complaint to tga: evolution supplements - the king kong ... · complaint to tga: evolution...

Complaint to TGA: Evolution Supplements - The King Kong Stack and numerous other illegally supplied products

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Acknowledgement:

This complaint was prepared by a 2018 Monash University Summer Vacation Scholarship student, then checked, edited and submitted by Assoc Prof Ken Harvey.

Summary:

This complaint must be accorded ‘critical’ priority because “The King Kong Stack” is being promoted and sold by Evolution Supplements (ABN: 99 382 528 968) without being listed on the ARTG; a breach of s.42DL(1)(g) of the Therapeutic Goods Act 1989. The claims made for these products also breach many provisions of the Therapeutic Goods Advertising Code 2015.

In addition, some products within “The King Kong Stack” contain ingredients such as Cardarine (Schedule 10) of such danger to health that they are prohibited from sale, supply and use to Australian consumers.

Furthermore, “The King Kong Stack” is just one of what appears to be many illegal products being promoted and sold by Evolution Supplements.

The King Kong Stack ($699.95) is comprised of four separate products:

• Kong ($199.95), contains five SARMS (Selective androgen receptor modulators) including Cardarine (Schedule 10).

• Metha-Quad Extreme ($299.95), contains androstenedione, a steroid hormone used by the body to make testosterone (Schedule 4) and other ingredients.

• Ar1macare Pro ($129.95) contains two anti-aromatase compounds, Androst 3,5-dien-7,17-dione and Abieta-8,11,13-trien-18-oic acid (Schedule 4) and many other ingredients.

• Sup3r PCT ($179.95), a prohormone formula by Olympus Labs contains 2-Androstenone, Bioperine, 6,7 Dihydroxybergamottin, etc.

All these products are therapeutic goods according to the definition of therapeutic goods on the TGA web site; products for use in humans in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury

• influencing inhibiting or modifying a physiological process.

These products are the responsibility of the TGA.

In addition, “The King Kong Stack” is just one of what appears to be many illegal products being promoted and sold by Evolution Supplements. Urgent action is required to review all products available for sale by this company.

Ironically, we note that a complaint to the CRP (2018/03/015) about a similar product, referred to the TGA and highlighted by the ABC, has yet to receive an outcome.

Finally, there are many other Australian outlets providing similar illegal products; these also need action.


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Complaint detail:

Product name: “The King Kong Stack”. Neither this name nor the constituent products are listed on the ARTG.

Sponsor: Evolution Supplements, ABN: 99 382 528 968, https://evolutionsupplements.com.au/.

N.B. An ABN on their website: 61 620 247 878 appears inaccurate.

Their warehouse address is said to be: Suite 100, Level 1, 447 Victoria Street Wetherill Park NSW 2164, P: (02) 9688 2217.

Ingredients and claims: The King Kong Stack ($699.95) is comprised of four separate products:

• Kong ($199.95), contains five SARMS (Selective androgen receptor modulators) including Cardarine (Schedule 10). Said to provide benefits of lean mass gains, muscle definition, endurance and fat loss.

• Metha-Quad Extreme ($299.95), contains androstenedione, a steroid hormone used by the body to make testosterone (Schedule 4) and other ingredients. Said to produce rapid increases in size and strength, dry gains that leave no unwanted water retention, density to the muscle resulting in a mature look to the physique, and vascularity that will be mistaken for a contest prep bodybuilder.

• Ar1macare Pro ($129.95) contains two anti-aromatase compounds, Androst 3,5-dien-7,17-dione and Abieta-8,11,13-trien-18-oic acid (Schedule 4?) and many other ingredients. Purported to suppress estrogen levels, “to aid your metamorphosis into a Demigod”.

• Sup3r PCT ($179.95), a prohormone formula by Olympus Labs contains 2-Androstenone, Bioperine, 6,7 Dihydroxybergamottin, etc. Said to, “decrease body fat, increase muscle mass, improve strength and endurance, speed up muscle recovery and harden your muscles”.

Advertisement type: Internet.

