Update 15 May 2012: I have been sent evidence that “horse chestnut” (listed as “esculin”) was scheduled as S3 in December 1979.
Posted 12 May 2012
Health Intelligence magazine states on its front cover as a byline: “The Science of Health.” In its advertising blurb on its associated company Solal Technologies’ website, it is stated to be “Sophisticated. Cutting edge. Credible.” The editorials in Edition 15 (May 2012) are however misleading, and disturbingly so.
The first [text] editorial by Colin Levin bemoans the new food labelling regulations from the Department of Health as having gone too far “[i]n their noble intention to prevent (sic) consumers from misleading claims.” He even quotes the Health Products Association of South Africa (HPA) which is “disappointed” that the regulations don’t address the relationship between certain food (sic) and various diseases.
So what’s the problem?
If Mr Levin and/or his editorial team (and the HPA) had perhaps done their homework and checked their facts, they would have been informed that the food labelling regulations they’re concerned about are just “phase 1” – and that “phase 2” which will specify which scientifically established health claims for foods can be made, will come into effect later in 2012 or in 2013. It must be acknowledged however that Mr Levin is not a health professional. The second, perhaps more concerning editorial is by pharmacist Brent Murphy – who should know better. He states that because certain substances contained in natural and complementary medicines and herbal extracts have “now” been scheduled (in March 2012) there is an “unfair attack on the South African complementary and natural medicines industry”. The heading states: “SA Government blocks access to natural medicines.”
He “proves” his point by listing 19 substances which were supposedly scheduled or rescheduled in March. Had Mr Murphy done his homework however, he would have discovered that six of the 19 substances in fact appeared in the schedules as long ago as the mid-1980s; that seven of the substances appear in the 2003 schedules; and only six substances (less than a third of his list) have in fact been “newly scheduled”. This can hardly be considered “blocking access to natural medicines”!
I have written a letter to the editors of Health Intelligence which I’ve requested be published in Edition 16 (July/August 2012) of Health Intelligence. However that is a long time to wait, and it may not even be published, so I have reproduced the letter below:
Too soon and too late!
Your editorials on pages 1 and 3 respectively of Health Intelligence Edition 15 are full of errors! On page 1 you wrongly imply that the food labelling requirements, which came into force on 1 March 2012, prohibit important health benefit claims. In fact, the new Food Labelling Regulations that came into effect on 1 March 2012 are only phase 1 of the regulations. Phase 2 which will contain among other, permissable science-based health claims, will only come into effect later in 2012 or early in 2013. You have not checked your facts and your comments have come “too soon”. You yourself seem to have confused the baby and the bathwater. The lawmakers have not in fact “banned” any truthful statements!
On page 3 under a misleading headline, you ostensibly quote Dr Benjamin Rush. The esteemed Professor Szasz calls this quote a “bogus statement” because: “Rush never said any such thing and . . . the quotation is an obvious fabrication.” You then state that there were numerous changes to the Schedules in March 2012, and provide a list of 19 of these changes. However six of those substances have been scheduled since the early-1980s! Seven appear in the 2003 Schedules (when the schedules were changed in the Medicines Act) – including sylimarin – the chemical in milk thistle you refer to. Only six substances (less than a third of your list!) are “newly” scheduled. You have not checked your facts, your list is highly misleading and your comments come “too late”.
Your pronouncement of a so-called “attack” on the SA complementary and natural medicines industry as reflected in your “list”, seems to be rather over-exaggerated. Many of the players in the complementary and natural medicines industry (including the Health Products Association) have anyway simply ignored these schedules for many many years.
Perhaps the real issue is that five of the six newly scheduled substances which now require a prescription are sold by SOLAL Technologies (Pty) Ltd. Three substances which should be sold only on prescription but clearly have not been, are also SOLAL products. Twelve of the nineteen scheduled substances as listed are sold in SOLAL products without their scheduling status being stated on the website, and for a thirteenth product – the incorrect scheduling status has been given!
SOLAL claims their products are “Prescribed by Doctors”. A recent ASA ruling, based on a confidential survey, has accepted this claim as substantiated (truthful), so there should be no problem with consumers obtaining prescriptions for these SOLAL products. Hopefully the people wanting scheduled SOLAL products which require a prescription, will have been properly assessed and diagnosed by their doctors. Presumably only those doctors who prescribe SOLAL products.
