complaint to tga: pharmacare laboratories fatblaster fat ...€¦ · loss; aid weight loss”,...

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products Page 1 of 6 This is a high priority complaint to test the TGA's will to act on recalcitrant sponsors of complementary medicines. These products were initially sponsored by CatMedia; then acquired by Pharmacare Laboratories who have sponsored more recent products. They have had 22 complaints upheld by the now abolished Therapeutic Goods Advertising Complaint Resolution Panel (CRP) from 2008 to 2017, see: http://tgacrp.com.au/complaint-register/?_search=FatBlaster (18), http://tgacrp.com.au/complaint- register/?_search=FatMagnet (1)and http://tgacrp.com.au/complaint- register/?_search=Fat%20Magnet (4). The most recent upheld complaint (2017/10/001) involved the promotion of Pharmacare Laboratories (Naturopathica) FatBlaster and FatMagnet products, also promoted by other advertisers. I have appended the CRP determination about this complaint. The Panel noted the advertisements breached the Therapeutic Goods Advertising Code, sections 4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(7), 6(3)(c) and 6(3)(d). The Panel requested Pharmacare Laboratories to withdraw these representations and advertisements and advise third parties that the representation(s) they used should also be withdrawn. Regardless, these products continue to be advertised with claims that have been repeatedly judged to be misleading and deceptive. Furthermore, Pharmacare Laboratories has the unenviable reputation of the having the most upheld complaints of any sponsor of complementary medicines over the life of the CRP. I submit that this complaint is "high priority" because the sponsor is recalcitrant, these products have had numerous upheld complaints and the ongoing advertising claims by the sponsor (and others) that state or imply that the products can cause the body to absorb less fat from food (over and above diet and exercise) and thus aid fat loss or weight loss are misleading and deceptive. These claims clearly impact on the consumers ability to appropriately use these goods. In addition, obesity is an increasing public health problem in Australia, the overweight and obese are a vulnerable population and such people are inevitably attracted to a pill promising a “quick fix”. It is particularly reprehensible that misleading and deceptive claims for these products continue to be made as they are likely to divert consumers from more evidence-based weight loss programs. The products involved (ARTG Public Summary Documents appended) are: 1. ARTG ID: 145959 Product name: Naturopathica FatBlaster FatMagnet Active ingredients: Ascorbic acid, poliglusam, Psyllium Husk Powder Sponsor: Cat Media Pty Ltd 2. ARTG ID: 167323 Product name: Naturopathica FatBlaster Active ingredients: Camellia sinensis, Chromium picolinate, Citrus aurantium, Cyanocobalamin, potassium iodide, pyridoxine hydrochloride, Panax ginseng, Paullinia cupana, Psyllium Husk Powder, Riboflavin, Thiamine nitrate, Zingiber officinale Sponsor: Cat Media Pty Ltd 3. ARTG ID: 212760 Product name: FatBlaster Max Active ingredients: chromic chloride hexahydrate, Camellia sinensis, Chromium picolinate, Citrus aurantium, Coffea canephora, Cyanocobalamin, Eleutherococcus senticosus, Fucus vesiculosus, Garcinia quaesita, Ilex paraguariensis, Nicotinamide, pyridoxine hydrochloride, Paullinia cupana, Plantago afra, Plectranthus barbatus, Riboflavin, Thiamine nitrate Sponsor: Cat Media Pty Ltd

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Page 1: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

Page 1 of 6

This is a high priority complaint to test the TGA's will to act on recalcitrant sponsors of complementary medicines.

These products were initially sponsored by CatMedia; then acquired by Pharmacare Laboratories who have sponsored more recent products. They have had 22 complaints upheld by the now abolished Therapeutic Goods Advertising Complaint Resolution Panel (CRP) from 2008 to 2017, see: http://tgacrp.com.au/complaint-register/?_search=FatBlaster (18), http://tgacrp.com.au/complaint-register/?_search=FatMagnet (1)and http://tgacrp.com.au/complaint-register/?_search=Fat%20Magnet (4).

The most recent upheld complaint (2017/10/001) involved the promotion of Pharmacare Laboratories (Naturopathica) FatBlaster and FatMagnet products, also promoted by other advertisers. I have appended the CRP determination about this complaint. The Panel noted the advertisements breached the Therapeutic Goods Advertising Code, sections 4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(7), 6(3)(c) and 6(3)(d). The Panel requested Pharmacare Laboratories to withdraw these representations and advertisements and advise third parties that the representation(s) they used should also be withdrawn.

Regardless, these products continue to be advertised with claims that have been repeatedly judged to be misleading and deceptive.

Furthermore, Pharmacare Laboratories has the unenviable reputation of the having the most upheld complaints of any sponsor of complementary medicines over the life of the CRP.

I submit that this complaint is "high priority" because the sponsor is recalcitrant, these products have had numerous upheld complaints and the ongoing advertising claims by the sponsor (and others) that state or imply that the products can cause the body to absorb less fat from food (over and above diet and exercise) and thus aid fat loss or weight loss are misleading and deceptive. These claims clearly impact on the consumers ability to appropriately use these goods.

In addition, obesity is an increasing public health problem in Australia, the overweight and obese are a vulnerable population and such people are inevitably attracted to a pill promising a “quick fix”. It is particularly reprehensible that misleading and deceptive claims for these products continue to be made as they are likely to divert consumers from more evidence-based weight loss programs.

The products involved (ARTG Public Summary Documents appended) are:

1. ARTG ID: 145959 Product name: Naturopathica FatBlaster FatMagnet Active ingredients: Ascorbic acid, poliglusam, Psyllium Husk Powder Sponsor: Cat Media Pty Ltd

2. ARTG ID: 167323 Product name: Naturopathica FatBlaster Active ingredients: Camellia sinensis, Chromium picolinate, Citrus aurantium, Cyanocobalamin, potassium iodide, pyridoxine hydrochloride, Panax ginseng, Paullinia cupana, Psyllium Husk Powder, Riboflavin, Thiamine nitrate, Zingiber officinale Sponsor: Cat Media Pty Ltd

3. ARTG ID: 212760 Product name: FatBlaster Max Active ingredients: chromic chloride hexahydrate, Camellia sinensis, Chromium picolinate, Citrus aurantium, Coffea canephora, Cyanocobalamin, Eleutherococcus senticosus, Fucus vesiculosus, Garcinia quaesita, Ilex paraguariensis, Nicotinamide, pyridoxine hydrochloride, Paullinia cupana, Plantago afra, Plectranthus barbatus, Riboflavin, Thiamine nitrate Sponsor: Cat Media Pty Ltd

