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Complaint to TGA: ELITESUPPS.COM.AU - Therapeutic goods not on ARTG

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Responsible body Domain Name: ELITESUPPS.COM.AU

Business name: elitesupps.com.au

Domain Registrant Contact Email: [email protected]

Holder Name: BARVA PTY LTD

Address: 42 Wollongong St, FYSHWICK, 2609 ACT

Customer support: 02-62392137

Address for service of documents: 48 Weddin Cct, PALMERSTON, 2913, ACT

ABN: 34 604 487 550 Advertisement type: Internet – Web site: https://www.elitesupps.com.au/collections/weight-loss-supplements

Accessed on: 27 May 2020

Complaint details There are 199 products on the Elite Supplements web site categorised as ‘weight loss and ’fat burning’.

They are examples of products at the ‘food-medicine interface’.1 However, they are not found on the Therapeutic Goods (Declared Goods) Order 2019.2 They have also not been declared as a ‘Formulated supplementary sports foods’ according to FSANZ Standard 2.9.4. They do not have a ‘tradition as a food. While most are formulated as powders or liquids some are available as capsules. All have dose recommendations. A number contain ingredients regulated as complementary medicines, such as vitamins, chromium, green coffee bean extract, bitter orange, ferulic acid, coleus forskholii, ashwagandha and yerba mate. Some lack any ingredient list at all. They are all represented as being for therapeutic use and are likely to be taken for these reasons.

In my opinion, they fit the criteria of therapeutic goods.3 See also, ‘Update on proposed clarification that certain sports supplements are therapeutic goods’.4

These products appear to have been imported from the USA and promoted and sold without being listed on the ARTG. The latter process provides some reassurance to Australian consumers that regulatory standards will be followed. In contrast, it is well known that standards of dietary supplements in the USA are lax.5 Direct imports without regulatory oversight by the TGA place Australian consumers at risk of substandard and adulterated products.

1 https://www.tga.gov.au/blogs/tga-topics/let-medicine-be-thy-medicine-and-food-thy-food 2 https://www.legislation.gov.au/Details/F2020L00465 3 https://www.tga.gov.au/food-medicine-interface-guidance-tool-fmigt 4 https://www.tga.gov.au/update-proposed-clarification-certain-sports-supplements-are-therapeutic-goods 5 https://pubmed.ncbi.nlm.nih.gov/27072845/

mailto:[email protected]

https://connectonline.asic.gov.au/RegistrySearch/faces/landing/bn/SearchBnRegisters.jspx?_adf.ctrl-state=1a0qvaxuna_4

tel:02-62392137

https://www.elitesupps.com.au/collections/weight-loss-supplements

https://www.tga.gov.au/blogs/tga-topics/let-medicine-be-thy-medicine-and-food-thy-food

https://www.legislation.gov.au/Details/F2020L00465

https://www.tga.gov.au/food-medicine-interface-guidance-tool-fmigt

https://www.tga.gov.au/update-proposed-clarification-certain-sports-supplements-are-therapeutic-goods

https://pubmed.ncbi.nlm.nih.gov/27072845/


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This represents a serious breach of s.42DL(12) &/or s.42DLB(9) of the Therapeutic Goods Act 19896 and the full penalties available under the law must be applied.

In addition, many other Australian web sites sell the same or similar products. For example:

• https://www.aaasupplements.com.au/categories/weight-loss.html

• https://spartansuppz.com/collections/fat-burners

• https://www.nutritionwarehouse.com.au/instantsearchplus/result/?q=weight%20loss

• https://www.suppkings.com.au/product-category/weight-loss/

• https://www.rockhardsupplements.com.au/category/weigh-loss-supplements

• https://www.bodyinmotion.com.au/collections/weight-loss

• Etc.

Action needs to be taken against these sites also.

Signed and dated Dr Ken Harvey MB BS, FRCPA, AM

Associate Professor Public Health and Preventive Medicine

Monash University 27 May 2020

URLs and claims (a selection only, screen shots appended) • https://www.elitesupps.com.au/collections/weight-loss-supplements/products/diablo-version-ii

Home › Fat Burners / Weight Loss › Diablo V2 - Claims:

‘DIABLO Version 2 is the new and improved version to send your stubborn fat storage into overdrive with the addition of a FREE Elite Supps Shaker, perfect for the summer time. The enhanced formula has been created to:

o Convert stored fat into energy o Assist in the metabolism of free fatty acids o Increase in energy, mental focus, mood and motivation.

