Solal’s Melatonin Slow Release

, , ,

Posted 13 September 2012

Does Solal’s Melatonin Slow release, Herbal Sleep and Magnesium Glycinate work?

A consumer did not think so – laying a complaint with the Advertising Standards Authority arguing that the claims for these products are exaggerated or unproven.

Melatonin Slow Release / K Charlston / 17971
Ruling of the : ASA Directorate
In the matter between:
Mr Kevin Charleston Complainant(s)/Appellant(s)
Solal Technologies (Pty) Ltd Respondent

12 Sep 2012

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6241

Mr Charleston lodged a consumer complaint against a Solal print advertisement promoting its “… three natural products [that] help treat some of the underlying causes of insomnia …”

The three products are promoted as follows:

“Herbal SleepTM – to help you fall asleep Contains a combination of natural sedating herbal extracts like valerian, corydalis and passionflower, to gently induce sleep …”

“Melatonin Slow Release – to keep you sleeping all night Melatonin is produced by the body to maintain sleep throughout the night. Melatonin levels decline throughout adulthood. Unlike standard quick release melatonin tablets, a slow release mechanism is useful to help prevent waking a few hours after falling asleep. SOLAL is the only brand of slow release melatonin in South Africa …”

“Magnesium Glycinate – for optimal EEG sleep brain waves Magnesium promotes healthy brain waves during sleep. The glycinate form of magnesium is important because it is better absorbed than other forms and is only available from SOLAL Technologies …”

In addition to this, the words “REDUCED SEX DRIVE”, “HEART ATTACKS”, “DEPRESSION” and “STROKES” appear at the top as part of the image, and the copy states, inter alia, that “… lack of sleep can also cause heart attacks, strokes, memory problems and depression”.

COMPLAINT
In essence the complainant submitted the implication that the combination of these three products is effective in treating insomnia has no scientific basis and requires substantiation.

In addition, the complainant argued that the references to insomnia, heart attacks and reduced sex drive are in contravention of Appendix F of the Code.

Insofar as the claims made for the different components / products, he argued that the available evidence relating to melatonin suggests that it may possible aid in shortening the time it takes to fall asleep, but there is nothing to show that it has any effect on sleep efficiency, or the percentage of time spent sleeping at night.

Insofar as Magnesium Glycinate is concerned, the claim that it ensures “optimal EEG Sleep brain waves” is patently untrue as there is no such thing as an “optimal EEG Sleep brain wave” and there is no such thing as a “healthy brain wave”.

While the complainant noted that there is, in fact, another company that also claims to sell slow release melatonin (contradicting the advertiser’s claim that it sells the only such product in South Africa, he explained that “I don’t particularly care about this claim – but it points to the level of research and absence of truth in the rest of the advert”. Given this, the Directorate did not consider this aspect of the complaint as relevant.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the Code were taken into account:

Section II, Clause 4.1 – Substantiation (with reference being made to Clause 4.25 of Section I – Scientific substantiation)

Appendix F – References to diseases

RESPONSE
Fluxman’s attorneys, acting on behalf of the respondent, argued that the complaint is malicious, vexatious, invalid, and constitutes an abuse of the ASA process.

It submitted certain documents in support of the efficacy claims made, and argued why Appendix F is not valid or constitutional. Insofar as the substantiation is concerned, it relied on an opinion from Professor Sarel F Malan,and Dr Neil D Burman.

ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.

Status of the complainant

The respondent has, on numerous occasions, argued that the complainant is vexatious and is complaining in bad faith, constituting an abuse of ASA procedures and processes.

This issue was dealt with extensively in Solal Stress Damage Control / K Charleston / 19746 (22 March 2012), in which the Directorate rejected this argument. The new accusations put forward have not changed the Directorate’s view in this regard. It is also noted that the respondent has not appealed the Directorate’s ruling in the Stress Damage Control matter, and as such this decisions still stands.

Accordingly, the Directorate still at present regards the complaint as a consumer complaint as defined in the Code.

Appendix F

While the contents of and applicability of Appendix F have generated much debate and resulted in, inter alia, rulings on the issue from the Directorate as well as the Advertising Standards Committee and the Final Appeal Committee, this issue has since become moot, as this appendix was effectively deleted from the Code (refer Nycomed-Dona / K Charleston / 20066 (16 August 2012) for a brief explanation.

