Fimea classifies lipolysis injection products as medicines citing health risks in Finland

The Finnish Medicines Agency, Fimea, has classified products used in lipolysis injection treatments as medicines. These products, marketed for subcutaneous administration to dissolve fat cells in areas such as double chins, pose health risks, according to Fimea.

In its announcement, Fimea identified three specific products classified as medicines based on their composition, dosage method, and product form. These classifications are legally binding. The products are as follows:

– Lemon Bottle Ampoule Solution For Face And Body, injection
– Lipolax Plus Koru Pharma Korea, injection
– Michelangelo Renaissance Body Sculpting and Reshaping, injection

Fimea noted that the medical efficacy of these products has not been scientifically proven, and they do not hold marketing authorization as medicines. Furthermore, administering injections requires medical expertise, Fimea stated.

In March, Fimea and the Finnish Safety and Chemicals Agency (Tukes) warned consumers and businesses about safety risks associated with the Lemon Bottle product. The safety of the product has not been studied, and information regarding its composition is unreliable. The Swiss medicines authority’s laboratory examined samples and found that the injection’s composition does not match the manufacturer’s claims.

Additionally, an investigation by Yle’s MOT team into lipolysis injection training revealed substantial risks. The investigation ultimately led Fimea and Tukes to look into the matter more closely. A Finnish company was selling injection training and the related lipolysis products online to anyone, with the online training priced at 299 euros. Fimea’s chief pharmacist, Kristiina Pellas, expressed serious concerns about the content of the training in an interview with MOT, highlighting that cosmetic products intended for surface application can contain substances or impurities that may cause infections when injected beneath the skin. The purity standards for medicines, she noted, are vastly different. Fimea initiated the product classification process immediately upon receiving the training materials from MOT.