TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories-Additional information requested - Medreach Pty Ltd
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
The request (Simon Doctor, 9/08/2018)
“In your complaint regarding the Naturopathica FatBlaster products, you refer to the Panel’s
Determination of a complaint regarding the FatBlaster FatMagnet product, but it would assist if you
could identify which other FatBlaster products you wish to complain about and any particular
aspects of the advertising of them which may concern you, beyond an alleged lack of efficacy
evidence generally with these products”.
My response
As I said in my telephone conversation of 10 August 2018, I believe my 6 July 2018 complaint (AC-
GBKDH2XG/2018) contained the information you requested, especially the arrows that pointed to
specific claims that I alleged breached the Therapeutic Gods Advertising Code 2015.
While I did not detail specific sections of the Code that I alleged were breached for each product,
this could have readily been ascertained by your staff using the arrows provided. Your staff are paid
to investigate complaints; I am not.
Regardless, since it appears unlikely that you will satisfactorily progress my complaint without
additional information, this is now provided under protest.
On 6 July 2018 I complained about six Pharmacare listed weight loss products; I’ve now added three
more. I’ve also added several FatBlaster products, now formulated as foods (shakes, etc), which
largely contain the same ingredients as the listed products. These need to be referred by the TGA to
FSANZ and State Health Departments.1
I have previously noted that 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”. The sponsor of these products, Pharmacare Laboratories (Cat Media) has
exploited this vulnerability by introducing a succession of listed products, containing various
ingredients (mainly under the FatBlaster name), all implying by their name, claims and product
illustrations that they will produce clinically useful weight loss, over and above that obtained by diet
and exercise alone.
I first raised these issues in the medical literature 10 years ago (attached).2 I have suggested the TGA
should target complementary medicines claiming to assist weight loss as an important priority for
their enhanced post-marketing monitoring program.3
Despite at least 30 upheld complaints by the Complaint Resolution Panel (CRP) concerning listed
weight loss products over the last 10 years the TGA has done nothing to tackle this systemic
problem. This is particularly reprehensible as ongoing misleading and deceptive claims for these
products are likely to divert consumers from more evidence-based weight loss programs.
The sponsor has ignored numerous upheld complaints &/or made only minor changes to wording
&/or introduced new products with different ingredients making similar claims. In addition,
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.
A formal complaint about your request, and the failure of the TGA to address longstanding
misleading and deceptive claims for listed weight loss products, will be sent to the Health Secretary
and Health Minister.
1
https://compliance.tga.gov.au/advertising-complaint
2
https://www.ncbi.nlm.nih.gov/pubmed/18205557
3
https://www.tga.gov.au/compliance-and-education-listed-medicines
Page 1 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
Meanwhile, even though the TGA has many more resources that me, you now want more specific
details of the advertising claims about the appended products that concern me.
I allege that the ingredient combinations in the following products lack evidence to substantiate the
indications and claims made, and their continued promotion, including the product names and pack
illustrations, represent repeated, multiple breaches of the Therapeutic Goods Advertising Code
2015. I also note that many specific indications on the product ARTG Public Summary Documents are
equally misleading and deceptive. The details follow.
Specific concerns (from the most recent products listed on the ARTG to the earliest)
1. ARTG ID 299770 Product name: Naturopathica Reducta Sugar Craving Mints
Active ingredients: Gymnema sylvestre, zinc citrate dihydrate
Sponsor: Cat Media Pty Ltd
https://www.health365.com.au/naturopathica-reducta-mints-30s
Page 2 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
The claims:
• A unique formulation of Gymnemic and Zinc that bind to the sweet receptors in your
mouth to help reduce sugar cravings in minutes
• Helps stop sugar cravings so you can avoid those tempting sweet snacks.
• Use Reducta Mints:
o Between meals to avoid snacking
o To curb your appetite
o To avoid dessert temptation
o Right after a snack to reduce the desire for more.
There is good scientific evidence that the leaves of Gymnema sylvestre R.Br. (Asclepiadaceae)
can inhibit the sweet taste of sucrose, sodium saccharin, cyclamate and other compounds.4
However, I could find no scientific literature that translated this effect into “reducing sugar
cravings”, “avoiding snacking”, “curbing appetite”, “avoiding desert temptation” or “reducing
the desire for more (snacks)”. Nor could I find any evidence that zinc in this “unique formula”
would produce any additional effect.
While it is reasonable to claim that Gymnema sylvestre can inhibit the taste of sugar, I allege that
above the claims go well beyond this scientific fact and thus breach the Therapeutic Goods
Advertising Code 2015, s.4(10(b), 4(2)(a) & 4(2)(c).
In addition, the above advertisement lacks mandatory warning statements, a breach of s.6(3) of
the Code and the advertisement is categorised under “Weight management” yet it lacks the
necessary mention of the importance of an energy-controlled diet and physical activity, a s.7(3)
breach of the Code.
4
https://www.ncbi.nlm.nih.gov/pubmed/24511547
Page 3 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
2. ARTG ID: 295575 Product name: FatBlaster Clinical
Active ingredients: Curcuma longa, Moringa oleifera, Murraya koenigii
Sponsor: Cat Media Pty Ltd
Ingredients: Each capsule contains: Curcuma longa (Tumeric) ext. equiv. to dry rhizome 2.925g;
Moringa oleifera (Drumstick leaves) ext. equiv. to dry leaf 2.16g.; Murraya koenigii (Curry leaves)
ext. equiv. to dry leaf 945mg.
https://www.fatblaster.com.au/fatblaster-clinical-60s
Now
unqualified
https://www.fatblaster.com.au/clinical-weightloss
Page 4 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://www.fatblaster.com.au/clinical-weightloss
Video at: https://youtu.be/IcU0i5yC1eU
Claims and comment
• The Name: FatBlaster. This product does not “blast” fat. A s.4(1)(b), 4(2)(a), 4(2)(c) Code
breach.
• The body figures illustrated above are not typical of the results likely to be achieved. A
4(2)(c) Code breach.
• Australia's latest breakthrough in weight loss to help you lose up to 6x more weight than
diet and exercise alone. In a 2016 Clinical trial, the FatBlaster Clinical formula5 was
shown to help users lose up to 6x more weight than dieting and exercise alone.
FatBlaster Clinical was also shown to help reduce centimetres from hips and waist.
