Canada’s Cosmetic and Natural Health Product Regulatory Environment
Canada has a robust and very well-defined regulatory framework for cosmetics and natural health products (NHPs). Overall, this regulatory environment is a blessing and I fully support it. There are instances, however, where the broad brush of regulations stifles the small business owner.
Cosmetics and NHPs in Canada are regulated by the Health Products and Food Branch of Health Canada. Under Health Canada regulations, cosmetics are defined as "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." Very simply, a cosmetic is pretty much anything that is applied to the skin.
All cosmetics for sale in Canada must be registered with Health Canada. The process entails filling out an online form for each product sold, or variant of a product. The ingredients of the product must be listed and the concentration of each ingredient must be documented. This is a very helpful to the entrepreneur. If there is ever any scientific or other data found to show that ingredients pose any sort of risk to the consumer, manufacturers and distributors are notified of the ingredient risk and asked to ensure their product meets the restrictions for use of said ingredient in their products.
One exception to the definition of a cosmetic is sunscreen. Sunscreen is applied to the skin and can be formulated to improve or alter the complexion of the skin. However, inherent in the purpose of the sunscreen is a therapeutic claim that the product will block potentially harmful UVA/UVB rays. And that’s the line between a cosmetic and a NHP. In general, if the product makes a claim of a therapeutic benefit, then it is considered a NHP.
NHPs must undergo stringent registration processes before going to sale. This registration process is far more complex than registering a cosmetic. Health Canada provides a vast library of materials about registering NHPs, but nowhere have I found a simple, step-by-step guide on how to register a NHP. Interestingly, one will discover that there are numerous consulting firms that offer services to assist businesses register their NHPs; at a significant cost, however. The cost is prohibitive for most small businesses. The majority of the cost covers the necessary scientific research and laboratory data that must be generated to validate any health claim made about the NHP.
One exception to NHPs is insect repellent. Insect repellents are in a category all to themselves and have their own, ever more stringent, regulatory requirements for sale. While insect repellent are NHPs by definition, the controversial nature of many insect repellent ingredients in the past has paved the way for heightened restrictions for sale of insect repellents.
As mentioned at the beginning of the article, in general, I fully support this regulatory environment. Health Canada has, as its mandate, to protect the consumer. However, the broad brush of regulations is stifling for small businesses and, in some cases, just doesn’t make sense. Let me share two examples.
Example one; I have a wonderful recipe for all-natural sunscreen. The recipe is for a moisturizing sunscreen that offers very effective broad band protection, blocking 97%+ of UVB and UVA radiation (i.e., SPF 30+). All ingredients in the sunscreen are well within the regulatory guidelines for a cosmetic. But, because inherent in the product itself is the therapeutic claim of blocking UVB and/or UVA radiation, it must be registered as a NHP. But to register the product as a NHP would be cost prohibitive. Therefore, I cannot sell the product through my online store, even though all ingredients in the product meet the regulatory guidelines for safe usage as a cosmetic.
Example two; I have a recipe for all-natural insect repellent that is wonderful and very effective. I have been using this insect repellent for years. Not only does it smell wonderful, but it really works! And the list of ingredients is so simple and innocuous, that it’s frustrating to not be able to offer this for sale through my store without incurring even greater cost than to register a NHP. Again, all ingredients in the insect repellent are well within the regulatory guidelines for a cosmetic. But, because it is a NHP that makes a specific claim about repelling insects, it must be registered as an insect repellent. Costs to register an insect repellent are even greater than to register a NHP and are out of reach for most small business owners.
I am glad we have a regulatory framework in Canada that protects consumers and promotes the safe use of products we place on our skin. I fully support this regulatory framework. However, in some situations the framework has a stifling affect, and unnecessarily so, on small business owners who may be able to offer safe, all-natural product alternatives to the consumer.