Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-10-014 Feel Great Liquid Iron

Meeting held 21 January 2010

1.      The complaint concerned an internet advertisement published at the website www.brandsworldwide.com.au.

2.      The advertisement was headed “Fe²⁺el great Liquid Iron”. It included a wide range of claims such as, “faster absorption”, “designed to maximize absorption and therefore reduce constipation”, “studies have shown that particular forms of ionic iron are more readily absorbed than others”, “toddlers and school-aged children require iron for learning, memory, and behavioural problems as well as developmental delay”, “may serve as preventive agents against chronic diseases such as heart disease and cancer”, “deficiency [of vitamin B12] can cause anaemia”, and many other claims.

3.      It also included the words:

No one else is like you! We all differ inside and out. So depending on your age, gender, and lifestyle, you will need different amounts of iron. One thing we do have in common is that we all need it and don’t get enough in our diets, especially since the bioavailability of iron is low – only 10 to 15%

4.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

5.      The advertisement promoted the product Feel Great Liquid Iron.

6.      The advertiser was Brands Worldwide Pty Ltd.

7.      The complainant requested anonymity but acknowledged representing a commercial competitor of the advertiser.

8.      The complainant expressed the following concerns about the advertisement:

a)      That through the use of the words “feel great liquid iron” and the implication “that the starting form of the iron is Fe++ ionic iron”, the advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(h), and 4(2)(i) of the Code;

b)      That the words “a non-constipating liquid iron formula” breached section 4(1)(b) of the Code;

c)      That the words “faster absorption” breached sections 4(1)(b) and 4(5) of the Code;

d)     That the words “rapid absorption” breached section 4(1)(b) of the Code;

e)      That the words “it’s unique, non-constipating formula provides antioxidants that can help maintain normal blood and improve your wellbeing” breached sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), and 5 of the Code;

f)       That the words “Just a few teaspoons a day can improve the health and wellbeing of you and your family” breached sections 4(2)(a), 4(2)(b), 4(2)(d), and 4(2)(f) of the Code;

g)      That the words “Natralia Feel Great Liquid Iron is suitable for everyone including pregnant and post-natal women, children, and adolescents” breached sections 4(2)(b) and 4(2)(g) of the Code;

h)      That the words “Feel Great Liquid Iron’s formula is designed to maximise absorption and therefore reduce constipation” breached sections 4(1)(b), 4(2)(c), and 4(2)(h) of the Code;

i)        That the words “with these things combined Feel Great Liquid Iron can confidently profess to be one of the FIRST non-constipating iron supplement” breached sections 4(1)(b), 4(2)(b), 4(2)(c), and 4(2)(f) of the Code;

j)        That the words “studies have shown” breached section 4(4) of the Code;

k)      That the words “additional, essential nutrients” breached section 4(2)(e) of the Code;

l)        That the words “we all need it and don’t get enough in our diet” breached sections 4(2)(b) and 4(2)(d) of the Code;

m)    That the words “higher risk of developing iron deficiency” breached section 5 of the Code; and,

n)      That the “whole section” headed “antioxidants and essential nutrients” breached section 4(1)(b) of the Code.

9.      The complainant also provided evidence material in support of the complaint.

10.  In relation to the words “feel great liquid iron” and the use of the “Fe²⁺” notation, the advertiser argued that ‘“Fe²⁺el Great” is merely a brand name for liquid iron and does not imply that it is guaranteed to make you feel great”, and that “the design aspect doesn’t imply its consumable form to a general user”.

11.  In relation to the references to a “non-constipating formula”, the advertiser argued as follows:

If you carefully review our claim it is evident that the non-constipating claim is coming from another ingredient, Prunas domestica (sic). There are clinical trials associated with Prunas domestica and its non-constipating effect.... We do not claim that “our form of iron” is non-constipating... it is a usual practice within the industry that in multi-ingredient products, different claims can come from different ingredients. In this case the “non-constipating claim” is attributed to the active ingredient Prunas domestica and NOT ferrous gluconate.

12.  The advertiser provided a summary of reference information (but not the studies referred to) in relation to the Prunus domestica ingredient.

13.  In relation to the references to “faster absorption”, the advertiser stated that “according to basic principles of pharmacokinetic liquid dosage form absorbs faster than solid because it doesn’t need to go through a disintegration and dissolution phase to be absorbed into the bloodstream”. The advertiser provided a copy of a chart from the Physician’s Desk Reference showing the absorption rate of various methods of delivery, although the chart did not in fact include any reference to swallowed liquid dosage forms.

14.  In relation to the words “rapid absorption”, the advertiser argued that they were used “in the context of added vitamin C” since “there is evidence that vitamin C helps increase iron absorption”. The advertiser offered to change the advertisement to say, “formulated with vitamin C, which improves iron absorption”.

