Nexdius Pty Ltd and Minister for Health

[2017] AATA 2295

Nexdius Pty Ltd and Minister for Health [2017] AATA 2295 (21 November 2017)

Division:GENERAL DIVISION

File Number(s):      2016/2163

Re:Nexdius Pty Ltd

APPLICANT

AndMinister for Health

RESPONDENT

DECISION

Tribunal:Deputy President J W Constance

Senior Member A Poljak

Date:21 November 2017

Place:Sydney

The decision under review is affirmed.

..................................[sgd]...................................

J W Constance
Deputy President

CATCHWORDS

HEALTH – Therapeutic Goods – Advertisement – approval of television advertisement – therapeutic goods advertising code – characteristics of the reasonable person – claims, statements and comparisons – whether advertisement complies with clause 4 of the advertising code – unwarranted and unrealistic expectations – product effectiveness – correct and balanced statements – claims and statements verified by sponsor – abuse of trust or exploiting the lack of knowledge of consumers – whether language used could bring about fear or distress – Comparative advertisements – must not be misleading or likely to be misleading – public health messages – sunscreens – solar UV radiation – UVB – production of vitamin D – sunburn – decision affirmed

LEGISLATION

Therapeutic Goods Act 1989(Cth) s 42C

CASES

Cadbury Schweppes Pty Ltd v Darrell Lea Chocolate Shops Pty Ltd (2007) 159 FCR 397

SECONDARY MATERIALS

Therapeutic Goods Advertising Code 2015 (Cth)

Therapeutic Goods Regulations 1990 (Cth) reg 5G, 5M

REASONS FOR DECISION

Deputy President J W Constance
Senior Member A Poljak

21 November 2017

INTRODUCTION

1. Nexdius Pty Ltd (“Nexdius”), the applicant, sought to advertise three “Solar D” branded sunscreens; Solar D Daily Use SPF 50 (AUST L 224353); Solar D Active SPF 30 (AUST L 2243554); and Solar D Kids (AUST L 2243555) (“Solar D sunscreens” and “Solar D”). Nexdius is the sponsor of the Solar D sunscreens which are listed in the Australian Register of Therapeutic Goods (“ARTG”).

2. These proceedings concern certain claims and comparisons made and conveyed by an advertisement for the three Solar D sunscreens (“the Advertisement”). Nexdius asserts that the distinctive claim of Solar D sunscreens is that they provide a high level of broad-spectrum protection, including against sunburn, while allowing some of the sunlight through that users need to produce vitamin D.

3. On 31 March 2016, a delegate of the Minister for Health (“Minister”), pursuant to regulation 5M of the Therapeutic Goods Regulations 1990 (Cth) (“the Regulations”), decided to affirm the decision made on 8 September 2015, refusing to approve the Advertisement (the “decision”). The reason for the decision was that the Advertisement did not comply with reg. 5G(1)(a) of the Regulations in that, when assessed in terms of its probable impact on the reasonable person to whom it was directed, it did not comply with clauses 4(1)(b), 4(2)(a), (2)(d), (2)(e)(ii) and 4(5) of the Therapeutic Goods Advertising Code 2015 (Cth) (“the Code”).

4. The issues to be determined in these proceedings are:

   (a)the characteristics of the reasonable person to whom the Advertisement is directed (clause 3(2) of the Code);

   (b)what claims, statements and comparisons the Advertisement makes, and what images and words in the Advertisement convey, and are likely to convey, to the reasonable person to whom it is directed (clause 3(2) and 4(5) of the Code); and

   (c)whether the Advertisement, so understood, complies with clause 4 of the Code (regulation 5G(1) of the Regulations).

   RELEVANT LEGISLATIVE PROVISIONS

5. Under the Therapeutic Goods Act 1989 (Cth) (“the Act”), to be lawfully supplied in Australia, therapeutic goods must be included in the ARTG, unless the goods are exempted under the Regulations or excluded from this requirement in accordance with the Act.

6. Schedule 4 to the Regulations prescribes the types of therapeutic goods that must be included in the part of the ARTG for listed goods. Item 7 of Part 1 of Schedule 4 provides the types of sunscreens that must be listed. Sunscreens that do not satisfy the definition in Item 7 are required to be registered goods. It is not in dispute in these proceedings that the Solar D sunscreens are listed therapeutic goods in the ARTG.