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

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4. ARTG ID: 227714 Product name: FatBlaster Max Active ingredients: chromic chloride hexahydrate, Camellia sinensis, Chromium picolinate, Citrus aurantium, Coffea canephora, Cyanocobalamin, Eleutherococcus senticosus, Fucus vesiculosus, Garcinia quaesita, Ilex paraguariensis, Nicotinamide, pyridoxine hydrochloride, Paullinia cupana, Plantago afra, Plectranthus barbatus, Riboflavin, Thiamine nitrate Sponsor: Cat Media Pty Ltd

5. ARTG ID: 229539 Product name: FatBlaster Garcinia Max Active ingredients: Hydroxycitrate complex Sponsor: Cat Media Pty Ltd

ARTG ID: 278976 Product name: Naturopathica FatBlaster Triple-Tea Fat Burner Active ingredients: Camellia sinensis, Paullinia cupana Sponsor: Cat Media Pty Ltd

6. ARTG ID: 295575 Product name: FatBlaster Clinical Active ingredients: Curcuma longa, Moringa oleifera, Murraya koenigii Sponsor: Cat Media Pty Ltd

I allege that the ingredient combinations in these products lack evidence to substantiate the indications and claims made, and their continued promotion, including the product names and pack illustrations, represent repeated breaches of the Therapeutic Goods Advertising Code 2017, sections 4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(7), 6(3)(c) and 6(3)(d).

In addition, current specific indications on the ARTG Public Summary Documents are equally misleading and deceptive, for example:

• ARTG ID: 145959: “Reduces fat absorption from food that you eat/ helps pass out fat/helps in the elimination of dietary fat/ promotes/ increases/ improves fat excretion/ fat binding/ trapping”.

• ARTG ID: 167323: “Fatblaster is specifically formulated to assist you to achieve healthy weight levels with powerful herbs and a specific vitamin and mineral blend.”

• ARTG ID: 227714: “FatBlaster Max has been formulated with specifically researched ingredients such as Guarana, Green Tea and Bitter Orange which have been found to help support the thermogenic process, which in conjunction with a calorie-controlled diet and exercise, help you burn more fat*. The Green Coffee Bean extracts, Chromium, and B Vitamins contained in FatBlaster Max help to metabolise fats and carbs in the body to avoid them converting to unwanted fat.”

• ARTG ID: 278976: “This exclusive triple tea blend possesses naturally occurring compounds including Epigallocatechin-3-Gallate (EGCG), a powerful antioxidant found in nature, and is boosted with Guarana to support your metabolism and enhance your body's fat burning power.”

• ARTG ID: 295575: “Shown clinically/scientifically/ in trials to assist in achieving up to 7% body weight loss in 16 weeks in overweight humans, when reducing energy intake and engaging in daily light exercise. Shown clinically/scientifically/ in trials to reduce hips and waist by centimetres when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.

Substantiation notices for the indications listed for all these products are required.

Screen shots of misleading and deceptive advertising claims taken today (06/07/2018) follow. The arrows point out ongoing claims that CRP determination 2017/10/001 agreed breached the Therapeutic Goods Advertising Code (&/or similar claims on related products).

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

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https://fatblaster.com.au/fatblaster-fatmagnet-fat-absorber-60-pack

https://fatblaster.com.au/fatblaster-60s

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

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https://www.fatblaster.com.au/fatblaster-max-60s

https://www.fatblaster.com.au/fatblaster-garcinia-max

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

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https://fatblaster.com.au/fatblaster-triple-tea-fat-burner

See also claims at:

• https://chemistwarehouse.com.au/buy/59586/Naturopathica-FatMagnet-100-Tablets • https://pharmacy4less.com.au/fat-blaster-fat-magnet-value-pack-100-tabs.html • https://yourdiscountchemist.com.au/fatblaster-fatmagnet-60-tablets.html • https://priceline.com.au/fat-blaster-fatblaster-fatmagnet-fat-absorber-100-tablets • https://chemistwarehouse.com.au/buy/39961/Naturopathica-FatBlaster-MAX-60-Tablets • https://priceline.com.au/fat-blaster-max-weight-loss-support-60-tablets • https://chemistwarehouse.com.au/buy/71930/Naturopathica-Fatblaster-Garcinia-MAX-60-

Capsules • https://yourchemistshop.com.au/naturopathica-fatblaster-garcinia-max-60-capsules.html/ • https://goodpricepharmacy.com.au/naturopathica-fatblaster-garcinia-max-60-capsules • https://pharmacyonline.com.au/fatblaster-garcinia-max-2500mg-cap-x-60 • Etc.

Finally, some relevant references:

• https://mja.com.au/journal/2008/188/1/commercialism-choice-and-consumer-protection-regulation-complementary-medicines

• https://theconversation.com/new-weight-loss-claims-show-tga-reforms-arent-working-5526

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Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products

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• https://theconversation.com/do-over-the-counter-weight-loss-supplements-work-53167 • https://theconversation.com/five-supplements-that-claim-to-speed-up-weight-loss-and-

what-the-science-says-89856 • https://theconversation.com/want-to-set-up-a-weight-loss-scam-heres-how-3353 • https://theconversation.com/science-or-snake-oil-is-garcinia-cambogia-the-magic-weight-

loss-pill-its-hyped-up-to-be-59822 • https://theconversation.com/science-or-snake-oil-do-skinny-teas-boost-weight-loss-87353 • https://theconversation.com/science-or-snake-oil-do-the-enduring-hydroxycut-weight-loss-

products-work-62492 • https://choice.com.au/health-and-body/diet-and-fitness/weight-loss/articles/weight-loss-

pills

In conclusion, I note that the recently enacted Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 that states that,

“The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act….”.

Regardless, I insist on an immediate response to me as to the priority allocated to this complaint, the measures taken by the TGA to achieve compliance and the final outcome.

Sincerely, Ken --- Dr Ken Harvey MBBS, FRCPA, AM Associate Professor Department of Epidemiology and Preventive Medicine School of Public Health and Preventive Medicine

Monash University Alfred Campus 553 St Kilda Rd Melbourne VIC 3004 Mobile: +61 419181910 Email: [email protected] WWW: www.medreach.com.au 6 July 2018

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COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2017-10-001 Naturopathica FatBlaster FatMagnet

ARTG ID: AUST L 145959

Meeting held 14 December 2017

Complaint summary^

Complainant Dr Ken Harvey

Advertisers Pharmacare Laboratories Pty Ltd

Discount Natural Health Products

Woolworths Group

Subject matter of complaint Internet advertisements

Type of determination Final

Sections of the Code,

Regulations or Act found to

have been breached*

Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(7), 6(3)(c), 6(3)(d)

Sections of the Code,

Regulations or Act found not

to have been breached*

Code section 4(2)(f)

Sanctions

Withdrawal of representations

Withdrawal of advertisements

* only sections of the Code, Act, or Regulations that were part of the complaint or were raised by the

Panel are listed.