Scientifically shown to help reduce centimetres from your hips and waist. See comment
on clinical trial below.
• Channel 7 news item (a placed advertisement is not bone fide news, see below).
5
When used in conjunction with diet and exercise.
Page 5 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://youtu.be/IKOCQnb1MI0
Naturopathica FatBlaster Clinical Weight Loss Diet Pill- Channel 7 News
Blurb: FatBlaster Clinical is Australia's latest breakthrough in weight loss to help you lose up to 6x
more weight than diet and exercise alone.
Transcript: “It’s the holy grail for some looking to shed weight. A tablet claims to boost metabolism
and breakdown fat. Doctors behind the product say it's different to other weight loss products
because it backed by scientific evidence”.
Comment: the terms “latest breakthrough” and “holy grail” are a s.4(2)(a) & 4(2)(c) Code breach.
The “doctor” was a PhD employed by PLT Health Solutions, marketer of LI85008F (SLENDACOR™).
As.4(2)(c) and 4(6)(iii) Code breach. See comment on clinical trial below.
https://youtu.be/IKOCQnb1MI0
Transcript: “This winter his diet remains the same, but the scales have shifted, from this down to
this”.
Comment: A deceptive and misleading visual, a s.4(2)(a), 4(2)(c) Code breach. Also s.7(3) as this
statement does not “balance” product claims with the need for an energy-controlled diet and
physical activity.
Page 6 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://youtu.be/IKOCQnb1MI0
Transcript: "Usually I'd gain 10 in winter and this winter I've lost 10 kilos".
Comment: Screen caption implies “Rob” was part of the published clinical trial when he was not
(s.4(2)(c) Code breach). In addition, the claimed loss of 10 Kg in 8 weeks without diet and exercise is
not typical of the published trial results not does it “balance” product claims with the need for an
energy-controlled diet and physical activity (s.7(3) Code breach). Also, potential s.4(7) breach;
testimonial needs verification by a statutory declaration.
https://youtu.be/IKOCQnb1MI0
Transcript: “For the last 8 weeks Rob has trialled a weight loss pill claimed to boost the body’s ability
to shed fat using a formula of three botanical ingredients”.
Comment: Implies “Rob” was part of the published clinical trial when he was not (s.4(2)(c) Code
breach).
Page 7 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://youtu.be/IKOCQnb1MI0
Transcript: Dr Barbara Davis, PTL Health Solutions, "It prevents the maturation of fat cells so that
they don't hold as much fat; also helps to break down fat and eliminate it from the body".
Comment: Endorsement by an implied health professional, a s4.(6)(b)(iii) Code breach.
https://youtu.be/IKOCQnb1MI0
Transcript: “A 16-week study …. the group who had received the active ingredient lost over 5 kg, up
to 6 times more that the placebo group….”
Comment: See notes on the clinical trial below.
Page 8 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://youtu.be/IKOCQnb1MI0
Transcript: “FatBlaster Clinical is a different formulation from the original FatBlaster…”
https://youtu.be/IKOCQnb1MI0
Transcript: “The supplement is being rolled out in Australian pharmacies.”
Page 9 of 22
TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://youtu.be/IKOCQnb1MI0
Transcript: “And while some experts agree it may assist in weight loss, they’re skeptical it’s worth
the $70 a month spend.”
Comment: That is not what Dr Fuller (or any other “expert”) said, a s.4(1)(b), 4(2)(a) & 4(2)(c) Code
breach.
Dr Nick Fuller: “It’s not that miracle weight loss cure. It’s only achieving the same amount of weight
loss as if someone went out and changed several aspects of their lifestyle”. “Like diet and exercise”.
https://www.fatblaster.com.au/
Page 10 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://www.fatblaster.com.au/
Comment: the claimed loss of 9 Kg (Karen) and 7 Kg (Rob) in 8 weeks without mention of diet and
exercise is not typical of the published trial results not does it “balance” product claims with the
need for an energy-controlled diet and physical activity (s.7(3) Code breach). In the video (above)
Rob claimed a loss of 10 km, now its 7kg. Also, a potential s.4(7) breach; both testimonials needs
verification by a statutory declaration.
Clinical trial: The strong claims, “Australia's latest breakthrough in weight loss”, “lose up 6x more
weight than dieting and exercise alone” and “reduce centimetres from hips and waist” were
attributed to a “2016 Clinical trial” which lacked information (in some advertisements and the ARTG
Public Summary) on the authors or where to find the study.
The study is appended.6 It was conducted in Bangalore, (Bengaluru) India, funded by the product
developer, Laila Nutraceuticals, India and the product promotor, PLT Health Solutions
(SLENDACOR™), who each provided an author of the paper.
It involved 150 overweight Indian participants (body mass index 27-29.9 kg/m2, 29.3% male; ages
21-50 years) randomized into placebo (n =70) and intervention (n =70) groups studied for 16 weeks.
The dose of the three active herbal ingredients (LI85008F) was two 450 mg capsules taken one
before breakfast and one before dinner. Participants were also advised to walk for 30 min, 5 d/week,
and maintain a diet of ~1800 kcal/d as instructed by a dietitian.
At the end of the trial period, the LI85008F supplemented group showed significant reductions in
body weight: (mean ± SD: 5.36 ± 1.769 vs. 0.87 ± 1.381 kg; P < 0.0001) and BMI (mean ± SD: 2.05 ±
0.693 vs. 0.34 ± 0.559 kg/m2; P < 0.0001), compared with placebo. Significant reductions in waist
and hip circumferences, and a 2.08-fold reduction of waist/hip ratio, were also noted in the LI85008F
supplemented group.
While the results were impressive (some would say too good to be true) the study was conflicted by
the commercial interests involved, it was performed on an Indian (not Australian) population and
the results have yet to be replicated.
6
https://www.ncbi.nlm.nih.gov/pubmed/29923305
Page 11 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
In addition, I would have expected the placebo group to lose more weight on the diet and exercise
regime. But there was no monitoring of what the participants ate. Without this, it is not possible to
say that the supplement was the effective component. Did those taking the supplement eat less?
Several side effects were labelled as 'minor' but included gastritis, loose stool and dehydration.
Although the authors said there was no difference in these side effects between the groups, no data
was given. We need to know how common the side effects were. Any of these three could lead to
changes in appetite and/or weight.