Accordingly, the concerns raised in relation to the alleged contravention of Appendix F cannot be considered at this time.

Substantiation
Effectively, the complainant raised three points of concern:

The respondent has no proof that its combination of products (i.e. the three products promoted in the advertisement) are effective in treating insomnia;

There is nothing to show that melatonin has any beneficial effect on the percentage of time actually spent sleeping;

The claim that Magnesium Glycinate allows for optimal EEG sleep brain waves is false, as there is no such thing as an “optimal” EEG sleep brain wave or even a “healthy” brain wave.

The evidence relied on by the respondent is in the form of verification from Professor Malan and Dr Burman. It should be noted that the respondent initially submitted all its supporting documentation insisting that it be treated as confidential in terms of Clause 5 of Section I. When the Directorate advised that it would not regard this information as confidential as it was available publicly, it withdrew these submissions, effectively leaving the Directorate with only the two opinions referred to above.

This is problematic in the sense that the Directorate is not able to consider the evidence relied on to satisfy itself that the conclusions reached by the experts are echoed in the evidence (see the ruling of the Advertising Industry Tribunal (the AIT) in Lifebuoy / Dettol / 14813 (27 August 2011) for more detailed explanation).

Effectively, the respondent is now expecting the Directorate to simply believe the say-so of the experts relied on without being able to satisfy itself to the soundness of these opinions. This is not adequate, and the Directorate cannot accept this.

By virtue of this, it is not necessary at this point in time to determine whether or not Dr Burman and/or Prof Malan meet the criteria of independent and credible experts in the field to which the claims relate.

For the above reasons, the following claims are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code:

“… three natural products [that] help treat some of the underlying causes of insomnia …”

“Melatonin Slow Release – to keep you sleeping all night Melatonin is produced by the body to maintain sleep throughout the night … a slow release mechanism is useful to help prevent waking a few hours after falling asleep”

“Magnesium Glycinate – for optimal EEG sleep brain waves Magnesium promotes healthy brain waves during sleep …”

The respondent is therefore instructed to remove these claims with immediate effect within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and not use them again in future unless new substantiation has been submitted, evaluated, and a new Directorate ruling issued.

The complaint is partially upheld.

, , ,

17 Responses to Solal’s Melatonin Slow Release

  1. Angela 6 October, 2012 at 6:57 pm #

    I am sorry you guys are doing this. I am occasionally insomniac and get enormous relief from taking 1 Solal melatonin cap and magnesium before sleep time, and it works every time.
    I suppose you would rather people supported big pharma and took schedule 6 narcotics, but this worked for me.

  2. Kevin Charleston 7 October, 2012 at 11:36 am #

    Angela, I’m happy that you feel that taking Melatonin works for you. Unfortunately there is no evidence that it works better than a sugar pill (Placebo) for anyone else. Your anecdote is not evidence in support of any generalised statement about the product.

    You’re supposition is wrong. I don’t want or expect anyone to support ‘big pharma’. I expect all pharmaceutical and health ‘supplement’ companies to make accurate and truthful statements about their products. Unfortunately Solal, like many other ‘neutraceutical’ companies, fail to do so.

    • Susan 11 July, 2014 at 9:38 am #

      Kevin, thank you for taking the time to lay this complaint with the ASA. Consumers are easily duped with slick, albeit false,advertising. It’s great to see someone taking a stand and forcing Solal to be accountable to the consumer. Well done!

  3. Dusty 1 July, 2013 at 12:19 pm #

    I am usuing Melatonin and have never slept this well before for the correct amount of time I need to sleep, I wake up refreshed and feel I am ready for a full days work, just skipping the tablet for one night has made me realise how they work

  4. Wynand Kuypers 7 August, 2013 at 11:49 pm #

    I will confess that I was a regular user of this non-adictive over the counter Solal melatonin pills for insomnia for more than 3 years.Its sedative action, allowed me to fall asleep in a very short time.Side-effects from these product on me was mild, for instance more than normal dreams, and occasionally shorter periods of sleep, but always refreshed when awakening.I don’t think that claims of detoxification on the label of the product can be proved, but the mode of action on sleeping patterns was proved in me.I only think that Solal shouldt make their products available in smaller quantities.

