Bio-Strath – a nutritional supplement or a medicine?

Posted 30 May 2013

This is an ASA ruling that is difficult to fully read or understand. In essence, Prof Roy Jobson originally appealed an ASA Directorate decision to not rule on the description of Bio-Strath as “a herbal wholefood supplement”. He asserted this description was misleading because, given the medicinal claims Bio-Strath was making, it is a medicine within the definition of “medicine” as defined in the Medicines and Related Substances Act and therefore may not be described as a “herbal wholefood supplement”. Prof Jobson therefore appealed the decision to not rule on this. Bio-Strath then stated that they would change the description to “daily nutritional supplement” and suggested that that would meet Prof Jobson’s concerns and there would be no need to “waste the appeal committee’s time.” The appeal was referred to the Advertising Standards Committee, who ruled that it was acceptable to refer to the product as a nutritional supplement, despite it being a medicine, as this is how similar products are referred to by the industry. Prof Jobson then appealed to the Final Appeal Committee . . .  

SA Natural Products / Prof R Jobson / 18390 (FAC)
Ruling of the : ASA Appeal Committee
In the matter between:
Professor Roy Jobson Complainant(s)/Appellant(s)
SA Natural Products (Pty) Ltd Respondent

23 May 2013

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6563

Decision appealed against: Decision of the Advertising Standards Committee upholding a decision of the Advertising Standards Committee

Code: Section II of the Code, clause 4.2.1

Held: The appeal dismissed with no order as to costs 

1. The Appellant, Professor Roy Jobson, lodged a complaint against the Respondent’s advertising of a product, Bio-Strath, on the Respondent’s website in July 2011. Thereafter, on 31 July 2011 and 2 August 2011 respectively, the Appellant extended his complaint to include two advertisements for Bio-Strath published in the Sunday Times Lifestyle magazine on 31 July 2011, and a television commercial flighted on M-Net on

1 August 2011. The complaint raised two issues. The first related to the description of Bio-Strath as “a herbal wholefood supplement”. The Appellant asserted this description was misleading because, given the claims the Respondent makes in respect of Bio-Strath, it is a medicine within the definition of “medicine” as defined in the Medicines and Related Substances Act, 101 of 1965 (“the Medicines Act”) and accordingly may not be described as a “herbal wholefood supplement”. Secondly, the Appellant asserted that several of the claims made by the Respondent concerning the effect of Bio-Strath required substantiation. 

2. In its ruling delivered on 6 March 2012, the Directorate found that the question whether Bio-Strath constituted a medicine within the meaning of the Medicines Act and therefore needed to be registered in terms of the Act was not a matter within its jurisdiction. It therefore concluded that it was not able to consider the first aspect of the complaint. On the second aspect of the complaint, the Directorate initally found that the claims made by the Respondent in respect of Bio-Strath had not been substantiated.

Following the submission of further materials by the Appellant in terms of Clause 4.1.7 of Section II of the ASA Code, the Directorate concluded that some of the claims had been substantiated but that others had not. The Appellant then elected to have the question of substantation referred to arbitration in terms of clause 4.1.8.2 of Section II of the ASA Code, read with clause 16 of the ASA Procedural Guidelines. We were informed at the hearing of this appeal, that that arbitration has not yet been concluded.

The issues arising from the second aspect of the complaint (relating to substantiation of the claims made in respect of Bio-Strath) are therefore not before this Committee in this appeal.

 

3. After receiving the Directorate ruling, the Appellant lodged an appeal to the Advertising Standards Committee (the ASC) in respect of the ASA Directorate’s conclusion that it could not consider whether the description of Bio-Strath as a “herbal wholefood supplement” was misleading. In response, the Respondent informed the Appellant and the Directorate that it had decided to change the description of Bio-Strath from a “herbal wholefood supplement” to a “daily nutritional supplement”. The Directorate took the view that it was “functus officio” and could not consider the question whether the changed description was adequate to address the issue raised by the first aspect of the complaint and thus referred the issue to the ASC in terms of clause 8.5 of the Procedural Guidelines.

 

4. Before the ASC, the Appellant argued that the revised description did not address the complaint, because the claims made in respect of Bio-Strath brought the product within the definition of “medicine” in the Medicines Act and that it would be misleading to describe a “medicine” as a “daily nutritional supplement”, just as it had argued that it had been misleading to describe the product as a “herbal wholefood supplement”. The Respondent conceded that Bio-Strath fell within the statutory definition of “medicine”

but argued that it was not improper or misleading for it be described as a “daily nutritional supplement”, even if it was a medicine, and that many similar products were so described. In making this assertion, it referred to the trade publication MIMS 2010 which contains a section of over-the-counter medicines described as “nutritional supplements”.

