Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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Acknowledgements:

This complaint was worked up by 2019 Monash BMS3052 students; then checked and submitted by Assoc Prof Ken Harvey.

Product and Sponsor

Product name: Sensuous Raging Bull Male Enhancement Formula 100ml Sponsor: Sensuous Pty Ltd Address: PO Box 1252, Paradise Point, Queensland, 4216, Australia ARTG no: Not listed Product Ingredients:

Purified Water Boswellia carterii Dicapryl Ether Jojoba Oil Polyacrylamide C13-14 Isoparaffin Laureth-7 Propionyl L- Carnitine HCL Polygonum Cuspidatum Resveratrol (Root Extract) Mucuna pruriens (velvet bean) seed extract Trichilia catigua (catauba) bark extract Epimedium grandiflorum (Horny goat weed) leaf extract Turnera diffusa (damiana) leaf extract Ginkgo biloba leaf extract, Panax pseudo ginseng root extract Tribulus terrestris (tribulus) fruit extract Gluconodetlalactone Potassium Sorbate Sodium Benzoate Citric Acid (amount/doses not mentioned)

Advertisement type:

Internet – Web site

Accessed on:

15/01/2020

URL(s) listed (screen shots appended)

• https://sensuous.com.au/store/raging-bull--p23189 • https://www.nawtysecrets.net.au/products/raging-bull-male-enhancement-formula • https://www.chemistwarehouse.com.au/buy/85773/sensuous-raging-bull-male-enhancement-formula-

100ml • https://www.ebay.com.au/itm/Sensuous-Raging-Bull-Male-Enhancement-Formula-

100ml/323087473050

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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• https://www.epharmacy.com.au/buy/85773/sensuous-raging-bull-male-enhancement-formula-100ml • https://www.chemistdirect.com.au/sexual-health/for-him/sensuous-raging-bull-male-enhancement-

formula-100ml • https://www.maxim.com.au/archives/7973 • Etc.

Complaint Summary

This product is making therapeutic claims. ‘Raging Bull™ has been uniquely formulated using a combination of herbs, traditionally known for their sexual benefits, including improvements in: Penile strength and size, greater blood flow, increased libido and desire and stronger erections’. ‘Bigger, Better Stronger’, ‘Male Enhancement Formula’.

However, it cannot be found on the ARTG and thus is illegally supplied, a serious breach of the Therapeutic Goods Act 1989

Sensuous Raging Bull™ contains a complex mix of herbal ingredients, vitamins and minerals that are applied topically. Some claims &/or ingredients are said to be supported by traditional evidence, but many others lack this statement and thus appear to be scientifically based. No scientific evidence was found to support the claims made for the herbal ingredients. Some online sites such as ebay.com.au lacked required information. In addition, claiming that the product has ‘no known side effects' is both untrue and unacceptable.

It is alleged the claims documented breach the Therapeutic Goods Act 1989, s.42DL(12) and the Therapeutic Goods Advertising Code (No.2) 2018, s.9(a), 9(b), 10(a)(ii), 10(d)(i), 12(3)(b),(e) &(f), 13(7), 15(3)(a) and 17(2).

This products preys on vulnerable consumers concerned about their sexual performance. Because of this, it is suggested this complaint should be given a medium priority, with a view to removing it from the marketplace.

Introduction

This products preys on vulnerable consumers concerned about their sexual performance. The product makes therapeutic claims, cannot be found on the ARTG, and contains a complex mix of herbal ingredients, vitamins and minerals to be applied topically. Some claims &/or ingredients are said to be supported by traditional evidence, but many others appear to be scientifically based. Herbal ingredients have varied active constituents and clinical trial results are only valid for specific identified extracts. In addition, combinations of herbs with other ingredients are not necessarily additive or synergistic, they can also be antagonistic and adverse effects are more likely the greater the number of ingredients combined. No scientific evidence was found supporting the claims made for this combination product, or its individual ingredients.

Claims disputed

1. ‘Raging Bull™ has been uniquely formulated using a combination of herbs, traditionally known for their sexual benefits, including improvements in: Penile strength and size, greater blood flow, increased libido and desire and stronger erections’. ‘Bigger, Better Stronger’, ‘Male Enhancement Formula’.

2. ‘Apply this male genital moisturiser, twice daily and you should feel increased blood flow straight away and the benefits will continue to improve with use and optimal results should be noticed in about 7 to 10 days’.

