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Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
Page 1 of 9
Acknowledgement:
This complaint was worked up by the Monash University BMS3052 WAM Thurs 6pm Student group 12; then edited, checked by Mal Vickers and submitted by Assoc Prof Ken Harvey.
Summary:
Coenzyme Q10 plays a central role in mitochondrial oxidative phosphorylation and the production of adenosine triphosphate (ATP). It also functions as an antioxidant in cell membranes and lipoproteins.
Except for rare genetic disorders, CoQ10 deficiency has not been described in the general population. It is assumed that normal biosynthesis, with or without a varied diet, provides enough CoQ10 to sustain energy production in healthy individuals.
The fundamental problem with the promotion of this product is that Swisse extrapolate evidence from CoQ10’s important role in the body, and possible role as adjunctive therapy in heart failure and myocardial reperfusion injury, to making implied claims that taking this product as a supplement will benefit normal healthy people.
This is a common logical fallacy employed by the complementary medicine industry to mislead the public and arouse unwarranted expectations of product effectiveness.
Accordingly, we allege the following claims made for Swisse Ultiboost Co-enzyme Q10 products breach the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a), 4(2)(c) and 7(2).
Claims:
1. Heart Health: Co-enzyme Q10 is important for heart health, supports a healthy cardiovascular system and helps maintain cardiovascular system health.
We dispute the implied claim that taking co-enzyme Q10 as a supplement in people without cardiovascular disease (including heart failure) is important for heart health, supports a healthy cardiovascular system and helps maintain cardiovascular system health.
2. Healthy Arteries & Blood Vessels: Co-enzyme Q10 helps support artery and blood vessel health.
We dispute the implied claim that taking co-enzyme Q10 as a supplement in people without pre-existing disease helps support artery and blood vessel health.
3. Cellular Energy Production: Co-enzyme Q10 occurs naturally in most cells of the body and plays a vital role in the body’s cellular energy production processes. It is required by cells that have high energy requirements such as those in the heart, brain and muscles.
We accept this statement is in accord with scientific knowledge about the role of CoQ10 in the body but point out it provides no justification for supplementation in healthy people.
4. Antioxidant Support: Co-enzyme Q10 is known for its powerful antioxidant function. This vitamin-like substance helps to protect cells against free radical damage.
This statement is also in accord with scientific knowledge about the role of CoQ10 but also provides no justification for its supplementation in healthy people. Current recommendations are that a healthy diet can provide all the antioxidants you need to fight free radical damage.
5. Ageing Support: There may be an increased need for supplemental co-enzyme Q10 in the elderly due to levels decreasing with age.
Once again, the implied claim is that taking CoQ10 as a supplement will be beneficial for the elderly. We dispute this claim.
Advertisement type: Internet
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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Where did it appear:
• https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-absorb-well-co-enzyme-q10
• https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
• https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-co-enzyme-q10-(1)
• https://www.chemistwarehouse.com.au/buy/66485/swisse-ultiboost-co-enzyme-q10-150mg-50-capsules
• https://www.woolworths.com.au/shop/productdetails/806468/swisse-ultiboost-high-strength-co-enzyme-q10
• https://www.pharmacyonline.com.au/swisse-ultiboost-co-enzyme-q10-absorb-well-50mg-cap-x-45
• http://www.mychemist.com.au/product.asp?id=79795&pname=Swisse+Ultiboost+Co+Enzyme+Q10+150mg+180+Capsules
• Etc.
Date seen: 31 October 2018
Products:
1. Swisse Ultiboost High Strength Co-Enzyme Q10; ARTG ID: 304748 Active ingredients: ubidecarenone - 300 mg ARTG Start Date 19/06/2018 Uses permitted indications:
• Antioxidant/Reduce free radicals formed in the body
• Maintain/support heart health
• Maintain/support artery health
• Maintain/support blood vessel health
• Maintain/support (state vitamin/mineral/nutrient) levels in the body Warning:
• Do not take while on warfarin therapy without medical advice.