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The advertisement(s)^

1. The complaint concerned internet advertisements published at the websites www.fatblaster.com.au,

www.discountnaturalhealth.com and www.woolworths.com.au, viewed by the complainant in October

2017.

2. The advertisement at www.fatblaster.com.au included:

a) representations such as “Australia’s #1 Weight Loss Supplement Brand”, “to help: increase fat

loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then

passes right out of your body. As a result, it can aid healthy weight maintenance*/fat loss through

reduction in fat absorption”, “now you can help prevent your body from absorbing some of the fat

you eat naturally with FatMagnet! 60s”;

b) text in the form of a footnote stated, “*In conjunction with healthy diet and exercise. FatMagnet

can assist anyone who is concerned about gaining weight or who is actively trying to lose

weight/reduce excess body fat.”; and

c) in the form of a testimonial, the words “eating is a lot better now that I’ve been using the Fat

Magnet! I am full of energy and life. My I Will challenge for myself is working. I am staying

strong and I know I can do this. Watch this space.”

3. The advertisement at www.discountnaturalhealth.com included:

a) under the heading, “What it does”, the text:

“Naturopathica FatBlaster FatMagnet Fat Absorber is the Fat Eliminator that aids weight loss and

increases fat loss. FatBlaster FatMagnet is a naturally derived product specially formulated to help

with weight and fat loss.

“FatBlaster FatMagnet contains Chitosan (pronounced kite-o-san), a naturally occurring soluble

fibre that is chemically similar to the plant fibre cellulose. Unlike plant fibre however, Chitosan

has been seen in vitro to have a “magnetic” binding affinity for lipids or fats in the digestive tract.

The positively charged Chitosan binds with the negatively charged fat and bile acids before they

have a chance to be metabolised, thus preventing them from being absorbed into the bloodstream.

This fat is then passed out of the body, without contributing to your daily calorie intake.

“Now you can help prevent your body from absorbing some of the fat you eat naturally with

FatMagnet! In the body, FatMagnet can bind to some of the fat you eat, and then passes right out

of your body. As a result, it can aid weight loss and fat loss through reduction in fat absorption.”

b) under the heading, “What is in it?”, the text:

“Chitosan - Chitosan is an aminopolysaccharide derived from ‘chitin’ found in plankton and

the exoskeleton (shells) of crustaceans such as shrimp, lobster and crab. Chitosan has been

shown in vitro to “magnetically” attract lipids and act like a sponge, to prevent fat in the

digestive tract from being absorbed. Chitosan dissolves in the stomach and becomes a gel

which traps fat in the digestive tract, thereby preventing its absorption and subsequent storage.

After trapping the fat it then encourages its elimination from the body”.

“Plantago afra powder (Psyllium Husk) - Psyllium husk or Isphagula is the covering of seeds

grown on the plant, Plantago afra or Psyllium, which flourishes in the Middle East. Psyllium

seed husk has long been recognized as an excellent supplement for added dietary fibre. The

physical FatBlaster FatMagnet characteristics of Psyllium seed husk makes it useful for any

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condition that requires improvement of the gastrointestinal transit time, since the inert bulk of

the husks helps provide a constant volume of solid material irrespective of other aspects of the

diet or any condition of the gut”.

“Vitamin C (Ascorbic Acid) -The health benefits of Vitamin C are widely publicised however

it has been specifically included in this formula for a different reason. Several published

reports have shown that chitosan works synergistically with Vitamin C as it enhances the

effectiveness of Chitosan”.

4. The advertisement at www.woolworths.com.au included claims such as “scientifically studied”, “in

vitro studies have shown that this special natural fibre is capable of trapping fat, so that it is unable to

be absorbed and stored by the body”, “fat magnet aids excretion of fat through the body”, “for

maximum results, FatBlaster FatMagnet can be used in conjunction with FatBlaster or FatBlaster

Max”, and “Directions: Adults: For weight loss, take 2 tablets, 30 minutes before each meal. For

maximum fat loss, up to 4 tablets, 30 minutes before meals.” It showed a stylised image of a burger

next to a horseshoe magnet, depicting fat being drawn from the burger. It also included a simple bar

graph showing “increased fat loss” from “fat magnet fibre” as compared with a “test baseline”. It also

included an illustration showing fat becoming coated with FatMagnet and passing through the

digestive tract.

5. The complainant also referred to a video advertisement at the website www.youtube.com. However,

the Panel did not consider this aspect of the complaint as it was not possible to determine the identity

of the person responsible for the advertisement. The Panel noted that Pharmacare had requested the

removal of the video from You Tube.

6. An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.

The product(s)

7. The advertisement promoted the product Naturopathica FatBlaster FatMagnet (AUST L 145959).

The advertiser(s)

8. The advertisers were Pharmacare Laboratories Pty Ltd, Discount Natural Health Products and

Woolworths Group.

The complaint^

9. The complainant was Dr Ken Harvey.

10. The complainant referred to the advertisements collectively in setting out the alleged breaches.

11. The complainant highlighted the following claims and stated that they breached sections 4(1)(b),

4(2)(a) and 4(2)(c) of the Code:

a) Australia’s number 1 weight loss supplement brand

b) Scientifically studied

c) Fat Magnet Fat Absorber - To help Increase fat loss - Aid weight loss

d) Absorb less fat, lose more weight

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e) FatMagnet can assist anyone who is concerned about gaining weight or who is actively trying to

lose weight/reduce excess body fat

f) Several published reports have shown that chitosan works synergistically with Vitamin C as it

enhances the effectiveness of Chitosan

12. The complainant highlighted the following claims and stated that they breached section 4(2)(f) of the

Code:

a) Once taken, FatMagnet can bind to some of the fat you eat, and then passes right out of your body.

As a result, it can aid healthy weight maintenance*/fat loss through reduction in fat absorption

b) Chitosan has been shown in vitro to “magnetically” attract lipids and act like a sponge, to prevent

fat in the digestive tract from being absorbed

c) Take 2 tablets 30 minutes before each meal. For maximum fat loss, up to 4 tablets, 30 minutes

before meals

d) Watch how Fat Magnet attracts the oil in a glass of water, binds to it and the takes it away

13. The complainant alleged that the claims referring to “scientific studies” and the illustration of fat

being attracted “magnetically” caused the advertisement to breach section 4(4) of the Code.

14. The complainant also alleged that the testimonial stating “eating is a lot better now that I’ve been

using the Fat Magnet! I am full of energy and life” would breach section 4(7) of the Code “unless the

sponsor can provide a statutory declaration of authenticity”.