7. Pursuant to section 42C of the Act, it is an offence to publish or broadcast; or cause to be published or broadcast; in “specified media” (including television), an advertisement that is required by the Regulations to be an approved advertisement and the advertisement is not approved.

8. In practice, the power to approve an advertisement for sunscreens in specified media has been delegated to the Australian Self Medication Industry (“ASMI”).

9. The advertising of “designated therapeutic goods” (as defined in the Regulations) is regulated by Part 2, Division 2 of the Regulations. Relevantly, reg. 5G provides:

   (1)  If an application for approval of an advertisement is made and the prescribed fee is paid, the Secretary must approve the advertisement if the Secretary is satisfied that it:

   (a)  complies with the Therapeutic Goods Advertising Code;…

   (3)  Otherwise, the Secretary must refuse to approve the advertisement.

   (4)  An approval may be subject to conditions imposed by the Secretary.

   The Code

10. The Code is a legislative instrument, the object of which is to ensure that the advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible, and does not mislead or deceive consumers (clause 1(1)). The conformity of an advertisement with the Code “should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed” (clause 3(2)).

11. The provisions of the Code at issue in this matter are that an advertisement for therapeutic goods must:

    ·contain correct and balanced statements only in claims which the sponsor has verified (clause 4(1)(b));

    ·not be likely to arouse unwarranted and unrealistic expectations of product effectiveness (clause 4(2)(a));

    ·not abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress (clause 4(2)(d));

    ·not contain any matter which is likely to lead persons to believe:

    (i)that they are suffering from a serious ailment; or

    (ii)that harmful consequences may result from therapeutic goods not being used.

    Sunscreen preparations are exempted from (ii) if the claims made in the advertisement are consistent with current public health messages (clause 4(2)(e));

    and the requirement that:

    ·Comparative advertisements must be balanced and must not be misleading or likely to be misleading, either about the therapeutic goods advertised or the therapeutic goods, or classes of therapeutic goods, with which it is compared. Points of comparison should be factual and reflect the body of scientific evidence. Comparisons should not imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual (clause 4(5)).

    THE ADVERTISEMENT

12. The Advertisement contains a number of statements, the most pertinent being:

    (a)“... I have found the next generation in sunscreen. It allows some of the sunlight that allows our bodies to produce vitamin D…” (“First Statement”); and

    (b)“…I know it is the best. I put it on my kids everyday so they get some of the sunlight they need but are still protected against sunburn…” (“Second Statement”).

13. The proposed visuals attached to these statements are of a female surfer on the beach and a mother watching children in a swimming pool.

14. In addition, there is a proposed visual of a female model at a fashion shoot with the attached statement “… I use under my makeup, don’t get sunburnt and it is so smooth on my skin…”.

    The characteristics of the reasonable person to whom the advertisement is directed (clause 3(2) of the Code)

15. Nexdius contends that the target audience for the Advertisement is users of sunscreen products for the prevention of sunburn, for both themselves and their children; and consumers who may be interested in the additional benefit offered by the Solar D sunscreens in relation to the greater scope for vitamin D production. This identification of the target audience by Nexdius is very broad and in our minds, appears to be a general description of the consumers of Solar D sunscreens but does not adequately identify the target audience or reasonable person to whom the Advertisement is directed.

16. When considering the conformity of the Advertisement with the Code it should be assessed in terms of its probable impact upon the reasonable person to whom it is directed. The proposed visuals attached to the Advertisement transcript are of women. A female surfer on the beach, a mother watching her children in a swimming pool, and a female model at a fashion shoot. The Advertisement transcript includes, inter alia, statements referring to the use of the sunscreen under make up and its smooth texture on the skin. As a starting point, we find that the visuals and transcript of the Advertisement are directed towards women and mothers with young children. This is supported by the expert report of Dr Paul Harrison dated 3 March 2017 (“Harrison report’), which examines the likely effects, in relation to consumer behaviour, of the Solar D advertisement, and, specifically, the probable impact on the reasonable person to whom it is directed. Dr Harrison has expertise in marketing and consumer behaviour. Nexdius does not challenge Dr Harrison’s expertise.