2. Swisse Ultiboost Absorb Well Co-Enzyme Q10; ARTG ID: 218376 Active ingredients: ubiquinol-10 - 50 mg ARTG Start Date 11/12/2013 Specific Indications in addition to above:
• Ubiquinol is a bioavailable form of Co-enzyme Q10 for increased absorption
• Supplementation with CoQ10 may support quality of life in elderly people#
• CoQ10 levels may be lower in elderly people
• Supports the maintenance of healthy ubiquinol levels.
• Co-enzyme Q10 helps maintain normal cholesterol levels in healthy people#
3. Swisse Ultiboost Co-Enzyme Q10; ARTG ID: 198572 Active ingredients: ubidecarenone- 150 mg ARTG Start Date 18/06/2012 Specific Indications as for ARTG 218376
# These specific indications are not present in the most recent public summary for ARTG 304748 and are also disputed.
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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Screen shots:
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-high-strength-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-absorb-well-co-enzyme-q10
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-absorb-well-co-enzyme-q10
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-co-enzyme-q10-(1)
https://swisse.com/en-au/products/vitamins-supplements/heart-health/swisse-ultiboost-co-enzyme-q10-(1)
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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Claims disputed and rationale:
1. Heart Health: Co-enzyme Q10 is important for heart health, supports a healthy cardiovascular system, helps maintain cardiovascular system health.
As justification (under their Science tab) Swisse cited Flowers et al. (2014). Co-enzyme Q10 supplementation for the primary prevention of cardiovascular disease (Review)', Cochrane Database of Systematic Reviews, 12: 1-37.1
This review aimed to determine the effects of coenzyme Q10 supplementation as a single ingredient for the primary prevention of CVD.
The review included trials administering CoQ10 as a single supplement in healthy adults or those at high risk of CVD (but without a diagnosis of CVD) and assessed cardiovascular events or major CVD risk factors, such as blood pressure and lipid levels.
They found six completed randomised controlled trials with a total of 218 participants randomised. All were conducted in participants at high risk of CVD. Two examined CoQ10 supplementation alone and four examined CoQ10 supplementation in patients on statin therapy.
The trials were small and short-term, none measured cardiovascular events or adverse events, and two of the six trials were regarded as being at high risk of bias. Very few small trials contributed to the analyses and no conclusions could be drawn.
They also identified five ongoing trials and the results from these will add to the evidence base in due course. More longer-term trials are needed to determine the effect of CoQ10 on cardiovascular events.
An Editorial by Stanton RA, (2015) also concluded that, until further research into CoQ10 is published, convincing evidence that this is a useful supplement remains elusive.2
Other references cited by Swisse included:
• Alehagen et al. (2015) which studied the combination of selenium and CoQ10 on
cardiovascular mortality (KiSel-10 intervention study) over 4-years in an elderly selenium-deficient Swedish population.3 This study was judged irrelevant due to combination therapy.
• A Health Canada Monograph on CoQ10 that cited studies in heart failure and protection of myocardial reperfusion injury (Rosenfeldt et al. 2007; Baggio et al. 1994; Langstone et
al. 1988).4 Also judged irrelevant to primary prevention in healthy people.
• Shah et al. (2007) who found that one 50 mg dose of CoQ10 had no effect on ECG variables in 26 young health volunteers and exhibited only mild and transient effect on systolic blood pressure.5
Another Cochrane review (Madmani ME, et al., 2014) looked at trials that assessed the beneficial and harmful effects of coenzyme Q10 in patients with heart failure.6 No conclusions could be drawn on the benefits or harms of coenzyme Q10 in heart failure as trials published to date lacked information on clinically relevant endpoints.