15. The complainant provided a detailed summary of a number of PubMed searches he had carried out in

relation to the claims cited in the complaint, and provided full copies of some evidence material.

Additional matters raised by the Panel

16. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified

in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates

contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or

the Code in other ways. The Panel was so satisfied and raised as additional matters for all of the

advertisements, possible breaches of sections 6(3)(c) and 6(3)(d) of the Code because the

advertisements may lack certain mandatory information including the statements “always read the

label” and “use only as directed”.

The advertisers’ response to the complaint^

17. Discount Natural Health Products and Woolworth Group stated that their respective advertisements

were the responsibility of the product sponsor, Pharmacare Laboratories Pty Ltd, and that they had

withdrawn the advertisements from publication. Both essentially stated that it was impossible for

them to confirm that all of the claims published on their respective websites were compliant with the

Code, Regulations, and Act. Woolworths also relied upon trading terms, pursuant to which

Pharmacare provided a warranty as to compliance with relevant legislation.

18. Pharmacare responded in detail to the substance of the complaint.

19. In relation to the claim “Australia’s number 1 weight loss supplement brand”, Pharmacare referred to

sales data from IRI Worldwide, dating to mid-2016, showing share of sales by dollars for the “Total

Diet Nutrition” segment in grocery and pharmacy.

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20. In relation to the claim “scientifically studied”, Pharmacare argued that it held “sufficient evidence for

the active ingredients used in the FatBlaster FatMagnet formula that they have been scientifically

studied for the therapeutic claims on the ARTG of the goods”. It stated that there was “a large body of

scientific evidence, published in peer reviewed journals and TGA recognised texts and monographs,

that support the claims”, and referred to an “Evidence Table” on this point. Pharmacare also noted

that the “alleged packshot used on the Woolworths website is an outdated packaging design which is

no longer supplied to the market” and that it had “requested Woolworths to update the render and the

marketing collateral.”

21. In relation to the claims “Fat Magnet Fat Absorber - To help Increase fat loss - Aid weight loss”,

Pharmacare argued that “all the evidence used by the complainant is irrelevant and not applicable to

the FatBlaster FatMagnet product. This is because the complainant ignored an important instruction

on the product’s ARTG, and on its label and website being the disclaimer – ‘in conjunction with a

healthy calorie controlled diet and physical exercise’. The complainant only considered the benefits

and effects of the active ingredients without the combined effect from taking the goods with diet and

exercise (as reflected by the research he provided).” Pharmacare discussed the evidence it supplied in

relation to this argument.

22. In relation to the claims “absorb less fat, lose more weight”, Pharmacare argued that this claim

appeared in the youtube.com advertisement, which was uploaded by a third party. Pharmacare argued

that it “should not be held solely responsible for an advertisement published by a 3rd party” but that

“in order to resolve the matter of this Complaint, [it had] taken the initiative to contact the You Tube

office and request the video clip to be removed from the YouTube platform.”

23. In relation to the claim “FatMagnet can assist anyone who is concerned about gaining weight or who

is actively trying to lose weight/reduce excess body fat”, Pharmacare stated that, while it did not agree

that this claim breached the Code, it had amended this part of its advertisement to state: “FatMagnet

can assist adults who are actively wanting to lose weight/reduce excess body fat/maintain healthy

weight*. *In conjunction with healthy calorie-controlled diet and exercise.”

24. In relation to the claim that “several published reports have shown that chitosan works synergistically

with Vitamin C as it enhances the effectiveness Chitosan”, Pharmacare argued that it held sufficient

evidence to support the claim and provided copies of evidence material said to do so.

Findings of the Panel

the advertisements

25. Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and

the principles of the Code, and the total presentation and context of the advertisement. Section 3(2) of

the Code states that the conformity of an advertisement with this Code should be assessed in terms of

its probable impact upon the reasonable person to whom the advertisement is directed. In assessing

the advertisements, the Panel was mindful not only of the particular words cited by the complainant,

but of the entire context of each advertisement and its likely impact on a reasonable consumer.

26. The Panel was satisfied that the fatblaster.com.au advertisement would convey to an ordinary and

reasonable consumer that, inter alia, FatMagnet tablets:

a) when consumed, bind to some of the fat in food, and together with that fat pass out of the body;

b) aid in healthy weight maintenance;

c) reduce the absorption of fat from food or prevent the body from absorbing some of the fat in food;

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d) cause weight loss; and,

e) cause a reduction in body fat.

27. The Panel noted the “disclaimer” stating “*in conjunction with healthy diet and exercise”. The

asterisk on the disclaimer linked it to the claim “can aid healthy weight maintenance”. The Panel also

noted that it referred to a healthy diet and exercise but did not refer to any change in diet or exercise

levels, to kilojoule/calorie intake control, or to a hypocaloric or weight-loss diet.

28. The Panel was satisfied that an ordinary and reasonable consumer viewing the advertisement would

conclude that the claims about binding fat, preventing fat absorption, causing weight loss, and causing

a reduction in body fat were claims about the effects of the FatMagnet tablets and were not contingent

on any particular diet or exercise regimen such as a healthy diet and exercise, a calorie-controlled diet,

or a hypocaloric diet.

29. This advertisement also contained the claim “Australia’s #1 Weight Loss Supplement Brand”.

30. The Panel was satisfied that the discountnaturalhealth.com advertisement would convey to an

ordinary and reasonable consumer that, inter alia, FatMagnet tablets:

a) act as a “fat eliminator”;

b) aid weight loss;

c) increase fat loss;

d) has a “magnetic” affinity for lipids or fats and prevent fat absorption into the bloodstream;

e) cause fat from food to be passed out of the body without contributing to daily calorie intake;

f) help prevent the body from absorbing fat you eat;

g) assist with weight loss and weight management; and,

h) reduce excess body fat.

31. The Panel noted that in limited instances claims were linked to references to “an energy-controlled

diet and exercise program”, but did not in any case refer to changes in diet or exercise or to a

hypocaloric diet. The Panel was satisfied that, viewed as a whole, the claims about product benefits in

the discountnaturalhealth.com advertisement were not confined to cases where consumers were also

utilising “an energy-controlled diet and exercise program”. The Panel was satisfied that an ordinary

and reasonable consumer viewing the advertisement would conclude that the FatMagnet tablets would

aid weight loss, increase fat loss, prevent fat absorption, and so on, independently of any diet or

exercise.

32. The Panel also noted that this advertisement conveyed that the advertised product and its ingredients

would work in a particular way (for example, “the positively charged Chitosan binds with the

negatively charged fat and bile acids before they have a chance to be metabolised”).

33. This advertisement also contained the claims that chitosan “works synergistically with vitamin C” and

“vitamin C… has been shown to increase the effectiveness of Chitosan”.