17. The Harrison report is relevant because these proceedings concern certain claims and comparisons made by the Advertisement. The very purpose of advertising is to engage a specific consumer audience. The Code reflects this, at clause 3(2), by expressly invoking the person to whom the advertisement is directed, and requiring attention to be focused on that class of persons. Clause 3(2) provides:

    “The conformity of an advertisement with this Code should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed.” [Emphasis added]

18. In addition, expert evidence in relation to consumer perceptions and behaviour has been accepted as relevant and admissible in claims where consumer behaviour is in issue; see Cadbury Schweppes Pty Ltd v Darrell Lea Chocolate Shops Pty Ltd (2007) 159 FCR 397.

19. In the Harrison Report, Dr Harrison opines that the principal audience/target market for the Advertisement, at a very broad level, is young, Caucasian, relatively affluent women. Without providing a specific age range, he clarifies that “…the target market for this campaign is likely to be young, aspirational mothers, who are concerned about being connected to each other through their social identity, and through this demonstrating a concern with both their appearance and the well-being of their young children. In addition, the target market is likely to place high value on how they are perceived by their social group, with a desire to be perceived as successful and attractive, as well as good mothers.”

20. In addition to opining on the target audience, Dr Harrison provides an expert opinion on factors relevant to the decision-making process of consumers, including what they are influenced by; aspects of the Advertisement that are likely to influence the response of the audience; and a consumer’s probable perceived efficiency of the product based on the Advertisement.

21. On face value, it appears that the focus of the reasonable person to whom the Advertisement is directed would be on the health impacts of the Solar D sunscreens i.e. the products protect against sunburn but allow some of the sunlight that enables our bodies to produce vitamin D. However, Dr Harrison notes that although comparisons between products may come into the consumer decision-making process; this process is rarely based on rational drivers. He says consumers do not compare products equally, but are instead influenced by a range of cognitive, social, and psychological processes. He opines that the “…most influential comparison consumers will make on this advertisement is likely to be on perceived benefits gained”, and that “the benefits gained and emphasised in the Advertisement are unlikely to be predominantly about sun protection, health or vitamin D, but rather cultural acceptance in appearing as successful mothers, physical acceptance through youth and beauty, and social acceptance in a peer group by using an appropriate and socially sanctioned product”. Women would likely adopt a risk management approach, “where even when product claims are deemed dubious, doing something (i.e. buying the product) may be perceived as a better strategy than doing nothing”.

    Claims, statements and comparisons made by the Advertisement (clause 3(2) and 4(5) of the Code)

22. The respondent contends that, properly understood, the Advertisement conveys the following claims and messages:

    (a)Solar D is the next generation of sunscreen and, implicitly, all other sunscreens are the present generation of sunscreen;

    (b)Solar D is effective in ways that other sunscreens (the present generation) are not;

    (c)the distinctive modes of effectiveness of Solar D are that :

    (i)it allows users (including children) to get some of the sunlight human bodies need to produce vitamin D and thereby to produce some of the positive health effects of vitamin D production, while still protecting users against sunburn (and, implicitly, the possible consequential adverse health effects of sunburn);

    (ii)implicitly, by comparison, other sunscreens do not allow users (including children) to get some of the sunlight human bodies need to produce vitamin D and thereby to produce some of the positive health effects of vitamin D production. Other sunscreens impede the body’s ability to produce vitamin D by blocking sunlight, such that use of other sunscreens, instead of Solar D, will result in a differential of vitamin D production arising from exposure to sunlight. That differential is sufficiently psychologically meaningful to be linked to reduced (and possibly insufficient) vitamin D levels and reduced enjoyment of the positive health effects of vitamin D production.

23. Nexdius accepts that the Advertisement is comparative. The use of express terms such as “next generation” and superlative “the best” involve inherently comparative statements and convey claims of comparative advantage.

    RELEVANT SCIENTIFIC MATTERS

24. The scientific matters relevant to the context of the Advertisement are solar ultraviolet (“UV”) radiation, UVB and vitamin D production. In considering these matters, we are assisted by the considerable expertise of Professor Michael Holick and Professor Rebecca S Mason; both of whom provided a number of detailed written reports in these proceedings and gave oral evidence (concurrently) at hearing.

25. The evidence as to uncontroversial scientific matters surrounding solar UV radiation, vitamin D production and the effects of sunscreen are relevantly summarised below.

