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 claims made by these products can be more absolute than the ones acceptable for cosmetics, as long as they are backed by evidence.
If you have any questions, please feel free to contact Focal Point Research Inc. We are industry leading Over the Counter Drug Regulatory Consultants that you can trust to help guide your company in the right direction.