The results for much of what they measured also had huge confidence intervals – e.g. fat mass, lean
mass, LDL and other blood fats. They show only that the variation was too great to draw any valid
conclusion.
I submit that this trial does not justify the strong promotional claims made for an Australian
audience especially as the promotion merely says, “use in conjunction with a healthy, energy-
controlled diet and exercise program” and does not spell out the ~1800 kcal/d diet and the 5 d/week
30 min walk exercise regime used in the trial.
In summary, taking all the above into account, I allege breaches of the Therapeutic Goods
Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(6)(iii), and.7(3). Also, a potential s.4(7)
breach.
Page 12 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
3. ARTG ID 295230 Product name: Reducta
Active ingredients: Caralluma adscendens var. fimbriata, Crocus sativus
Sponsor: Cat Media Pty Ltd
https://www.pharmacydirect.com.au/Product/naturopathica-reducta-hunger-reduction-40-tablets-
28349.aspx
Claims:
• Hunger Reduction 40 Tablets
• Reduce Hunger & Snacking
• Reducta helps you eat less, therefore giving you more control over your hunger.
This product has had 3 previous complaints upheld by the Complaint Resolution Panel (CRP).7
Determination 2013-02-027 noted breaches of the Code, s.4(1)(b), 4(2)(a) & 4(2)(c). The CRP
specifically asked the sponsor to withdraw any representations that the advertised product can
reduce hunger. Because of non-compliance, this recommendation was sent to the Secretary on 13
Feb 2014.
Following investigation, the Delegate's decision was made on 11 April 2014.8 The Delegate ordered
Pharmacare Laboratories Pty Ltd to:
7
http://www.tgacrp.com.au/complaint-register/?_search=Reducta
8
https://www.tga.gov.au/advert-complaint/reducta-pharmacare-laboratories-pty-ltd-complaint-no-2013-02-
027
Page 13 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
“withdraw any representations, including implied representations, that the product can be
used for hunger reduction, unless those representations are worded to the effect that
Caralluma fimbriata has been traditionally used for hunger reduction in India in times when
food was scarce”.
On the 24 April 2014 PharmaCare Laboratories Pty Ltd provided written assurance to the delegate of
the Secretary that they would comply fully with the regulation 9 orders made on 11 April 2014.
I allege that the sponsor has wilfully breached that order by continuing to claim that this product can
reduce hunger & snacking with no mention of “traditional” indications. In addition, the most recent
scientific review I could find noted:
“Only one drug from C. fimbriata has been released under the trade name Genaslim for body
weight control, but the clinical trials on the product does not support appetite-suppressant
activity in the extract even though GRAS status has been given to the extract of C. fimbriata
(Slimaluna)”.9
See also: “TGA, once again, fails to reign in shonky weight-loss product”.10
In short, ongoing breaches of the Code, Code, s.4(1)(b), 4(2)(a) & 4(2)(c).
9
https://www.ncbi.nlm.nih.gov/pubmed/22191633
10
https://theconversation.com/tga-once-again-fails-to-reign-in-shonky-weight-loss-product-10227
Page 14 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
4. ARTG ID: 278976 Product name: Naturopathica FatBlaster Triple-Tea Fat Burner
Active ingredients: Camellia sinensis, Paullinia cupana
Sponsor: Cat Media Pty Ltd
https://fatblaster.com.au/fatblaster-triple-tea-fat-burner
Comment: The name FatBlaster Triple-tea fat burner is deceptive and misleading (this product does
not blast or burn fat) as is the prominent claim “Fat Burner”. The claims, “Burn more fat” and
“Increase thermogenesis”, “fat burning tea ingredients” are also misleading, deceptive as there is no
good evidence this product produced clinically relevant weight loss. The claim, “FatBlaster Triple-
Tea Fat Burner is high in Epigallocatechin gallate (EGCG) which can help metabolic processes and
assist in fat burning” is not appropriate or understandable scientific information. Finally, the
illustration is not typical of the results likely to be achieved.
See also: "Science or Snake Oil: do skinny teas boost weight loss".11 Cochrane review: "Green tea for
weight loss and weight maintenance in overweight or obese adults" 12
In short, breaches of the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c) and
4(4).
11
https://theconversation.com/science-or-snake-oil-do-skinny-teas-boost-weight-loss-87353
12
https://www.cochrane.org/CD008650/ENDOC_green-tea-for-weight-loss-and-weight-maintenance-in-
overweight-or-obese-adults
Page 15 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
5. ARTG ID: 229539 Product name: FatBlaster Garcinia Max
Active ingredients: Hydroxycitrate complex
Sponsor: Cat Media Pty Ltd
https://www.fatblaster.com.au/fatblaster-garcinia-max
Etc.
Comment: There have been 14 complaints upheld by the CRP for products containing Garcinia
cambogia. Determination 2014-11-006 has a nice review of the literature and non-compliance
resulted in a recommendation to the Secretary that clearly has had no effect on other sponsors as
seen in the advertisement for this product.
The name FatBlaster Garcinia Max is deceptive and misleading (this product does not blast fat) The
claim that HCA “mobilises fat storage” and “supports fat consolidation” lacks clinical relevance. The
illustration is not typical of the results likely to be achieved and the testimonial needs verification by
a statutory declaration.
See also: “Science or Snake Oil: is Garcinia cambogia the magic weight-loss pill it’s hyped up to
be?”13 “Five supplements that claim to speed up weight loss – and what the science says”.14
In short, breaches of the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c) and
possibly 4(7).
13
https://theconversation.com/science-or-snake-oil-is-garcinia-cambogia-the-magic-weight-loss-pill-its-hyped-
up-to-be-59822
14
https://theconversation.com/five-supplements-that-claim-to-speed-up-weight-loss-and-what-the-science-
says-89856
Page 16 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
6. ARTG ID: 212760 and 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.
https://www.fatblaster.com.au/fatblaster-max-60s
Etc.
Comment: the CRP has upheld 6 previous complaints about products with this name. I allege the
name FatBlaster Max is deceptive and misleading (this product does not blast fat) as is the claim
“ultimate weight loss”.