 

5. The ASC rejected Appellant’s complaint in its ruling handed down on 20 August 2012. It concluded that, when advertising a product, it is not necessary to describe the product “with reference to its proper pharmacological classifcation.” Instead it found that ordinary language could be used, as long as the language used is recognised in the industry, properly conveys the nature and composition of the product and will be understood by the average, reasonable consumer.

 

6. On 17 September 2012, the Appellant lodged an appeal to this Committee against the decision of the ASC. On 3 October, the Respondent lodged its notice of opposition to the appeal. It opposed the appeal and also asserted that the appeal was procedurally flawed. The Respondent asserted that, before the appeal should be enrolled, a decision should be taken as to whether the appeal should be rejected, on the basis contemplated in clause

12.2 of the Procedural Guidelines.[fn 1] That question was considered by the Chairperson of the Final Appeal Committee, two final Appeal Committee members and the Directorate on 27 November 2012 as provided for in clause 12.2. It was found that the appeal did not fall to be rejected on the basis asserted by the Respondent. After several requests by counsel appearing for the parties for postponements of the date of the appeal hearing, the appeal was heard on 21 May 2013.

 

Submissions of the parties on appeal

7. On appeal, it was argued on behalf of the Appellant that the Committee had the power to decide whether Bio-Strath is a medicine as defined in the Medicines Act; that Bio-Strath is a medicine as defined; that, as a medicine, it is misleading within the meaning of clause 4.2.1 of the ASA Code to describe it as a “daily nutritional supplement”; and that accordingly the Respondent should be instructed to desist from describing it as such and that it should employ a different description such as “tonic” that would reflect that Bio-Strath is a medicine. Further, the Appellant argued that the ASC erred in relying on the MIMS publication for the conclusion that the phrase “nutritional supplement” is widely used to describe over-the-counter medicines like Bio-Strath.

 

8. In written argument lodged on behalf of the Respondent, it was argued that, once Respondent had changed the product description of Bio-Strath from “a herbal wholefood supplement” to a “daily nutritional supplement”, the original complaint was “dead” and that therefore the appeal should not have been entertained by the ASC because the issues raised in the original complaint had fallen away. Accordingly, went the argument, the appeal to this Committee is not a valid appeal, either. In oral argument, however, the Respondent accepted that even if this Committee were to find that the ASC had erred in considering the question whether the new description of the product was in conflict with the Code, that given that this Committee has now had full argument on the matter, it would not be appropriate to dismiss the appeal on that narrow ground alone.

 

9. On the merits of the appeal, the Respondent argued that the use of the term “daily nutritional supplement” was not misleading within the meaning of clause 4.2.1 of the ASA Code as it is a term commonly used in the supplementary medicines industry and would be eaily understood by the average consumer. It also argued that it was permissible for the ASC to refer to MIMS to support the conclusion that the term “daily nutritional supplement” is a commonly used term that will be understood by the average consumer.

 

Issues for decision

10. The following issues arise for decision on appeal:

(a) Did the ASC err in considering the question whether the new description of Bio-Strath, as a “daily nutritional supplement”, was misleading within the meaning of clause 4.2.1 of the ASA Code, given that the Directorate had not considered the new definition?

(b) Should this Committee consider the merits of the appeal?

(c) If the Committee does consider the merits of the appeal, is the new description of Bio-Strath misleading within the meaning of clause 4.2.1 of the ASA Code?

(d) Did the ASC err in its reliance on MIMS 2010 in its judgment?

(e) Appropriate relief and costs.

 

Did the ASC err in considering the new description of Bio-Strath?

11. It is clear that the Appellant did not lodge a new complaint concerning the new definition of Bio-Strath with the ASA Directorate and that the ASA Directorate has never, therefore, considered the new definition and the question whether it is in breach of the ASA Code. On previous occasions this Committee has stated clearly that parties will not be permitted to raise new matters on appeal,[fn 2] and that appeals are therefore ordinarily confined to the issues considered by the committee against whose decision an appeal has been lodged. The effect of the withdrawal of a contested product description will thus ordinarily terminate the complaint.

It may be, though we need not decide this question now, that a minor change to a contested product description or contested advertisement may not be sufficient to terminate a complaint, where the cause of complaint persists, or where the purpose of the withdrawal is to avoid a decision on the complaint.