15.  In relation to the references to the words “provides antioxidants that can help maintain normal blood and improve your wellbeing”, the advertiser argued that the product “provides antioxidant[s] from acerola which promotes general wellbeing” and “iron is an essential element of haemoglobin”, and that “therefore this claim is substantiated.”

16.  In relation to the words “just a few teaspoons a day can improve the health and wellbeing of you and your family”, the advertiser stated, “this is a general level claim that has been made from antioxidants and vitamins. They generally support health and general wellbeing”.

17.  In relation to the words “suitable for everyone including pregnant and post-natal women, children, and adolescents”, the advertiser argued that “this is a general suitability statement indicating that this product doesn’t have any specific contraindication to any specific consumer” and that “for children and adolescents it is recommended in the direction that they speak with their GP first to determine the appropriate dose”.

18.  In relation to the words “Feel Great Liquid Iron’s formula is designed to maximise absorption and therefore reduce constipation”, the advertiser stated that they “will delete this statement from the website”.

19.  In relation to the words “with these things combined Feel Great Liquid Iron can confidently profess to be one of the FIRST non-constipating iron supplement”, the advertiser argued that the advertisement did not claim that the advertised product was “THE FIRST” non-constipating iron supplement but that it was “one of the first”. The advertiser argued that the evidence provided by the complainant relating to another iron supplement said to be “non-constipating” related to a product that would be regarded as illegal therapeutic goods.

20.  In relation to the words “studies have shown”, the advertiser stated that a reference had been added and included the reference in their response.

21.  In relation to the words “additional essential nutrients”, the advertiser stated that they had “deleted the word ‘essential’ from relevant text”.

22.  In relation to the words “we all need it and do not get enough in our diets” and “higher risk of iron deficiency”, the advertiser stated that they would “delete this statement from the website”.

23.  In relation to the “anti-oxidants and essential nutrients section”, the advertiser stated that they had deleted the word “essential” but that “the whole section does not breach 4(1)(b) because all these statements and the general statement contains correct and balanced statements only and includes claims which have been verified through the gathering of credible evidence and included on the product’s ARTG record”, and that “the mentioned function of these ingredients is quite well established among scientific authorities.”

24.  The advertiser provided additional documentary material in relation to the complaint.

the words “feel great liquid iron” and the “Fe²⁺” notation

25.  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”.

26.  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.” Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that “contain any claim, statement or implication that it is effective in all cases of a condition”. Section 4(2)(i) of the Code prohibits representations that the goods advertised are completely safe, harmless, or free of side-effects.

27.  The Panel did not find that these words amounted to a representation that the advertised product would invariably lead to “feeling great” for all users of the product. Nor did the Panel find them to convey any representation strong enough to be regarded as misleading, unverified, or likely to arouse unwarranted expectations. The Panel was satisfied that both the words and the “Fe2+” notation was essentially mere puff which did not make meaningful representations to consumers, other than conveying that the advertised product was a liquid iron supplement.

28.  These aspects of the complaint were therefore not justified.

the words “a non-constipating liquid iron formula”, “unique, non-constipating formula”, and other references to “non-constipating”

29.  The Panel noted the advertiser’s argument that the “non-constipating” claim was based on the Prunus domestica ingredient and not on the form of iron used in the supplement. The Panel rejected this argument. The advertisement clearly included words such as “designed to maximize absorption and therefore reduce constipation” and “studies have shown that particular ionic forms of iron are more readily absorbed than others”. The Panel found that the advertisement represented the product to be “non-constipating” because it was “designed to maximise absorption”, and that it represented the product to be “more readily absorbed” because of the “particular ionic form of iron” used in the product.

30.  Moreover, the Panel noted that even if the “non-constipating” claim had in fact been based on the inclusion of the Prunus domestica ingredient in the product, the advertiser had provided no evidence that this ingredient could have such benefits when consumed in conjunction with an iron supplement. To the extent that the advertiser provided evidence in relation to Prunus domestica, it consisted of summaries of monograph material (and not copies of the material itself), apparently prepared by the advertiser, which could have supported a claim that prunes have a mild laxative effect when consumed as a food. Even if the advertiser had provided the evidence rather than stating that the evidence existed, it is clear that evidence for a laxative effect from prunes consumed as a food is not evidence that an iron supplement will be “non-constipating” if a prune extract is included in its formulation.

31.  The Panel was therefore satisfied that the advertisement, through the use of the “non-constipating” claim, breached sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code,. This aspect of the complaint was therefore justified.

32.  Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods. The Panel was not satisfied that the claims that the product was non-constipating breached sections 4(2)(f) or 4(2)(h) of the Code. These aspects of the complaint were therefore not justified.

the words “provides antioxidants that can help maintain normal blood and improve your wellbeing”

33.  In complaining about this aspect of the advertisement, the complainant also included the words “this unique, non-constipating formula”. The Panel noted that the entire claim including the reference to non-constipating benefits was already found to be in breach of various sections of the Code because of that reference. For clarity, the Panel noted that it did not find the claims relating to antioxidants, the maintenance of normal blood, or improved well-being to breach sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), or 5 of the Code.

