, or as a natural health product. This system can lead to confusion and misunderstanding regarding whether a product is safe.
The proposed framework is designed to assist consumers in selecting personal care products based on their relative risk. In this new system any product that is currently regulated as a cosmetic, over the counter drug, or natural health product could be classified as a low, moderate, or high risk product. This progressive design would also ensure that the finances and resources dedicated [...] Learn more
What are Natural Health Products?
Natural Health Products (NHPs) are a subset of drugs regulated under the Natural Health Products Regulations in Canada. They are defined as “a substance or a combination of substances described in Schedule 1 of the Natural Health Products Regulations (NHPR), a homeopathic medicine, or a traditional medicine, that is intended to provide a pharmacological activity or other direct effect in:
- diagnosing, treating, mitigating, or preventing a disease, disorder, or abnormal physiological state or its symptoms in humans
- restoring or correcting organic functions in humans
- modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
What Kind of Claims Can Natural Health Products Make?
NHPs must have a health claim that links the product to a disease or health related condition. This claim cannot refer to diseases and conditions listed in Schedule A
, such as diabetes and cancer, without approval from the Natural and Non-prescription Health Products Directorate (formerly the Natural Health Products Directorate). Claims for traditional use must include the statement “traditionally used…” with reference to the particular culture or system of medicine whose terminology appears [...] Learn more
What are Over the Counter (OTC) Drugs?
In Canada, drugs are defined
as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals". Over the counter (OTC) drugs are products with a Drug Identification Number (DIN) that do not require a prescription. Any health claims made by the product must be approved by Health Canada before going to market. The claims must be supported by evidence and comply with any applicable monographs. Just because your product doesn’t qualify as a cosmetic, doesn’t necessarily mean that it will be approved as a drug.
What are Acceptable Claims for Over the Counter Drugs?
OTC drugs can include low level pain killers, laxatives, and nausea tablets, as well as anti dandruff shampoo, antiperspirant and SPF facial cream. All these products are classified as drugs because they affect the normal function of the body. Unlike cosmetics, OTC drugs can make claims like “stops hair growing back”, “numbing effect”, and “anti-cavity”. The [...] Learn more