Prof Roy Jobson, Rhodes University, Grahamstown
I have tabulated below the various substances/products listed by Mr Murphy and the years for which I have evidence of publication of their scheduled status. The 1979 reference comes from an “MCC circular”. The 1985 reference comes from a publication known as the “blue book” used by previous Registrars of Medicines, including the present Director-General of Health. The 2003 and 2012 references come from Government Gazettes and the Department of Health.
|Schedule||Name||Year published in Schedules||SOLAL?|
|S1||Probiotics (lactobacillus acidophilus and bifidus)||2003 (or earlier)||Sells, scheduling not stated|
|S1||Enzymes (specifically protein digestive enzymes)||2003 (or earlier)||Not listed on website|
|S1||Phosphatidylcholine and phosphatidylserine||2003 (or earlier)||Sells both, scheduling not stated|
|S1||Tryptophan (new in 2012 – dose <5 mg / kg / day)||1985 (or earlier)||Sells, scheduling not stated|
|S2||N-acetyl-cysteine (listed as acetylcysteine)||1985 (or earlier)||Sells, scheduling not stated*|
|S2||Progesterone cream vaginal use (listed under “Hormones”)||2003 (or earlier)||Vaginal cream not listed on website|
|S2||Melatonin for jet lag (dose not > 6 mg / day) NEW||2012||Sells for insomnia (see below)|
|S3||Horse chestnut (listed as “esculin”)||1979||Not listed on website|
|S3||Pygeum africanum||1985 (or earlier)||Not listed on website|
|S3||Milk thistle extract – sylimarin||2003 (or earlier)||Sells, scheduling not stated|
|S3||Vitamin D3 > 500 IU per day||1985 (or earlier)||Sells, 500 IU per day dosage|
|S4||Fish oils (listed as DHA and EPA) NEW||2012||Sells, scheduling not stated|
|S4||Melatonin when not used for jet lag NEW||2012||Sells, scheduling not stated|
|S4||Niacin NEW||2012||Sells, scheduling not stated|
|S4||Progesterone cream for HRT (listed under “Hormones”)||2003 (or earlier)||Sells, incorrect schedule given as S2|
|S5||7-keto DHEA NEW||2012||Sells, scheduling not stated|
|S5||Lithium orotate||2003 (or earlier)||Not listed on website|
|S5||Tryptophan (listed as L-tryptophan for medicinal use)||1985 (or earlier)||Sells, scheduling not stated|
|S5||5 Hydroxy Tryptophan (5 HTP) NEW||2012||Sells, scheduling not stated|
*Because of its S2 scheduling status, comments about this substance were included in the important High Court judgment against Dr Matthias Rath, 13 June 2008. It is hard to believe that Mr Murphy could have missed it.
This analysis was prepared by Professor Roy Jobson. Professor Jobson is a medical doctor and Associate Professor of Pharmacology in the Faculty of Pharmacy at Rhodes University. He has previously served as a Council member of the Medicines Control Council (MCC), was the inaugural Chairperson of the MCC’s Pharmacovigilance Committee, and a member of its Clinical Trials and Complementary Medicines Committees. He is an Associate of the College of Clinical Pharmacologists of the Colleges of Medicine of South Africa. He is a Council member of the Allied Health Professions Council of South Africa as a community representative. His analysis of these editorials does not reflect an official viewpoint of any of these institutions.
Text of Colin Levin’s editorial:
|New food labelling regulations: throwing the baby out with the bath water?|
A nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people. – John F KennedyThe 1st of March saw the arrival of new regulations governing what can and can’t be said in food advertising and on food labels-These regulations are mostly good. For example, they prevent a food making a nutrition claim if such a claim applies to all foods in that class anyway. For example, a claim that brand-xyz of olive oil is cholesterol-free is not allowed because all olive oil [and all plant oils, in fad] never contain cholesterol (cholesterol is only found in animal fats). Other amendments include new stricter definitions of low fat, fat-free, sugar-free etc. They also make it compulsory to list allergens such as soya, dairy, eggs, nuts and shellfish, amongst others.But the regulations have gone too far. In their noble intention to prevent consumers from misleading claims, they have effectively banned truthful claims, too. This means that consumers can no longer be informed about the health value of beneficial ingredients. Indeed even the words “healthy’ and ”nutritious” aren’t permitted as a description of healthy or nutritious ingredients. For example, no longer is a manufacturer who fortifies their product with omega-3 fat allowed to say that omega-3 fats are good for the heart; nor are words like “contains heart-healthy omega-3’s” allowed. Antioxidant claims are also banned. So the truthful claim that a food is fortified with lycopene or vitamin C contains antioxidants is also not allowed. Basically, there’s a total blanket ban on truthful descriptions of any benefits of any ingredients added to make a food healthy or healthierThe result is that consumers are denied the opportunity to make fully-informed decisions about which food to choose based on their health benefits. The Health Products Association of South Africa is also concerned. In a recent press statement they said: ‘The HPA is disappointed that helpful information with regard to the relationship between certain food and various diseases such as osteoporosis, cardiovascular conditions and even cancer have not been addressed in the regulations. Increasingly, consumers are looking for information on functional foods that may reduce the risk of disease or promote optimal health. The absence of this component in the new laws deprives the consumer of valuable health enhancing information.”Surely it could never have been the intention of law-makers to ban truthful statements? But that has been the effect.Yours in good health.Colin Levin- Publishing Editor