IDAAM Publications

Volume 1

January-March 2023

Cosmetics as QUASI and OTC drugs

Akshay R Yadav, Vaibhavi A Soundatti

Over the Counter (OTC) products can be called some of the cosmetics with drug claims and ‎some others that contain chemicals with the ability to change the physiology and biochemistry ‎of in particular skin and nails. A product is either a cosmetic or a medicine, according to the ‎Cosmetic Directive of the EU. In Europe, cosmetics are considered to be several products ‎which are listed under OTC in the US. With the latest changes in the EU Cosmetic ‎Legislation, the regulation of cosmetics is tighter than that of cosmetics in the USA. Similar ‎labeling standards to those of the US Cosmetic Regulations are required by the VI ‎Amendment to the Cosmetic Directive. The Cosmetic Directive also mandates that a ‘Dossier’ ‎be prepared and made available for each product to be put on the market, including, but not ‎limited to, details on the safety evaluation and evidence of the product’s effectiveness. The ‎production, distribution and importation of cosmetics are not permitted in the US and the ‎EU, although they are licensed in Japan. Under the Pharmaceutical Affairs Rule, cosmetics ‎are regulated. They can be known as narcotics, quasi-drugs, or cosmetics. The ones that have a ‎‎”mild effect” on the body are quasi-drugs. Cosmetics are categorized into a group of goods ‎and are approved accordingly. Although the criteria for labeling and dossiers could still cause ‎problems, harmonization of the US Cosmetic Regulations may be possible with EU ‎regulations. However, the analysis of the harmonization measures taken by the US, the EU ‎and Japan shows that, in order to achieve harmonization, Japan needs a more serious ‎commitment.‎
Keywords: Cosmetics, Over the Counter (OTC) Drugs, Cosmetic Directive, Quasi-Drugs, EU Regulations.‎