The claims, “Burn more fat”, “Burn more calories”, “new, improved formula”, “FatBlaster Max is for
those who want to take their weight loss to the next level” are not supported by evidence about the
ingredients while “trigger thermogenesis” is not appropriate or understandable scientific
information. and lacks clinical relevance. The illustrations are not typical of the results likely to be
achieved and the testimonial needs verification by a statutory declaration.
In short, breaches of the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c), 4(4)
and most likely 4(7).
Page 17 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
7. ARTG ID 172079 Product name: Naturopathica FatBlaster Diuret
Active Ingredients: Apium graveolens, Arctostaphylos uva-ursi, Petroselinum crispum,
Taraxacum officinale
Sponsor: Cat Media Pty Ltd
https://www.fatblaster.com.au/fatblaster-diuret-60s
Etc.
Comment: The CRP has upheld 5 previous complaints about this product.15
I allege the name FatBlaster is deceptive and misleading (this product does not blast fat).
In addition, the advertisement does not state (as the ARTG public summary does) that the
ingredients are “traditional” diuretics.
Furthermore, “rapid slimming” by the use of diuretics removes water, not fat and is potentially
dangerous.
Finally, the illustrations coupled with the claim “flatten your tummy” are not typical of the results
likely to be achieved while the testimonial is most unlikely to relate to this product or be typical of
results achieved.
In short, breaches of the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c), 4(4)
and most likely 4(7).
15
http://www.tgacrp.com.au/complaint-register/?_search=Diuret
Page 18 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
8. 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
https://www.fatblaster.com.au/fatblaster-60s
Etc.
Comment: At least 11 previous complaints upheld by the CRP.16
I allege the name FatBlaster is deceptive and misleading (this product does not “blast fat”) as is the
claim “expert weight loss.
The claim, “trigger thermogenesis” is not appropriate or understandable scientific information.
The claim, “supporting increased fat burning” is not on the ARTG and has lacks clinical relevance.
Finally, the illustrations are not typical of the results likely to be achieved, and the testimonial needs
verification by a statutory declaration.
In short, breaches of the Therapeutic Goods Act 1989, s.22(5) and the Therapeutic Goods Advertising
Code 2015, s. 4(1)(b), 4(2)(a), 4(2)(c), 4(4) and possibly 4(7).
16
http://www.tgacrp.com.au/complaint-register/?_search=fatblaster
Page 19 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
9. ARTG ID: 145959 Product name: Naturopathica FatBlaster FatMagnet
Active ingredients: Ascorbic acid, poliglusam, Psyllium Husk Powder
Sponsor: Cat Media Pty Ltd
https://www.fatblaster.com.au/fatblaster-fatmagnet-fat-absorber-60-pack
Etc.
Comment: At least 4 previously upheld complaints by the CRP about this product.17,18
I allege the name FatBlaster FatMagnet is deceptive and misleading as this product does not blast fat
nor attract fat out of the body as the name (and illustration) implies.
The illustration is not typical of the results likely to be achieved and the claim “can assist adults who
are actively wanting to lose weight” lacks clinical evidence for this specific product formulation.
In short, breaches of the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), and 4(2)(c).
17
http://www.tgacrp.com.au/complaint-register/?_search=Fat%20magnet
18
http://www.tgacrp.com.au/complaint-register/?_search=Fatmagnet
Page 20 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
Products reformulated as foods
The following FatBlaster products are now formulated as foods (shakes, etc). They largely contain
the same ingredients as the listed products. These need to be referred by the TGA to FSANZ and
State Health Departments.
https://www.fatblaster.com.au/
Page 21 of 22TGA Complaint, AC-GBKDH2XG/201 (6 July 2018), Pharmacare Laboratories–
Additional information requested
https://www.fatblaster.com.au/products?p=2&weight_loss_category=5
https://www.fatblaster.com.au/products?p=2&weight_loss_category=5
15 August 2018
Dr Ken Harvey 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: kenneth.harvey@monash.edu
WWW: www.medreach.com.au
Page 22 of 22P H A R M A C EU TI C A L S A N D P R E SC R I BI N G
Commercialism, choice and consumer protection:
regulation of complementary medicines in Australia
Ken J Harvey, Viola S Korczak, Loretta J Marron and David B Newgreen
C omplementary and alternative medicines (CAMs) are being
used increasingly in Australia, often in conjunction with
conventional medicines.1 While the demand for CAMs is
growing, the regulatory framework is weak. The electronic lodge-
ment facility, introduced in 1996, has made it easier to place new
ABSTRACT
• Controls on the supply and promotion of complementary
medicines in Australia are weak.
• We used weight-loss products as an example to compare the
CAMs on the Australian Register of Therapeutic Goods (ARTG). regulation in Australia of listed complementary medicines
Concern about the regulation of CAMs has been growing among and registered pharmaceutical products.
2
organisations suchJournal
The Medical as CHOICE.
of Australia ISSN: 0025- • Complementary medicines are listed without evaluation for
Here, we review the regulatory requirements for CAMs, com-
729X 7 January 2008 188 1 21-25 efficacy, while conventional pharmaceutical products are
pare ©The
weight-loss products
Medical Journallisted on the ARTG
of Australia 2008 with registered registered after evaluation for quality, safety and efficacy.
pharmaceutical products, analyse complaint procedures and
www.mja.com.au
Pharmaceuticals
advocate policy change.and Prescribing
We have focused on weight-loss prod- • From 1996 to 2006, over 1000 “weight-loss” products were
ucts because of widespread concern about an obesity “epidemic”, listed on the Australian Register of Therapeutic Goods; most
extensive advertising of the products and the large number on contained multiple unevaluated ingredients (herbs, vitamins,
the market. minerals) of dubious efficacy. Over the same period, 10
conventional medicines were registered; each contained one
evaluated ingredient of proven efficacy.
Regulation of therapeutic goods in Australia
• The number of listed weight-loss products (and complaints
In 1989, the federal Parliament passed the Therapeutic Goods Act about their promotion) is increasing. These appear to be a
1989 (Cwlth), which created the ARTG. The ARTG has two parts: direct consequence of the decision not to evaluate listed
one for “registered goods” and the other for “listed goods”. Some products for efficacy and the lower fees for listing a product,
goods captured by the Act are classified as “exempt goods” and compared with registration.
are not entered in the ARTG (ss. 9A, 18). Box 1 shows the
• Complaint procedures (now overloaded) are no substitute for
differences between the various categories of therapeutic goods.
adequate regulation at the time of market entry.