3. ‘Many guys who are using penis pumps and/or jelqing have reported that they are experiencing better and more lasting results using Raging Bull as part of their daily exercise routines, as well as helping them

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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with size, desire and providing them with stronger erections’. (testimonial mentioned on maxim magazine).

4. ‘No side effects’ See screen shot of enquiry

Evidence reviewed

‘A Urologist’s Guide to Ingredients Found in Top-Selling Nutraceuticals for Men’s Sexual Health’ (2015) is appended.1 According to the authors, the top-selling nutraceuticals marked for men’s sexual health in the U.S. contain a blend of multiple supplements (up to 33 in one formulation identified), the most common being ginseng, tribulus, zinc, horny goat weed, B complex vitamins / trace minerals, fenugreek, L-arginine, maca, DHEA, ginkgo, and yohimbine. The currently available medical literature evaluating the efficacy of these substances is generally of low quality. Also, given the decreased oversight relative to prescription medication, there is limited study of toxicity in the setting of monotherapy, combination with prescribed medications or other supplements. In conclusion, they were not recommended. See also, ‘Rise of herbal and traditional medicine in erectile dysfunction management’.2

Some additional notes on specific ingredients contained in the Sensuous Raging Bull product follow. However, no evidence was found about their topical use.

Ginkgo biloba – According to the U.S. National Center for Complementary and Integrative Health (NCCIH) there is no conclusive evidence that Ginkgo biloba is helpful for any health condition including memory enhancement and intermittent claudication (poor blood supply to the legs). 3 In addition, NCCIH notes the side effects of ginkgo may include headache, stomach upset, and allergic skin reactions. The only relevant vaguely study found was by Wu et al. which investigated the effects of IV ginkgo biloba extract on the blood flow of healthy elderly individuals. 4 However, given the product was administered intravenously, not topically, it provided no support for the above claim.

Tribulus terrestris – This is a common ingredient in products taken orally purporting to improve sexual functions, believed by some as a precursor of testosterone. While some studies in humans have shown mixed results, most find Tribulus no more effective than a placebo on improving symptoms of erectile dysfunction or serum total testosterone.5 No evidence supporting topical use was found

Epimedium sagittatum -Also known as Horny Goat weed, this extract contains a substance called icariin which is shown to have the effect of dilating blood vessels through PDE5 inhibitory action in smooth muscle. While animal studies have exhibited positive results, particularly with reference to the improvement of blood flow in the corpus cavernosum of rats. 6 However, none of this research has been replicated in humans.

In summary, no scientific evidence was found to support the claims made for the herbal ingredients. Some online sites such as ebay.com.au lacked required information. In addition, claiming that the product has ‘no known side effects' is both untrue and unacceptable.

It is alleged the claims documented breach the Therapeutic Goods Act 1989, s.42DL(12) and the Therapeutic Goods Advertising Code (No.2) 2018, s.9(a), 9(b), 10(a)(ii), 10(d)(i), 12(3)(b),(e) &(f), 13(7), 15(3)(a) and 17(2).

1 https://www.ncbi.nlm.nih.gov/pubmed/26531010 2 https://www.ncbi.nlm.nih.gov/pubmed/21948222 3 https://nccih.nih.gov/health/ginkgo/ataglance.htm 4 https://www.sciencedirect.com/science/article/abs/pii/S0944711307003157 5 https://www.ncbi.nlm.nih.gov/pubmed/24630840 6 https://www.ncbi.nlm.nih.gov/pubmed/21729132

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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This products preys on vulnerable consumers concerned about their sexual performance. Because of this, it is suggested this complaint should be given a medium priority, with a view to removing it from the marketplace.

Signed and dated

Dr Ken Harvey MB BS, FRCPA, AM Associate Professor

Public Health and Preventive Medicine Monash University

15 January 2020

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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Appendix (Screen shots with offending claims arrowed)

https://sensuous.com.au/store/raging-bull--p23189

https://sensuous.com.au/store/raging-bull--p23189

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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https://www.ebay.com.au/itm/Sensuous-Raging-Bull-Male-Enhancement-Formula-100ml/323087473050

https://www.nawtysecrets.net.au/products/raging-bull-male-enhancement-formula

Missing required information

Missing required information

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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https://www.maxim.com.au/archives/7973

Complaint to TGA – Sensuous Pty Ltd, Sensuous Raging Bull Male Enhancement Formula 100ml,

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