34.  Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. Sections 5(1) and 5(2) prohibit certain references to a wide range of serious health conditions.

35.  The Panel did not agree with the complainant that the words “normal blood” conveyed any implicit representation regarding serious blood disorders that could breach section 4(2)(b) or 5 of the Code.

the words “with these things combined Feel Great Liquid Iron can confidently profess to be one of the FIRST non-constipating iron supplement”

36.  Although this aspect of the complaint and the advertiser’s response focused on the word “first”, the Panel noted that its findings in relation to the “non-constipating” claim meant that the entire claim that the product was “one of the first non-constipating” supplements was in any case unverified and misleading. The Panel was therefore satisfied that these words breached sections 4(1)(b) and 4(2)(c) of the Code, and these aspects of the complaint were therefore justified.

37.  The Panel did not however agree with the complainant that these words breached sections 4(2)(b) and 4(2)(f) of the Code, and these aspects of the complaint were therefore not justified.

the words “faster absorption” and “rapid absorption”

38.  Section 4(5) of the Code requires that comparisons made in advertisements must be balanced and must not be misleading or likely to be misleading.

39.  The evidence provided by the advertiser in support of the “faster absorption” claim consisted solely of a chart that was stated to be from the Physician’s Desk Reference which they stated showed “proof in principle regarding increased rates of absorption”. The chart showed absorption rates of various dosage forms, namely: pill, “gel-capsual” (sic), transdermal patch, sublingual liquid, intramuscular injection and intra-oral pray. The Panel noted that the chart did not include an entry for oral liquids which are swallowed, and therefore did not appear to address the matter adequately.

40.  In relation to the words “rapid absorption”, the advertiser stated that the “claim was made in context of added vitamin C”. As with the bulk of the evidence provided by the advertiser, the evidence material in relation to this question consisted of an entry in a table of references prepared by the advertiser, but no copies of the material to which the references applied. Although only a single reference was supplied in relation to vitamin C and iron absorption, the Panel did accept that the addition of vitamin C could plausibly be said to improve iron absorption. However, “improved” absorption is not the same as “rapid” absorption, and the Panel did not accept that the advertiser had provided any evidence to support the “rapid absorption” claim.

41.  The Panel was satisfied that the words “faster absorption” breached sections 4(1)(b) and 4(5) of the Code, and that the claim of rapid absorption breached section 4(1)(b) of the Code. These aspects of the complaint were therefore justified.

the words “just a few teaspoons a day can improve the health and wellbeing of you and your family”

42.  The Panel did not find that these words breached sections 4(2)(a), 4(2)(b), 4(2)(d), or 4(2)(f) of the Code as alleged by the complainant. These aspects of the complaint were therefore not justified.

the words “Natralia Feel Great Liquid Iron is suitable for everyone including pregnant and post-natal women, children, and adolescents”

43.  Section 4(2)(g) of the Code prohibits representations that therapeutic goods are “infallible, unfailing, magical, miraculous”, or that they are “a certain, guaranteed or sure cure”.

44.  The Panel did not find that these words breached section 4(2)(g) of the Code as alleged by the complainant. This aspect of the complaint was therefore not justified.

45.  However, the Panel was satisfied that words such as “suitable for everyone” breached section 4(2)(g) of the Code by conveying a representation that the advertised product was unfailing and infallible, and a certain cure. This aspect of the complaint was therefore justified.

the words “studies have shown that particular forms of ionic iron are more readily absorbed than others”

46.  Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate, balanced and not misleading”, and requires that publication of scientific research results should “identify the researcher and financial sponsor of the research.” The Panel was satisfied that the information presented in the advertisement, in the context of the words “studies have shown”, constituted scientific information and scientific research results falling within section 4(4).

47.  As a preliminary matter, the evidence provided by the advertiser in response to this aspect of the complaint was the abstract of a study relating to “iron deficiency anemia in pregnancy and in the immediate post-partum period”. The abstract of the study provided by the advertiser (the whole study was not provided) stated that products containing ferrous (2+) salts were more easily absorbed than those containing ferric (3+) salts in patients with iron deficiency anaemia in pregnancy and the immediate post-partum period. The Panel did not find this evidence satisfactory, in particular because it related to patients suffering from iron deficiency anaemia and not to ordinary healthy consumers to whom the advertisement was directed, while no evidence was provided by the advertiser as to the validity of extrapolating this evidence to ordinary healthy consumers.

48.  While the Panel was prepared to accept the general proposition that “particular forms of ionic iron are more readily absorbed than others”, it  did not accept that the evidence provided could support the claim made.

49.  Regardless of any of the foregoing, however, the Panel found that the advertisement breached section 4(4) of the Code by failing to “identify the researcher and financial