“Registered” medicines are considered to be of relatively higher
risk and are individually evaluated by the Therapeutic Goods • Regulatory reform of listed and homoeopathic products is
Administration (TGA) for quality, safety and efficacy before required.
market entry. “Listed” medicines are considered to be of relatively MJA 2008; 188: 21–25
lower risk (Box 2).3
Most, but not all, CAMs are listed medicines.4 Initially, the
TGA did not require sponsors to have evidence to support Sponsors self-assess their medicines as being listable using the
claims made about their products. In 1999, concern that web-based electronic listing facility (ELF) of the ARTG. The ELF
improbable therapeutic claims were being made about CAMs led system automatically checks that the ingredients entered are
to the introduction of a requirement that sponsors hold substan- consistent with those allowed in listed medicines and asks the
tiating evidence.5 Further, since a report by the Expert Commit- sponsors to certify that they hold evidence to support the indica-
tee on Complementary Medicines in the Health System, a tions (and thus claims) made. Sponsors may pick either a coded
random sample of about 20% of new listings is said to be indication such as “May aid or assist weight loss . . .” or a custom
assessed each year for compliance with TGA requirements.6 indication entered as free text in a memo field. More than one
Both these measures have been introduced to increase monitor- entry into either field is allowed. After payment of a fee, the ELF
ing of CAMs. system automatically generates an “AUST L” number and a
In 1991, the government introduced fees and charges to certificate of listing.
industry for services provided by the TGA, such as ARTG Since the introduction of the ELF, the time taken to list a product
applications, good manufacturing practice inspections and has been reduced from around 5 months to 10 days or less for
annual licensing. The aim was to achieve 50% cost recovery. In about 90% of applications.8
1998, the government determined that 100% of costs would be Complaints from the public about listed products need to be
recovered.7 Illustrative TGA fees (at 1 July 2007) were $170 200 submitted to various authorities, as summarised in Box 3.9
for registering and evaluating a new prescription medicine (a new In February 2007, the Australian Government reintroduced a
chemical entity); $990 for registering and evaluating an over-the- provision of the Therapeutic Goods Advertising Code, which had
counter product or CAM (plus $6570–$46 000, depending on existed before August 2005, prohibiting health care professionals
the number of pages of data submitted); and $540 for listing a from endorsing therapeutic goods in advertisements to consumers.
medicine. The annual charge for a registered (non-biological) This provision took effect from 8 March 2007, but allowed existing
prescription medicine was $3030; for a registered over-the- advertisements to continue for either 2 years after approval (eg, in
counter product, conventional or CAM, $920; and for a listed print) or 1 year if approval had not been required (eg, Internet
medicine, $690.7 advertisements).10
MJA • Volume 188 Number 1 • 7 January 2008 21P H A R M A C EU TI C A L S A N D P R E SC R I BI N G
1 Contrasting requirements of the Therapeutic Goods Administration (TGA) for different categories of goods
Registered goods Listed goods
Requirement (pharmaceutical products) (complementary medicines) Exempt goods
Label designation AUST R AUST L na
Compliance with Code of Good Yes Yes No
Manufacturing Practice
Manufacturers licensed by TGA Yes Yes No
Efficacy evaluated by TGA Yes No No
Stability (shelf-life) evaluated by TGA Yes No No
Individual ingredients evaluated for Yes Yes Some (eg, those in antiperspirants,
safety by TGA fluoride toothpastes)
Examples All medicines included in a Most herbal preparations, Homoeopathic medicines,
poisons schedule, vitamins, minerals, glucosamine, extemporaneously dispensed
all PBS medicines, some homoeopathic medicines medicines, dandruff shampoos,
all other medicines not listed or (if the sponsors so choose), antiperspirants,
not exempt goods export goods fluoride toothpastes
na = not applicable. PBS = Pharmaceutical Benefits Scheme. ◆
An example: weight-loss products
2 Main criteria used by the Therapeutic Goods
Administration for listed complementary medicines In Australia, both listed and registered weight-loss products are
(with the exception of homoeopathic products) available. To determine the numbers of each and compare them,
we asked the TGA to search the ARTG for registered or listed
• They may contain only ingredients approved for use in listed
products with the indication “weight loss”, or similar, for the
medicines (those with well established quality and safety profiles);
period 1996 to 2006. We then supplemented the list by searching
• They must be labelled and advertised only for indications the shelves of pharmacies and health food shops and Australian
consistent with low risk (eg, symptomatic relief of non-serious Internet sites. Because of problems encountered, the TGA made
diseases, disorders and conditions) and must not be indicated for
available a subset of the ARTG database so that we could refine
the treatment of a serious form of a disease, condition, ailment or
their search for weight-loss products. For the registered and listed
defect as specified in the Therapeutic Goods Advertising Code;
products found, we compared the therapeutic claims with the
• There must be evidence (which can be either traditional or published evidence. The website of the Therapeutic Goods Adver-
scientific), held by the sponsor of the product, to support any claim tising Code Council was used to identify complaints and select
that the sponsor makes relating to the medicine; and
illustrative case studies.
• They do not contain substances that are scheduled in the
Standard for the Uniform Scheduling of Drugs and Poisons or Products identified
otherwise restricted (eg, included in Part 4 of Schedule 4 of the
Therapeutic Goods Regulations 1990). ◆
The initial search output received from the TGA failed to show
some registered weight-loss products, such as orlistat (Xenical
[Roche]) and sibutramine (Reductil [Abbott]). It also failed to
show many listed CAMs that were being actively promoted for
3 Bodies handling complaints about listed products and weight loss.
registered over-the-counter products Some of these problems resulted because the ELF system
allowed sponsors of listed products to enter information into the
Complaint Regulation
ARTG in free text without verification by TGA staff. Some non-
About product quality or Therapeutic Goods standard indications had been used for weight-loss products (such
claims made on the pack or Administration’s Office of as “thermogenic”, “body sculpting”, “reduce carb cravings”), which
pack insert Complementary Medicines made a complete search for such products difficult, if not imposs-
About promotional claims made Complaints Resolution Panel ible.
in specified media assesses concerns against the Our own search found over 1000 new weight-loss products
(television, radio, Internet, Therapeutic Goods Advertising listed on the ARTG from 1996 to 2006. New listings generally
newspapers, magazines, Code
increased over the period, from 45 in 1996 to 144 in 2006. Most
outdoor signs and cinema)
contained multiple ingredients (herbs, vitamins, minerals).
