Guys for those of you in Australia currently using aussie suppliers for sarms please be aware that GW will be reclassified to a schedule drug under the TGA from june 2018 this means that the drug is :
Schedule 10
Substances of such danger to health as to warrant prohibition of sale, supply and use
Summary of ACMS advice to the delegates
The committee recommended that new entries in Schedule 10 and in the index be created for cardarine as follows:
Schedule 10 – New Entry
CARDARINE.
Index - New Entry
CARDARINE.
Schedule 10
The committee also recommends an implementation date of 1 June 2018 as this is the earliest practicable implementation date.
Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the advice included:
a.the risks and benefits of the use of a substance:
◦Risks: Cardarine is banned from use as a performance enhancement substance in sports. Demonstrated risks based on the results of animal toxicological studies include carcinogenicity. Development of the drug was abandoned based on the results of toxicological data from animal studies. It has no approved or regulated use. There is very little data available on long-term use in humans. There is reported misuse and inappropriate use by athletes/fitness/gym users, some of whom access cardarine through “black market” channels.
◦Benefits: There have been no clearly substantiated benefits based on clinical data or scientific evidence. Cardarine was initially trialled in a small number of early phase trials for potential uses in dyslipidaemia, obesity and diabetes. Limited data show that cardarine has an effect on PPARδ receptors, with effects on skeletal muscle, fat and glucose metabolism.
b.the purposes for which a substance is to be used and the extent of use of a substance:
◦Cardarine was developed as a therapeutic agent and abandoned due to toxicity issues most likely related to its mechanism of action.
◦Nil approved uses – there are no products registered on the ARTG containing cardarine. There is no established therapeutic value.
◦Various websites claim that cardarine can enhance athletic performance, hence the marketing of cardarine to gyms and the bodybuilding scene. Athletes use it as an endurance booster based on its limited clinical and experimental data. Presently, its use appears to be limited to internet purchases, anti-ageing clinics and compounding pharmacies; possible availability through gyms etc.
◦Cardarine is on the WADA prohibited list.
c.the toxicity of a substance:
◦Cardarine is associated with a higher rate of numerous cancers and a high frequency of reproductive toxic effects in preclinical settings.
◦Toxicity has been evaluated in long-term animal studies, showing an increase in tumour formation. These animal studies (usually performed in parallel with early clinical development) resulted in termination of the clinical development program.
◦The increase in tumour development was not replicated in the early human studies, which used lower doses and shorter study duration, so long-term effects in humans are unknown.
d.the dosage, formulation, labelling, packaging and presentation of a substance:
◦Nil approved products or accepted dosages.
◦Cardarine is available via internet purchase. It is frequently referred to as “Endurobol” and is available as oral liquid, capsule or powder for performance enhancement. Dosage is reported to be 10-30 mg/day and intended for use in cycles of 4-8 weeks on and at least 4 weeks off between cycles.
e.the potential for abuse of a substance:
◦There is evidence of abuse in ergogenic settings, based on its pharmacological properties, to assist with weight loss and endurance. There are no known documented reports of dependence.
◦Its use has been detected following testing of athletes.
f.any other matters that the Secretary considers necessary to protect public health
◦Cardarine satisfies SPF factors of a Schedule 10:
1.Cardarine poses a potential public health risk as a result of its sale, possession or supply that requires management. The potential health risk does not include potential for abuse, diversion into illicit products or other factors which would warrant inclusion in Schedule 9.
2.Cardarine has a public health risk that substantially outweighs the benefit to the extent that no schedule would provide appropriate public access to any proposed or known products.
Time to stock up.
Schedule 10
Substances of such danger to health as to warrant prohibition of sale, supply and use
Summary of ACMS advice to the delegates
The committee recommended that new entries in Schedule 10 and in the index be created for cardarine as follows:
Schedule 10 – New Entry
CARDARINE.
Index - New Entry
CARDARINE.
Schedule 10
The committee also recommends an implementation date of 1 June 2018 as this is the earliest practicable implementation date.
Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the advice included:
a.the risks and benefits of the use of a substance:
◦Risks: Cardarine is banned from use as a performance enhancement substance in sports. Demonstrated risks based on the results of animal toxicological studies include carcinogenicity. Development of the drug was abandoned based on the results of toxicological data from animal studies. It has no approved or regulated use. There is very little data available on long-term use in humans. There is reported misuse and inappropriate use by athletes/fitness/gym users, some of whom access cardarine through “black market” channels.
◦Benefits: There have been no clearly substantiated benefits based on clinical data or scientific evidence. Cardarine was initially trialled in a small number of early phase trials for potential uses in dyslipidaemia, obesity and diabetes. Limited data show that cardarine has an effect on PPARδ receptors, with effects on skeletal muscle, fat and glucose metabolism.
b.the purposes for which a substance is to be used and the extent of use of a substance:
◦Cardarine was developed as a therapeutic agent and abandoned due to toxicity issues most likely related to its mechanism of action.
◦Nil approved uses – there are no products registered on the ARTG containing cardarine. There is no established therapeutic value.
◦Various websites claim that cardarine can enhance athletic performance, hence the marketing of cardarine to gyms and the bodybuilding scene. Athletes use it as an endurance booster based on its limited clinical and experimental data. Presently, its use appears to be limited to internet purchases, anti-ageing clinics and compounding pharmacies; possible availability through gyms etc.
◦Cardarine is on the WADA prohibited list.
c.the toxicity of a substance:
◦Cardarine is associated with a higher rate of numerous cancers and a high frequency of reproductive toxic effects in preclinical settings.
◦Toxicity has been evaluated in long-term animal studies, showing an increase in tumour formation. These animal studies (usually performed in parallel with early clinical development) resulted in termination of the clinical development program.
◦The increase in tumour development was not replicated in the early human studies, which used lower doses and shorter study duration, so long-term effects in humans are unknown.
d.the dosage, formulation, labelling, packaging and presentation of a substance:
◦Nil approved products or accepted dosages.
◦Cardarine is available via internet purchase. It is frequently referred to as “Endurobol” and is available as oral liquid, capsule or powder for performance enhancement. Dosage is reported to be 10-30 mg/day and intended for use in cycles of 4-8 weeks on and at least 4 weeks off between cycles.
e.the potential for abuse of a substance:
◦There is evidence of abuse in ergogenic settings, based on its pharmacological properties, to assist with weight loss and endurance. There are no known documented reports of dependence.
◦Its use has been detected following testing of athletes.
f.any other matters that the Secretary considers necessary to protect public health
◦Cardarine satisfies SPF factors of a Schedule 10:
1.Cardarine poses a potential public health risk as a result of its sale, possession or supply that requires management. The potential health risk does not include potential for abuse, diversion into illicit products or other factors which would warrant inclusion in Schedule 9.
2.Cardarine has a public health risk that substantially outweighs the benefit to the extent that no schedule would provide appropriate public access to any proposed or known products.
Time to stock up.