Where did it appear:

• https://evolutionsupplements.com.au/the-king-kong-stack/

• https://www.facebook.com/EVOSUPPS/

Date seen: 3/12/2018

https://evolutionsupplements.com.au/

https://evolutionsupplements.com.au/contact-us/

https://evolutionsupplements.com.au/the-king-kong-stack/

https://www.facebook.com/EVOSUPPS/


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Screen Shots (taken 11/12/2018)

The King Kong Stack:






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Kong:

https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/





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METHA-QUAD EXTREME:

https://evolutionsupplements.com.au/blackstone-labs-metha-quad-extreme-30-tablets/




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AR1MACARE PRO:

https://evolutionsupplements.com.au/olympus-labs-ar1macare-pro-240-capsules/



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SUP3R PCT:

https://evolutionsupplements.com.au/olympus-labs-sup3r-2-60-capsules/





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https://whattsupps.com.au/product/sup3r-pct-by-olympus-labs/

https://whattsupps.com.au/product/sup3r-pct-by-olympus-labs/


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Claims disputed and rationale:

Kong:

The “Kong” supplement is not listed on the ARTG and is being illegally advertised within Australia, breaching 42DL(1)(g) of the Therapeutic Goods Act 1989.

The disclaimer that the product is for ‘Research Purposes Only’ and ‘Not for Human Consumption’ is irrelevant given that “Kong” is promoted and sold to anyone via the Internet by an Australian ASIC registered company, Evolution Supplements.1 In addition, we could find no evidence of any research being conducted by this company.2

The sponsor website, Evolution Supplements states Kong is the “Highest purity 5 SARMS STACK”. SARMs are Schedule 4 prescription only drugs. Additionally, “Kong” contains 20mg of GW501516 or Cardarine, a Schedule 10 poison, the highest level of regulation and cannot be sold for any purpose as of June 1st, 20183. This decision was due to Cardarine being a potential carcinogen and its effect on humans has not been systematically investigated.

METHA-QUAD EXTREME:

The Metha-Quad Extreme supplement is not listed on the ARTG, breaching 42DL(1)(g) of the Therapeutic Goods Act 1989. The product contains 150mg of Androsterone. Androsterone is classified as an anabolic-androgenic steroid (Schedule 4) and is a dangerous drug being illegally supplied.

AR1MACARE PRO:

The Ar1macare Pro supplement is not listed on the ARTG, and is being illegally advertised and supplied, breaching 42DL(1)(g) of the Therapeutic Goods Act 1989.

The sponsor website, Evolution Supplements provides a randomised controlled trial showcasing the treatment of cyclical mastalgia4. Cyclical mastalgia is classified as breast pain and only affects pre-menopausal women. Therefore, the randomised controlled trial only included females and prescribed 1.8ml (equivalent to 32.4mg) of Vitex Agnus Castus whereas Ar1macare Pro contains 600mg of Vitex Agnus Castus. Thus, this randomised controlled trial is not generalisable towards the Ar1macare Pro product nor is it generalisable towards the target audience of males. The claim that Vitex Agnus Castus within Ar1macare can “be considered an efficient alternative phytotherapeutic agent in the treatment of mastalgia” exploits the lack of knowledge of consumers and arouses unrealistic expectations of the product’s effectiveness breaching s.4(1)(b), s.4(2)(a) and s.4(2)(d) of the Therapeutic Goods Advertising Code 2015.

