Is it true that there is a ban on the sale of warming patches with capsaicin?

Hello, Since the topic of patches is quite controversial, I send URPL opinions on warming patches with capsaicin which solves the topic of classification of patches. The Office for Registration of Medical Devices and Biocidal Products informs that the above-mentioned warming patches do not meet the definition of a medical device given in Article 2 paragraph 1 point 38 of the Act of 20 May 2010 on medical devices (Journal of Laws of 2017, item 211, as amended). The above-mentioned warming patches are a carrier of active substances, i.e. capsaicin, methyl salicylate, camphor and menthol. The active substances contained in the patch have a warming effect, relieve pain. Capsaicin and methyl salicylate act on vanilloid TPRV1 receptors, menthol reduces the sensitivity of TRPM8 pain receptors, camphor dilates blood vessels and stimulates nerve endings. The main action of the patches is the pharmacological action of the above-mentioned active substances. According to the guidelines of the European Commission contained in chapter A.2.1.1. MEDDEV 2.1/3 rev. 3, Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative, is understood to mean the interaction between the molecules of a substance and cellular elements, usually called receptors, which either triggers a direct reaction or blocks a reaction to another agent. Guidelines available at: http://ec.europa.eu/growth/sectors/medical-devices/guidance_en Therefore, Capsicum Plaster warming patches do not meet the definition of a medical device given in the Act of 20 May 2010 on medical devices, because a medical device cannot achieve its main intended action in the body or on the human body with pharmacological agents. In addition, according to the guidelines of the European Commission contained in the guide "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES" in point 4.9, capsaicin patches cannot be qualified as medical devices. Guidelines available at: https://ec.europa.eu/docsroom/documents/29021 In the opinion of the Office, warming patches ......... they must be a medicinal product and be authorised to place the medicinal product on the market. Due to the fact that they were erroneously recognized by the manufacturer as a medical device, they should not be introduced into the territory of the Republic of Poland. Pursuant to Article 124 of the Pharmaceutical Law Act of 6 September 2001 (Journal of Laws of 2017, item 2211), anyone who places on the market or stores a medicinal product for marketing without a marketing authorisation is subject to a fine, restriction of liberty or imprisonment for up to 2 years.

Thank you very much for the information. I greet you cordially