About other advertising, such as Complaints Resolution Homoeopathic products are not included on the ARTG. Over the
pharmacy window displays, Committee of the
same period, 10 conventional medicines for weight loss were
brochures, leaflets and Complementary Healthcare
registered with the ARTG, each containing one ingredient, (orli-
catalogues Council of Australia or Australian
Self-Medication Industry’s
stat, diethylpropion, phentermine, sibutramine). All these sub-
Complaints Panel stances are officially scheduled poisons, and products containing
them are registered for the management of obesity, unless the
22 MJA • Volume 188 Number 1 • 7 January 2008P H A R M A C EU TI C A L S A N D P R E SC R I BI N G
product is for export. Those containing months before the results are made public.
4 Xantrax (Hershel-Beck
orlistat and sibutramine have been fully Meanwhile, promotional campaigns con-
Laboratories), an example of a listed
evaluated. Phentermine-containing medi- tinue. In addition, the sanctions imposed
weight-loss product
cines were “grandfathered” on to the appear ineffectual, as shown by the fact that
ARTG because they were already on the Ingredients some companies repeatedly breach the
Australian market when the Act took effect Each Xantrax tablet contains: Therapeutic Goods Advertising Code. For
in February 1991. Diethylpropion is no • Camellia sinensis (green tea) example, from March 2004 to November
longer marketed. The safety and efficacy of • Citrus aurantium fruit (bitter orange) 2007, the sponsor of Xantrax, Cat Media Pty
these agents has been comprehensively • Paullinia cupana (guarana) Ltd, has had at least 28 complaints about its
reviewed.11 • Panax ginseng (Korean ginseng) p rod u ct s, 22 of w hi c h h av e be en
Thus, sponsors could decide not to • Ilex paraguariensis (yerba mate)
upheld.16,17 In 2006, the Panel received over
market products they had placed on the 350 complaints, more than twice the
• 11 additional vitamins and minerals
ARTG or to take them off the market but number received in 2005. Of these, 170
Therapeutic claims
leave them on the ARTG. Taking into have been finalised and 100 are still being
account these limitations, we found about Xantrax helps by: processed, 60 concerning homoeopathic
100 times as many listed weight-loss • delaying gastric emptying thus prolonging products and which were referred to the
products on the ARTG as registered prod- a sense of fullness TGA, and 22 referred to other bodies. The
ucts. It is not possible to be too specific • suppressing appetite system is clearly overloaded and under-
about numbers because there were con- • maintaining healthy energy levels resourced. We submitted complaints over 6
founding factors, such as the inclusion in • improving exercise performance months ago that have yet to be addressed.
the listed goods part of the ARTG of • enhancing the body’s ability to cope with We submitted complaints over 12 months
prescription-only medicines that were stress ago that have been referred to other jurisdic-
destined for export. • supporting healthy metabolism tions, about which we have heard no more;
In our opinion, the indications for meanwhile, promotion continues.
weight-loss products listed on the ARTG
(and thus their promotional claims) were Implications
often not in accord with the limited scien-
tific evidence available. Furthermore, the In 2003, the Expert Committee on Comple-
number of such listed products is increas- mentary Medicines in the Health System was
ing each year at a much greater rate than established to reassure the public about the
registered products. It is possible that this safety and quality of CAMs. The Committee
has been influenced by the decision not to said (Finding 4.1.1) that the “Government
evaluate listed products for efficacy and needs to take a more active role in ensuring
also the lower fees for listing a product that consumers have access to reliable infor-
compared with registration. mation about complementary medicines,
and the skills to interpret information and
make informed decisions”.6 In 2005, the
A typical weight-loss product government responded to the expert com-
An example of a publicly available, listed mittee report by accepting, noting or sup-
weight-loss product is shown in Box 4. We porting all but one of th e 49
are unaware of publicly available evidence recommendations. The TGA established the
from clinical trials to support the thera- Complementary Medicines Implementation
peutic claims made for this product or for Reference Group to oversee the implementa-
many other listed (and homoeopathic) tion and has provided progress reports.18
weight-loss products. Several systematic Despite the widespread use of CAMs,
reviews have evaluated the commonly many consumers are unaware that listed
included ingredients and have concluded medicines do not undergo the same strin-
that, at best, more definitive clinical trials gent evaluation process as registered medi-
are required before conclusions can be Pharmacy poster for Xantrax. cines, or indeed, that there is a difference
drawn.12,13 While these products are of between the two. Consumers are not suffi-
relatively low risk, some herbal ingredi- ciently protected by regulation in this case. It
ents can cause harm by themselves and also by interacting with is difficult to reconcile the therapeutic claims made for many
conventional medicines; both kinds of event may be under- CAMs with the objects of the Act: “to provide for . . . a national
reported.14,15 system of controls relating to the quality, safety, efficacy and timely
The Complaints Resolution Panel found that the claims made availability of therapeutic goods…” (s. 4, our italics).
about the illustrated product, Xantrax (Hershel-Beck Laborato- In an attempt to explain the difference, the TGA produced a
ries), breached the Therapeutic Goods Advertising Code as they pamphlet in 1995 called Buying medicines — what’s on the label for
were misleading and likely to arouse unwarranted and unrealistic me? It was available in pharmacies and health food shops and is
expectations of product effectiveness.16 In our experience, it now on the Internet.19 While the content reflects the legal
usually takes 3 to 4 months for submitted complaints to be situation, the omission that AUST L listed medicines are not
adjudicated by the Complaints Resolution Panel and several more evaluated for efficacy diminishes the utility of the pamphlet for the
MJA • Volume 188 Number 1 • 7 January 2008 23P H A R M A C EU TI C A L S A N D P R E SC R I BI N G
very people to whom it is directed. This has financial as well as (as with the Food and Drug Administration in the United States)
health implications for consumers. Brian Grogan, national presi- has led to commercial considerations outweighing the need for
dent of the Pharmaceutical Society of Australia, has noted: consumer protection.22,23
While those products that lack evidence for effectiveness may Listed weight-loss products would be a good place to start the
not actively harm the physical health of those who take them, regulatory reform, given the increasing problem of obesity in
they may well be harming patients’ financial health, some of Australia.