Furthermore, existing data were derived from small, heterogeneous trials that concentrated on physiological measures; their results are inconclusive. Until further evidence emerges to support
1 https://www.ncbi.nlm.nih.gov/pubmed/25474484 2 https://www.heartlungcirc.org/article/S1443-9506(15)00401-1/fulltext 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4666408/ 4 http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=ubiquinol&lang=eng 5 https://www.ncbi.nlm.nih.gov/pubmed/17341532 6 https://www.ncbi.nlm.nih.gov/pubmed/24049047
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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the use of coenzyme Q10 in heart failure, the authors concluded there might be a need to re-evaluate whether further trials testing coenzyme Q10 in heart failure are desirable.
A more recent meta-analysis of the efficacy of coenzyme Q10 in patients with cardiac failure was performed by Lei and Liu (2017).7 Compared with the meta-analysis published by Madmani in 2014 (above), the authors included 14 additional clinical investigations and 2149 more participants than in the previous meta-analysis. They also assessed the efficacy of coenzyme Q10 in the endpoints of mortality and NYHA classification.
They found that in patients with heart failure, the administration of coenzyme Q10 resulted in lower mortality and improved exercise capacity compared with the effects of placebo treatment. However, no significant difference was found between coenzyme Q10 and placebo in the endpoints of left heart ejection fraction and New York Heart Association (NYHA) cardiac function classification.
They noted several limitations in their meta-analysis and concluded that more rigorous, large-sample, international trials were needed to confirm their results.
Accordingly, we dispute the implied claim that taking co-enzyme Q10 as a supplement in people without cardiovascular disease (including heart failure) is important for heart health, supports a healthy cardiovascular system and helps maintain cardiovascular system health.
We allege this claim breaches the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a) & 4(2)(c).
2. Healthy Arteries & Blood Vessels: Co-enzyme Q10 helps support artery and blood vessel health.
Swisse cited Gao L et al. (2012). 'Effects of coenzyme Q10 on vascular endothelial function in humans: a meta-analysis of randomized controlled trials'. Atherosclerosis, 221: 311-316.8
The authors noted that the effect of oral CoQ10 supplementation on endothelial function in patients with coronary artery disease, heart failure and diabetes mellitus had been investigated by many studies. However, the results of these studies were inconsistent, and the sample sizes were relatively small. As a result, the precise effect of CoQ10 supplementation on endothelial function has not been established.
They reviewed 5 studies involving 194 participants of whom 97 were randomly allocated to CoQ10 therapy and 97 to control. They noted that 44.3% of participants had diabetes, 34.5% had hypertension, and 27.8% had established coronary artery disease. They found that CoQ10 supplementation was associated with significant improvement in flow-dependent endothelial-mediated dilation (FMD), a functional parameter commonly used as a biomarker of vascular function.
The results were not broken down into participants with or without pre-existing disease so the relevance of this surrogate measure to a normal patient population is uncertain.
The authors concluded that to what extent CoQ10-mediated improvement in endothelial function is causally related to a reduction in cardiovascular events can only be determined by large, long-term randomized trials on clinical endpoints.
Accordingly, we dispute the implied claim that taking co-enzyme Q10 as a supplement in people without pre-existing disease helps support artery and blood vessel health.
We allege this claim breaches the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a) & 4(2)(c).
7 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5525208/ 8 https://www.ncbi.nlm.nih.gov/pubmed/22088605
Complaint to TGA: Swisse Ultiboost Co-enzyme Q10
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3. Cellular Energy Production: Co-enzyme Q10 occurs naturally in most cells of the body and plays a vital role in the body’s cellular energy production processes. It is required by cells that have high energy requirements such as those in the heart, brain and muscles.
4. This statement is in accord with scientific knowledge about the role of CoQ10 in the body, but it provides no justification for supplementation in healthy people.
Except for rare genetic disorders, CoQ10 deficiency has not been described in the general population. It is assumed that normal biosynthesis, with or without a varied diet, provides sufficient CoQ10 to sustain energy production in healthy individuals.9
5. Antioxidant Support: Co-enzyme Q10 is known for its powerful antioxidant function. This vitamin-like substance helps to protect cells against free radical damage.