    Sunscreen and Solar UV Radiation

26. Solar UV radiation reaching the Earth’s surface comprises two wavelength bands: UVB (280-320 nm) and UVA (320-400 nm). The vast majority (in terms of numbers of photons) being UVA (>95%).

27. The adverse clinical effects of UV radiation are well documented and include sunburn (technically, erythema) in the short-term and skin cancer and other skin damage (particularly elastosis, which can lead to wrinkling and stiffness) in the long-term.

28. Sunscreens are labelled with a sun protection factor (SPF), which is the primary standard measure used throughout the world to indicate a sunscreen’s level of protection against erythema. Sunscreen products with a lower SPF should allow the transmission of more UV radiation than higher SPF products. “Broad-spectrum” sunscreens protect against both UVA and UVB radiation.

    UVB and vitamin D production

29. UV radiation, specifically the UVB component, is vital for normal health and development because it facilitates the production of vitamin D in the body.

30. Vitamin D appears to play an important and beneficial role in numerous physiological systems, particularly bone and muscle development and immunity, and is essential for overall health. Vitamin D deficiency can have significant health consequences such as causing rickets in children and precipitating and exacerbating osteopenia, osteoporosis and fractures in adults. Vitamin D deficiency has also been associated with increased risk of common cancers, autoimmune diseases, hypertension and infectious diseases.

31. Vitamin D is produced in the skin as a result of the photochemical interaction of UVB radiation with the steroidal compound 7-dehydrocholesterol (7DHC) which is naturally present in the skin. Upon entering the skin, photons of UVB radiation (290-315 nm) interact with and excite the 7DHC molecules, leading to the production of an intermediate compound, the precursor to vitamin D, pre-vitamin D3 (pre-D). Pre-D is thermodynamically unstable and is subsequently converted into vitamin D, much of which is stored in body fat cells. Vitamin D which enters the circulation is converted to calcidiol in the liver and subsequently to its active form, calcitriol, in the kidneys. The serum concentration of calcidiol is the value used for determining ‘vitamin D concentration’ in vivo.

32. Vitamin D is also found in small amounts in some foods and may be obtained from the consumption of those foods. However, the amount of vitamin D obtained from food is generally only a small proportion of the average person’s intake/production (less than 10%), and most people get most of the vitamin D they need from exposure to solar radiation (specifically, UVB) or supplements.

33. Several factors limit the production of vitamin D in human skin. The most important is whether people go out into the sun at all when there is some UVB, that is, neither too early nor too late in the day. There is also a large inter-individual variation in the production of vitamin D that results from large variations in metabolism; environmental factors; personal factors (such as skin pigmentation, age and genetic factors) and behavioural factors (such as sun avoidance and clothing). Additionally, there is concern that sunscreen use, by blocking UVB transmitters to the skin, may negatively affect vitamin D synthesis of long-term vitamin D levels.

34. Some data indicates that people will achieve a sufficient vitamin D status (greater than 50nmol/L) if, in those days when there is some UVB, they expose approximately 15% of body surface (that is arms and hands or equivalent areas of skin), around the middle of the day, to one third of the amount of sun exposure that would just cause slight reddening of the skin. This amount of sunlight exposure depends on skin colour, latitude and time of year and time of day, but for people with mostly white skin, in summer in Australia, this equates to approximately 6 to 10 minutes, mid-morning or mid-afternoon.

    CONSIDERATION

    Does the Advertisement Comply with Clause 4 of the Code: Reg. 5G(1) of the Regulations?

    Clause 4(1)(b): Correct and balanced statements only and claims verified by the sponsor

    Sunscreen use, transmission of sunlight and vitamin D production

35. The distinctive claim of Solar D is that it allows users to get some of the sunlight human bodies need to produce vitamin D. For the following reasons, we are satisfied that this claim is a correct and balanced statement and is verified by Nexdius.

36. Professor Holick opined in his report dated 20 October 2016, that in regards to the results contained in the TGA Laboratory Report, “the increased UVB transmittance observed for the Solar D products versus the tested comparators can certainly be physiologically significant in relation to cutaneous vitamin D production, particularly in the context of sunscreen use over large exposure areas and over time (e.g. people wearing minimal clothing or swimwear at the beach)” (at [39]). He goes on to say that “…cutaneous vitamin D production occurs linearly relative to UVB exposure until equilibrium is reached. Therefore, even a small increase in UVB transmittance will result in a proportional increase in cutaneous vitamin D production, and if a large area of skin is exposed, then the cumulative dose of vitamin D produced may be substantial” (at [40]).