34. The Panel was satisfied that the woolworths.com.au advertisement would convey to an ordinary and

reasonable consumer that, inter alia, FatMagnet tablets:

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a) aid fat loss and weight loss

b) cause more fat pass to through the digestive system;

c) trap fat so that it is unable to be absorbed and stored by the body;

d) cause “increased fat loss” through “fecal fat excretion”;

e) surround or encase particles of fat in the digestive tract and thereby cause them to be excreted

(because of the imagery used in the advertisement);

f) aid weight loss through the reduction of fat absorption;

g) reduce excess body fat;

h) have benefits in relation to weight management;

i) cause weight loss; and,

j) cause more fat loss if more tablets were taken.

35. The Panel also was satisfied that the advertisement conveyed that all of these claims were made on the

basis of a robust and clear body of scientific evidence, not only because of the words “scientifically

studied” but also because of the use of a bar graph which had the appearance of depicting scientific

research results, and the very definite descriptions of the mode of action of the tablets.

36. The Panel noted that this advertisement included the words “in conjunction with a calorie controlled

diet” and “always use in conjunction with a healthy, energy-controlled diet and exercise program”.

The Panel was satisfied that, while these words conveyed that the product should be used with a

healthy, energy-controlled diet and exercise program, they did not convey that the product would only

work in the ways described if used in conjunction with a particular diet.

37. In relation to all three of these advertisements, the Panel was satisfied that the claims of product

efficacy were, either expressly or by implication, that the advertised product would have the claimed

benefits to a significant and meaningful degree. For example, the claim that the advertised product

would prevent some fat from being absorbed was, by clear implication, a claim that the amount of fat

so prevented would be significant and contributed to a non-trivial amount of actual fat reduction and

weight loss.

38. The Panel did not consider those aspects of the complaint that were confined to the youtube.com

advertisement as it did not appear that it was the responsibility of Pharmacare. The Panel noted that,

in any case, its findings in relation to the other three advertisements were likely to be generally

applicable to the youtube.com advertisement.

responsibility for the advertisements

39. Under regulation 42ZCAA of the Regulations, the person apparently responsible for an advertisement

is the person who, based on the particulars of a complaint and the assessment of the Panel, appears to

be responsible for requesting the publication of the advertisement.

40. The Panel was satisfied, on the basis of the material before it, that:

a) Pharmacare Laboratories was responsible for the fatblaster.com.au advertisement and jointly

responsible for the woolworths.com.au and discountnaturalhealth.com advertisements;

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b) Discount Natural Health Products was responsible for the discountnaturalhealth.com

advertisement; and,

c) Woolworths was responsible for the woolworths.com.au advertisement.

41. The Panel noted that only Pharmacare had provided a substantive response to the complaint and

considered this response in relation to all three advertisements.

the evidence material

42. Evidence material was provided to the Panel by the complainant and by Pharmacare.

43. The Panel reviewed the full body of evidence material before it and was satisfied as follows:

a) there was evidence that in the year to mid-June 2016, the Naturopathica brand was the best-selling

brand by sales value in the “Diet Nutrition” segment in the grocery and pharmacy channels. No

information was provided as to the scope of the “Diet Nutrition” segment or the products included

within it, no explanation was provided as to how it could be related to a claim about a “Weight

Loss Supplement” category, and the information was not particularly recent. The submitted

material clearly, in the Panel’s view, was not evidence that the Naturopathica brand, the FatBlaster

brand, or the FatMagnet brands was “Australia’s #1 weight loss supplement brand”;

b) while there was evidence that ingredients in the advertised product had indeed been “scientifically

studied”, there was clearly insufficient evidence to support a view that the relevant scientific

studies formed a robust and clear body of evidence in support of the claimed product or ingredient

benefits;

c) there was no sufficiently persuasive evidence that, to any significant or non-negligible extent, the

chitosan ingredient would bind to fat or oil, attract lipids, act like a sponge in relation to lipids, or

prevent any fat from food from being absorbed in real-world use by humans;

d) there was no sufficiently persuasive evidence that taking four tablets of the advertised product

would cause “maximum fat loss”;

e) while some items of evidence material provided very modest support for claims of weight loss or

fat loss, on the balance of probabilities and in view of the whole body of evidence, the advertised

product was unlikely to have any effect on weight loss or fat loss whatsoever, and if it did have

any effect the effect would be so modest as to be negligible in any real-world case of use by

consumers;

f) there was no sufficiently persuasive evidence that the advertised product would be of any

assistance to consumers in relation to weight gain, weight loss, or fat reduction;

g) the evidence in relation to vitamin C enhancing the effectiveness of chitosan was limited and was

insufficient to be relied upon to support advertising claims directed at consumers, and, in any case,

appeared to involve a dose of vitamin C that did not correspond to the dose used in the advertised

product;

h) there was no sufficiently persuasive evidence to support the bar chart or diagram of the digestive

tract shown in the woolworths.com.au advertisement.

44. In short, the Panel was satisfied on review of all of the evidence material that, on the balance of

probabilities, the product would either not work in the way described at all, or would work to such a

negligible degree that consumers would in any case be misled by claims of effectiveness.

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45. In forming its views the Panel noted that isolated and unreplicated studies cannot generally be

regarded as persuasive evidence; unless there is a wide and robust body of evidence with results

replicated independently across different studies, the evidence cannot be regarded as adequate to

support claims directed at consumers. No such evidence was provided in this case.

alleged breaches of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code

46. Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and

balanced statements only and claims which the sponsor has already verified.” Section 4(2)(a) of the

Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of

product effectiveness”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or

by implication or through emphasis, comparisons, contrasts or omissions”.

47. The complainant alleged that the following claims breached these provisions:

a) Australia’s number 1 weight loss supplement brand

b) Scientifically studied.

c) Fat Magnet Fat Absorber - To help Increase fat loss - Aid weight loss

d) Absorb less fat, lose more weight.

e) FatMagnet can assist anyone who is concerned about gaining weight or who is actively trying to

lose weight/reduce excess body fat; and,

f) Several published reports have shown that chitosan works synergistically with Vitamin C as it

enhances the effectiveness Chitosan.

48. For the reasons noted above, the Panel was satisfied that each of these claims was unverified and

inaccurate, was likely to arouse unwarranted expectations, and was misleading in breach of sections

4(1)(b), 4(2)(a) and 4(2)(c) of the Code.

49. The Panel found, therefore, that these aspects of the complaint were justified.

claims alleged to breach section 4(2)(f) of the Code

50. Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use”

of therapeutic goods.

51. The complainant highlighted the following claims and stated that they breached this provision:

a) Once taken, FatMagnet can bind to some of the fat you eat, and then passes right out of your body.