whom may have to forgo other more beneficial evidence-based
treatments or other necessities.20 Acknowledgements
In addition, any herb has many different chemical constituents, We are most grateful for the information provided by officers of the
the presence and concentration of which vary, depending on the Therapeutic Goods Administration and the Therapeutic Goods Advertising
source of the herb, and the extraction and standardisation methods Code Council.
used. Marked variations of chemical constituents have been found
in different commercial products that purported to contain the Competing interests
same amount of a particular herb.21 Currently, the TGA accepts
None identified.
crude assays that do not necessarily confirm that one herbal
product has the same chemical constituents as another that has
been proven to be clinically effective. In addition, the TGA does Author details
not require stability data on listed products. Ken J Harvey, FRCPA, Adjunct Senior Research Fellow1
Finally, the large number of repeated breaches of the Advertising Viola S Korczak, BEc(SocSc), MIPH, Health Policy Officer2
Code by certain companies, together with an increasing backlog of Loretta J Marron, BSc, AssocDipBus3
complaints, shows that complaint procedures are no substitute for David B Newgreen, BPharm, MBA4
adequate regulation at the time of market entry. Consumers (and 1 School of Public Health, La Trobe University, Melbourne, VIC.
health professionals) cannot exercise informed choice about CAMs 2 Choice (Australian Consumers’ Association), Sydney, NSW.
if they are denied information about the quality and efficacy of 3 Brisbane, QLD
these products. 4 Melbourne, VIC.
Correspondence: k.harvey@medreach.com.au
Solutions
References
How could the present situation be improved? We propose the
1 MacLennan AH, Myers SP, Taylor, AW. The continuing use of complemen-
following actions:
tary and alternative medicine in South Australia: costs and beliefs in 2004.
• AUST L medicines (and homoeopathic medicines) should Med J Aust 2006; 184: 27-31.
include on their labels a statement, such as “This medicine has not 2 CHOICE. Test: slimming pills. http://www.choice.com.au/viewArti-
been evaluated by Australian health authorities for efficacy”. cle.aspx?id=105065&catId=100232&tid=100008 (accessed Nov 2007).
• A campaign to educate the public about such matters is needed. 3 Therapeutic Goods Administration. The Therapeutic Goods Administra-
tion’s risk management approach to the regulation of therapeutic goods.
This would best be done by the National Prescribing Service, Version 1. Canberra: Department of Health and Ageing, 2004. http://
which is currently conducting a survey of educational needs in tga.gov.au/about/tgariskmnt.pdf (accessed Nov 2007).
relation to CAMs. 4 Therapeutic Goods Administration. Listed complementary medicines. In:
• Ethical codes of conduct and complaint procedures for CAMs, Australian regulatory guidelines for complementary medicines part II
(ARGCM). Canberra: Department of Health and Ageing, 2005. http://
over-the-counter and prescription drugs should be streamlined,
www.tga.gov.au/docs/html/argcm.htm#argcmp2 (accessed Nov 2007).
harmonised and brought under one adequately resourced author- 5 McEwen J. What does TGA approval of medicines mean? Aust Prescriber
ity. Consistent (and meaningful) sanctions should be imposed on 2004; 27: 156-158.
companies that repeatedly breach codes (for example, corrective 6 Expert Committee on Complementary Medicines in the Health System.
advertising orders and fines linked to company turnover, with the Report to the Parliamentary Secretary to the Minister for Health and
Ageing. Canberra: Commonwealth of Australia, 2003: 22, 115. http://
money used to support the complaint system).
www.tga.gov.au/docs/pdf/cmreport.pdf (accessed Nov 2007).
• The ARTG database should be updated with respect to listed 7 Therapeutic Goods Administration. Submission to the Productivity Com-
products. Sponsors should be required to add key evidence mission Review of Cost Recovery by Commonwealth Agencies. Can-
supporting each indication on the ARTG and entries should be berra: Department of Health and Ageing, 2000. http://www.pc.gov.au/__
checked by staff of the regulatory body and coded with respect to data/assets/pdf_file/0019/39250/sub094.pdf (accessed Nov 2007).
8 Therapeutic Goods Administration. Summary of fees and charges at 1
therapeutic indication. This information should be publicly availa- July 2007. Canberra: Department of Health and Ageing. http://
ble on the Internet. www.tga.gov.au/fees/fees07.htm (accessed Nov 2007).
• The TGA should check the analysis of herbal products more 9 Therapeutic Goods Administration. Making a complaint about advertis-
thoroughly and allow sponsors to use clinical trial evidence ing. Canberra: Department of Health and Ageing, 2007. http://
www.tga.gov.au/docs/html/advcomplaint.htm (accessed Nov 2007).
relating to other products only where their own product has been
10 Pyne C. Therapeutics products endorsements by doctors to be banned
shown to have an identical herbal preparation, extraction and [media release]. Canberra: Department of Health and Ageing, 2007; 7
standardisation process. Feb (CP08/07). http://www.health.gov.au/internet/ministers/publish-
• Finally, we believe that, in the longer term, the listing system ing.nsf/content/mr-yr07-cp-pyn008.htm (accessed Nov 2007).
should be scrapped, and CAMs (including homoeopathic medi- 11 Ioannides-Demos LL, Proietto J, McNeill JJ. Pharmacotherapy for obes-
ity. Drugs 2005; 65: 1391-1418.
cines) should be assessed for efficacy and delisted if evidence is 12 Egger G, Cameron-Smith D, Stanton R. The effectiveness of popular,
lacking. Public money should be used for this, not listing fees. non-prescription weight loss supplements. Med J Aust 1999; 171: 604-
There is a current perception that 100% cost-recovery by the TGA 608.
24 MJA • Volume 188 Number 1 • 7 January 2008P H A R M A C EU TI C A L S A N D P R E SC R I BI N G
13 Pittler MH, Ernst E. Complementary therapies for reducing body weight: Department of Health and Ageing, 2006. http://www.tga.gov.au/cm/
a systematic review. Int J Obes 2005; 29: 1030-1038. cmreport3.pdf (accessed Nov 2007).