1. At hearing, Professor Mason accepted that broad-spectrum sunscreens in Australia are designed to, and do, impede the transmission of UVB such that with the use of sunscreen (if applied correctly) vitamin D synthesis would be lower than it would otherwise be. She accepted the proposition that an increased exposure to UVB reception, will generally lead to an increase in vitamin D production, so long as the people being exposed are not hitting their threshold limit. Specifically in regards to Solar D, Professor Mason agreed that it lets more UVB through.

2. A Therapeutic Goods Administration (“TGA”) laboratory test was conducted comparing two of Nexdius’ sunscreens (one of which is the subject of these proceedings) to a Nivea brand SPF 15 product and a Cancer Council brand SPF 30+ product (“the TGA Tests”). Three test methods were used to measure UV transmittance of each of the four sunscreens: a solution test method at two different concentrations of test product (0.8mg/mL and 0.4mg/mL), and a thin film method. The methodology, results and conclusions of the TGA Tests are set out in a report dated 24 November 2015 (“TGA Laboratory Report”).

3. In conclusion, the TGA Laboratory Report records:

   “…With regard to the transmission of UVB radiation, both Solar D samples were observed using the aforementioned test (expanded to cover the UVB region) to have some limited transmittance of UVB wavelength. More transmittance was observed at the lower concentration. The amount of UVB radiation permitted by the Solar D sunscreens to pass to the skin will therefore depend on the thickness of the sunscreens applied to the skin.

   The corresponding comparators had less transmittance of UVB wavelengths than the Solar D samples at the same concentrations…

   Given the limited transmittance of UVB radiation by the Solar D samples observed in the test, it is uncertain as to whether the amount of UVB radiation reaching the skin, when the Solar D sunscreens are applied as directed, will be significant in terms of vitamin D production.”

4. In general terms, the results of the TGA tests indicate that Solar D sunscreens generally let through more UVB radiation than other sunscreens, particularly in circumstances where the testing involved lower concentration/thicknesses of sunscreens. While this proposition is somewhat accepted by the respondent, only one Solar D product the subject of these proceedings was tested; the Solar D products were tested against a limited number of other sunscreens, of differing SPF indexes; and the TGA Tests were laboratory and not clinical tests. Despite these limitations, the ultimate conclusion of the TGA Tests that Solar D sunscreens let through more UVB radiation than other sunscreens is consistent with the results of testing done by an independent Australian laboratory, Dermatest.

5. The Dermatest testing was conducted at 1.3mg/mL thickness, higher than the 0.4mg/mL and 0.8mg/mL of the TGA tests, yet the same comparative advantage was illustrated at that thickness. Professor Mason accepted that, subject to ignoring the apparently anomalous Cancer Council SPF 30 product, the Dermatest results show that the Solar D product let through “significantly” more UVB than the comparators.

6. The Kockott study, in which Professor Holick participated, compared an experimental Solar D formulation which optimised UVB transmission, against a regular commercial sunscreen (Neutrogena) with the same SPF rating for their respective abilities to permit the production of vitamin D with exposure to simulated solar UV radiation.[1]

   [1] Kockott D, Herzog B, Reichrath J, Keane K, Holick MF, ‘New Approach to Develop Optimise Screens That Enable Cutaneous Vitamin D Formulation with Minimal Charisma Risk’ (2016) PLoS ONE 11(1): e0145509.doi:10.137/journal.pone.0145509.

7. The results of the Kockott study showed 1.5 times the amount of pre-D generation with the Solar D product compared to the comparator Neutrogena products and concluded “Based on our previous observations the in vitro results can be directly translated to what would be expected when the sunscreens are used on human skin. Therefore we have proof of principle that sunscreen can be produced for optimising pre-vitamin D3 production while retaining its sun protection factor for reducing erythema.”

8. Although Professor Mason made some criticisms of the study in her written reports, these criticisms seemed to fall away in light of further material. She accepted the conclusions in the Kockott study, but indicated uncertainty regarding “what to make of it in relation to the real world”. She accepted that the results may be directly translated to what would be expected when the sunscreens are used on human skin, but qualified this by saying that you cannot infer what is going to happen in skin just from what happens in a test tube. Although she accepted that there would be increased reception of UVB and production of pre-D for the Solar D product compared to the Neutrogena product, in the absence of data and in lieu of clinical tests or skin tests, she did not know “how big that effect would be”.

