Classification Fraxin™ Anti-Wrinkle
As Fraxin™ Anti-Wrinkle contains only herbal ingredients, neither of which feature on the current MHRA or FDA 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- The product is classed as herbal. The licensing of medical and many health practices (e.g. massage therapists) occurs on a state level. There is currently no licensing or certification for herbalists in any state that precludes the rights of anyone to use, dispense, or recommend herbs.
In the absence of licensing, the First Amendment of the Constitution protects our freedom of speech to provide information to clients related to their health. However, this is restricted by the necessity to avoid practicing medicine without a license.
Medical practice is regulated on the state level, and herbalists should familiarize themselves with the language of the statutes in the state in which they practice. Generally speaking, only physicians (and in some cases some others such as nurse practitioners) can legally diagnose, prescribe, treat, or cure disease.
Herbalists (who are not also MDs) should be clear and transparent with all clients and the public about this; the AHG advises all practitioners to utilize an Informed Consent and Disclosure form that makes this clear.
Fraxin CORP LLC ensures that all manufacturing is undertaken in line with the relevant requirements of "Good Manufacturing Processes".