 

12. When the ASC considered the new product description, it relied on the fact that the Directorate had referred the revised description to it in terms of clause 8.5 of the Procedural Guidelines. Clause 8.5 provides that:

 

“On receipt of the written representations by the parties and depending on the urgency, complexity and novelty of the subject matter of the complaint, the Directorate shall, at it is own discretion, either make a ruling on the complaint or refer the complaint to the appropriate committee for consideration….”

 

13. Clause 9.1 of the Guidelines, which also provides for the referral of issues by the Directorate to the ASC, provides that:

 

“The Advertising Standards Committee will consider and rule on all consumer complaints either referred to it by the Directorate or on appeal by any party who feels aggrieved by a ruling made by the Directorate.”

 

14. Read together, clauses 8.5 and 9.1 contemplate the referral of an issue to the ASC by the Directorate without the Directorate having made a decision on the issue. The obvious consequence of such a referral is that the determination of an issue that has been referred by the Directorate is not properly understood, an appeal, but a decision at first instance by the ASC. The circumstances in which such referrals may be made is placed in the hands of the Directorate by clause 8.5. It is not necessary now to consider what the limits of that discretion may be, though perhaps it is worth observing that the disadvantage of pursuing such a course is that a referral by the Directorate deprives the ASC of the benefit of a ruling by the Directorate on an issue. What is clear is that once the ASC has made a decision upon an issue, an appeal lies against that decision to this Committee. The fact that the ASC referred to the case as an “appeal” rather than as a “referral” does not affect our conclusion. Properly understood, the ASC dealt with this case as a referral from the Directorate. It is that referral that is on appeal to this Committee.

 

15. The Respondent was wrong, therefore, to suggest that once it had changed the product description, the matter “died.” That may be the ordinary consequence of the withdrawal of a disputed advertising claim.

Here, however, once the Appellant complained about the revised product description, the Directorate chose to refer that issue to the ASC in terms of clause 8.5. Once the ASC determined the question referred to it, that decision became subject to appeal to this Committee.

 

Should this Committee determine the merits of the appeal?

16. The Committee notes that the ASC determined the issue before it on referral by the Directorate, that both parties accepted that it would be appropriate for this Committee to determine the merits of the appeal and that the Committee has had full written and oral argument put before it on the merits of the dispute. In the circumstances, the Committee should determine the merits of the appeal.

 

Is the new description of Bio-Strath misleading within the meaning of clause 4.2.1 of the ASA Code?

17. It was argued on behalf of the Appellant that because of the claims made by the Respondent concerning Bio-Strath, which are claims relating to the health benefits of the product, Bio-Strath falls within the definition of “medicine” in the Medicines Act. Consequently, asserted the Appellant, it would be misleading to describe Bio-Strath either as a “herbal wholefood supplement” or as a “daily nutritional supplement”.

 

18. The definition of “medicine” in the Medicines Act provides:

 

“’Medicine’ means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in –

(a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or

(b) restoring, correcting or modifying any somatic or psychic or organic function in man and includes any veterinary medicine.”

 

This is a very broad definition that could include within its ambit many substances that are colloquially understood to be foods. Yet, the definition of “foodstuff” in the Foodstuffs, Cosmetics and Disinfectants Act, 54 of 1972, (the Foodstuffs Act) excludes any “medicine” as defined in the Medicines Act[fn 3] so a “medicine” as defined in the Medicines Act cannot be a “foodstuff” as defined in the Foodstuffs Act.

 

19. On several occasions, the courts have grappled with the breadth of the definition of medicine.[fn 4] In a recent Western Cape High Court decision, Treatment Action Campaign v Rath, the Court took the view that the question of whether a particular substance is a medicine is a question of statutory interpretation[fn 5] and that in seeking to determine what constitutes a “medicine”, a purposive interpretation should be given to the definition.

Zondi J held that that the purpose of the Act is to regulate substances in respect of which medicinal effects are claimed, and that a medicine will therefore be a substance inrespect of which medicinal claims are made.

According to this approach, Zondi J reasoned that, although on a literal interpretation of the definition of “medicine”, Rooibos tea may fall within the definition, on a purposive interpretation, Rooibos tea would not fall within it, unless medicinal claims were made in respect of Rooibos tea.[fn 6]

 

20. Adopting this approach it was argued on behalf of the Appellant that as medicinal claims were being made in respect of Bio-Strath it constituted a “medicine” within the meaning of the Medicines Act and as such to avoid being misleading within the contemplation of clause 4.2.1 of the ASA Code, it would have to be described in a manner consistent with its status as a medicine. The corollary of Appellant’s argument is that if no medicinal claims were made in respect of Bio-Strath it would not constitute a medicine and it would not need to be described as such.