Evolution Supplements claims that “In a study of 75 infertile men, mucuna pruriens significantly improved serum testosterone, LH, dopamine, adrenaline, and noradrenaline levels.” The study purchased seeds of mucuna pruriens from an authorized dealer and were dried under shade and ground to a fine powder with a laboratory mill5. The infertile men were prescribed 5g/day of mucuna pruriens seed powder in a single dose with milk. This is incomparable towards the product, Ar1macare Pro, which contains 300mg of mucuna pruriens and there is no guarantee that this product is therapeutically identical to the dosage used in the trial. Therefore, the results of this study

1 https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/ 2 http://www.anzctr.org.au. 3 https://www.tga.gov.au/book-page/12-cardarine 4 https://www-sciencedirect-com.ezproxy.lib.monash.edu.au/science/article/pii/S0960977699900395 5 https://www.ncbi.nlm.nih.gov/pubmed/18973898


http://www.anzctr.org.au/

https://www.tga.gov.au/book-page/12-cardarine

https://www-sciencedirect-com.ezproxy.lib.monash.edu.au/science/article/pii/S0960977699900395

https://www.ncbi.nlm.nih.gov/pubmed/18973898


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are not generalisable towards the Ar1macare products. This is a breach of s.4(1)(b), s.4(2)(a), s.4(2)(c), s.4(2)(d) and s.4(4) of the Therapeutic Goods Advertising Code 2015.

Evolution Supplements also claims that the Beta Vulgaris extract within Ar1macare Pro is “a powerful antioxidant used in medical treatment of liver diseases”. This statement is a clear breach of s.4(2)(b) and s.5(2) as Ar1macare Pro is claiming to treat a serious disease. Moreover, there are no studies available that have been completed on humans, only studies involving rats/mice. Consequently, Evolution Supplements is making a false claim as there are no human trials available and animal studies are insufficient to generalise towards the broad human population. This is also a breach of s.4(1)(b), s.4(2)(a), s.4(2)(c) and s.4(2)(d) of the Therapeutic Goods Advertising Code 2015.

SUP3R PCT:

The Sup3r PCT supplement is not listed on the ARTG and is being illegally advertised for purchase within Australia, breaching 42DL(1)(g) of the Therapeutic Goods Act 1989.

Sup3r PCT contains 150mg of Vitamin B6, 7,500% of the daily intake. Long term excessive supplementation of vitamin B6 (>100mg/day) can cause nerve damage6. The sponsor is exploiting consumers’ lack of knowledge and leading them to believe, ‘more is better’. Moreover, the sponsor is disregarding their personal responsibility to inform consumers of the possible harm and side effects that may arise due to the overconsumption of this compound. This claim is a breach of s.4(1)(b), s.4(2)(b), s.4(2)(c) and s.4(2)(d) of the Therapeutic Goods Advertising Code 2015.

Conclusion:

This composite product breaches s.42DL(1)(g) of the Therapeutic Goods Act 1989 and contains dangerous ingredients scheduled as poisons. The King Kong Stack also encourages dangerous polypharmacy, recommending 12 capsules a day for 1-4 weeks followed by 10 capsules a day for 4-8 weeks.

The claims made about the individual products (and lack of warnings) breach the Therapeutic Goods Advertising Code, 2015 s.4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(4), 5(2) and 6(3)(b).

These products are the responsibility of the TGA. Urgent action is required to review all products available for sale by this company.

In addition, “The King Kong Stack” is just one of what appears to be many illegal products being promoted and sold by Evolution Supplements.7

Ironically, we note that a complaint to the CRP (2018/03/015) about a similar product, referred to the TGA and highlighted by the ABC,8 has yet to receive an outcome.

Finally, there are many other Australian outlets providing similar illegal products; these also need action.9,10,11

6 https://ods.od.nih.gov/factsheets/VitaminB6-Consumer/ 7 https://evolutionsupplements.com.au/ 8 https://www.abc.net.au/triplej/programs/hack/massive-blackmarket-in-sarms-research-chemicals/9666006 9 https://whattsupps.com.au/ 10 https://www.thesuppstop.com.au/ 11 https://supplementwarehouse.com/

https://ods.od.nih.gov/factsheets/VitaminB6-Consumer/

https://evolutionsupplements.com.au/

https://www.abc.net.au/triplej/programs/hack/massive-blackmarket-in-sarms-research-chemicals/9666006

https://whattsupps.com.au/

https://www.thesuppstop.com.au/

https://supplementwarehouse.com/

complaint to tga: evolution supplements - the king kong ... · complaint to tga: evolution...

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