Cosmetic products are, put simply, products that are characterized by being intended for application to external parts of the human body or hygienic purposes, such as soaps, creams, perfume and makeup. Cosmetic products often raise demarcation issues in relation to pharmaceuticals, and although the same stringent requirements do not apply to cosmetic products, there are a number of regulations for manufacturers to observe. Setterwalls’ Life Sciences team has extensive experience of issues related to cosmetic products, both regulatory and in relation to marketing and other related issues.
Cosmetic products are characterized in that they are intended to be applied to the external parts of the human body or to the teeth and mucous membranes of the oral cavity, such as toothpaste, skin cream, shampoo, makeup or deodorant. The purpose of such products should be to clean or perfume, change the appearance, correct body odor, protect skin, mucous membranes, hair, nails and teeth or to keep them in good condition. Other examples of cosmetic products are hair dye products, nail polish, mouthwash and sunscreen. Occasionally, demarcation issues arise in relation to pharmaceuticals, and mainly with regard to two aspects: how the product is intended to be applied and its function.
A cosmetic product must not bear just any marketing claims. Several different regulations govern how marketing can be designed. For example, if medical claims are made, the product can be classified as a medicinal product. The supervisory authority for cosmetic products is the Swedish Medical Products Agency. Setterwalls has extensive experience and expertise in these types of issues.
Contrary to what applies to medicinal products, cosmetic products do not undergo an authorization procedure, but the ultimate responsibility for the products to comply with the rules, lies with you who place or offer the products on the market. There are rules on manufacture and import which mean, for example, that a cosmetic product must be safe and comply with the substance rules. The product should also have a product information document that shall include i.a. a safety assessment.
Setterwalls’ Life Sciences team assists with questions about demarcation in relation to other regulations, but also with regard to manufacturing and imports, and how the marketing of the cosmetic product should be designed to be in line with current regulations for such products. Setterwalls’ trademark department assists in all legal matters related to trademark protection, often an important part in the launch and commercialization of a cosmetic product.