This afternoon, at about 4.30, this ‘ad’ appeared on the HC MXC forum. (edited screen shot below)
It moved me into seeing what the FDA was all about re approvals in the ‘Cosmetic’ arena.
Apparently as at last year, the only pharma company with an FDA approved 'medical grade cannabis' product on the market was GW Pharmaceuticals, which is listed in the UK and the US, and is capped at $3.5BN. GW may well still be the only Medical Grade cannabis FDA approved product in the US.
However, as we know, MGC Pharma has applied for ‘cosmetic’ approval of its range of (currently) 15 different CBD based cosmetic products.
“The FD&C Act (Food Drug & Cosmetic Act) defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the firm's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law.”
I also discovered that the International Cooperation on Cosmetics Regulations (ICCR) is an international group of regulatory authorities from the United States, the European Union, Japan, Canada, and Brazil. …………. and that ICCR members work together to promote regulatory alignment, in order to maximize consumer protection while minimizing barriers to trade.
On 11th May, MGC Pharmaceuticals received approval from the European Commission’s Cosmetic Products Notification Portal (CPNP), for its MGC Derma Cannabidiol (CBD) based “Ananda” cosmetic products.
Given these regulatory authorities are on the same page of the same book, I dare say that FDA and TGA approvals may well be ‘rubber stamped’. Unlike a ‘medical or drug based product, these authorities simply need to be satisfied that ‘the products and ingredients are safe and properly labeled, in full compliance with the law’.
My previous suspicion that FDA approval would take quite some time, appears to be not necessarily so given its pathway to ‘cosmetics’ approval is significantly less complicated and less ‘test / trial’ demanding than ‘drug’ approval.
Suffice to say, if this is indeed the case, then FDA (USA) and TGA (Aust) approvals for MGC’s Ananda cosmetic range may well be much sooner than expected! If that proves to be the case, it will be a total ‘disruptive’ game changer for MXC as it will explode the global market potential for distribution of Ananda and if it sees fit, also facilitate possible OEM cosmetics for those who want their own CBD cosmetic label.
The driving force behind this company is without peer!
Shareholders are in the box seat for something truly amazing!
MXC Price at posting:
5.2¢ Sentiment: Buy Disclosure: Held
