Sédatif PC – does it work?

,

Posted 10 December 2020

A complaint was laid with the ARB (Advertising Regulatory Board) objecting to the claims that this product is effective for stress, anxiety and minor sleep disorders. The complainant noted that stress and insomnia are disabling conditions, which means consumers would expect a product making these types of claims to be supported by objective evidence.

Furthermore, the principle of homeopathic medicine manufacture, is to dilute the primary ingredient (which in itself has no evidence of treating these conditions), to a point where the product contains no residual molecules of its original respective ingredients. Imagine diluting panado to a point where there is not a single molecule of panado left in the tablet, and then claiming it will alleviate your headache.

In other words, according to my argument, this product is no better than simply drinking a teaspoon of tap water. If you have stress, anxiety and minor sleep disorders, find something that really works. Using this product will not help you, and you may not realise that it is not helping you because you are unaware that it contains no active ingredient. Alternatively, if you are happy with a potential benefit from a placebo response, then use this product.

Below is the ruling of the ARB.

Decision of the ADVERTISING REGULATORY BOARD

Complainant : Dr Harris Steinman
Advertiser : Lebron (Pty) Ltd
Consumer/Competitor : Consumer
File reference : 1059 – Sédatif PC – Dr Harris Steinman
Outcome : Upheld
Date : 8 December 2020

The Directorate of the Advertising Regulatory Board has been called on to consider a consumer complaint against a television commercial for Sédatif PC seen on Mnet at 21:44 on 6 October 2020. The Complainant noted that the same commercial is also available on YouTube at https://www.youtube.com/watch?v=za7ulueoLD4.

Description of the Advertising

The animated commercial depicts an agitated lady sitting on a couch while the word “STRESS” appears in neon lighting on the wall behind her. As she glances at her phone, the word “SLEEPLESS” appears on its screen. During this, the voice-over states “Stress? Struggling to sleep? Have you considered the alternative?

At this point, the lady opens the lid of a box of Sédatif PC tablets, while the voice-over states “Sédatif PC supports calm during the day, and better sleep at night”. The lady is then shown at her office desk working with a smile on her face.

As she leaves the office, she grabs the box of Sédatif PC, and the voice-over states “Take Sédatif PC to help manage anxiety and minor sleep disorders. It’s not habit forming and does not cause day-time drowsiness. Maintain your balance with Sédatif PC. Your day and night homeopathic medicine”.

At the end, the product packaging is displayed on-screen, and the words “Stress, anxiety and sleeplessness” are visible on the top panel of the box. The words “DAY & NIGHT HOMEOPATHC MEDICINE” appear on the left-hand side of the screen, while “Not habit- forming” and “No drowsiness” appear on the right-hand side.

Complaint

The Complainant objected to the claims that this product is effective for stress, anxiety and minor sleep disorders. He noted that stress and insomnia are disabling conditions, which means consumers would expect a product making these types of claims to be supported by objective evidence.

However, the manufacturer acknowledges that the product contains no residual molecules of its respective ingredients, and specifically notes that it is diluted to a concentration of 10 -12. In other words, it is diluted to a point that none of the original ingredient molecules from which this product is derived are present in the actual product.

To support his complaint, the Complainant explained that he searched the Natural Medicines Comprehensive Database, one of the most comprehensive and reputable natural medicine databases available. This database contained no evidence to support the claims for the ingredients said to be present in this product.

Similarly, PubMed (which comprises more than 30 million citations for biomedical literature from MEDLINE, life science journals, and online books) contained no evidence of efficacy for this product or the relevant ingredients said to be contained in it. 

In addition, the Complainant claims to have searched other scientific journals (including homeopathic based journals) and found no evidence to support the Advertiser’s claims. 

In the few instances where homeopathic products were tested for efficacy against the management of insomnia and anxiety, these tests either do not stand up to conventional scientific scrutiny, drew inappropriate conclusions, or concluded that these products were no more effective than placebos. In certain instances, these studies were not conducted on humans, but on mice. 