This statement is also in accord with scientific knowledge about the role of CoQ10 but provides no justification for its supplementation in healthy people. Current recommendations are that a healthy diet can provide all the antioxidants you need to fight free radical damage. 10 ,11
6. Ageing Support: There may be an increased need for supplemental co-enzyme Q10 in the elderly due to levels decreasing with age.
There are inconsistencies with measurements of plasma levels of CoQ10 in individuals of different ages with varying levels of physical activity. Among young people, more physical activity may correlate with lower CoQ10 levels in plasma, but in older people, higher levels of physical activity are related to higher plasma levels of CoQ10. More physical activity in older people may thus negate any need for supplements of CoQ10.12
Finally, only rare cases of documented coenzyme Q10 deficiency with symptoms of weakness, fatigue, and seizures have been reported.13 Thus it can be assumed that a varied diet and a normal in-vivo synthesis will supply enough CoQ10 to healthy individuals.14
The implied advertising claim is that taking CoQ10 as a supplement will be beneficial for the elderly, however the evidence does not support this.
We allege this claim breaches the Therapeutic Goods Advertising Code 2015, s.4(1)(b), 4(2)(a) & 4(2)(c).
We also allege that as CoQ10 is a vitamin-like co-enzyme that s7(2) of the Code applies and that the absence of a statement to this effect is a breach of the Code.
Previous complaints:
Three upheld complaints about Co10 products were found including one referred to the Secretary (appended as it is not available on the CRP web site).15 Typically, no outcome of the latter referral is available on the TGA web site.
Dr Ken Harvey MBBS, FRCPA, AM Mobile: +61 419181910
2 November 2018
9 https://lpi.oregonstate.edu/mic/dietary-factors/coenzyme-Q10 10 https://theconversation.com/health-check-the-untrue-story-of-antioxidants-vs-free-radicals-15920 11 https://theconversation.com/what-are-antioxidants-and-are-they-truly-good-for-us-86062 12 https://www.ncbi.nlm.nih.gov/pubmed/24384733 13 https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=938 14 https://www.nature.com/articles/1600880 15 http://www.tgacrp.com.au/complaint-register/?_search=Coenzyme%20Q10
COMPLAINTS RESOLUTION PANEL DETERMINATION
Complaint 2016-12-003 Blooms Coenzyme Q10 150 Max
ARTG ID: AUST L 170927
Meeting held 20 April 2017
Complaint summary^
Complainants Requested anonymity
Advertiser Phytologic Holdings Pty Ltd T/A Blooms Health
Subject matter of complaint Internet advertisements
Type of determination Final
Sections of the Code,
Regulations or Act found to
have been breached*
Act section 42DL(1)(f)
Code sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(6)(b), 5(1), 5(2)
Sections of the Code,
Regulations or Act found not
to have been breached*
None
Sanctions
Publication of retraction
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.
The advertisement(s)^
1. The complaint concerned internet advertisements published at the websites
www.bloomshealth.com.au, www.discountdrugstores.com.au, www.pharmacydirect.com.au,
www.pharmacyonline.com.au, viewed by the complainant in December 2016.
2. The advertisement at www.bloomshealth.com.au/coenzyme-q10-energy-enzyme/ (the sponsor’s
website) comprised an article by Gerald Quigley, a well-known pharmacist, in which the benefits of
Coenzyme Q10 (CoQ10) were described as “amazing” and promoted its use for disease states
ranging from high blood pressure and heart attacks to deficiencies of the immune system and cancer.
Other aspects relating to CoQ10 were discussed, including prescription medicines’ interference with
CoQ10, its effect on ageing, weight loss, antioxidant action and other effects. The article concluded
by referring to Blooms Coenzyme Q10 150 Max.
