In light of the ongoing COVID-19 pandemic, many businesses have shifted their business models to respond to the urgent need for certain products and services during this global crisis. For example, some businesses have transitioned into manufacturing, importing and/or selling hand sanitizer, personal protective equipment (PPE), disinfectants, cleaners and the list goes on. For the most part, these are regulated products under the Food and Drugs Act (FDA). The problem is, it is not always easy to determine how simply the type of product or product name may regulate a product. Rather, it is necessary to determine how the product is intended to be marketed in order to properly classify the product.
Moreover, while some businesses’ foray into the regulated-product space will be a short stay during the pandemic, others may view this as an opportunity to expand their product lines and/or service offerings.
With every new or innovative product your business intends to market comes the question, how will my product be regulated?
Classification under the FDA
As the name suggests, the FDA and the regulations made thereunder regulate food and drugs in Canada. The FDA also regulates natural health products (NHPs), medical devices and cosmetics. However, what is less apparent is how a particular product may fall within this matrix. A common misconception is that the composition of a product or its common name will solely dictate how the product will be regulated. However, what is often more consequential is what will be said about the product to consumers and how the product will be perceived by consumers.
This is illustrated by the use of the phrase “manufactured, sold or represented for use” in the definition of each product under the FDA (emphasis added)[1]:
- Food: includes any article manufactured, sold or represented for use as food or drink for human beings, including chewing gum, and any ingredient that may be mixed with food for any purpose whatever;
- Drug: includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals (…);
- NHP: means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans (…);
- (Medical) Device: means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals (…);
- Cosmetic: includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.
Accordingly, to properly determine how a product will be regulated it is necessary to look beyond the common name of the product and its composition to the claims that will be made about the product on its packaging, labelling and advertising. Examples of claims that must be taken into consideration when classifying a product include:
- What is the product intended to do?
- How are similar products perceived?
- What “special advantages” will be claimed about the product in relation to comparator products?
Classification examples
The classification approach above can be seen in the following examples:
- Vitamin-infused beverage – Food or NHP? Vitamins, which are typically sold in a tablet format, are commonly regulated as NHPs.[2] When vitamins are infused in a beverage, does the beverage become regulated as an NHP? Making this determination requires considering various factors, including representation and public perception. Notably, the presence of a health claim or presence of medicinal ingredients (…) is not a primary factor in determining classification.[3]
- Cleaning product – Disinfectant drug or consumer product? Cleaning products are typically lumped together and commonly believed to be regulated as consumer products due to their wide spread availability in general stores carrying a wide variety of household goods. However, making claims that a cleaning product is a disinfectant, kills bacteria or is useful against COVID-19, can result in the product being regulated as a drug rather than a general consumer product. Notably the composition of a cleaning product is not determinative of its classification.[4]
It is important to classify products into the correct regulatory regime, as each regulatory camp comes with a unique set of regulatory requirements concerning licensing, packaging and labelling, marketing and advertising, reporting, recall etc. Please contact Dentons’ Regulatory group if you have questions about how your new product offerings may be regulated.
[1] For all products the definition is found in the FDA, s. 2 except for NHPs where the definition is found in s. 1 of the Natural Health Product Regulations made under the FDA.
[2] See NHPR, schedule 1 (Included NHP Substances) for a list of vitamins that are NHP substances.
[3] NHP-Food GD
[4] Guidance documents on disinfectants: Summary (available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/summary.html).