9. Professor Holick’s response was that clinical trials which had been considered by the Kockott study team (of which he was a part of) could not be accomplished for practical and scientific reasons, and instead they adopted a method they had “been routinely using, for the past 30 years” which they felt “very confident with, in terms of being able to translate that in vitro system to in vivo human” based on other published work. Professor Mason speculated that about 50 people would be required for a clinical trial however Professor Holick advised that he and his colleagues had actually done the ‘power calculations’ and found that they would need at least 500-1000 participants. In regards to the possibility of skin tests, it was accepted that a high-intensity lamp would need to be used to conduct such a test. This again raised some issues. Professor Holick advised:

   “We thought about this. So the radiation is one over distance squared. So the closer that you make it, there’s no question that there is a better flux (indistinct) Sperti lamp is a fluorescent lamp system, and as Professor Mason has suggested, it actually generates a fair amount of heat. So when we really brought it very close (indistinct) a piece of bacon, basically – so even though we had it on ice, there is still that surface of the skin, the epidermis, which is extremely thin, which is where your pre-vitamin D is made, just basically got destroyed.”

10. Having regard to the scientific material and the general consensus of the experts, it is plain that the relationship between UVB, to the production of pre-D and then vitamin D in the skin, is a linear relationship. The active form of vitamin D in serum is ultimately 25-hydroxyvitamin D (“25 OHD”). The process of converting vitamin D to 25 OHD occurs in the liver and is not a linear relationship. It is a much more complex process and is dependent on a number of variable factors, most significantly, metabolism. As these proceedings concern an Advertisement for a sunscreen, the only relationship of concern is the linear relationship between UVB in the skin leading to the creation of pre-D and vitamin D. This is all the Advertisement says and it is the only input Solar D can relevantly control.

11. Ultimately, Professor Mason accepted that the Solar D products allow some sunlight through that then allows more pre-vitamin D to be produced, 50% more in a test tube system, and that this would probably allow a little more vitamin D to be produced in a living system compared to comparative products. Professor Holick concurred, and reiterated that the Solar D products permit a few more of the vitamin D producing UVB photons through, and as a result, we would make some more vitamin D in the skin than would usually be made when using other comparative products, and that making vitamin D does have a physiological and helpful benefit (to a material degree).

    Protection against sunburn

12. It is not in contention that the Solar D products protect users against sunburn.

13. The TGA Record Summaries for the Solar D products indicate that they possess a SPF of either greater than 50 or greater than 30, consistent with their labelling as ‘SPF 50’ or ‘SPF 30’ sunscreens; and they satisfy the requirements for ‘broad-spectrum’ sun protection. The specific indications are listed as, “broad-spectrum UVA/UVB protection; helps protect against sunburn; vitamin D friendly; and permits passage of some of the sunlight your skin uses naturally to make vitamin D”. The TGA Record Summaries list standard indications of broad-spectrum sunscreen in preparation of SPF 50 and SPF 30. One such indication is they may assist in preventing and may reduce the risk of some skin cancers.

14. However, the respondent contends that the Advertisement implicitly claims “that solar D protects against the possible consequential adverse health effects of the sun exposure that causes sunburn”. Those effects are said to extend to skin cancer. We do not agree for the following reasons.

15. Professor Mason states in her report dated 9 March 2017 at [100], “…sunburn does not properly reflect DNA or lipid damage, or the generation of reactive oxygen and nitrogen species, which damage DNA, lipids and proteins, and which can occur at sun exposure doses that do not cause erythema. Sunburn does not reflect the systemic immune suppression induced by sunlight, which also contributes to the development of skin cancers.” She goes on to say at [102] that “critically, the action spectrum for sunburn/erythema is unlikely to coincide exactly with the action spectrum for skin cancer development”. However, Professor Mason speculates at [104]:

    “Given the limited relationship between sunburn and skin cancer development, and the different action spectra for various types of sun damage in skin, with most information tending to suggest that exposure to the high energy wavelengths of UVB radiation is key for development of skin cancers, there is a theoretical possibility that the slightly greater transmission of UVB by Solar D, may, over time, potentially slightly increase the risk of skin cancers in people who use this product compared with users of other sunscreens”.