3. The product page advertisement at www.bloomshealth.com.au/products/coenzyme-q10-150-max/
included a pack shot and representations such as “assists with the optimal absorption of the powerful
antioxidant Coenzyme Q10”, “helps to improve stamina and endurance”, “With 150mg Coenzyme
Q10 and 150mg Omega 3 fish oil, Blooms Coenzyme Q10 150 Max supplies an advanced health
and stamina formula in one daily capsule”, “can help maintain performance as well as assist
recovery following exercise”, “CoenzymeQ10 is a powerful free radical scavenger that may assist in
maintain peripheral circulation and reduces oxidation of LDL (bad) cholesterol”, “assists
maintenance of heart health – in particular heart muscle function and peripheral circulation” and
others.
4. The Discount Drug Stores website advertisement included a pack shot of the product and the
representations “assists with the optimal absorption of the powerful antioxidant Coenzyme Q10”,
“helps to improve stamina, endurance and recovery after exercise”, “With 150mg Coenzyme Q10,
150mg Omega 3 and 50IU Vitamin E, Blooms Coenzyme Q10 150 Max supplies an advanced
health and stamina formula in one capsule a day.”
5. The Pharmacy Direct website advertisement included a pack shot of the product and the wording
“Help put the spring back in your step with Blooms Coenzyme Q10 150 Max to assist the
production of cellular energy and help support stamina and endurance!”
6. The Pharmacy Online advertisement included similarly worded representations.
7. An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.
The product(s)
8. The advertisements promoted the product Blooms Coenzyme Q10 150 Max (AUST L 170927).
The advertiser(s)
9. The advertiser was the sponsor of the product, Phytologic Holdings Pty Ltd.
The complaint^
10. The complainant requested anonymity.
11. The complainant alleged that claims in the advertisements breached sections 4(1)(b), 4(2)(a),
4(2)(c), 4(2)(d), 4(6)(b), 5(1) and 5(2) of the Code and listed them as follows:
a) Sections 4(1)(b), 4(2)(a) and 4(2)(c) in relation to the claims “Assist in maintenance of ‘general
heart health’ and “offer[s] support for those with cardiovascular disease”. The complainants
stated that “There are no studies investigating or supporting the use of CoQ10 in the general
population for “heart health” and held that there was no evidence available to support claims
relating to the use of coenzyme Q10 for “cardiovascular disease” (angina, stroke), “peripheral
circulation”;
b) Sections 4(1)(b), 4(2)(a) and 4(2)(c) in relation to the representation that “In patients taking
“cholesterol reducing medication (statins) and beta blockers” CoQ10 is “shown by research to be
useful”. The complainants held that research demonstrated that any decrease of CoQ10 level in
muscles was insignificant and did not improve statin-induced myopathy and that there is
insufficient evidence of CoQ10 interference with statins;
c) Sections 4(1)(b), 4(2)(a) and 4(2)(c) in relation to the inadequacy of evidence to support
representation that CoQ10 can “increase energy levels in both sedentary individuals and in
athletes, Increases endurance and stamina”;
d) Sections 4(1)(b), 4(2)(a) and 4(2)(c) in relation to inadequacy of evidence to support the
representation “Obese people are often deficient in CoQ10 and supplementation”; and in relation
to the claim “CoQ10 retards various aspects of the aging process, including the aging process
within the brain. It has been shown to retard the accelerated death of cells involved in the aging
process” as “There is no research on CoQ10 for the prevention of brain aging in healthy adults.”
e) Sections 4(1)(b), 4(2)(a) and 4(2)(c) (through the complainant’s wording) “Once the body levels
of CoQ10 become more than 25 per cent deficient, many disease states start to flourish. These
can range from high blood pressure and heart attacks to deficiencies of the immune system and
cancer.” The complainant also specifically raised breaches of section 5(1) (in relation to cancer),
5(2) (because references to cardiovascular disease) and 4(2)(d) of the Code in relation to this
claim.
f) Section 4(6)(b) of the Code by containing an endorsement by a healthcare professional – Mr
Quigley in his capacity as a pharmacist.
12. The complainant stated “Copies of referenced material are available upon request” and provided lists
of references as footnotes. No actual copy of any paper was provided to the Panel.