DIABLO Version 2 targets visceral and subcutaneous fat with ingredients that increase fat breakdown and elevate fat utilization for energy via thermogenesis. Basically put, you can literally feel an increase in your body temperature as it targets and destroys stubborn fat.

Don’t let your stubborn fat prevent you from revealing your best possible physique, let DIABLO Version 2 destroy it for you.

Benefits include:

o New & Improved DIABLO Fat Loss Formula o Target & Release Stubborn Fat for Energy o Retrain Your Body to Preferentially Burn Fat

6 https://www.legislation.gov.au/Series/C2004A03952

https://www.aaasupplements.com.au/categories/weight-loss.html

https://spartansuppz.com/collections/fat-burners

https://www.nutritionwarehouse.com.au/instantsearchplus/result/?q=weight%20loss

https://www.suppkings.com.au/product-category/weight-loss/

https://www.rockhardsupplements.com.au/category/weigh-loss-supplements

https://www.bodyinmotion.com.au/collections/weight-loss

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/diablo-version-ii

https://www.legislation.gov.au/Series/C2004A03952


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o Adaptable Dosing for a Custom Solution o No Artificial Dyes or Colours o 60 Full Serving.’

No ingredients or nutritional information listed on the web site yet available to purchase.

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/oxyshred-hardcore

Home › Fat Burners / Weight Loss › Oxyshred Hardcore - Claims:

‘The Dark horse of Oxyshred, better than every before! OxyShred Hardcore has been designed for users looking for tremendous amount of energy and focus that lasts long throughout the day as well as annihilating any unwanted weight. EHP Labs OxyShred Hardcore is here to get you lean and one step closer to your weight loss goals.

o Fat Burning Powerhouse o Proven Fat Burning Ingredients o Better Focus & Better Mood o Extreme Energy

Directions for use: Take 1 scoop of Oxyshred upon waking on an empty stomach with 250-500mL of cold water for the morning kick and metabolism ignition. 15-20 minutes before you train, consume 1 scoop of Oxyshred with about 150-200mL of water for to increase your energy, mood & fat burning process.’

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/oxyshred

Home › Fat Burners / Weight Loss › OxyShred The #1 Fat Burners - Claims:

‘OxyShred is the world’s best fat burner! The most advanced and potent thermogenic ever developed. Dont take our word for it. See the reviews from tens of thousands of Elite Supps customers and check our their amazing results and achievements.

o Limits Calorie Absorption by the Body (reduces appetite) o Destroys Stubborn Fat Cells o Immunity Supports / No Jitters or Anxiety o Mood Enhancers o Constant Energy

OxyShred introduced a market first. Scientifically researched fat cell break down know as hyper-lipolysis, Hyper-Lipolysis is a complex process of enhanced burning of the subcutaneous fat molecules. The key Hyper-lipolysis Matrix is a scientific break-through based on proprietary ratios and concentrations. Ensure you stay hydrated because you will sweat!

What Seperates Oxyshred From the Rest?

Oxyshred is not overly caffeinated which is the cheap way our for many fat-burners. It has an optimal dosage of active ingredients which work synergistically with each other. Oxyshred also has the added benefit of Chromium which regulates blood sugar balance and in effect strongly reduces cravings.’

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/oxyshred-hardcore

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/oxyshred


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• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/alphamine-pre-order

Home › Fat Burners / Weight Loss › Alphamine - Claims:

‘PES Alphamine is one of the most highly regarded fat burners on the market and for good reason better yet, it comes with a free PEScience Shaker + Samples! Some of the biggest benefits are:

o Appetite suppression o Increased thermogenesis and fat burning o Superior mental focus o Enhanced energy o Incredible Value

Alphamine is the source of energy for anyone and everyone. While energy drinks and caffeine are on every corner, Alphamine delivers unparalleled taste and formula. Now with the human research-backed combination of energy, thermogenesis and leaning.

Each scoop contain a full serving of theanine to provide mental focus, improved sleep, boosted mood and enhanced weight loss.

One serve will have your energy levels running on high and your metabolic engine room running on overdrive, burning more calories than you normally would of otherwise. This, over time, when combined with a sound nutrition and training protocol will get you into the caloric deficit you require to assist in losing body fat. Alphamine will have you energised, focused and in fat burning mode. It even has a kick ass taste too!

Are you lacking energy? Need motivation for early morning exercise? Struggling to lose that unwanted body fat? Finding it hard to suppress those food craving? PES Alphamine Advanced may just be what you are looking for.’

