Complaint to TGA – N-Hance Pty Ltd, WYLD MAN, WYLD WOMEN 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: WYLD MAN & WYLD WOMEN Sponsor: N-Hance Pty Ltd Address: PO Box 8303, BAULKHAM HILLS, NSW, 2153 Australia WYLD MAN - ARTG no: 264894, Product Ingredients: Epimedium sagittatum 150 mg Ginkgo biloba 60 mg Panax ginseng 50 mg Paullinia cupana 89.3 mg Schisandra chinensis 187.5 mg Tribulus terrestris 50 mg Zinc amino acid chelate 30 mg WYLD WOMEN - ARTG no: 264912 Product Ingredients: Calcium carbonate 250 mg Calcium pantothenate 13.64 mg Chromium picolinate 201.13 microgram Cyanocobalamin .025 mg Eleutherococcus senticosus 66.67 mg Equivalent: Eleutherococcus senticosus (Dry) 1000 mg Folic acid 50 microgram Ginkgo biloba 60 mg Equivalent: Ginkgo biloba (Dry) 3 g Heavy magnesium oxide 86.37 mg Nicotinamide 12.5 mg Paullinia cupana 83.33 mg Equivalent: Paullinia cupana (Dry) 416.67 mg Pyridoxine hydrochloride 25 mg Riboflavine 12.5 mg Thiamine nitrate 12.5 mg Tribulus terrestris 8.33 mg Equivalent: Tribulus terrestris (Dry) 500 mg Turnera diffusa 100 mg, Equivalent: Turnera diffusa (Dry) 1000 mg Advertisement type: Internet – Web site Accessed on: 08/01/2020 URL(s) listed (screen shots accessed 08/01/2020 appended) https://wyld.com.au/ https://wyld.com.au/wyld-products/wyld-man-natural-aphrodisiac https://www.chemistwarehouse.com.au/buy/56896/Wyld-For-Men-60-Tablets https://shop.coles.com.au/a/a-nsw-metro-alexandria/product/wyld-man-tablets https://wyld.com.au/wyld-blog/benefits-of-wyld-man-and-wyld-woman https://www.pharmacy4less.com.au/wyld-for-men-tabs-60-4.html https://www.ebay.com.au/itm/WYLD-MAN-VITALITY-SEX-DRIVE-ENHANCE-SEXUAL-DESIRE-MEN- HORNY-GOAT-WEED-TRIBULUS/162432779317 Etc. Page 1 of 11 Complaint to TGA – N-Hance Pty Ltd, WYLD MAN, WYLD WOMEN Complaint Summary These products prey on vulnerable consumers concerned about their sexual performance. Many complaints about similar products have been upheld by the TGCRP. Because of this, it is suggested this complaint should be given a medium priority. Both WYLD MAN and WYLD WOMEN contain a complex mix of herbal ingredients, vitamins and minerals. Some claims &/or ingredients are said to be supported by traditional evidence, but many other claims 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. In addition, many claims made were inconsistent with the ARTG entries, while some, such as ‘no known side effects' are untrue and unacceptable. It is alleged the claims documented breach the Therapeutic Goods Advertising Code (No.2) 2018, s.9(b), 9(d), s.10(a)(ii), 10(d)(ii), 12(3)(f) & 13(7), s.17(2). The ARTG Public Summary also contains many unsupported claims This product and similar exploitative ones such as ‘Horny Goat Weed for Him’ and ‘Horny Goat Weed for Her’ should be removed from the ARTG. Introduction These products prey on vulnerable consumers concerned about their sexual performance. Numerous complaints about similar products have been upheld by the TGCRP.1 Because of this it is suggested this complaint should be given a medium priority. Both WYLD MAN and WYLD WOMEN make numerous claims and contain a complex mix of herbal ingredients, vitamins and minerals. Some ingredients are said to have traditional evidence of use, but other claims 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 ingredients combined. No good scientific evidence was found supporting the numerous claims made for this combination product or for its individual ingredients. Claims disputed • 'Ignite your WYLD side'. 