Additional matters raised by the Panel
13. 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
possible breaches of:
Section 42DL(1)(f) of the Act because of the references to statins and beta blockers
Section 5(2) of the Code because the references to serious conditions and diseases such as high
blood pressure, heart attacks and cancer, as well as cardiovascular disease as raised by the
complainant
Section 4(2)(b) of the Code because the advertisement may lead to consumers self-diagnosing or
inappropriately treating potentially serious diseases
The advertiser’s response to the complaint^
14. 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.
15. As the advertising claims included in the retailer website advertisements were substantially the same
the sponsor’s advertising, the Panel did not seek a response from the retailers as it appeared that the
sponsor was apparently responsible for the claims. The Panel, therefore, sought a response only from
the sponsor, Phytologic Holdings Pty Ltd (Phytologic).
16. Phytologic acknowledged that “the article written by Mr Quigley breached the Therapeutic Goods
Advertising Code 2015 (the Code) in the ways described by the complainant, and have removed the
page from our website.”
17. Phytologic disputed the complainant’s allegation of inadequate evidence for the claims of support of
normal heart health, stating “Without contending that the overall message of the article went beyond
what was allowed by the Code, it is widely acknowledged in published literature that coenzyme
Q10’s normal roles in the body involve supporting heart health as well as energy production.
18. In support of their claims, Phytologic provided a copy of: a Health Canada Monograph: Coenzyme
Q10 (2007); Thorne Research Inc. Monograph: Coenzyme Q10. Alternative Medicine Review
(1998) a paper, Pizzorno JE Jr, Murray MT. Textbook of Natural Medicine Vol 1 (2nd ed) (1999) and
an internet article on coenzyme Q10 from an integrated medicine website.
Findings of the Panel
claims that were misleading, unverified etc
19. 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”. Section 4(2)(d) of the
Code prohibits advertisements which “abuse the trust or exploit the lack of knowledge of consumers
or contain language which could bring about fear or distress.”
20. The Panel’s view of the evidence was that none of it related directly to the advertised product, most
of it (and the references) was old and out-of-date, inadequate to support any extrapolation to benefits
for heart muscle function and peripheral circulation, let alone serious diseases, conditions or
disorders, and none was provided to support the claims “In patients taking cholesterol reducing
medication (statins) and beta blockers” CoQ10 is “shown by research to be useful”, “increase energy
levels in both sedentary individuals and in athletes, Increases endurance and stamina”, “Obese
people are often deficient in CoQ10 and supplementation” and “Once the body levels of CoQ10
become more than 25 per cent deficient, many disease states start to flourish. These can range from
high blood pressure and heart attacks to deficiencies of the immune system and cancer.” Therefore,
none of the evidence was appropriate for the claims of benefit made for this product in advertising
directed to consumers.
21. The Panel was satisfied that all of these representations were misleading, unverified, likely to arouse
unwarranted expectations, and abused the trust and exploited the lack of knowledge of consumers,
thus causing the advertisements to breach sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(2)(d) of the Code.
22. The Panel found, therefore, that these aspects of the complaint were justified.
references to serious health concerns
23. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-
diagnosing or inappropriately treating potentially serious diseases”.
24. Section 5(1) of the Code prohibits advertisements that “contain, expressly or by implication, a
representation specified in Part 1 of Appendix 6.” The representations specified in Part 1 of
Appendix 6 of the Code include representations regarding the treatment, cure, or prevention of
neoplastic diseases (cancer).
25. Section 5(2) of the Code prohibits advertisements that “refer, expressly or by implication, to serious
forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior
approval is given under the Therapeutic Goods Act 1989.” The diseases and conditions specified in
Part 2 of Appendix 6 of the Code include “serious forms of” a wide range of health concerns
including immune system and cardiovascular disease.