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/deficit

Home › Fat Burners / Weight Loss › Deficit - Claims:

‘Faction Labs Thermogenic Activator DEFICIT, has been specifically formulated to reinforce your fat loss journey by supporting metabolic function, minimising cravings, elevating mood and enhancing mental clarity.

o 100% Open Label Formula o Scientifically proven o Laser Focus o Increase Sweat and Water Loss o Suppress Appetite

With over 4g of active ingredients per serve, DEFICIT delivers everything you need to Shred, Sweat, Focus and Suppress! Feel Better, Live Better and Be Better with Faction Labs DEFICIT. The Faction Team recognise that excellence doesn’t allow for excuses. The ability to overcome challenges and the never-ending need to maintain focus will ultimately determine our success. We trade solely in the currency of logic and leave no room for the weak. Failure is not an

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/alphamine-pre-order

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/deficit


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option! Embrace the power of change with the knowledge Faction is the instrument of your evolution.’

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/destiny-mn-x-es

Home › Fat Burners / Weight Loss › Destiny Red Skin - EliteSupps Exclusive - Claims:

‘A great deal of craftsmanship has gone into the creation of DESTINY 3.0 fat burner in collaboration with Elite Supps. MN is all about innovation, research and utilising effectively dosed ingredients to bring and showcase the best fat burner possible.

o Mental clarity and sharp thinking o Boost metabolism and appetite suppressant o Great energy with no crash o Can be used a pre workout o TASTES DELICIOUS!

There are no bread crumb ingredients or prop blends, as we have absolutely nothing to hide. We want everyone to enjoy the taste and feeling DESTINY fat burner brings just as much as we do.

Formulated with the most effective and utilised fat metaboliser Acetyl L-Carnitine, DESTINY has 1,800 mg per scoop. With added ingredients to accelerate the fat burning process, DESTINY will boost your metabolism while suppressing appetite, as well as improve mood, focus and energy during the day (no crash). It can also be taken as a pre-workout in a single or double serve (2 serves = more energy).

DESTINY contains a carnitine metaboliser called GBBGO® (Gamma-Butyrobetaine HCl) - an ingredient which helps your body produce and utilise more carnitine. With an effective dose of 1,800 mg Acetyl L-Carnitine combined with 5 mg GBBGO®, this is the ultimate combination.

Acetyl L-Carnitine makes fat cells more mobile, so they can easily enter your mitochondria (muscles cells). This process promotes the transportation of fatty acids into the muscles, where they can then be burned off as energy (beta-oxidation).

DESTINY is formulated with nootropics. Nootropics are categorised as "smart drugs". Alertness, focus and an enhanced mental capacity are what one can expect. With consistent mental clarity, sharp thinking and an up-beat feeling, you’ll remain focused and happy throughout the day, especially during your workouts.’

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/carnibolic-v2

Home › Fat Burners / Weight Loss › Carnibolic V2 - Claims:

‘L-Carnitine evolved! New and improved Carnibolic v2 is the best L-Carnitine in its category. The number one low caffiene fat burner on the market. Now with a free Elite Supps duffle bag

o Helps Curb Cravings o Supports Fat Metabolism o Low Stimulant

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/destiny-mn-x-es

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/carnibolic-v2


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o Our thoughts... you are looking at the best supplement in the entire elitesupps Australia catalogue.

Buy 10+ Please Contact Us For Special Price

CARNIBOLIC™ contains powerful fat-fighting ingredients such as Garcinia Cambogia and Green Coffee Bean Extract, which, among other beneficial effects, help to satiate appetite and curb cravings. One of the primary functions of the L-Carnitine amino acid is to support your body to metabolize fat. It achieves this by carrying fatty acids from the bloodstream to the mitochondria of your cells to be used as fuel - while carrying waste products out. CARNIBOLIC™ works to support this process thorugh a large dosage of L-Carnitine and the metabolic enhancer Green Tea Extract.

A major concern with athletes trying to lean up is that their body is storing fat faster than they can burn it off. This is especially true for indivudals who focus on anaerobic exercise (like weight lifting), which utilizes carbohydrates and the glycogen system as its primary energy source. By working to rev up your bodies ability to utilize fatty acids, CARNIBOLIC™ is designed to prevent your body from ever storing fat in the first place, no matter how you train. By targeting fat utilization and storage with the L-Carnitine Tartrate found in CARNIBOLIC,™ you can help your body accelerate the process of achieving lean, defined musculature.

Free item and promotions applicable one per cart*

Directions for use:

Cardiovascular Support Usage: Take 1-2 scoops 2-3 times daily with a meal or as directed by your qualified healthcare practitioner.

Performance Enhancing Suggested Usage: Take 1-2 scoops on an empty stomach prior to workout or as directed by your qualified health care practitioner.’