16. Professor Holick considers new research (“the Felton study”) on this issue in his second report dated 21 December 2016, and states that the new research “…has revealed that low levels of UVB exposure are not actually associated with increased risk of non-melanoma skin cancer compared to non-exposure. It appears that, although the increased UVB at these low levels does result initially in correspondingly low levels of observable DNA damage as expected, the natural mechanisms for repairing such damage are able to adequately counter the damage and quickly repair it”.[2]

    [2] Felton SJ, Cooke MS, Kift R et al., ‘Concurrent beneficial (vitamin D production) and hazardous (cutaneous DNA damage) impact of repeated low-level summer sunlight exposures’ (2016) Br J Dermatol, 175: 1320-1328

17. Professor Holick goes on to say (at [9]), “given the low levels of UVB exposure with which we are concerned in this proceeding (i.e. transmittance of up to 5-6% UVB in the context of Solar D sunscreen use), based on the [Felton study] and the literature relating to melanoma, it is unlikely that the increased UVB transmittance observed with Solar D (up to 5-6%) would, at these low levels, be associated with increased unrepaired DNA damage to any significant extent or be associated with an increased risk of melanoma”.

18. At hearing, Professor Mason described the Felton study as a “lovely study” and said that it showed in normal individuals small amounts of UV exposure on a three times weekly basis does not cause cumulative damage. She went on to accept that, theoretically, a slightly greater transmission of UVB by Solar D may have beneficial effects in terms of protection against skin cancers.

19. In any event, as outlined above, Professor Holick and Professor Mason considered the correlation, if any, between UVB exposure and skin cancer. Given that such a correlation is not linear, the experts were unable to say with certainty that a slight increase in UVB exposure could be associated with an increase in risk of skin cancer.

20. In any event, we are not convinced that the Advertisement claims “that solar D protects against the possible consequential adverse health effects of the sun exposure that causes sunburn”. This is not conveyed by the wording of the Second Statement or the remainder of the transcript of the Advertisement. No effect of sun exposure apart from sunburn is mentioned.

21. We are satisfied that the statements made of Solar D, that it allows users to get some of the sunlight human bodies need to produce vitamin D while still protecting against sunburn (First and Second Statements) are correct and balanced and are verified by Nexdius. Accordingly, the Advertisement complies with clause 4(1)(b) of the Code.

    Clause 4(2)(a): unwarranted and unrealistic expectations of product effectiveness

22. For all the reasons already outlined, we are not satisfied that the Advertisement is likely to arouse unwarranted and unrealistic expectations of product effectiveness. We have accepted that the claims made in the Advertisement are verified by Nexdius and the balance of the scientific evidence.

    Clause 4(2)(d): abuse the trust or exploit the lack of knowledge of consumers

23. The respondent contends that the Advertisement abuses the trust and exploits the lack of knowledge of consumers in that the reasonable person, to whom the Advertisement is directed, would think that using the Solar D products would result in a meaningful amount of vitamin D production in the human body. This contention has little force in light of the evidence of Dr Harrison. As already stated, he found that the focus of the consumers to whom the Advertisement is directed, would not predominantly be on the health impacts that the sunscreen might bring, but was more likely to be on cultural acceptance.

24. Accordingly, we are not convinced that the reasonable consumer would engage in a minute analysis of what really are fairly simple messages. Accordingly, we find that the Advertisement complies with clause 4(2)(d) of the Code.

    Clause 4(2)(e)(ii): likely to lead persons to believe that harmful consequences may result from therapeutic goods not being used

25. Solar D products are sunscreen preparations and are exempted from clause 4(2)(e)(ii) if the claims made in the advertisement are consistent with current public health messages. In our minds, the claims made in the Advertisement are consistent with current public health messages. Reasons for this are as follows.

26. The Position Statement – Risks and Benefits of Sun Exposure (“Position Paper”), approved by the Australian and New Zealand Bone and Mineral Society, the Australasian College of Dermatologists, Cancer Council Australia, Endocrine Society of Australia and Osteoporosis Australia, provides, inter alia:

    “Given the considerable evidence showing UV to be carcinogenic, skin cancer prevention in Australia must remain as a high public health priority. For this reason, extended and deliberate sun exposure without any form of sun protection when the UV index is 3 or above is not recommended, even for those diagnosed with vitamin D deficiency…

    A balance is required between excessive sun exposure which increases the risk of skin cancer and enough sun exposure to maintain adequate vitamin D levels.”