As a result, it can aid healthy weight maintenance*/fat loss through reduction in fat absorption.

b) Chitosan has been shown in vitro to “magnetically” attract lipids and act like a sponge, to prevent

fat in the digestive tract from being absorbed.

c) Take 2 tablets 30 minutes before each meal. For maximum fat loss, up to 4 tablets, 30 minutes

before meals.

d) Watch how Fat Magnet attracts the oil in a glass of water, binds to it and the takes it away.

52. The Panel was satisfied that these claims were misleading and unverified. However, while in a sense

any use of the product would therefore be “inappropriate”, the Panel considered that misleadingness

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Page 10 of 13

ought properly to have been raised by the complainant by way of alleging a breach of section 4(2)(c)

of the Code, and that, misleadingness aside, the claims did not encourage inappropriate or excessive

use.

53. The Panel found, therefore, that this aspect of the complaint was not justified.

scientific information

54. Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate,

balanced and not misleading”, and requires that publication of scientific research results should

“identify the researcher and financial sponsor of the research.”

55. The complainant alleged that the claims in the woolworths.com.au advertisement referring to

“scientific studies” and the illustration of fat being attracted “magnetically” caused the advertisement

to breach this provision.

56. The woolworths.com.au advertisement did not include information identifying the researcher and

financial sponsor of the research.

57. The Panel found, therefore, that this aspect of the complaint was justified.

testimonial

58. Section 4(7) of the Code requires that testimonials included in advertisements for therapeutic goods

“must be documented, genuine, not misleading and illustrate typical cases only.”

59. There was no clear evidence, such as a statutory declaration, as to the genuineness of the testimonial

in the fatblaster.com.au advertisement.

60. The Panel found, therefore, that this aspect of the complaint was justified.

minimum requirements

61. The advertisements ought to have included the words “always read the label” (section 6(3)(c) of the

Code), and the words “use only as directed” (section 6(3)(d) of the Code). The advertisements did not

include these mandatory statements.

62. The Panel found, therefore, that these aspects of the complaint were justified.

Sanctions

63. The Panel requests Pharmacare Laboratories Pty Ltd, Discount Natural Health Products and

Woolworths Group, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods

Regulations 1990:

a) to withdraw their respective advertisements from further publication;

b) to withdraw (as applicable) from their respective advertisements any representations that have

been found above to breach the Code, including:

i) the Naturopathica, FatBlaster, or FatMagnet brand is the number one weight loss supplement

in Australia;

ii) the advertised product can aid fat loss or weight loss;

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iii) the advertised product can cause the body to absorb less fat from food;

iv) the advertised product can offer benefits in relation to weight gain, weight loss, or the

reduction of body fat;

v) vitamin C enhances the effects of the chitosan ingredient;

vi) any of the above claims are supported by a persuasive body of scientific evidence, including

through words such as “scientifically studied” or “several published reports have shown”;

vii) are conveyed by the testimonial; and,

viii) are conveyed by the illustrations in the woolworths.com.au advertisement;

c) to give a written undertaking not to use the representations in (b) above in any other

advertisement*;

d) where the representation has been provided to other parties such as retailers or website publishers,

and where there is a reasonable likelihood that the representation has been published or is intended

to be published by such parties, to advise those parties that the representation(s) should be

withdrawn; and,

e) within 14 days of being notified of this request, to provide evidence to the Panel of its compliance,

including a response in writing that they will comply with the Panel’s sanctions, and where

appropriate, supporting material such as copies of instructions to advertising agents or publishers,

or correspondence with retailers and other third party advertisers.

64. The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which

permit the Panel to make recommendations to the Secretary in the event of non-compliance with this

request.

Dated 23 April 2018

For the Panel

Allan Asher

Chairman

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Appendix A: Definitions and footnotes

In this determination, unless otherwise specified:

a) “the Act” means the Therapeutic Goods Act 1989;

b) “the Regulations” means the Therapeutic Goods Regulations 1990;

c) “the Code” means the Therapeutic Goods Advertising Code;

d) “the Register” means the Australian Register of Therapeutic Goods;

e) “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to

advertisements in specified or broadcast media (in relation to which complaints may be made to

the Panel under Regulation 42ZCAB). It should be noted that HTML metatags and other

information which can be retrieved by internet search engines, whether or not it is ordinarily

viewed directly by consumers, constitutes advertisement material.

^Readers of the determination should note that the sections “complaint summary”, “the advertisement(s)”, “the complaint”,

and “[a party]’s response to the complaint”, are summaries that are intended to aid readers of this document. In reaching its

decision, the Panel considered all of the material before it, including material that may not be mentioned specifically in the

summaries. The summaries do not form part of the Panel’s reasoning.

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other

advertisement unless the advertiser satisfies the Panel that the use of the representation would not result in a contravention of

the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code. Under

the Panel’s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new

material that was not available at the time of the Panel’s determination has become available, or until at least 12 months have

passed since the Panel’s request was made.

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Page 13 of 13

Appendix B: Excerpt of the Advertisements

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Public Summary Summary for ARTG Entry: 145959 Naturopathica FatBlaster FatMagnet

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 12/10/2007

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Naturopathica FatBlaster FatMagnet

Product Type Single Medicine Product Effective date 16/09/2015

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Aids/helps/promotes/ increases weight loss in conjunction with a diet and exercise program/ For weight managementMay facilitate the depletion/ Aids in the reduction of excess body fat / Assists/ aids body fat loss/ maintain lean (fat free) body massReduces fat absorption from food that you eat/ helps pass out fat/helps in the elimination of dietary fat/ promotes/ increases/ improves fat excretion/ fat binding/ trappingFor general well beingIncreases daily fibre/ supports daily fibre requirement, supporting healthy digestive function

Warnings

Derived from seafood.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:25:51 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

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Components

1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral Visual Identification

Active Ingredients

Ascorbic acid 175 mg

poliglusam 525 mg

Psyllium Husk Powder 102.04 mg

Equivalent: Psyllium Husk Powder (Dry) 100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:25:51 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 22: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 167323 Naturopathica FatBlaster

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 5/12/2009

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Naturopathica FatBlaster

Product Type Single Medicine Product Effective date 17/08/2016

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Diet and weight lossFatblaster is specifically formulated to assist you to achieve healthy weight levels with powerful herbs and a specific vitamin and mineral blend.Can help:-support carbohydrate and fat metabolism-support healthy blood sugar metabolism in healthy individuals-support healthy thyroid function-achieve healthy weight-support digestive function-boost energy and performance-promote stamina-keep you feeling fullFatblaster can also help enhance physical performance, stamina and energy levels, to support you burn more calories through exercise.