 

21. It is important to emphasise that the approach to the definition of “medicine” in the Medicines Act relied upon by the Appellant, is a definition that hinges on the claims made in respect of a substance, not on the instrinsic nature of the substance itself. Accordingly, on Appellant’s argument, Rooibos tea which would ordinarily be considered by consumers to be a foodstuff, may be considered a medicine if medicinal claims are made in respect of it. This observation is important to a consideration of whether it is misleading in relation to describe Bio-Strath as a “daily nutritional supplement” something to which we turn in a moment.

 

22. In addition to his reliance on the definition of “medicine” in the Medicines Act, the Appellant also pointed to section 20 of the Medicines Act, read with section 29 of the Act, which makes it an offence for any person to publish “any false or misleading advertisement’ in respect of a medicine. It was argued that in deciding what constituted “misleading”

advertising for the purposes of the Code, the ASA should bear in mind what would constitute “misleading” advertising for the purposes of section 20 of the Medicines Act. In this regard, Appellant’s counsel pointed to the Preamble to the Code which provides that advertisements should be “legal, decent, honest and truthful”. The stipulation of “legal” in the Preamble to the Code, it was contended, requires the ASA to consider not only whether an advertisement is misleading in terms of the Code but also whether it would be found to be in breach of section 20 of the Medicines Act. The Committee notes that section 20 prohibits “false or misleading”

advertisements of medicines. This is similar language to Clause 4.2.1 of section II of the Code which prohibits advertisements that are “likely to mislead the consumer”. Given the similarities in the language of section 20 and clause 4.2.1 of section II of the Code, the Committee is not persuaded that it is likely there will ever be any material difference in the application of the two provisions. An ASA committee may consider whether an advertisement may be misleading within the meaning of section 20 in determining whether there has been a breach of the Code, but what is clear, and must be emphasised, is that the primary task for committees of the ASA is upholding the provisions of the ASA Code. As both this Committee and the Advertising Industry Tribunal have pointed out on previous occasions, it does not fall within the jurisdiction of the ASA to decide what constitutes a “medicine” for the purposes of the Medicines Act, and, in particular, what substances require to be registered in terms of that Act.[fn 7]

 

23. The primary issue in this case is the whether the description of Bio-Strath as a “daily nutritional supplement” is misleading advertising within the meaning of clause 4.2.1 of the Code. Clause 4.2.1 provides that:

 

“Misleading claims

Advertisements should not contain any statement or visual presentation which, directly or by implication, omission, ambiguity, inaccuracy, exaggerated claim or otherwise, is likely to mislead the consumer.”

 

The key operative provision of this clause is that an advertisement should not contain anything that “is likely to mislead the consumer”. The question in this case, then, is whether describing Bio-Strath as a “daily nutritional supplement” is likely to mislead the consumer.

 

24. In answering this question, it is necessary to note again that whether the medicinal claims made on behalf of Bio-Strath are themselves inaccurate or unsubstantiated is not a question before this Committee. As mentioned above, the question concerning the substantiation of the claims made on behalf of the product is a separate question that has been referred to arbitration. The substantiaion of claims is governed by a different provision of the Code, clause 4.1. That clause is not relevant to this appeal. The only question that this Committee is concerned with is whether the description “daily nutritional supplement” is misleading given the product being advertised.

 

25. The Appellant’s claim is that the description is misleading because first, because it suggests that the product is a food, which it cannot be, because it falls within the definition of “medicine” within the meaning of the Medicines Act; and secondly, because it fails to state clearly that the product is a “medicine” within the meaning of the Medicines Act.

 

26. We turn now to the first of these arguments, that the phrase “nutritional supplement” will mislead consumers because it suggests that the product is a foodstuff. In support of this argument, Appellant relied on the law of several foreign jurisdictions which apparently consider “nutritional supplements” to be “foodstuffs” not “medicines”. The Committee was not furnished with the definitions of “medicine” and “foodstuff” in those jurisdictions, nor were we provided with a description of the health regulatory systems in those jurisdictions. The mere fact that some jurisdictions consider nutritional supplements to be foodstuffs rather than medicines is a fact that on its own does not assist the Committee. Whether a nutritional supplement is a food or a medicine will depend on the legal definitions and regulatory system of each jurisdiction. As the definintion of “medicine” in the South African Medicines Act makes plain, there is no sharp and inherent distinction between what is a “medicine” and what is a “foodstuff”. The distinction may be drawn differently in different legal systems, depending on the manner of regulation. Reliance on foreign systems which classify nutritional supplements as foodstuffs, does not mean that nutritional food supplements actually are foods in some universal understanding of what constitutes a food. The foreign jurisprudence referred to by the Respondent thus does not assist us in answering the question which this Committee must answer, whether the description of the product as a “daily nutritional supplement” to a South African consumer is misleading.

