Request a Demo
In the USA and Canada, products typically classified as cosmetics in Europe—such as sunscreens or products targeting skin blemishes—are often regulated as Over-The-Counter (OTC) drugs. This presents both a significant opportunity and a challenge for companies aiming to enter these markets.
The USA represents a rapidly growing market for OTC cosmetic products. With a population exceeding 340 million people and an annual household spend of $338 on OTC products alone (IRI data, 2015), the demand continues to surge. For example, acne products alone saw a staggering growth of over 100% between 2020 and 2023, reaching annual sales of $536 million. Other categories are also seeing impressive sales increases.
These figures clearly demonstrate the tremendous growth potential for OTC cosmetic products in the USA. However, exporting OTC products can be a challenging without the proper knowledge and understanding of the country’s regulations and market trends.
In the USA, an OTC cosmetic is a cosmetic product manufactured according to an FDA Monograph, which defines the safety, effectiveness, and labelling of all active ingredients. All OTC cosmetic products must include standard “Drug Facts” information on the back and/or side of the container. Cosmetic products do not require FDA approval before marketing unless they contain colour additives or any restricted or hazardous ingredients.
In Canada, OTC products are regulated by the Natural and Non-Prescription Directorate (NNHPD), which is part of the Health Canada. These products are subject to pre-market approval before they can be sold legally in the Canadian market.
To help navigate these complexities, ChemLinked invited an experienced regulatory affairs consultant, Marina Bishop from CE.way, to explain requirements on exporting OTC cosmetic products to the USA and Canada. This session will cover essential regulatory requirements, market insights, and other vital considerations. By the end of this webinar, regulatory professionals and organisations will have a better understanding of the regulatory landscape surrounding OTC products in both USA and Canada and will gain valuable insights into how to export OTC cosmetic products successfully.
Notes:
The webinar livestreaming is freely available to all users. You are welcome to register for and participate in the webinar.
Kindly be aware that the access to the slides, recording, and Q&A collection is limited to ChemLinked premium members only [Upgrade now].