Warnings

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Additional Product information

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:24:54 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 23: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Pack Size/Poison information

Pack Size Poison Schedule

Components

1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral Visual Identification

Active Ingredients

Camellia sinensis 10 mg

Equivalent: Camellia sinensis (Dry) 100 mg

Chromium picolinate 50 microgram

Citrus aurantium 75 mg

Equivalent: Citrus aurantium (Dry) 750 mg

Cyanocobalamin .4 microgram

Panax ginseng 25 mg

Equivalent: Panax ginseng (Dry) 250 mg

Paullinia cupana 125 mg

Equivalent: Paullinia cupana (Dry) 500 mg

potassium iodide 32.7 microgram

Psyllium Husk Powder 250 mg

pyridoxine hydrochloride 5 mg

Riboflavin 210 microgram

Thiamine nitrate 219.78 microgram

Zingiber officinale 7.5 mg

Equivalent: Zingiber officinale (Dry) 150 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:24:54 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 24: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 212760 FatBlaster Max

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 30/07/2013

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. FatBlaster Max

Product Type Single Medicine Product Effective date 27/01/2016

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

FatBlaster MaxWeight Loss Support in conjunction with diet and exercise by helping to:·Burn more fat*·Burn more calories*·Boost Metabolism*·Boost Energy & performanceWeight Loss Support*If you are reading this, it may be because you are having trouble managing your weight, and you are not getting the results you want. That's where FatBlaster Max can help.FatBlaster Max's new and improved formula can help give your diet and exercise efforts extra support to help you achieve the body you want. It helps through 4 key actions:Action 1: Burn More Calories*Thermogenesis is a component of the metabolic rate, which helps your body burn calories*. FatBlaster Max has been formulated with specifically researched ingredients to help the thermogenic process, to help you burn even more calories when used with diet and exercise.Action 2: Burn More Fat*FatBlaster Max has been formulated with specifically researched ingredients such as Guarana, Green Tea and Bitter Orange which have been found to help support the thermogenic process, which in conjunction with a calorie-controlled diet and exercise, help you burn more fat*.Action 3: Boost Metabolism of Fats and Carbs*The Green Coffee Bean extracts, Chromium, and B Vitamins contained in FatBlaster Max help to metabolise fats and carbs in the body to avoid them

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:22:20 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 25: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

converting to unwanted fat. FatBlaster Max also helps support healthy glucose metabolism and healthy thyroid function.Action 4: Boost Energy & Exercise PerformanceExercise is one of the key ways of boosting your metabolism and helping to burn those unwanted calories, so by boosting your exercise, you can increase your results faster. FatBlaster Max has been formulated with ingredients such as Guarana, Yerba Mate & Green Tea, which together support exercise performance and help improve endurance.

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral Visual Identification

Active Ingredients

Camellia sinensis 48 mg

chromic chloride hexahydrate 128 microgram

Chromium picolinate 67 microgram

Citrus aurantium 66.67 mg

Equivalent: Citrus aurantium (Dry) 666.7 mg

Coffea canephora 67 mg

Equivalent: Coffea canephora (Dry) 469 mg

Cyanocobalamin 5 microgram

Eleutherococcus senticosus 23.33 mg

Equivalent: Eleutherococcus senticosus (Dry) 350 mg

Fucus vesiculosus 50 mg

Equivalent: Fucus vesiculosus (Dry) 250 mg

Garcinia quaesita 75 mg

Equivalent: Garcinia quaesita (Dry) 450 mg

Ilex paraguariensis 20 mg

Equivalent: Ilex paraguariensis (Dry) 100 mg

Nicotinamide 16 mg

Paullinia cupana 350.65 mg

Equivalent: Paullinia cupana (Dry) 1.4026 g

Plantago afra 250 mg

Plectranthus barbatus 1.47 mg

pyridoxine hydrochloride 6.08 mg

Riboflavin 5 mg

Thiamine nitrate 5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:22:20 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 26: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 227714 FatBlaster Max

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 8/09/2014

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. FatBlaster Max

Product Type Single Medicine Product Effective date 24/08/2016

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

FatBlaster MaxWeight Loss Support in conjunction with diet and exercise by helping to:·Burn more fat*·Burn more calories*·Boost Metabolism*·Boost Energy & performanceWeight Loss Support*If you are reading this, it may be because you are having trouble managing your weight, and you are not getting the results you want. That's where FatBlaster Max can help.FatBlaster Max's new and improved formula can help give your diet and exercise efforts extra support to help you achieve the body you want. It helps through 4 key actions:Action 1: Burn More Calories*Thermogenesis is a component of the metabolic rate, which helps your body burn calories*. FatBlaster Max has been formulated with specifically researched ingredients to help the thermogenic process, to help you burn even more calories when used with diet and exercise.Action 2: Burn More Fat*FatBlaster Max has been formulated with specifically researched ingredients such as Guarana, Green Tea and Bitter Orange which have been found to help support the thermogenic process, which in conjunction with a calorie-controlled diet and exercise, help you burn more fat*.Action 3: Boost Metabolism of Fats and Carbs*The Green Coffee Bean extracts, Chromium, and B Vitamins contained in FatBlaster Max help to metabolise fats and carbs in the body to avoid them

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:20:44 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 27: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

converting to unwanted fat. FatBlaster Max also helps support healthy glucose metabolism and healthy thyroid function.Action 4: Boost Energy & Exercise PerformanceExercise is one of the key ways of boosting your metabolism and helping to burn those unwanted calories, so by boosting your exercise, you can increase your results faster. FatBlaster Max has been formulated with ingredients such as Guarana, Yerba Mate & Green Tea, which together support exercise performance and help improve endurance.

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral Visual Identification

Active Ingredients

Camellia sinensis 48 mg

chromic chloride hexahydrate 128 microgram

Chromium picolinate 67 microgram

Citrus aurantium 66.67 mg

Equivalent: Citrus aurantium (Dry) 666.7 mg

Coffea canephora 67 mg

Equivalent: Coffea canephora (Dry) 469 mg

Cyanocobalamin 5 microgram

Eleutherococcus senticosus 23.33 mg

Equivalent: Eleutherococcus senticosus (Dry) 350 mg

Fucus vesiculosus 50 mg

Equivalent: Fucus vesiculosus (Dry) 250 mg

Garcinia quaesita 75 mg

Equivalent: Garcinia quaesita (Dry) 450 mg

Ilex paraguariensis 20 mg

Equivalent: Ilex paraguariensis (Dry) 100 mg

Nicotinamide 16 mg

Paullinia cupana 350.65 mg

Equivalent: Paullinia cupana (Dry) 1.4026 g

Plantago afra 250 mg

Plectranthus barbatus 1.47 mg

Equivalent: Plectranthus barbatus (Dry) 100 mg

pyridoxine hydrochloride 6.08 mg

Riboflavin 5 mg

Thiamine nitrate 5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:20:44 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 28: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 229539 FatBlaster Garcinia Max

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 20/10/2014

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. FatBlaster Garcinia Max

Product Type Single Medicine Product Effective date 25/11/2014

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Helps to:Minimise fat storage.Support fat oxidation.A healthy calorie controlled diet combined with exercise may help you burn more calories and support healthy weight maintenance.The Hydroxycitric acid (HCA) in Garcinia Cambogia, has been known to inhibit this conversion of sugar and carbs in the bloodstream into fat, helping to minimise the fat being stored in the body. PLUS, HCA has also been known to help support fat oxidation and glucose metabolism, which is thought to help burn more fat as energy.