27. The Position Paper provides a number of recommendations for the general population to maintain adequate vitamin D levels, while minimising the risk of skin cancer. It is noted that in summer, most Australian adults will maintain adequate vitamin D levels during typical day-to-day outdoor activities for example, a few minutes mid-morning or mid-afternoon sun exposure to arms and hands on most days of the week. In late autumn and winter, in those parts of Australia where the UV index is below 3 through most of the day, sun protection is not recommended and during these times of the year, to support vitamin D production it is recommended that people be outdoors in the middle of the day with some skin uncovered on most days of the week.

28. Professor Mason accepted that health campaigns promoting strict sun protection procedures to prevent skin cancer may increase a substantial health risk of vitamin D deficiency. However, she noted that despite it being an important message it was of a lower degree of importance.

29. It is noted in the Position Paper that “…sunscreen use should not put people at risk of vitamin D deficiency. When sunscreen is tested in laboratory conditions it is shown to limit the effectiveness of vitamin D production, however, population studies have shown that regular use of sunscreen has little effect on vitamin D levels”. However, based on the evidence of Professor Mason, the difference between laboratory conditions and population studies could have a lot to do with whether sunscreen is used as directed and/or whether people actually get out into the sun at all. In her opinion she said that “…there isn’t any question that if you use a sunscreen properly, the way your sunscreen is supposed to work, is to absorb that 95 or 98 or 99 per cent of the UVB. UVB is responsible for making vitamin D. So as a result, if you’re going to block out 99 per cent, you’re going to make 1 per cent vitamin D”.

30. We are satisfied that the Advertisement is consistent with current public health messages. Solar D protects against sunburn, is a broad-spectrum sunscreen with SPF ratings greater than 50 and greater than 30 but also allows a slight increase in UVB. This is consistent with recommendations for the general population to maintain adequate vitamin D levels, while minimising the risk of skin cancer.

    Clause 4(5): comparative advertisements

31. Comparative advertisements must be balanced and must not be misleading or likely to be misleading. As the Code requires, comparison should be factual and reflect the body of scientific evidence. They should not imply that the therapeutic goods or classes of therapeutic goods, with which comparison are made, are harmful or ineffectual.

32. As already stated, it is accepted by the parties that the claim made in the Advertisement in the First Statement that Solar D allows users to get some of the sunlight human bodies need to produce vitamin D, is a comparative claim.

33. Nexdius contends that the Advertisement suggests that users will receive more of the necessary sunlight which is required to produce vitamin D in the skin wearing a Solar D sunscreen in comparison to regular sunscreens. We do not agree. When reading the Advertisement transcript fairly, the word “some” does not mean this and does not convey this message. “Some” means an unspecified amount or number of and is not an expressly relative concept. Specifically, the words “next generation” and “some”, suggests that Solar D is different to other sunscreens (of the current generation) in that they do not allow some of the sunlight needed to produce vitamin D; in other words, these comparative products allow none. This proposition does not reflect the body of scientific evidence and may be misleading or likely to be misleading about the therapeutic goods with which Solar D is compared. It implies that other sunscreens are ineffectual.

34. Accordingly, we are satisfied that the Advertisement does not comply with clause 4(5) of the Code.

    DECISION

35. Regulation 5G(3) requires that an advertisement must be refused if any matter in sub- regulation 5G(1) is not satisfied. As compliance with the Code is a matter in reg. 5G(1)(a), and compliance with the Code is not satisfied in this case, under reg. 5G(3), approval of the Advertisement must be refused.

36. The decision under review is affirmed.

I certify that the preceding 72 (seventy-two) paragraphs are a true copy of the reasons for the decision herein of Deputy President J W Constance and Senior Member A Poljak

......................[sgd]..............................................

Associate

Dated: 21 November 2017

Date(s) of hearing:	26, 27 & 28 June 2017
Counsel for the Applicant:	Mr J Kirk
Solicitors for the Applicant:	Mills Oakley
Counsel for the Respondent:	Ms R Higgins
Solicitors for the Respondent:	Department of Health