 

27. To assess Appellant’s first argument, we should commence by asking what the description “daily nutritional supplement” is likely to suggest to a South African consumer. A “supplement” is something that is added to something, something that is ancillary or additional. “Nutritional” refers to nourishment or food. So the phrase “daily nutritional supplement”

suggests that the product is to be used to supplement food or nourishment on a daily basis. It was suggested on behalf of Appellant that because the word “nutritional” was used in the definition, it meant that the description suggested that the product was a foodstuff within the meaning of the Foodstuffs Act. Such a suggestion is misleading, the argument went, because the product is a “medicine” as defined in the Medicines Act, and cannot therefore be a foodstuff, as Respondent itself admits.

 

28. Yet calling a product a “daily nutritional supplement” does not suggest that it is a foodstuff. It suggests that the product is for the supplementation of foodstuffs, not necessarily a foodstuff itself. Most consumers will not consider a nutritional supplement to be food but rather as the word “supplement” suggests, something to be used in addition to foodstuffs. The Appellant’s first argument that the use of the word “nutritional” in the description conveys the meaning that the product is a foodstuff cannot therefore be accepted.

 

29. The other basis upon which the Appellant argued that the description was misleading was that it failed to inform the consumer that the product fell within the terms of the definition of “medicine” because of the claims made in respect of it. Appellant did not suggest that there was something intrinsically “medicinal” in the product itself. Appellant’s concern was that because claims made in respect of the product suggested that it had medicinal purposes, it must be described as a medicine.

 

30. In the view of the Committee, the question must be approached in light of the purpose and objects of the ASA Code. Clause 4.2.1 of section II of the Code prohibits misleading advertisement to ensure that the nature and composition of a product is not misleadingly described or represented to consumers. Describing Bio-Strath as a “daily nutritional supplement” is not misleading in reagrd [sic] to the nature of the product itself. As Appellant acknowledged, Bio-Strath falls within the definition of “medicine” because of the claims made in respect of it, not because of its intrinsic character.[fn 8] Moreover, it would not be necessary to describe it as a medicine to alert consumers to the fact that medicinal claims are made in respect of it for a consumer would know that from the promotional material setting out the claims. Of course, if the claims are not substantiated, they will not pass muster under clause 4.1 of section II of the Code. The protection for false claims thus lies in clause 4.1, and as stated above, that is a question that does not arise here.

 

31. In the view of the Committee, it is not misleading for a product in respect of which medicinal claims are made to be described without pertinent reference to the fact that the product constitutes a “medicine”

within the meaning of the Medicines Act. As the ASC held in this case, an advertisement will not be misleading within the meaning of the Code if a product is described using ordinary language, as long as that language does not mislead the ordinary consumer as to the nature and composition of the product.

 

32. In conclusion, the Committee finds that the product description of Bio-Strath as a “daily nutritional supplement” is not misleading within the meaning of clause 4.2.1 of Section II of the ASA Code. In the light of the conclusion reached, it is not necessary to consider whether the ASC’s reliance on the trade publication MIMS 2010 was inappropriate.

 

33. In the circumstances, the appeal must fail.

 

Costs

34. The Respondent argued that if the appeal failed, the Appellant should be ordered to pay Respondent’s costs on appeal. The Appellant argued that if the appeal failed, no order of costs should be made. According to Clause

12.6 of the Procedural Guidelines, the Chairperson of the Final Appeal Committee may award the costs of the appeal against any one of the parties, “on an applicable High Court Scale, or in such proportion as the Committee may determine.” Respondent also suggested that 27 of the 35 pages of written argument lodged by the Appellant were irrelevant to the Appeal. As appears from the reasons provided above, that assertion was not correct. It may be that the appeal has not succeeded, but it cannot be said that the arguments made in respect of the appeal were irrelevant or unnecessary.