26. The Panel was satisfied that the inclusion of references to high blood pressure, heart attacks,
deficiencies of the immune system and cancer, as well as cardiovascular disease, rendered the
advertisement on the www.bloomshealth.com.au in breach of sections 5(1) and 5(2) of the Code; and
that such references were likely to lead to consumers self-diagnosing or inappropriately treating
potentially serious diseases in breach of section 4(2)(b) of the Code.
27. The Panel found, therefore, that these aspects of the complaint were justified.
healthcare professional recommendation
28. Section 4(6)(b) of the Code prohibits representations that therapeutic goods are endorsed by
healthcare professionals.
29. The Panel was satisfied that the promotional article on the product by the pharmacist Gerald Quigley
clearly represented the advertised product as being endorsed by a healthcare professional, in breach
of this section of the Code.
30. The Panel found, therefore, that this aspect of the complaint was justified.
references to schedule 4 products
31. Section 42DL(1)(f) of the Act prohibits the publication of advertisements for therapeutic goods that
refer to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the
current Poisons Standard.
32. The Panel was satisfied that the reference to statins and beta blockers in the advertisement
constituted a breach of this section of the Act.
33. The Panel found, therefore, that this aspect of the complaint was justified.
Noted with no formal finding made
34. Section 22(5) of the Act makes it an offence to advertise therapeutic goods for an indication, where
the indication is not an indication accepted in relation to the inclusion of the goods in the Register.
The Panel notes that this section of the Act applies to all, including sponsors, healthcare
professionals and advertisers. The Panel noted, without making any formal finding as this matter had
not been raised in the complaint, that the advertisement on the Blooms website was likely to breach
this section of the Act because of the inclusion of a number of claims not included as indications for
the product on the Register.
Sanctions
35. The Panel requests Phytologic Holdings Pty Ltd, in accordance with subregulation 42ZCAI(1) of the
Therapeutic Goods Regulations 1990:
a) to withdraw the advertisements from further publication;
b) to withdraw all the representations found above to breach the Act or Code, including any
healthcare professional recommendation, any reference expressly or by implication, to serious
diseases, conditions, ailments or defects, and any representations regarding the treatment, cure,
or prevention of neoplastic diseases (cancer);
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;
e) to arrange for publication on the website www.bloomshealth.com.au, of a retraction in the form
of, and in accordance with, the conditions set out in the attachment to this determination; and,
f) 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.
36. The attention of the advertisers 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 June 2017
For the Panel
Allan Asher
Chairman
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.
Appendix B: Retraction
An advertisement to appear on the home page of the website www.bloomshealth.com.au at the earliest
opportunity.
A copy of the retraction advertisement, in the context of the page on which it will be published, is to be
provided to the Complaints Resolution Panel for approval before publication and distribution.
RETRACTION An advertisement for the product Blooms Coenzyme Q10 150 Max, which we published on this website, should not have been published. In the advertisement we unlawfully made claims that the product could offer benefits in relation to a range of health concerns, including serious conditions such as high blood pressure, heart attacks, cardiovascular disease, deficiencies of the immune system and cancer. A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided inadequate evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code. The Panel therefore requested that Phytologic Holdings Pty Ltd T/A Blooms Health publish this retraction. The full text of the Panel’s determination can be found at: www.tgacrp.com.au/complaints (reference 2016/12/003)
No other copy should be included in the advertisement.
Location: website front page, so that it can be viewed without scrolling the page
Size: No less than 500 pixels wide and 200 pixels high
Heading:
Arial or Helvetica
Red, black and blue on a white background per above
The letters should be no less than 20 pixels in height, and should be no smaller than any
other body text on the page
Bold
Text: Arial or Helvetica
Red on a white background
The letters should be no less than 14 pixels in height, and should be no smaller than any
other body text on the page
Bold
Text Box: Red on a white background
Duration: 90 days
HTML In the case of website retractions, the retraction is to be presented in ordinary and valid
HTML 4 in the body of the page. Pop-ups, Flash objects, or images are not acceptable
formats for website retractions.
Appendix C: Excerpt of the Advertisement