The Complainant then referenced a directive from the American Federal Trade Commission (FTC), which compels manufacturers of homeopathic remedies to either stipulate that their claims do not carry scientific backing, or to clarify that claimed efficacy is based on homeopathic theories dating back to the 1700s, which are not accepted by most modern medical experts.

Because the average consumer lacks understanding of homeopathic principles, he / she is unaware that that the product bought contains no active compounds, and that it is not supported by any objective evidence. This is not made clear in the advertising, meaning that consumers are unable to make an informed decision.

Response

In its initial replies directed to the ARB, the Advertiser indicated that it would challenge the Complainant’s arguments after consulting its principals and lawyers. It requested an extension.

Once the Directorate outlined the provisions for granting an extension (as outlined in Clause 8.2.3 of the Procedural Guide), the Advertiser submitted that it would approach the court should the ARB rule against its advertising, as the ARB is not the regulator of homeopathic products.

It submitted that its products were appropriately labelled in accordance with the relevant legislation, and that it was entitled to market its products with packaging bearing the claims “homeopathic”, “complementary” and a disclaimer. The complaint is misplaced and should be brought before the South African Health Products Regulatory Authority (“SAHPRA”). 

In addition, it provided a document expanding on this argument and noting again that it was not a member of the ARB, and was not obliged to furnish a defence. It acknowledged, however, that the ARB would still make a ruling which was binding on its members.

This document argues why the Complainant’s viewpoint and submissions are misplaced, and amount to an incorrect interpretation of the relevant studies. 

The document further makes the point that SAHPRA Guidelines for Discipline-Specific Safety and Efficacy acknowledges that complementary medicines (including homeopathic preparations) have their own innate systems for assuring quality, safety and efficacy. It would be inappropriate and unlawful for the ABR to impose its rules (as contained in Clause 4.1 of Section II of the Code) on this product, which follows an entirely different paradigm and set of rules as acknowledged by the SAHPRA. Any attempt to do so by the ARB would be “strongly opposed”.

Application of the Code of Advertising Practice

The Complainant identified Clause 4.1 of Section II (Substantiation) as relevant to this dispute.

Decision

Having considered all the material before it, the Directorate of the ARB issues the following finding.

Jurisdiction

The Advertiser submitted that it was not an ARB member, and that it was under no obligation to submit a response to this complaint.

It added that it would strongly oppose any attempt by the ARB to rule on this issue, as the matter should be placed before the appropriate regulator, namely the South African Health Products Regulatory Authority (“SAHPRA”).

The ARB’s Memorandum of Incorporation of the ARB states:

“3.3 The Company has no jurisdiction over any person or entity who is not a member and may not, in the absence of a submission to its jurisdiction, require non-members to participate in its processes, issue any instruction, order or ruling against the non-member or sanction it. However, the Company may consider and issue a ruling to its members (which is not binding on non-members) regarding any advertisement regardless of by whom it is published to determine, on behalf of its members, whether its members should accept any advertisement before it is published or should withdraw any advertisement if it has been published.

In other words, if you are not a member and do not submit to the jurisdiction of the ARB, the ARB will consider and rule on your advertising for the guidance of its members.

The ARB will rule on whatever is before it when making a decision for the guidance of its members. This ruling will be binding only on ARB members and on broadcasters in terms of the Electronic Communications Act. In addition, this ruling can only determine whether an advertisement complies with the Code of Advertising Practice.

The ARB will therefore proceed to consider this matter for the guidance of its members.

Scope of the ARB’s decision

Rulings by the ARB do not purport to, and should not be interpreted to be, a decision on any legislation or regulatory requirement. As a self-regulatory authority, the ARB administers the Code of Advertising Practice on behalf of its members. At the time of finalising this decision, the ARB’s members included the National Association of Broadcasters who, in turn, has delegated the responsibility for ensuring that all advertising broadcast to consumers on television and radio complies with the industry-accepted Code of Advertising Practice to the ARB. This commercial was broadcast on a local television station, and as such, the ARB is obligated to determine, for the benefit of its members, whether this commercial complies with the relevant portion of the ARB Code.