This contention of Respondent must thus be rejected. As to the issue of whether the unsuccessful Appellant should be ordered to pay the costs of Respondent, the Chairperson of the Committee notes that in Ozone Health Studios / Crookson / 19682 (31 January 2013), it was observed that there are important reasons why costs orders should not readily be made in the case of consumer complaints. Accordingly, there it was held that a costs order would not be made in such cases unless an appellant acted in in bad faith or for an ulterior purpose. In this case, it has not been shown that Appellant lodged the appeal in bad faith or for an ulterior purposes, nor can it be said that Appellant acted vexatiously, and it is accordingly not appropriate to make an order of costs.

 

35. The appeal accordingly fails, and no order is made as to costs.

 

– [fn 1] Clause 12.2 provides: “Notwithstanding the provisions of the previous subsection, the Directorate, together with the Chairperson of the Final Appeal Committee and two Final Appeal Committee members, shall be entitled to reject an appeal if, after due consideration of all circumstances and factors, if it is found by unanimous decision that the appeal is either –

12.2.1 an unfounded or frivolous appeal in the event of a clear and direct contravention of the Code;

12.2.2 a malicious or wilful appeal.”

– [fn 2] See the decision of the Appeal Committee in Bobtails Nature’s Best/Mars 14136 (11 July 2010), p 1 at para 4.

– [fn 3] “Foodstuff’ is defined in the Foodstuffs Act as: “any article or substance (except a medicine as defined in the Medicines and Related Substances Act, 1965 (Act 101 of 1965) ordinarily eaten or drunk by a person or purporting to be suitable, or manufactured or sold, for human consumption, and includes any part or ingredient of any such article or substance, or any substance used or intended or destined to be used as a part of ingredient of any such article or substance.”

– [fn 4] See, for example, Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines 1994 (4) SA 660 (T) and Treatment Action Campaign v Rath 2008 (4) All SA 360 (C).

– [fn 5] See Treatment Action Campaign, id., at para 34.

– [fn 6] Id. at para 42.

– [fn 7] See the decision of the Advertising Industry Tribunal in Dettol/Sara Lee/12667 (3 July 2009 reported in the (2008 – 9) 3 ASA Precedent Manual 364 at 367 and the decision of this committee Homemark Slim / HA Steinma[n] /12988 (25 May 2010).

– [fn 8] See discussion at para 21 above.

2 Responses to Bio-Strath – a nutritional supplement or a medicine?

  1. Dr Peter Desmarais 27 March, 2015 at 7:37 pm #

    In 2010 I wrote to the distributors of Biostrath, asking them to substantiate their claims.The quoted a journal which I cannot find anywhere and sent me some comments from their “medical expert” who was a homeopath!

  2. Roy 29 March, 2015 at 2:15 pm #

    It must be noted that in an arbitration report dated 18 July 2013, concerning certain of the actual claims made by Bio-Strath, the abitrator noted:
    *Claim 1: Counteract exhaustion, fatigue, examination stress – Claim 1 cannot be supported by the evidence submitted.
    *Claim 2: Build resistance to colds and infections – Neither study is . . . capable of support[ing] claim 2. There is no indication of how or if the product “builds” the measure of “resistance” and there is confusion on definitive classification of “colds” and “influenza.”
    *Claim 3: Speed up recovery in convalescence – “. . . inherent weaknesses associated with the reporting and methodology of the study do not support the wording of the claim as stated.”
    *Claim 4: Improve general well-being and concentration – [t]he claim associated with “improve . . . concentration” cannot be substantiated by any of the provided evidence to the satisfaction of the arbitrator and should be retracted. The claim associated with “improve well-being . . .” is not sufficiently defined nor supported by any of the evidence submitted and should be retracted.
    *Claim 5: Provide stamina for intensive work, study and sport – [t]he claim is not capable of being supported by the evidence presented . . .
    *Claim 6: Cope with stresses and strains of modern living – [t]he associated study would not justify or back up the claim made of this product.
    *Claim 7: Combat physical and mental tiredness and nervous tension – [t]he claim . . . in its entirety cannot be backed up [by] the studies submitted in support of this claim.

    In paragraph 30 of the Final Appeal Committee ruling (23 May 2013) quoted above, it is stated: “Of course, if the claims are not substantiated, they will not pass muster under clause 4.1 of section II of the Code. The protection for false claims thus lies in clause 4.1, and as stated above, that is a question that does not arise here.”

    Also, subsequently, important regulations to the Medicines Act (R870 of 15 November, 2013) and the Foodstuffs Act (R429 of 29 May 2014)have been published which begin to make these issues clearer.

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