As Fraxin™ Anti-Wrinkle contains only herbal ingredients, neither of which feature on the current MHRA prohibited list, it has been determined that the product should be considered as a herbal remedy when in it's powdered form and when extraction has been delivered via traditional methods.
Fraxin™ Anti Wrinkle will be distributed to users in it's raw form (extract) and will need to be prepared at the practitioners premises via addition of distilled water or saline.
This process must be undertaken following a face to face consultation and the subsequent recommendation of Spilanthol and Toosendanin for anti-wrinkle management.
All practitioners must have undergone a verified Fraxin™ Anti-Wrinkle training scheme or alternatively have a minimum of 5 years training experience as a herbalist and as an aesthetics practitioner.
Section 12.1 of the Medicines Act 1968 permits a practitioner to supply herbal remedies exempt from licensing providing that each remedy is manufactured or assembled on the practitioner's premises and is supplied on the basis of a one to one consultation. In this case, the Spilanthol/Toosendanin herbal remedy is assembled on the premises of the practitioner.
Classification in Europe- The product is available within the EU under the same exemption as in the UK and per the European Directive on Traditional Herbal Medicine Products (formally 2004/24/EC). The product can only be provided after a face to face consultation.
Classification in the United States- FDA regulates the product as a dietary supplement. Our research allows us to claim that the product can aid in reducing the appearance of fine lines and wrinkles on the face. Disclaimer This has not been validated by the FDA
Fraxin CORP LLC ensures that all manufacturing is undertaken in line with the relevant requirements of "Good Manufacturing Processes".
FOR U.S.- Link