The Allegation before the Directorate does not suggest that the Advertiser is in breach of the relevant laws, and does not appear to comment on the acceptability of homeopathy as a practice. It merely alleges that the Complainant was unable to find evidence in accordance with Clause 4.1 of Section II of the Code that support the advertiser’s claims.

The Advertiser’s arguments that an adverse decision in terms of Clause 4.1 would effectively create a set of rules that are contrary to those imposed by the SAHPRA are noted. However, the Directorate does not believe that this is the case.

The Directorate specifically notes that it:

  • Is not making a finding as to the safety of the product;
  • Is restricted to a finding on the claims raised in the complaint, based on the Clause 4.1 of Section II expressly notes that “Documentary evidence, other than survey data, must emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the field to which the claims relate and be acceptable to the ARB” (emphasis added).

This appears to align with the SAHPRA approach to which the Advertiser refers. In principle, an entity making efficacy claims relating to a homeopathic product is free to provide verification from any expert in the subject matter. The Code does not dictate the medical paradigm from which such an expert should emanate, and does not prescribe the type of evidence that is needed. It simply requires advertisers to provide appropriate evidence that their product has been tested or reviewed, and that the product, when used at the recommended dose, would deliver on any claimed efficacy. This is particularly true as the advertising in question clearly spells out that it is a homeopathic product. Consumers are therefore already alerted that this product falls under a particular paradigm.

Advertisers are, therefore, still at liberty to submit any evidence they believe to be appropriate to an independent expert in the field to which the advertised claims relate. The chosen expert, in turn, is at liberty to consider the evidence and provide an unequivocal statement that such evidence (irrespective of its nature or origins) is sufficient to conclude that the product in question will deliver the claimed efficacy when used as directed.

Merits

Clause 4.1 of Section II requires advertisers to hold evidence that supports any advertising claims that are capable of objective verification. It further stipulates that such evidence should emanate from, or be evaluated by an independent and credible expert in the field to which the claims relate.

There can be no dispute that claims to alleviate “stress”, to “… supports calm during the day, and better sleep at night” as well as “… help manage anxiety and minor sleep disorders” are capable of objective verification.

The Complainant listed several references, and elaborated on why these do not, in his opinion, support the relevant claims. The Advertiser, on the other hand, submitted arguments as to why the Complainant’s allopathic paradigm is flawed and why his conclusions are incorrect. 

The Directorate notes that, while it is for the Advertiser to prove the claim that they have chosen to make in advertising, and not for the Complainant to disprove it, the Complainant has nonetheless had regard to natural product and homeopathic sources in formulating his complaint. It would therefore appear, ex facie, that the Complainant accepts that this product is situated within a particular paradigm, and alleges that there is no support for the product even within that paradigm.

This presents the Directorate with two opposing views, each motivated by the respective

parties’ own arguments and evidence.

It is for this reason that the Code requires independent verification from an appropriate expert. The ARB does not possess the relevant skills and knowledge to determine which medical argument is correct, and which research findings should be interpreted in which manner. Clause 4.1 of Section II permits the ARB to rely on the informed opinion of an expert in the field, and base its decision to accept (or reject) the claims on this opinion.

The Advertiser opted not to submit an independent opinion or review of its supporting material to an expert in the relevant field, which means that the ARB has nothing to show that these claims are true and supported by appropriate evidence.

By virtue of this, the Directorate has no choice but to find that the Advertiser’s claims to alleviate “stress”, to “… supports calm during the day, and better sleep at night” and to “… help manage anxiety and minor sleep disorders” are currently not substantiated within the meaning of Clause 4.1 of Section II of the Code.

Sanction

Members of the ARB and broadcasters are advised not to accept advertising from the Advertiser for its “Sédatif PC” product claiming to alleviate stress, or manage anxiety and sleeping disorders.

 

,

No comments yet.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.