No ingredients or nutritional information listed on the web site yet available to purchase.

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/prometheus

Home › Fat Burners / Weight Loss › Prometheus - Claims:

‘Slimtum™ Prometheus uses the twin fires of cutting edge science and natural wisdom to elevate your fat burning to Olympian levels.

o Increased Fat Loss o Boosts Metabolism o Suppresses Appetite

Elite Supps know how amazing this product is and we had to ensure we stocked up big on it for our amazing customers! The strongest capsuled thermogenic product on the market! Get Increased metabolic function, thermogenesis, energy, blood sugar sensitivity and appetite reduction with Prometheus now! Prometheus contains a potent stimulant formulation, giving you the prolonged energy and focus for the most demanding routines.

Directions for use: Take 2 capsules 1-2 times daily before workout or first thing in morning.’

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/prometheus


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• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/ghost-burn

Home › Fat Burners / Weight Loss › Ghost Burn - Claims:

‘Ghost Burn features a fully transparent and well put together combination of ingredients. It includes one of the most common and effective weight loss ingredient 3g of Carnitine with 1.5g from Carnitine Tartrate and Acetyl-l-Carnitine.

o Scientifically Validated Ingredients o Long Lasting Energy o Effective Fat Burning o Improve Mental Focus

Ensure you're burning fat optimally with a fully transparent product that not only gets the job done, but tastes great!

Directions for use: Take 1-2 serves daily with 300-400mls water (or as desired).’

• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/fire-ball

Home › Fat Burners / Weight Loss › Fireball - Claims:

‘Fireball is the newest fat burner to the Elite Supps Catalogue! Utilising a combination of ingredients scientifically designed to support calorie processing and energy requirements. Through synergy and clinical doses creates a one-stop shop for torching those unwanted fatty stores. Fireball provides clean energy, mental clarity and an increase in thermogenesis, along with adaptogen herbs to curb cortisol response, and GBBGO® to keep carnitine levels elevated for longer.

o No jitters, No crash o Clinical Lipolysis o Mood, Focus and Energy Support o Amazing flavours

Carnitine Lipolysis Blend - with two different forms of carnitine available, at a total dose of 2g, the Carnitine in Fireball will help transport and free up fatty acids to be burnt as fuel - preserving muscle tissue and enhancing the efficiency of fat metabolization. The GBBGO® present in the blend will increase your bodies carnitine production, and will minimise the conversion of bioavailable carnitine into GBB.

Coleus Forskholii - This root extract is a potent upregulator of a hormone called Cyclic AMP (cAMP). This hormone plays a huge role in the regulation of glycogen and fat metabolisation, making it a highly effective addition to any fat burner. In addition to this, we’ve also added Yerba Mate Tea Leaf Extract to keep the cAMP levels in your system for longer - this is done by inhibiting production of the enzyme; ‘cAMP-dependent phosphodiesterase’.

Ashwaganda - This root extract is a highly effective adaptogen and anti-cortisol agent, making it your fat burning best friend. The addition of Ashwaganda in the formula will help reduce any negative stress on the body from dieting, long sessions, or your day to day life, meaning you can do what you’re doing for longer, and feel better doing it!’

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/ghost-burn

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/fire-ball


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• https://www.elitesupps.com.au/collections/weight-loss-supplements/products/xenevar-cyro-series

Home › Fat Burners / Weight Loss › Xenevar Cryo Series - Claims:

‘Victory Labs Xenevar NEW Cyro Series is a new revolutionary fat burner, that is formulated to take your fat loss to new heights.

o Rapidly Accelerated Fat Transportation o Appetite Control & Mood Enhancement o Multi-Sourced Carnitine & Definition Complex o High Energy Sustained Release Caffeine Matrix

With advanced nutrient delivery methods, It will excite your senses, increase your mood, supress your appetite and support your metabolism while pushing you to train to a level you never thought possible.

Complete with a few of the most contemporary fat burning ingredients like raspberry ketones and mangostee, partnered with tried and true actives like carnitine, Xenevar covers all requirements for effective fat loss.

With satisfying flavours like bubblegum and raspberry vanilla, Victory Labs Xenevar is one of the most quirky and effective fat burners on the market today.

Directions for use: Take 2 Scoops with 900ml of water before breakfast with or prior to working out.’

Etc

https://www.elitesupps.com.au/collections/weight-loss-supplements/products/xenevar-cyro-series



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Appendix (Screen shots with offending claims arrowed




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No ingredients or nutritional information listed on the web site yet available to purchase



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responsible body...literally feel an increase in your body temperature as it targets and destroys...

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