14 Adverse Drug Reactions Advisory Committee. Adverse reactions to 19 Therapeutic Goods Administration. Buying medicines: what’s on the
complementary medicines. Aust Adverse Drug React Bull 2005; 24: 1. label for me? Canberra: Department of Health and Ageing, 2007. http://
http://www.tga.gov.au/adr/aadrb/aadr0502.htm (accessed Nov 2007). www.tga.gov.au/docs/html/buymed.htm (accessed Nov 2007).
20 Pharmaceutical Society of Australia. Check the evidence before pro-
15 Pittler MH, Schmidt K, Ernst E. Adverse events of herbal food supple-
claiming a ‘miracle’ [media release]. Sydney: PSA, 2006. http://
ments for body weight reduction: systematic review. Obes Rev 2005; 6:
www.psa.org.au/site.php?id=235 (accessed Nov 2007).
93-111. 21 Jiang B, Kronenberg F, Nuntanakorn P, et al. Evaluation of the botanical
16 Therapeutic Products Advertising Complaints. Complaints Resolution authenticity and phytochemical profile of black cohosh products by high-
Panel determination. Complaint 4-1106 Xantrax. Sydney: Complaints performance liquid chromatography with selected ion monitoring liquid
Resolution Panel, 2007. http://www.tgacrp.com.au/index.cfm?pageID= chromatography-mass spectrometry. J Agric Food Chem 2006; 54: 3242-
13&special=complaint_single&complaintID=809 (accessed Nov 2007). 3253.
17 Therapeutic Products Advertising Complaints, Complaints Resolution 22 Kmietowicz Z. Repeal law that puts “FDA on the payroll of the industry”,
Panel. Complaints register. Sydney: Complaints Resolution Panel, 2007. says former NEJM editor. BMJ 2007; 334: 447. http://www.bmj.com/cgi/
http://www.tgacrp.com.au/index.cfm?pageID=13 (accessed Nov 2007). content/short/334/7591/447-a (accessed Nov 2007).
23 Hennessy S, Strom BL. PDUFA reauthorization — drug safety’s golden
18 Therapeutic Goods Administration. Implementation of the government
moment of opportunity? N Engl J Med 2007; 356: 1703-1704.
response to the recommendations of the expert committee on comple-
mentary medicine in the health system. Progress report. Canberra: (Received 3 May 2007, accepted 31 Oct 2007) ❏
MJA • Volume 188 Number 1 • 7 January 2008 25Received: 8 April 2018 Revised: 15 June 2018 Accepted: 16 June 2018
DOI: 10.1111/dom.13443
ORIGINAL ARTICLE
Efficacy of a novel herbal formulation for weight loss
demonstrated in a 16-week randomized, double-blind,
placebo-controlled clinical trial with healthy overweight adults
Kashinath Dixit MD1 | Dinesh V. Kamath MD2 | Krishnaraju V. Alluri MS3 |
Barbara A. Davis PhD4
1
Krupa Centre for Diabetes and Obesity,
Bengaluru, India Aim: To re-evaluate the weight loss efficacy of LI85008F in healthy overweight adults via a
2
Sudeep Diabetes Care Centre, Bengaluru, 16-week randomized, double-blind, placebo-controlled clinical study.
India Materials and Methods: One hundred and forty overweight participants (body mass index [BMI]
3
Laila Nutraceuticals R&D Center, Vijayawada, 27-29.9 kg/m2, 29.3% male; ages 21-50 years) were randomized into placebo (n =70) and
India
LI85008F (n =70) groups. The participants received either 900 mg/d of LI85008F in two divided
4
PLT Health Solutions Inc., Morristown, New
doses or two identical placebo capsules. In addition, participants were counselled to follow an
Jersey
~1800 kcal/d diet and to engage in walking for 30 min, 5 d/wk throughout the study.
Correspondence
Barbara A. Davis, PhD, PLT Health Solutions Results: At the end of the trial period, the LI85008F supplemented group showed significant
Inc., 119 Headquarters Plaza, Morristown, NJ reductions in body weight (5.36 1.769 vs. 0.87 1.381 kg; P < 0.0001) and BMI
07960. (2.05 0.693 vs. 0.34 0.559 kg/m2; P < 0.0001), compared with placebo. Significant reduc-
Email: barbara@plthealth.com
tions in waist and hip circumferences, and a 2.08-fold reduction of waist/hip ratio, were noted
Funding information
in the LI85008F supplemented group. LI85008F supplementation also resulted in significant
This study was funded by Laila Nutraceuticals,
India and PLT Health Solutions Inc. (grant improvements in lipid profiles, compared with the placebo; low-density lipoprotein (LDL) choles-
number C007185). terol decreased, while high-density lipoprotein (HDL) cholesterol increased, resulting in a signifi-
cantly improved LDL/HDL ratio. No major adverse events were reported by the participants
during the study.
Conclusions: The unique herbal extract blend LI85008F, combined with modest calorie restric-
tion and physical activity, is well tolerated, safe, and effective for weight management in over-
weight men and women.
KEYWORDS
body mass index, body weight management, Curcuma longa, LI85008F, Moringa oleifera,
Murraya koeingii, randomized double-blind placebo-controlled clinical study
1 | I N T RO D UC T I O N Alternative strategies for body weight management have become
widely adopted because of the high cost and potentially adverse
An estimated 1 billion adults are overweight and at least 300 million effects of conventional pharmaceutical and/or surgical interventions.
are obese worldwide, with prevalence increasing in most countries.1,2 Among those approaches, nutritional ingredients such as botanicals
Body mass index (BMI) is an established measure for classifying are popular for the management of overweight and obesity.5
3
weight, and is often used as a surrogate for total body fat. Over- The herbal combination, LI85008F, was developed to meet the
weight and obesity, classified by a BMI of 25-29.9 and ≥30 kg/m2, need for high quality, clinically evaluated botanical body weight man-
respectively, have been associated with increased risk of comorbid- agement dietary ingredients. An in vitro screening programme, estab-
ities such as type 2 diabetes, cardiovascular disease, osteoarthritis, lished by Laila Nutraceuticals (Vijayawada, India), evaluated hundreds
4
and some cancers. of herbal extracts for their ability to inhibit fat accumulation by
Diabetes Obes Metab. 2018;1–9. wileyonlinelibrary.com/journal/dom © 2018 John Wiley & Sons Ltd 1You can also read