'WYLD MAN GIVES YOU THE ENDURANCE AND STAMINA YOU NEED TO PERFORM AT YOUR PEAK WHEN IT COUNTS. CREATED FOR OPTIMAL PERFORMANCE, WYLD HELPS YOU GET THE MOST OUT OF YOUR BODY WHEN IT COUNTS'! These claims, together with the illustrations, and others unqualified by "traditionally used" implies scientific evidence for the products claim as an aphrodisiac which is unsupported. • 'HELPS TO SUPPORT HEALTHY SEXUAL FUNCTION Due to maintenance of healthy circulation with Ginkgo biloba leaf'. 'Maintain blood flow to the extremities'. Also lacks evidence. • 'Most people experience an increase in their sex drive within two weeks', 'Recharge sex drive', 'Maintain a healthy sperm count'. Lacks evidence and not on the ARTG. 1 https://www.tgacrp.com.au/complaint-register/?_search=horny Page 2 of 11 Complaint to TGA – N-Hance Pty Ltd, WYLD MAN, WYLD WOMEN • 'A Low libido in men can also be addressed via supplementation. This supplementation revolves around addressing the more physical nature of a low libido. WYLD Man is a perfect solution to increase libido naturally. The men’s formula has been created for increased performance and sex drive with 3000mg of Tribulus making it one of the most potent formulas on the market'. Lacks evidence • 'WYLD WOMAN FIRES UP YOUR BODY AND MIND GIVING YOU INCREASED SEXUAL DESIRE' & 'HELPS TO SUPPORT HEALTHY SEXUAL FUNCTION Due to maintenance of healthy circulation with Ginkgo Biloba leaf'. Lacks evidence and not on ARTG. • 'There are no known side effects' Untrue and completely unacceptable. • Pharmacy4less and ebay.com.au web sites lack required information. • Also, dubious testimonials, unlikely to be typical, need verification by statuary declarations. Evidence reviewed ‘A Urologist’s Guide to Ingredients Found in Top-Selling Nutraceuticals for Men’s Sexual Health’ (2015) is appended.2 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’.3 Some additional notes on specific ingredients contained in the WYLKD product follow. Ginkgo biloba – ‘'HELPS TO SUPPORT HEALTHY SEXUAL FUNCTION’, healthy circulation, 'Maintain blood flow to the extremities', 'WYLD WOMAN FIRES UP YOUR BODY AND MIND GIVING YOU INCREASED SEXUAL DESIRE' & 'HELPS TO SUPPORT HEALTHY SEXUAL FUNCTION Due to maintenance of healthy circulation with Ginkgo Biloba leaf' 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).4 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. 5 However, given the product was administered intravenously, not orally, it provided no support for the above claim. Tribulus terrestris – ‘The men’s formula has been created for increased performance and sex drive with 3000mg of Tribulus making it one of the most potent formulas on the market'. This is a common ingredient in products purporting to improve sexual functions, believed by some as a precursor of testosterone. While some studies in humans have shown mixed results, most find 2 https://www.ncbi.nlm.nih.gov/pubmed/26531010 3 https://www.ncbi.nlm.nih.gov/pubmed/21948222 4 https://nccih.nih.gov/health/ginkgo/ataglance.htm 5 https://www.sciencedirect.com/science/article/abs/pii/S0944711307003157 Page 3 of 11 Complaint to TGA – N-Hance Pty Ltd, WYLD MAN, WYLD WOMEN tribulus no more effective than a placebo on improving symptoms of erectile dysfunction or serum total testosterone.6 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.7 However, none of this research has been replicated in humans. Panax Ginseng –Wyld Men claims the product helps a healthy sperm count. The only study found showed improved sperm count and motility in rats, not humans.8 Alleged regulatory breaches: Therapeutic Good Advertising Code (No. 2) 2018 s. s.9(a), s.9(b), 9(d), s.10(a)(ii), 10(d)(ii), 12(3)(f) & 13(7), s.17(2). The ARTG Public Summary also