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:19:07 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 29: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

1. Formulation 1

Dosage Form Capsule, hard

Route of Administration Oral Visual Identification

Active Ingredients

Hydroxycitrate complex 250 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:19:07 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 30: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 278976 Naturopathica FatBlaster Triple-Tea Fat Burner

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 10/08/2016

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Naturopathica FatBlaster Triple-Tea Fat Burner

Product Type Single Medicine Product Effective date 22/12/2017

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

To Help·Burn more fat·Increase thermogenesis·Boost exercise performance·Boost Energy·Achieve Healthy Weight*1.One way to help achieve a healthy weight is to actively increase your calorie and fat burning rate* by boosting the action of thermogenesis in your body.2.Loaded with nutrients and rich in antioxidants, triple tea blend contains powerful antioxidant compounds shown to increase thermogenesis. Each of our three teas are specially selected to provide a blend of key nutritional compounds such as epigallocatechin gallate to help assist you in your weight loss program.*The How3.This exclusive triple tea blend possesses naturally occurring compounds including Epigallocatechin-3-Gallate (EGCG), a powerful antioxidant found in nature, and is boosted with Guarana to support your metabolism and enhance your body's fat burning power. Boosting your metabolism and thermogenesis may help your body burn more fat and calories*.4.When used in conjunction with a healthy calorie-controlled diet and exercise helps to boost fat & calorie burning and support weight management viathermogenesis.5.For best results: when used in conjunction with diet and exercise, help you reach your weight loss goals.6.This product combines a special triple strength blend of nature's most popular teas including Matcha Green Tea, Oolong Tea and Black Tea, and for

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:17:55 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 31: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

an extra kick, is boosted with energy boosting Guarana. Together with diet and exercise, can help boost your body's thermogenic fat and calorie* burningand energy expending power, and help to give you an energy lift. Plus, it provides anti-oxidant support.7.Matcha Green Tea is a stone-ground, green tea that's been used in Japanese tea ceremonies for hundreds of years. The secret behind matcha's benefits is its antioxidant rich loading of catechins.8.Oolong Tea also known as "Black Dragon Tea" naturally contains caffeine, which combined with EGCGs also found in black tea work together to support fat oxidation (fat burning).*9.Black Tea is brimming with health benefits, thanks to its high content of unique antioxidant compounds. In addition, the process that gives Black Teaits rich, deep colour also boosts its content of naturally occurring caffeine for added energy.* When used in conjunction with an energy-reduced diet and increased physical activity.

Warnings

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral Visual Identification

Active Ingredients

Camellia sinensis 25 mg

Camellia sinensis 150 mg

Equivalent: Camellia sinensis (Dry) 3.75 g

Camellia sinensis 50 mg

Equivalent: Camellia sinensis (Dry) 250 mg

Paullinia cupana 416 mg

Equivalent: Paullinia cupana (Dry) 2.08 g

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:17:55 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 32: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

Public Summary Summary for ARTG Entry: 295575 FatBlaster Clinical

ARTG entry for Medicine Listed 

Sponsor Cat Media Pty Ltd

Postal Address PO Box 384,MONA VALE, NSW, 1660 Australia

ARTG Start Date 27/10/2017

Product category Medicine 

Status Active

Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Officeof Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notifiedof the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. FatBlaster Clinical

Product Type Single Medicine Product Effective date 27/10/2017

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Helps decrease/reduce waistline/waist circumference.Helps decrease/reduce excess body fat.Aid/assist/helps body fat loss.Helps enhance/promote/increase body fat loss.Helps decrease/reduce body weight.Helps enhance/promote/increase weight loss.Helps maintain/support healthy Body Mass Index (BMI).Helps decrease/reduce hip circumference.May aid or assist weight loss by suppression of appetite in conjunction with (or as part of) a kilojoule/calorie controlled eating plan.May assist weight loss when reducing energy intake and engaging in daily light exercise for 30 minutes.May assist with appetite control for the purpose of weight loss when reducing energy intake and engaging in daily light exercise for 30 minutes.Shown clinically/scientifically/ in trials to assist in achieving up to 7% body weight loss in 16 weeks in overweight humans, when reducing energy intake and engaging in daily light exercise.Shown clinically/scientifically/ in trials to reduce hips and waist by centimetres when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.Scientifically shown to help reduce centimetres from hips and waist when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.May assist/ scientifically shown/ to help in losing up to 7% body weight (over 16 weeks) when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.

Public Summ

ary

Page 1 of 2 Produced at 06.07.2018 at 02:16:36 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Page 33: Complaint to TGA: Pharmacare Laboratories FatBlaster Fat ...€¦ · loss; aid weight loss”, “Once taken, FatMagnet can bind to some of the fat you eat, and then passes right

May assist/ scientifically shown/ to help in losing up to 12 pounds (5.4 kg) (over 16 weeks) in overweight individuals, when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.Scientifically/ clinically shown to help overweight subjects lose up to 6 times more weight compared to placebo when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.Scientifically/ clinically shown to help reduce waist/ hip measurement/ circumference by up to 1 cm in 14 days when used in conjunction with a program of reduced intake of dietary calories/ with a calorie/energy-reduced diet and increased exercise/ physical activity.Helps/ promotes lipolysis which helps the body breakdown and burn fat.(Helps promote lipolysis which) helps the body breakdown and burn fat.

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule

Components

1. Formulation 1

Dosage Form Capsule, hard

Route of Administration Oral Visual Identification

Active Ingredients

Curcuma longa 45 mg

Equivalent: Curcuma longa (Dry) 2.925 g

Moringa oleifera 270 mg

Equivalent: Moringa oleifera (Dry) 2.16 g

Murraya koenigii 135 mg

Equivalent: Murraya koenigii (Dry) 945 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summ

ary

Page 2 of 2 Produced at 06.07.2018 at 02:16:36 AESTThis is not an ARTG Certificate document.The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information