  5. Eugene Naude 25 August, 2014 at 8:42 pm #

    Solal melatonin did work why is there always some “complainant” always trying to spoil a good product, maybe you have other issues to be sorted out.

    • Harris 25 August, 2014 at 9:12 pm #

      @Eugene
      How do you know whether it worked for everyone and not only just for you? Was it a real effect or a placebo effect? If it works for only 5% of people, should it claim to work for the majority of people?

  6. Julie 1 September, 2014 at 9:13 am #

    I have also been using the Solal Slow Realease Melatonine for many years. I only take half a tablet and also found that I sleep better. I have told many people about it and their feedback is the same.
    I have now found out that it has been taken off the market, is this true? I did manage to get the last bottle from our pharmacist but only with a prescription from our doctor.

  7. Sue 3 January, 2015 at 5:01 pm #

    I have used melatonin on ad hoc occasions particularly when I am having high stress periods at work. It has helped fantastically, without the groggy morning after effect which I had got when a friend gave me a prescription sleeping tablet.
    I was told by my health shop the other day that this has now been made schedule 5, so can only be obtained with a prescription – which is a real pain as I don’t have medical aid….
    This confused me as I thought it was natural and not addictive – so why then the rescheduling???

  8. Jenny Kidson 23 January, 2015 at 11:38 am #

    I would like to find out how I can get Solal Melatonin. Can I get it on a script. Please help. Thanks Jenny

  9. Jan 1 February, 2016 at 9:09 am #

    I do not know who Kevin is but he has managed to have a good product banned. Whether it is placebo effect or not does not matter. It works for everyone I have asked about it.

    I would like to find out how I can get Solal Melatonin. Can I get it on a script. Please help.

    • Harris 1 February, 2016 at 9:24 am #

      @Jan
      Kevin was not responsible for having melatonin “banned”. It is not banned but now scheduled, i.e., regulated by the Medicines Control Council. Kevin pointed out to the ASA that Solal was making claims for this product that was supported by evidence, i.e. some claims made fro melatonin are true, but marketers often make a great deal of additional claims that are false. Read the commentary at the end of this post

  10. Christine 12 September, 2016 at 4:32 pm #

    I find it interesting that the MCC has approved a schedule 4 version of slow release Melatonin (2 mg) marketed under the brand name Circadin at roughly 4 times the original Solal price for less than half the dosage and quantity.

    It’s not surprising health care is more & more expensive when the MCC colludes with pharmaceutical companies to rip off the consumer.

    If it’s not effective, why approve its use?

  11. Samantha 1 February, 2017 at 8:30 am #

    I wonder what am I now supposed to give my 11 year old child to sleep? She is on 1000mg Keppra twice a day for epilepsy – side effect is insomnia, among others, but she battles to sleep. Pharmacist says give her one Allergex – guess what? Epilepsy is a contra-indication with Allergex!And no doctor wants to give her anything prescribed medication because she is to young. Then the teachers at the schools have issues because the kids are tired. I am sure my daughter is not the only one in South Africa battling this. Lekker, neh….

    • Harris 1 February, 2017 at 8:46 am #

      @Samantha
      Because she is on Keppra, it is important to discuss the side effects and what else you can use with the health professional who prescribed this medication, for he/she will know your child’s condition better than any other.

  12. Andrew g 26 August, 2017 at 8:59 am #

    You need a script to get melatonin. It was always a schedule 4. Just that some bottles were incorrectly marketed as schedule 2. The authorities only realized in 2014 that it was a schedule 4 hence the removal from the shelves. This happened just after there was an application for circadin to be licensed. Then in about 2016 circadin was approved. Both circadin and melatonin are available with script. They only work where you hav a certain type of sleep disorder that places your mind in a type of jet lag state.

  13. Albertus Van Schalkwyk 27 November, 2019 at 2:25 am #

    Works wonders for Non-24-Hour Sleep-Wake Disorder. I’d, however, rather have it as a regulated medicine, because I don’t see if it is sold as a supplement, how you can be sure of the purity and dose from batch to batch. Having to pay twice the amount of money for it is not nice, and my medical aid does not want to pay for it as chronic, but it is a step in the right direction.Also a bunch of idiots started using it recreationally to “come down” from stimulants, and some children went into comas from consuming their parents’ stash of it. So Schedule 4 is the right classification for it.

Leave a Reply

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